niacinamide has been researched along with Metastase in 250 studies
nicotinamide : A pyridinecarboxamide that is pyridine in which the hydrogen at position 3 is replaced by a carboxamide group.
| Excerpt | Relevance | Reference |
|---|---|---|
| "We conducted an open-label, randomized, two-arm multi-center study to assess the efficacy and safety of paclitaxel versus paclitaxel + sorafenib in patients with locally advanced or metastatic HER2-negative breast cancer." | 9.24 | A randomized phase II study of paclitaxel alone versus paclitaxel plus sorafenib in second- and third-line treatment of patients with HER2-negative metastatic breast cancer (PASO). ( Decker, T; Göhler, T; Indorf, M; Nusch, A; Overkamp, F; Rösel, S; Sahlmann, J; Trarbach, T, 2017) |
| "We investigated the efficacy and toxicity of sorafenib, a multikinase inhibitor of vascular endothelial growth factor receptor tyrosine kinase, in combination with vinorelbine therapy in a phase I/II trial in patients with metastatic breast cancer." | 9.19 | Phase I/II trial of vinorelbine and sorafenib in metastatic breast cancer. ( Chow, W; Chung, C; Frankel, P; Hurria, A; Luu, T; Mortimer, J; Somlo, G, 2014) |
| "Sorafenib is the standard treatment of patients with advanced hepatocellular carcinoma (HCC), with demonstrated outcome benefits in randomized clinical trials." | 9.19 | Safety and efficacy of sorafenib in the treatment of advanced hepatocellular carcinoma: a single center experience. ( Beveridge, RD; Campos, GB; Daroqui, JC; Esparcia, MF; Estellés, DL; Huerta, ÁS; Imedio, ER; Ortiz, AG; Salcedo, JM; Urtasun, JA, 2014) |
| " We evaluated the efficacy and safety of dual angiogenesis blockade with bevacizumab and sorafenib in patients with metastatic breast cancer." | 9.17 | A phase II study of combined VEGF inhibitor (bevacizumab+sorafenib) in patients with metastatic breast cancer: Hoosier Oncology Group Study BRE06-109. ( Burkhardt, C; Johnson, C; Miller, KD; Mina, LA; Yu, M; Zon, R, 2013) |
| "We conducted a phase 2b, randomised, double-blind, placebo-controlled screening trial to evaluate the addition of the multikinase inhibitor sorafenib (antiproliferative/antiangiogenic) to first-line paclitaxel for human epidermal growth factor receptor 2 (HER2)-negative locally recurrent/metastatic breast cancer." | 9.17 | A double-blind, randomised, placebo-controlled, phase 2b study evaluating sorafenib in combination with paclitaxel as a first-line therapy in patients with HER2-negative advanced breast cancer. ( Bondarde, S; Gradishar, WJ; Jain, M; Kaklamani, V; Lokanatha, D; Lokker, NA; Raina, V; Ro, SK; Sahoo, TP; Schwartzberg, L, 2013) |
| "We aimed to investigate the efficacy and tolerability of sorafenib combined with cisplatin and 5-fluorouracil (5-FU) in patients with recurrent or metastatic nasopharyngeal carcinoma (NPC)." | 9.17 | Phase II study of sorafenib in combination with cisplatin and 5-fluorouracil to treat recurrent or metastatic nasopharyngeal carcinoma. ( Hu, ZH; Huang, PY; Huang, Y; Lin, SJ; Liu, JL; Liu, LZ; Ma, YX; Pan, JJ; Song, XQ; Wu, JX; Wu, X; Xu, F; Xue, C; Yu, QT; Zhang, J; Zhang, JW; Zhang, L; Zhao, HY; Zhao, LP; Zhao, YY, 2013) |
| "This phase I clinical trial was conducted to determine the safety, efficacy, and molecular effects of sorafenib with temsirolimus in patients with advanced melanoma." | 9.16 | Phase I study of the combination of sorafenib and temsirolimus in patients with metastatic melanoma. ( Bassett, RL; Bedikian, AY; Culotta, KS; Dancey, JE; Davies, MA; Deng, W; Fox, PS; Gupta, S; Huang, S; Hwu, P; Hwu, WJ; Kim, KB; Lazar, AJ; Liu, W; Madden, TL; Ng, CS; Papadopoulos, NE; Prieto, VG; Wright, JJ; Xu, Q, 2012) |
| "The phase III Sorafenib Asia-Pacific (AP) trial-conducted in China, Taiwan and South Korea - confirmed that sorafenib improves overall survival (OS) and is safe for patients with advanced hepatocellular carcinoma (HCC)." | 9.16 | Efficacy and safety of sorafenib in patients with advanced hepatocellular carcinoma according to baseline status: subset analyses of the phase III Sorafenib Asia-Pacific trial. ( Chen, Z; Cheng, AL; Fang, F; Guan, Z; Kang, YK; Kim, JS; Lentini, G; Pan, H; Qin, S; Tak, WY; Tsao, CJ; Voliotis, D; Xu, J; Yang, TS; Yu, S; Zou, J, 2012) |
| "Sorafenib, a multikinase inhibitor of cell proliferation and angiogenesis, inhibits the mitogen-activated protein kinase pathway that is activated in most uveal melanoma tumors." | 9.16 | Phase II trial of sorafenib in combination with carboplatin and paclitaxel in patients with metastatic uveal melanoma: SWOG S0512. ( Aparicio, AM; Bhatia, S; Lao, CD; Margolin, KA; Moon, J; Othus, M; Ribas, A; Sondak, VK; Weber, JS, 2012) |
| "Between Dec 1, 2006, and July 4, 2008, patients with untreated HER2-negative metastatic breast cancer were randomly assigned (using a randomisation list created by personnel not associated with the study) in a 1:1:1 ratio to paclitaxel (90 mg/m(2) on days 1, 8, and 15 every 3 weeks) plus either masked motesanib 125 mg orally once per day (n=91), masked placebo orally once per day (n=94), or open-label bevacizumab 10 mg/kg intravenously on days 1 and 15 of each 28-day cycle (n=97), after stratification according to adjuvant or neoadjuvant chemotherapy (taxane-containing regimens vs other regimens vs none), number of metastatic sites (<3 vs ≥3), and hormone receptor status (positive vs negative)." | 9.15 | Motesanib, or open-label bevacizumab, in combination with paclitaxel, as first-line treatment for HER2-negative locally recurrent or metastatic breast cancer: a phase 2, randomised, double-blind, placebo-controlled study. ( Adewoye, H; Adrover, E; Alba, E; Almel, S; Baños, A; Cabaribere, D; Crown, J; Eiermann, W; Hei, YJ; Hurvitz, S; Jagiełło-Gruszfeld, A; Kennedy, MJ; Lang, I; Latreille, J; Lemmerick, Y; Lindsay, MA; Mackey, JR; Martin, M; Moroose, R; Munoz, M; Pienkowski, T; Pinter, T; Priou, F; Provencher, L; Ramos, M; Roche, H; Rolski, J; Rupin, M; Snyder, R, 2011) |
| "The safety of oral sorafenib up to a maximum protocol-specified dose combined with dacarbazine in patients with metastatic, histologically confirmed melanoma was investigated in a phase I dose-escalation study and the activity of the combination was explored in an open-label phase II study." | 9.15 | Sorafenib and dacarbazine as first-line therapy for advanced melanoma: phase I and open-label phase II studies. ( Affolter, A; Ahmad, T; Chao, D; Chevreau, C; Corrie, P; Eisen, T; Gibbens, I; Gore, ME; Harries, M; James, MG; Jouary, T; Lorigan, P; Marais, R; Montegriffo, E; Nathan, PD; Negrier, S; Ottensmeier, C; Prendergast, S; Robert, C; Strauss, UP, 2011) |
| "This trial was conducted to assess the efficacy and safety of sorafenib in patients with metastatic breast cancer." | 9.14 | Phase II multicenter, uncontrolled trial of sorafenib in patients with metastatic breast cancer. ( Bergamini, L; Bianchi, G; Gianni, L; Laferriere, N; Lathia, C; Loibl, S; Peña, C; Raab, G; Salvagni, S; Siena, S; Zamagni, C, 2009) |
| "Sorafenib monotherapy in patients with metastatic melanoma was explored in this multi-institutional phase II study." | 9.14 | A phase II trial of sorafenib in metastatic melanoma with tissue correlates. ( Buckley, M; Christos, PJ; Goldberg, L; Hamilton, A; Liebes, L; Min, C; Osman, I; Ott, PA; Pavlick, AC; Polsky, D; Safarzadeh-Amiri, S; Wright, JJ; Yee, H; Yoon, J, 2010) |
| "The aim is to study the effectiveness and side effects of sorafenib administration after transarterial chemoembolization (TACE) in advanced hepatocellular carcinoma (HCC) patients." | 7.88 | Effectiveness and the strategy to treat the side effects of sorafenib administration after transarterial chemoembolization in advanced hepatocellular carcinoma patients. ( Jian, W; Li, C; Sun, X; Xie, F; Zhang, K, 2018) |
| "We report an advanced HCC patient with many lung metastases who failed sorafenib treatment." | 7.88 | The excellent antitumor effect of apatinib alone as second-line therapy in a patient with sorafenib-refractory hepatocellular carcinoma: A case report. ( Duo, J; Ma, X; Zhao, Y; Zhu, H, 2018) |
| "We previously found that a low dose of sorafenib had a prometastatic effect on hepatocellular carcinoma (HCC), which was caused by downregulation of TIP30 expression." | 7.83 | Metformin inhibits the prometastatic effect of sorafenib in hepatocellular carcinoma by upregulating the expression of TIP30. ( Cao, M; Cui, Y; Fang, F; Gao, J; Guo, Z; Li, H; Li, Q; Song, T; Sun, H; You, A; Zhang, T; Zhang, W; Zhou, H; Zhu, X, 2016) |
| "Sorafenib is recognized as a standard treatment for advanced hepatocellular carcinoma (HCC)." | 7.83 | Metformin sensitizes sorafenib to inhibit postoperative recurrence and metastasis of hepatocellular carcinoma in orthotopic mouse models. ( Cao, M; Cui, Y; Fang, F; Gao, J; Guo, Z; Li, H; Li, Q; Song, T; Sun, H; Yin, H; You, A; Zhang, T; Zhang, W; Zhou, H; Zhu, X; Zuo, B, 2016) |
| "Liver resection combined with postoperative sorafenib to prevent recurrence remains a controversial approach for cases of hepatocellular carcinoma (HCC), especially cases with a high risk of recurrence." | 7.83 | Hepatocellular carcinoma cases with high levels of c-Raf-1 expression may benefit from postoperative adjuvant sorafenib after hepatic resection even with high risk of recurrence. ( Hao, J; Lei, J; Li, B; Liu, Z; Wang, W; Wen, T; Wu, L; Yan, L; Zeng, Y; Zhang, P; Zhong, J; Zhu, J, 2016) |
| "Chordoma patients were treated with sorafenib 800 mg/day for 9 months, unless earlier occurrence of progression or toxicities." | 7.83 | Circulating vascular endothelial growth factor (VEGF) as predictive factor of progression-free survival in patients with advanced chordoma receiving sorafenib: an analysis from a phase II trial of the french sarcoma group (GSF/GETO). ( Bertucci, F; Blay, JY; Bompas, E; Camoin, L; Clisant, S; Decoupigny, E; Goncalves, A; Laurence, V; Lebellec, L; Mir, O; Penel, N; Toiron, Y; Tresch-Bruneel, E, 2016) |
| "Sorafenib, an oral multikinase inhibitor, is approved for advanced hepatocellular carcinoma (HCC) treatment." | 7.81 | Sorafenib for the treatment of advanced hepatocellular carcinoma with extrahepatic metastasis: a prospective multicenter cohort study. ( Aino, H; Iwamoto, H; Koga, H; Kuromatsu, R; Nagamatsu, H; Nakano, M; Niizeki, T; Okamura, S; Satani, M; Shimose, S; Shirono, T; Tajiri, N; Tanaka, M; Torimura, T, 2015) |
| "Sorafenib is considered to be the first-line therapy for advanced hepatocellular carcinoma (HCC)." | 7.81 | Down-regulation of SDF1-α expression in tumor microenvironment is associated with aspirin-mediated suppression of the pro-metastasis effect of sorafenib in hepatocellular carcinoma. ( Chen, J; Jia, H; Lu, L; Lu, M; Pei, Y; Qin, L; Zhu, W, 2015) |
| "Sorafenib is the first molecularly targeted drug recommended as a treatment for advanced hepatocellular carcinoma (HCC)." | 7.81 | [Efficacy of Sorafenib for Extrahepatic Recurrence of Hepatocellular Carcinoma after Liver Resection]. ( Kakisaka, T; Kamachi, H; Kamiyama, T; Orimo, T; Shimada, S; Taketomi, A; Tsuruga, Y; Wakayama, K; Yokoo, H, 2015) |
| "Sorafenib, a multi-tyrosine kinase inhibitor, is a standard treatment for advanced hepatocellular carcinoma (HCC)." | 7.79 | Suppression of natural killer cells by sorafenib contributes to prometastatic effects in hepatocellular carcinoma. ( Bu, Y; Chai, ZT; Jia, QA; Kong, LQ; Lu, L; Sun, HC; Tang, ZY; Wang, L; Wang, M; Wang, WQ; Wu, WZ; Zhang, KZ; Zhang, QB; Zhu, XD, 2013) |
| "We previously demonstrated the pro-metastasis effect of sorafenib in hepatocellular carcinoma (HCC), which is mediated by down-regulation of tumor suppressor HTATIP2." | 7.79 | Aspirin minimized the pro-metastasis effect of sorafenib and improved survival by up-regulating HTATIP2 in hepatocellular carcinoma. ( Ao, JY; Chai, ZT; Kong, LQ; Li, JQ; Lu, L; Sun, HC; Tang, ZY; Wang, L; Wang, WQ; Wu, WZ; Zhang, KZ; Zhang, QB; Zhang, W; Zhang, YY; Zhu, XD, 2013) |
| "Although sorafenib is accepted as the standard of care in advanced hepatocellular carcinoma (HCC), its therapeutic benefit is marginal." | 7.79 | Efficacy of sorafenib monotherapy versus sorafenib-based loco-regional treatments in advanced hepatocellular carcinoma. ( Ahn, SH; Chang, S; Chon, CY; Han, KH; Kim, BK; Kim, DY; Kim, SU; Lee, S; Park, JY; Park, Y, 2013) |
| "To evaluate the effect of sorafenib on the glucose tolerance and diabetic status of patients with metastatic renal cell carcinoma (RCC) or advanced hepatocellular carcinoma (HCC)." | 7.78 | The effect of sorafenib treatment on the diabetic status of patients with renal cell or hepatocellular carcinoma. ( Caccialanza, R; Ganini, C; Imarisio, I; Magnani, L; Paglino, C; Porta, C, 2012) |
| "Antiangiogenic agents can sometimes promote tumor invasiveness and metastasis, but little is known about the effects of the antiangiogenic drug sorafenib on progression of hepatocellular carcinoma (HCC)." | 7.78 | Sorafenib down-regulates expression of HTATIP2 to promote invasiveness and metastasis of orthotopic hepatocellular carcinoma tumors in mice. ( Kong, LQ; Li, Q; Song, TQ; Sun, HC; Tang, ZY; Wang, L; Wang, WQ; Wu, WZ; Xiong, YQ; Xu, HX; Zhang, QB; Zhang, W; Zhu, XD; Zhuang, PY, 2012) |
| "There has been no report on sorafenib therapy in patients with metastatic hepatocellular carcinoma (HCC) who had been treated with systemic chemotherapy." | 7.77 | Clinical outcomes of sorafenib treatment in patients with metastatic hepatocellular carcinoma who had been previously treated with fluoropyrimidine plus platinum-based chemotherapy. ( Bang, YJ; Han, SW; Im, SA; Kim, JW; Kim, TY; Lee, JO; Oh, DY, 2011) |
| "To investigate the inhibitory role and the underlying mechanisms of sorafenib on signal transducer and activator of transcription 3 (STAT3) activity in hepatocellular carcinoma (HCC)." | 7.77 | Sorafenib inhibits growth and metastasis of hepatocellular carcinoma by blocking STAT3. ( Fan, J; Gao, Q; Gu, FM; Huang, XY; Jiang, JH; Li, QL; Pan, JF; Zhou, J, 2011) |
| "We report here the experience of the treatment with sorafenib for advanced hepatocellular carcinoma (HCC) in our department." | 7.77 | [Our experience of the treatment with sorafenib for unresectable hepatocellular carcinoma]. ( Ishizaki, M; Kaibori, M; Kwon, AH; Matsui, K; Matsushima, H; Nakatake, R; Sakaguchi, T, 2011) |
| "Sorafenib is a novel, orally administered multi-kinase inhibitor that has recently been approved for the treatment of advanced hepatocellular carcinoma." | 7.77 | [Three cases of hepatocellular carcinoma without distant metastasis effectively treated by sorafenib]. ( Egawa, C; Kato, T; Miki, H; Nakahira, S; Nakata, K; Okamura, S; Okishiro, M; Suzuki, R; Takatsuka, Y; Takeda, Y; Takeno, A; Tamura, S, 2011) |
| "Although clinical trials with sunitinib and sorafenib in metastatic renal cell carcinoma (mRCC) have included patients with moderate renal insufficiency (RI), the incidence of renal toxicity induced by their administration as well as the safety of these agents in patients with more severe renal insufficiency has not been extensively reported." | 7.76 | Sunitinib and sorafenib in metastatic renal cell carcinoma patients with renal insufficiency. ( Bukowski, R; Elson, P; Garcia, J; Golshayan, A; Khan, G; Rini, B; Wood, L, 2010) |
| "To evaluate (125)I seed brachytherapy combined with sorafenib in the treatment of patients with multiple lung metastases after orthotopic liver transplantation (OLT) for hepatocellular carcinoma (HCC)." | 7.76 | Feasibility of (125)I brachytherapy combined with sorafenib treatment in patients with multiple lung metastases after liver transplantation for hepatocellular carcinoma. ( Huang, Z; Li, C; Wu, P; Zhang, F; Zhang, L; Zhang, W, 2010) |
| " Most frequent drug-related adverse events were diarrhea, rash, aspartate aminotransferase elevation, vomiting, and nausea." | 6.79 | A phase II study of the efficacy and safety of the combination therapy of the MEK inhibitor refametinib (BAY 86-9766) plus sorafenib for Asian patients with unresectable hepatocellular carcinoma. ( Choi, HJ; Heo, J; Hsieh, WS; Hsu, C; Jeffers, M; Kappeler, C; Krissel, H; Lim, HY; Lin, CY; Park, JW; Poon, RT; Rajagopalan, P; Rau, KM; Tak, WY; Tay, MH; Yen, CJ; Yeo, W; Yoon, JH, 2014) |
| "Sorafenib was administered at 400 mg po twice daily continuously." | 6.77 | SWOG 0514: a phase II study of sorafenib in patients with unresectable or metastatic gallbladder carcinoma and cholangiocarcinoma. ( Ben-Josef, E; Blanke, CD; El-Khoueiry, AB; Eng, C; Gold, PJ; Govindarajan, R; Hamilton, RD; Lenz, HJ; Rankin, CJ, 2012) |
| "Tumor growth and intrahepatic metastasis were assessed, and immunohistochemistry was applied to analyze the activation of the PI3K/Akt/Snail-dependent pathway." | 5.40 | Activation of phosphatidylinositol 3-kinase/Akt signaling mediates sorafenib-induced invasion and metastasis in hepatocellular carcinoma. ( Chi, H; Meng, Z; Wang, H; Wang, P; Xu, L; Zhu, X, 2014) |
| "Sorafenib is an orally administered active multikinase inhibitor for metastatic renal cell carcinoma that is now considered a standard agent." | 5.39 | Stevens-Johnson syndrome induced by sorafenib for metastatic renal cell carcinoma. ( Amoh, Y; Fujita, T; Ikeda, M; Iwamura, M; Matsumoto, K; Mii, S, 2013) |
| "The overall survival of patients with hepatocellular carcinoma (HCC) remains poor, and the molecular pathogenesis remains incompletely defined in HCC." | 5.39 | αB-crystallin complexes with 14-3-3ζ to induce epithelial-mesenchymal transition and resistance to sorafenib in hepatocellular carcinoma. ( Ding, ZB; Fan, J; Huang, XY; Ke, AW; Qiu, SJ; Shi, GM; Shi, YH; Wang, XY; Xiao, YS; Yan, J; Zhang, C; Zhang, X; Zhou, J, 2013) |
| "Surgical resection is the first-line treatment for hepatocellular carcinoma (HCC) patients with well-preserved liver function." | 5.37 | Sorafenib suppresses postsurgical recurrence and metastasis of hepatocellular carcinoma in an orthotopic mouse model. ( Cheng, SQ; Deng, YZ; Feng, YX; Guan, DX; Li, JJ; Li, N; Qin, Y; Wang, H; Wang, HY; Wang, T; Wang, XF; Wu, MC; Xie, D; Yang, P; Yao, F; Zhu, YQ, 2011) |
| "Sorafenib is able to inhibit their signal transduction, both in vitro and in vivo, displaying anti-tumoural activity, anti-angiogenic effects, and reducing metastatic colony formation in lungs." | 5.35 | Sorafenib blocks tumour growth, angiogenesis and metastatic potential in preclinical models of osteosarcoma through a mechanism potentially involving the inhibition of ERK1/2, MCL-1 and ezrin pathways. ( Aglietta, M; Alberghini, M; Bottos, A; Bruno, S; Bussolino, F; Camussi, G; Cavalloni, G; Fagioli, F; Ferrari, S; Gammaitoni, L; Grignani, G; Migliardi, G; Motta, M; Picci, P; Pignochino, Y; Tapparo, M; Torchio, B, 2009) |
| "We conducted an open-label, randomized, two-arm multi-center study to assess the efficacy and safety of paclitaxel versus paclitaxel + sorafenib in patients with locally advanced or metastatic HER2-negative breast cancer." | 5.24 | A randomized phase II study of paclitaxel alone versus paclitaxel plus sorafenib in second- and third-line treatment of patients with HER2-negative metastatic breast cancer (PASO). ( Decker, T; Göhler, T; Indorf, M; Nusch, A; Overkamp, F; Rösel, S; Sahlmann, J; Trarbach, T, 2017) |
| "Sorafenib is the first anti-angiogenic agent to demonstrate activity in RMSGC patients, particularly in some histotypes such as HG-MEC, SDC and adenocarcinoma, NOS." | 5.22 | A phase II study of sorafenib in recurrent and/or metastatic salivary gland carcinomas: Translational analyses and clinical impact. ( Alfieri, S; Bergamini, C; Bossi, P; Civelli, E; Cortelazzi, B; Dagrada, GP; Granata, R; Imbimbo, M; Licitra, L; Lo Vullo, S; Locati, LD; Mariani, L; Mirabile, A; Morosi, C; Orlandi, E; Perrone, F; Pilotti, S; Quattrone, P; Resteghini, C; Saibene, G, 2016) |
| "We investigated the efficacy and toxicity of sorafenib, a multikinase inhibitor of vascular endothelial growth factor receptor tyrosine kinase, in combination with vinorelbine therapy in a phase I/II trial in patients with metastatic breast cancer." | 5.19 | Phase I/II trial of vinorelbine and sorafenib in metastatic breast cancer. ( Chow, W; Chung, C; Frankel, P; Hurria, A; Luu, T; Mortimer, J; Somlo, G, 2014) |
| "Sorafenib is the standard treatment of patients with advanced hepatocellular carcinoma (HCC), with demonstrated outcome benefits in randomized clinical trials." | 5.19 | Safety and efficacy of sorafenib in the treatment of advanced hepatocellular carcinoma: a single center experience. ( Beveridge, RD; Campos, GB; Daroqui, JC; Esparcia, MF; Estellés, DL; Huerta, ÁS; Imedio, ER; Ortiz, AG; Salcedo, JM; Urtasun, JA, 2014) |
| " We evaluated the efficacy and safety of dual angiogenesis blockade with bevacizumab and sorafenib in patients with metastatic breast cancer." | 5.17 | A phase II study of combined VEGF inhibitor (bevacizumab+sorafenib) in patients with metastatic breast cancer: Hoosier Oncology Group Study BRE06-109. ( Burkhardt, C; Johnson, C; Miller, KD; Mina, LA; Yu, M; Zon, R, 2013) |
| "We conducted a phase 2b, randomised, double-blind, placebo-controlled screening trial to evaluate the addition of the multikinase inhibitor sorafenib (antiproliferative/antiangiogenic) to first-line paclitaxel for human epidermal growth factor receptor 2 (HER2)-negative locally recurrent/metastatic breast cancer." | 5.17 | A double-blind, randomised, placebo-controlled, phase 2b study evaluating sorafenib in combination with paclitaxel as a first-line therapy in patients with HER2-negative advanced breast cancer. ( Bondarde, S; Gradishar, WJ; Jain, M; Kaklamani, V; Lokanatha, D; Lokker, NA; Raina, V; Ro, SK; Sahoo, TP; Schwartzberg, L, 2013) |
| "We aimed to investigate the efficacy and tolerability of sorafenib combined with cisplatin and 5-fluorouracil (5-FU) in patients with recurrent or metastatic nasopharyngeal carcinoma (NPC)." | 5.17 | Phase II study of sorafenib in combination with cisplatin and 5-fluorouracil to treat recurrent or metastatic nasopharyngeal carcinoma. ( Hu, ZH; Huang, PY; Huang, Y; Lin, SJ; Liu, JL; Liu, LZ; Ma, YX; Pan, JJ; Song, XQ; Wu, JX; Wu, X; Xu, F; Xue, C; Yu, QT; Zhang, J; Zhang, JW; Zhang, L; Zhao, HY; Zhao, LP; Zhao, YY, 2013) |
| "This phase I clinical trial was conducted to determine the safety, efficacy, and molecular effects of sorafenib with temsirolimus in patients with advanced melanoma." | 5.16 | Phase I study of the combination of sorafenib and temsirolimus in patients with metastatic melanoma. ( Bassett, RL; Bedikian, AY; Culotta, KS; Dancey, JE; Davies, MA; Deng, W; Fox, PS; Gupta, S; Huang, S; Hwu, P; Hwu, WJ; Kim, KB; Lazar, AJ; Liu, W; Madden, TL; Ng, CS; Papadopoulos, NE; Prieto, VG; Wright, JJ; Xu, Q, 2012) |
| "The phase III Sorafenib Asia-Pacific (AP) trial-conducted in China, Taiwan and South Korea - confirmed that sorafenib improves overall survival (OS) and is safe for patients with advanced hepatocellular carcinoma (HCC)." | 5.16 | Efficacy and safety of sorafenib in patients with advanced hepatocellular carcinoma according to baseline status: subset analyses of the phase III Sorafenib Asia-Pacific trial. ( Chen, Z; Cheng, AL; Fang, F; Guan, Z; Kang, YK; Kim, JS; Lentini, G; Pan, H; Qin, S; Tak, WY; Tsao, CJ; Voliotis, D; Xu, J; Yang, TS; Yu, S; Zou, J, 2012) |
| "Sorafenib, a multikinase inhibitor of cell proliferation and angiogenesis, inhibits the mitogen-activated protein kinase pathway that is activated in most uveal melanoma tumors." | 5.16 | Phase II trial of sorafenib in combination with carboplatin and paclitaxel in patients with metastatic uveal melanoma: SWOG S0512. ( Aparicio, AM; Bhatia, S; Lao, CD; Margolin, KA; Moon, J; Othus, M; Ribas, A; Sondak, VK; Weber, JS, 2012) |
| "Between Dec 1, 2006, and July 4, 2008, patients with untreated HER2-negative metastatic breast cancer were randomly assigned (using a randomisation list created by personnel not associated with the study) in a 1:1:1 ratio to paclitaxel (90 mg/m(2) on days 1, 8, and 15 every 3 weeks) plus either masked motesanib 125 mg orally once per day (n=91), masked placebo orally once per day (n=94), or open-label bevacizumab 10 mg/kg intravenously on days 1 and 15 of each 28-day cycle (n=97), after stratification according to adjuvant or neoadjuvant chemotherapy (taxane-containing regimens vs other regimens vs none), number of metastatic sites (<3 vs ≥3), and hormone receptor status (positive vs negative)." | 5.15 | Motesanib, or open-label bevacizumab, in combination with paclitaxel, as first-line treatment for HER2-negative locally recurrent or metastatic breast cancer: a phase 2, randomised, double-blind, placebo-controlled study. ( Adewoye, H; Adrover, E; Alba, E; Almel, S; Baños, A; Cabaribere, D; Crown, J; Eiermann, W; Hei, YJ; Hurvitz, S; Jagiełło-Gruszfeld, A; Kennedy, MJ; Lang, I; Latreille, J; Lemmerick, Y; Lindsay, MA; Mackey, JR; Martin, M; Moroose, R; Munoz, M; Pienkowski, T; Pinter, T; Priou, F; Provencher, L; Ramos, M; Roche, H; Rolski, J; Rupin, M; Snyder, R, 2011) |
| "The safety of oral sorafenib up to a maximum protocol-specified dose combined with dacarbazine in patients with metastatic, histologically confirmed melanoma was investigated in a phase I dose-escalation study and the activity of the combination was explored in an open-label phase II study." | 5.15 | Sorafenib and dacarbazine as first-line therapy for advanced melanoma: phase I and open-label phase II studies. ( Affolter, A; Ahmad, T; Chao, D; Chevreau, C; Corrie, P; Eisen, T; Gibbens, I; Gore, ME; Harries, M; James, MG; Jouary, T; Lorigan, P; Marais, R; Montegriffo, E; Nathan, PD; Negrier, S; Ottensmeier, C; Prendergast, S; Robert, C; Strauss, UP, 2011) |
| "This trial was conducted to assess the efficacy and safety of sorafenib in patients with metastatic breast cancer." | 5.14 | Phase II multicenter, uncontrolled trial of sorafenib in patients with metastatic breast cancer. ( Bergamini, L; Bianchi, G; Gianni, L; Laferriere, N; Lathia, C; Loibl, S; Peña, C; Raab, G; Salvagni, S; Siena, S; Zamagni, C, 2009) |
| "Sorafenib monotherapy in patients with metastatic melanoma was explored in this multi-institutional phase II study." | 5.14 | A phase II trial of sorafenib in metastatic melanoma with tissue correlates. ( Buckley, M; Christos, PJ; Goldberg, L; Hamilton, A; Liebes, L; Min, C; Osman, I; Ott, PA; Pavlick, AC; Polsky, D; Safarzadeh-Amiri, S; Wright, JJ; Yee, H; Yoon, J, 2010) |
| "The aim is to study the effectiveness and side effects of sorafenib administration after transarterial chemoembolization (TACE) in advanced hepatocellular carcinoma (HCC) patients." | 3.88 | Effectiveness and the strategy to treat the side effects of sorafenib administration after transarterial chemoembolization in advanced hepatocellular carcinoma patients. ( Jian, W; Li, C; Sun, X; Xie, F; Zhang, K, 2018) |
| "We report an advanced HCC patient with many lung metastases who failed sorafenib treatment." | 3.88 | The excellent antitumor effect of apatinib alone as second-line therapy in a patient with sorafenib-refractory hepatocellular carcinoma: A case report. ( Duo, J; Ma, X; Zhao, Y; Zhu, H, 2018) |
| "We previously showed that 1-methylnicotinamide (1-MNA) and its analog 1,4-dimethylpyridine (1,4-DMP) could inhibit the formation of lung metastases and enhance the efficacy of cyclophosphamide-based chemotherapy in the model of spontaneously metastasizing 4T1 mouse mammary gland tumors." | 3.85 | The effects of 1,4-dimethylpyridine in metastatic prostate cancer in mice. ( Chlopicki, S; Denslow, A; Gebicki, J; Maciejewska, M; Marcinek, A; Nowak, M; Switalska, M; Wietrzyk, J, 2017) |
| "Sorafenib was not statistically different from pazopanib using placebo as the comparator in the indirect comparison (HR = 0." | 3.85 | Multikinase inhibitors in metastatic renal cell carcinoma: indirect comparison meta-analysis. ( Chan, AL; Leung, HW, 2011) |
| "We previously found that a low dose of sorafenib had a prometastatic effect on hepatocellular carcinoma (HCC), which was caused by downregulation of TIP30 expression." | 3.83 | Metformin inhibits the prometastatic effect of sorafenib in hepatocellular carcinoma by upregulating the expression of TIP30. ( Cao, M; Cui, Y; Fang, F; Gao, J; Guo, Z; Li, H; Li, Q; Song, T; Sun, H; You, A; Zhang, T; Zhang, W; Zhou, H; Zhu, X, 2016) |
| "Sorafenib is recognized as a standard treatment for advanced hepatocellular carcinoma (HCC)." | 3.83 | Metformin sensitizes sorafenib to inhibit postoperative recurrence and metastasis of hepatocellular carcinoma in orthotopic mouse models. ( Cao, M; Cui, Y; Fang, F; Gao, J; Guo, Z; Li, H; Li, Q; Song, T; Sun, H; Yin, H; You, A; Zhang, T; Zhang, W; Zhou, H; Zhu, X; Zuo, B, 2016) |
| "Liver resection combined with postoperative sorafenib to prevent recurrence remains a controversial approach for cases of hepatocellular carcinoma (HCC), especially cases with a high risk of recurrence." | 3.83 | Hepatocellular carcinoma cases with high levels of c-Raf-1 expression may benefit from postoperative adjuvant sorafenib after hepatic resection even with high risk of recurrence. ( Hao, J; Lei, J; Li, B; Liu, Z; Wang, W; Wen, T; Wu, L; Yan, L; Zeng, Y; Zhang, P; Zhong, J; Zhu, J, 2016) |
| "Chordoma patients were treated with sorafenib 800 mg/day for 9 months, unless earlier occurrence of progression or toxicities." | 3.83 | Circulating vascular endothelial growth factor (VEGF) as predictive factor of progression-free survival in patients with advanced chordoma receiving sorafenib: an analysis from a phase II trial of the french sarcoma group (GSF/GETO). ( Bertucci, F; Blay, JY; Bompas, E; Camoin, L; Clisant, S; Decoupigny, E; Goncalves, A; Laurence, V; Lebellec, L; Mir, O; Penel, N; Toiron, Y; Tresch-Bruneel, E, 2016) |
| "Sorafenib, a multikinase inhibitor, has been used as an anti-angiogenic agent against highly vascular hepatocellular carcinoma (HCC) - yet associated with only moderate therapeutic effect and the high incidence of HCC recurrence." | 3.81 | CXCR4-targeted lipid-coated PLGA nanoparticles deliver sorafenib and overcome acquired drug resistance in liver cancer. ( Chang, CC; Chen, Y; Chiang, WH; Gao, DY; Lin, TsT; Liu, JY; Liu, YC; Sung, YC, 2015) |
| "Sorafenib, an oral multikinase inhibitor, is approved for advanced hepatocellular carcinoma (HCC) treatment." | 3.81 | Sorafenib for the treatment of advanced hepatocellular carcinoma with extrahepatic metastasis: a prospective multicenter cohort study. ( Aino, H; Iwamoto, H; Koga, H; Kuromatsu, R; Nagamatsu, H; Nakano, M; Niizeki, T; Okamura, S; Satani, M; Shimose, S; Shirono, T; Tajiri, N; Tanaka, M; Torimura, T, 2015) |
| "Sorafenib is considered to be the first-line therapy for advanced hepatocellular carcinoma (HCC)." | 3.81 | Down-regulation of SDF1-α expression in tumor microenvironment is associated with aspirin-mediated suppression of the pro-metastasis effect of sorafenib in hepatocellular carcinoma. ( Chen, J; Jia, H; Lu, L; Lu, M; Pei, Y; Qin, L; Zhu, W, 2015) |
| "Sorafenib is the first molecularly targeted drug recommended as a treatment for advanced hepatocellular carcinoma (HCC)." | 3.81 | [Efficacy of Sorafenib for Extrahepatic Recurrence of Hepatocellular Carcinoma after Liver Resection]. ( Kakisaka, T; Kamachi, H; Kamiyama, T; Orimo, T; Shimada, S; Taketomi, A; Tsuruga, Y; Wakayama, K; Yokoo, H, 2015) |
| " The relative role of such novel radiopharmaceutical versus (131)I scanning of thyroid cancer will require future histopathologic and clinical studies, but it may open new perspectives for presurgical staging of thyroid cancer, and diagnosis of radioiodine negative local relapses and/or distant metastases." | 3.80 | (99m)Tc-labeled-rhTSH analogue (TR1401) for imaging poorly differentiated metastatic thyroid cancer. ( Balogh, L; Dierckx, RA; Fremont, V; Galli, F; Manni, I; Piaggio, G; Signore, A; Szkudlinski, MW; Weintraub, BD, 2014) |
| " Here we confirm that bafilomycin A1 (BafA1), a selective vATPase inhibitor, significantly increased death of breast cancer cells in a hypoxia and Bnip3-dependent manner and significantly reduced tumor growth in MCF7 and MDA-MB-231 mouse xenografts." | 3.80 | Inhibition of the vacuolar ATPase induces Bnip3-dependent death of cancer cells and a reduction in tumor burden and metastasis. ( Graham, RM; Thompson, JW; Webster, KA, 2014) |
| "Sorafenib, a multi-tyrosine kinase inhibitor, is a standard treatment for advanced hepatocellular carcinoma (HCC)." | 3.79 | Suppression of natural killer cells by sorafenib contributes to prometastatic effects in hepatocellular carcinoma. ( Bu, Y; Chai, ZT; Jia, QA; Kong, LQ; Lu, L; Sun, HC; Tang, ZY; Wang, L; Wang, M; Wang, WQ; Wu, WZ; Zhang, KZ; Zhang, QB; Zhu, XD, 2013) |
| "We previously demonstrated the pro-metastasis effect of sorafenib in hepatocellular carcinoma (HCC), which is mediated by down-regulation of tumor suppressor HTATIP2." | 3.79 | Aspirin minimized the pro-metastasis effect of sorafenib and improved survival by up-regulating HTATIP2 in hepatocellular carcinoma. ( Ao, JY; Chai, ZT; Kong, LQ; Li, JQ; Lu, L; Sun, HC; Tang, ZY; Wang, L; Wang, WQ; Wu, WZ; Zhang, KZ; Zhang, QB; Zhang, W; Zhang, YY; Zhu, XD, 2013) |
| "In a randomized phase III clinical trial, patients with metastatic differentiated cancer of the thyroid who were treated with sorafenib achieved median progression-free survival of 10." | 3.79 | Sorafenib makes headway on metastatic thyroid cancer. ( , 2013) |
| "Although sorafenib is accepted as the standard of care in advanced hepatocellular carcinoma (HCC), its therapeutic benefit is marginal." | 3.79 | Efficacy of sorafenib monotherapy versus sorafenib-based loco-regional treatments in advanced hepatocellular carcinoma. ( Ahn, SH; Chang, S; Chon, CY; Han, KH; Kim, BK; Kim, DY; Kim, SU; Lee, S; Park, JY; Park, Y, 2013) |
| " NanoHHI potently suppressed in vivo tumor growth of HCC xenografts in both subcutaneous and orthotopic milieus, and in contrast to sorafenib, resulted in significant attenuation of systemic metastases in the orthotopic setting." | 3.78 | Polymeric nanoparticle-encapsulated hedgehog pathway inhibitor HPI-1 (NanoHHI) inhibits systemic metastases in an orthotopic model of human hepatocellular carcinoma. ( Anders, RA; Bai, H; Chenna, V; Fan, J; Hu, C; Khan, M; Maitra, A; Sun, HX; Sun, YF; Xu, Y; Yang, XR; Zhu, QF, 2012) |
| "To evaluate the effect of sorafenib on the glucose tolerance and diabetic status of patients with metastatic renal cell carcinoma (RCC) or advanced hepatocellular carcinoma (HCC)." | 3.78 | The effect of sorafenib treatment on the diabetic status of patients with renal cell or hepatocellular carcinoma. ( Caccialanza, R; Ganini, C; Imarisio, I; Magnani, L; Paglino, C; Porta, C, 2012) |
| "Antiangiogenic agents can sometimes promote tumor invasiveness and metastasis, but little is known about the effects of the antiangiogenic drug sorafenib on progression of hepatocellular carcinoma (HCC)." | 3.78 | Sorafenib down-regulates expression of HTATIP2 to promote invasiveness and metastasis of orthotopic hepatocellular carcinoma tumors in mice. ( Kong, LQ; Li, Q; Song, TQ; Sun, HC; Tang, ZY; Wang, L; Wang, WQ; Wu, WZ; Xiong, YQ; Xu, HX; Zhang, QB; Zhang, W; Zhu, XD; Zhuang, PY, 2012) |
| "Retrospective study on all the renal cell carcinoma patients with bone metastases treated with sunitinib or sorafenib between November 2005 and June 2012 at the University Hospitals Leuven and AZ Groeninge in Kortrijk." | 3.78 | Concomitant oral tyrosine kinase inhibitors and bisphosphonates in advanced renal cell carcinoma with bone metastases. ( Berkers, J; Beuselinck, B; Body, JJ; Debruyne, P; Dumez, H; Elaidi, R; Karadimou, A; Lerut, E; Paridaens, R; Rogiers, A; Schöffski, P; Van Cann, T; Van Poppel, H; Willems, L; Wolter, P, 2012) |
| "There has been no report on sorafenib therapy in patients with metastatic hepatocellular carcinoma (HCC) who had been treated with systemic chemotherapy." | 3.77 | Clinical outcomes of sorafenib treatment in patients with metastatic hepatocellular carcinoma who had been previously treated with fluoropyrimidine plus platinum-based chemotherapy. ( Bang, YJ; Han, SW; Im, SA; Kim, JW; Kim, TY; Lee, JO; Oh, DY, 2011) |
| "Multikinase inhibitors (MKIs) sunitinib and sorafenib have become a standard of care for metastatic renal cell carcinoma (mRCC)." | 3.77 | Safety and treatment patterns of multikinase inhibitors in patients with metastatic renal cell carcinoma at a tertiary oncology center in Italy. ( Canipari, C; Chen, K; Duh, MS; Imarisio, I; Neary, M; Paglino, C; Porta, C, 2011) |
| "To investigate the inhibitory role and the underlying mechanisms of sorafenib on signal transducer and activator of transcription 3 (STAT3) activity in hepatocellular carcinoma (HCC)." | 3.77 | Sorafenib inhibits growth and metastasis of hepatocellular carcinoma by blocking STAT3. ( Fan, J; Gao, Q; Gu, FM; Huang, XY; Jiang, JH; Li, QL; Pan, JF; Zhou, J, 2011) |
| "We report here the experience of the treatment with sorafenib for advanced hepatocellular carcinoma (HCC) in our department." | 3.77 | [Our experience of the treatment with sorafenib for unresectable hepatocellular carcinoma]. ( Ishizaki, M; Kaibori, M; Kwon, AH; Matsui, K; Matsushima, H; Nakatake, R; Sakaguchi, T, 2011) |
| "Sorafenib is a novel, orally administered multi-kinase inhibitor that has recently been approved for the treatment of advanced hepatocellular carcinoma." | 3.77 | [Three cases of hepatocellular carcinoma without distant metastasis effectively treated by sorafenib]. ( Egawa, C; Kato, T; Miki, H; Nakahira, S; Nakata, K; Okamura, S; Okishiro, M; Suzuki, R; Takatsuka, Y; Takeda, Y; Takeno, A; Tamura, S, 2011) |
| "Although clinical trials with sunitinib and sorafenib in metastatic renal cell carcinoma (mRCC) have included patients with moderate renal insufficiency (RI), the incidence of renal toxicity induced by their administration as well as the safety of these agents in patients with more severe renal insufficiency has not been extensively reported." | 3.76 | Sunitinib and sorafenib in metastatic renal cell carcinoma patients with renal insufficiency. ( Bukowski, R; Elson, P; Garcia, J; Golshayan, A; Khan, G; Rini, B; Wood, L, 2010) |
| "To evaluate (125)I seed brachytherapy combined with sorafenib in the treatment of patients with multiple lung metastases after orthotopic liver transplantation (OLT) for hepatocellular carcinoma (HCC)." | 3.76 | Feasibility of (125)I brachytherapy combined with sorafenib treatment in patients with multiple lung metastases after liver transplantation for hepatocellular carcinoma. ( Huang, Z; Li, C; Wu, P; Zhang, F; Zhang, L; Zhang, W, 2010) |
| "We identified 12 cases: 5 CRs with sunitinib, 1 CR with sorafenib, and 6 surgical CRs with sunitinib followed by residual metastasectomy." | 3.75 | Can tyrosine kinase inhibitors be discontinued in patients with metastatic renal cell carcinoma and a complete response to treatment? A multicentre, retrospective analysis. ( Bex, A; Cosentino, M; Ficarra, V; Flörcken, A; Grünwald, V; Johannsen, M; Kloeters, C; Miller, K; Rief, M; Rogalla, P; Roigas, J, 2009) |
| "Eight patients (21%) had thyroid dysfunction possibly caused by sorafenib [seven hypothyroidism (18%) and one hyperthyroidism (3%)] and eight additional patients (21%) had findings compatible with nonthyroidal illness." | 3.74 | Thyroid function test abnormalities in patients with metastatic renal cell carcinoma treated with sorafenib. ( Bukowski, R; Dreicer, R; Elson, P; Garcia, J; Ioachimescu, AG; Mekhail, T; Rini, BI; Tamaskar, I; Wood, L, 2008) |
| "Patients with post-treatment hypoalbuminemia had significantly shorter median PFS (6 months [95% CI 5-7 months]) and OS (11 months [95% CI 9-15 months]) than patients who had normal post-treatment albumin levels (PFS: 12 months [95% CI 11-16 months], P < 0." | 2.84 | Association of post-treatment hypoalbuminemia and survival in Chinese patients with metastatic renal cell carcinoma. ( Cai, W; Chen, Y; Huang, J; Huang, Y; Kong, W; Zhang, J; Zhou, L, 2017) |
| "The current treatment of metastatic renal cell carcinoma (mRCC) revolves around targeted agents, which have resulted in a median overall survival of 22 to 26 months in registration trials." | 2.84 | Patterns of Care and Clinical Outcomes in Patients With Metastatic Renal Cell Carcinoma-Results From a Tertiary Cancer Center in India. ( Joshi, A; Kannan, RA; Kothari, R; Menon, S; Noronha, V; Patil, VM; Popat, P; Prabhash, K; Ramaswamy, A; Sable, N; Sahu, A, 2017) |
| "metastatic renal cell cancer (mRCC) or GIST patients treated with sunitinib or sorafenib (VEGFR TKI patients n = 30); 2." | 2.79 | Impairment of cognitive functioning during Sunitinib or Sorafenib treatment in cancer patients: a cross sectional study. ( Bertens, D; Desar, IM; Kessels, RP; Langenhuijsen, JF; Mulder, SF; Mulders, PF; Punt, CJ; van Herpen, CM; van Spronsen, DJ; Vissers, KC, 2014) |
| " Most frequent drug-related adverse events were diarrhea, rash, aspartate aminotransferase elevation, vomiting, and nausea." | 2.79 | A phase II study of the efficacy and safety of the combination therapy of the MEK inhibitor refametinib (BAY 86-9766) plus sorafenib for Asian patients with unresectable hepatocellular carcinoma. ( Choi, HJ; Heo, J; Hsieh, WS; Hsu, C; Jeffers, M; Kappeler, C; Krissel, H; Lim, HY; Lin, CY; Park, JW; Poon, RT; Rajagopalan, P; Rau, KM; Tak, WY; Tay, MH; Yen, CJ; Yeo, W; Yoon, JH, 2014) |
| "After 2 weeks of IFN-alone treatment, eligible patients received 28-day cycles of continuous sorafenib 200 mg (Cohort 1) or 400 mg (Cohorts 2 and 3) twice daily combined with intramuscular IFN 6 (Cohorts 1 and 2) or 9 (Cohort 3) million international units (MIU) three times a week." | 2.77 | Phase I trial of sorafenib in combination with interferon-alpha in Japanese patients with unresectable or metastatic renal cell carcinoma. ( Fujii, H; Fukino, K; Hamamoto, Y; Hashine, K; Niwakawa, M; Sumiyoshi, Y; Tanigawa, T; Yamaguchi, R, 2012) |
| "Patients with metastatic pancreatic cancer have limited therapeutic options." | 2.77 | A randomized phase II of gemcitabine and sorafenib versus sorafenib alone in patients with metastatic pancreatic cancer. ( El-Khoueiry, AB; Gandara, D; Lenz, HJ; Ramanathan, RK; Shibata, S; Wright, JJ; Yang, DY; Zhang, W, 2012) |
| "Sorafenib was administered at 400 mg po twice daily continuously." | 2.77 | SWOG 0514: a phase II study of sorafenib in patients with unresectable or metastatic gallbladder carcinoma and cholangiocarcinoma. ( Ben-Josef, E; Blanke, CD; El-Khoueiry, AB; Eng, C; Gold, PJ; Govindarajan, R; Hamilton, RD; Lenz, HJ; Rankin, CJ, 2012) |
| "Sorafenib is an orally active multikinase inhibitor approved for the treatment of mRCC." | 2.77 | Phase II escalation study of sorafenib in patients with metastatic renal cell carcinoma who have been previously treated with anti-angiogenic treatment. ( Alonso, S; Calabrò, F; Caristo, R; Catalano, A; Cerbone, L; Di Paola, ED; Leone, A; Mancuso, A; Messina, C; Sternberg, CN; Vigna, L; Zivi, A, 2012) |
| "We performed a dose-escalation study to investigate the safety of sorafenib in combination with docetaxel and prednisone in chemo-naïve patients with metastatic castration-resistant prostate cancer (mCRPC)." | 2.77 | Phase I study of sorafenib in combination with docetaxel and prednisone in chemo-naïve patients with metastatic castration-resistant prostate cancer. ( Canon, JL; Clausse, M; D'Hondt, L; Duck, L; Kerger, J; Machiels, JP; Mardjuadi, F; Medioni, J; Moxhon, A; Musuamba, F; Oudard, S, 2012) |
| "Sorafenib is an oral multikinase inhibitor that blocks cell proliferation via the ERK pathway and angiogenesis via the VEGF pathway." | 2.76 | A phase II trial of sorafenib in first-line metastatic urothelial cancer: a study of the PMH Phase II Consortium. ( Blattler, C; Eisen, A; Hotte, SJ; McWhirter, E; Moore, MJ; Mukherjee, SD; Sridhar, SS; Tannock, IF; Wang, L; Winquist, E; Wright, JJ, 2011) |
| "Baseline patient-reported kidney cancer symptoms are linked to mPFS and mOS in a clear and interpretable way." | 2.76 | Baseline patient-reported kidney cancer-specific symptoms as an indicator for median survival in sorafenib-refractory metastatic renal cell carcinoma. ( Bushmakin, AG; Bycott, P; Cappelleri, JC; Kim, S; Rini, B; Rosbrook, B; Stadler, WM; Tarazi, J; Trask, PC, 2011) |
| "Sorafenib is a multikinase inhibitor that targets several molecular signals believed to be involved in the pathogenesis of thyroid cancer, including those implicated in DTC." | 2.76 | Rationale and design of decision: a double-blind, randomized, placebo-controlled phase III trial evaluating the efficacy and safety of sorafenib in patients with locally advanced or metastatic radioactive iodine (RAI)-refractory, differentiated thyroid ca ( Brose, MS; Chung, J; Kalmus, J; Kappeler, C; Nutting, CM; Reike, G; Schlumberger, M; Sherman, SI; Shong, YK; Smit, JW, 2011) |
| "Treatment of everolimus-resistant disease remains largely undefined in metastatic renal cell carcinoma (mRCC)." | 2.76 | Treatment of everolimus-resistant metastatic renal cell carcinoma with VEGF-targeted therapies. ( Busch, J; Fenner, M; Ganser, A; Grünwald, V; Seidel, C; Weikert, S, 2011) |
| "Sorafenib was administered orally at 400 mg twice daily on a continuous basis in 28-day cycles." | 2.75 | Phase II evaluation of sorafenib in advanced and metastatic squamous cell carcinoma of the head and neck: Southwest Oncology Group Study S0420. ( Guaglianone, PP; Huang, CH; LeBlanc, M; Moon, J; Urba, SG; Williamson, SK; Wolf, GT, 2010) |
| "Sorafenib was given at a dose of 400 mg orally twice daily in 28-day cycles." | 2.74 | Final analysis of a phase II trial using sorafenib for metastatic castration-resistant prostate cancer. ( Aragon-Ching, JB; Arlen, PM; Chen, CC; Dahut, WL; Draper, D; Figg, WD; Gulley, JL; Jain, L; Jones, E; Steinberg, SM; Venitz, J; Wright, JJ, 2009) |
| "Sorafenib-treated patients reported fewer symptoms, better quality of life (QOL), and greater treatment satisfaction." | 2.74 | Randomized phase II trial of first-line treatment with sorafenib versus interferon Alfa-2a in patients with metastatic renal cell carcinoma. ( Bukowski, RM; Cella, D; Demkow, T; Escudier, B; Hutson, TE; Laferriere, N; Negrier, S; Rolland, F; Scheuring, UJ; Shah, S; Staehler, M; Szczylik, C, 2009) |
| "Sorafenib was given 400 mg twice daily orally." | 2.74 | Evaluation of sorafenib treatment in metastatic renal cell carcinoma with 2-fluoro-2-deoxyglucose positron emission tomography and computed tomography. ( Boijsen, M; Lundstam, S; Lyrdal, D; Stierner, U; Suurküla, M, 2009) |
| "Sorafenib (Nexavar), is a multikinase inhibitor, which has demonstrated both antiproliferative and antiangiogenic properties in vitro and in vivo, inhibiting the activity of targets present in the tumoral cells (c-RAF [proto-oncogene serine/threonine-protein kinase], BRAF, (V600E)BRAF, c-KIT, and FMS-like tyrosine kinase 3) and in tumor vessels (c-RAF, vascular endothelial growth factor receptor [VEGFR]-2, VEGFR-3, and platelet-derived growth factor receptor β)." | 2.55 | Aggressive thyroid cancer: targeted therapy with sorafenib. ( Antonelli, A; Corrado, A; Fallahi, P; Ferrari, SM; Materazzi, G; Mazzi, V; Miccoli, M; Miccoli, P; Politti, U; Ulisse, S, 2017) |
| " Hypertension is an adverse effect of these drugs and the degree of hypertension associates with the anti-tumour effect." | 2.55 | Effects and Side Effects of Using Sorafenib and Sunitinib in the Treatment of Metastatic Renal Cell Carcinoma. ( Bauer, J; Grimm, D; Magnusson, NE; Randrup Hansen, C; Wehland, M, 2017) |
| " Severe adverse events (AEs) or poor compliance was observed in 64 (36." | 2.52 | Efficacy and Safety of Sorafenib Therapy on Metastatic Renal Cell Carcinoma in Korean Patients: Results from a Retrospective Multicenter Study. ( Chung, J; Hong, SH; Joo, KJ; Kim, CS; Kim, S; Kim, SH; Kim, TN; Kwak, C; Kwon, TG; Lee, SE; Nam, BH; Seo, IY; Seo, SI; Song, K, 2015) |
| "Treatment with sorafenib in patients with progressive DTC and MTC is a promising strategy, but the adverse event rate is high, leading to a high rate of dose reduction or discontinuation." | 2.50 | Sorafenib in metastatic thyroid cancer: a systematic review. ( Cabanillas, ME; Dadu, R; Dong, W; Feng, L; Lai, SY; Regone, RM; Thomas, L, 2014) |
| "Insights into the biology of clear-cell renal cell carcinoma (CCRCC) have identified multiple pathways associated with the pathogenesis and progression of this cancer." | 2.47 | Systemic therapy for metastatic non-clear-cell renal cell carcinoma: recent progress and future directions. ( Atkinson, B; Choueiri, TK; Chowdhury, S; Matrana, MR; Tannir, NM; Tsang, C, 2011) |
| "Metastatic renal cell carcinoma (mRCC) is a highly vascularized tumor with a generally poor prognosis." | 2.45 | Sorafenib reveals efficacy in sequential treatment of metastatic renal cell cancer. ( Kuczyk, MA; Merseburger, AS; Simon, A; Waalkes, S, 2009) |
| "Sorafenib is an oral multikinase inhibitor that inhibits Raf serine/threonine kinases and receptor tyrosine kinases involved in tumor growth and angiogenesis." | 2.44 | Safety, pharmacokinetics, and preliminary antitumor activity of sorafenib: a review of four phase I trials in patients with advanced refractory solid tumors. ( Awada, A; Clark, JW; Eder, JP; Hendlisz, A; Hirte, HW; Lenz, HJ; Moore, MJ; Richly, H; Schwartz, B; Strumberg, D, 2007) |
| "Treatment of patients with metastatic renal cell carcinoma is evolving rapidly due to the advent of novel targeted therapies." | 2.44 | [Angiogenesis inhibitors for the systemic treatment of metastatic renal cell carcinoma: sunitinib, sorafenib, bevacizumab and temsirolimus]. ( de Mulder, PH; Gietema, JA; Groenewegen, G; Haanen, JB; Jansen, RL; Kruit, WH; Mulders, PF; Osanto, S; Richel, DJ; Sleijfer, S; van den Eertwegh, AJ; Voest, EE, 2008) |
| "Metastatic renal cell carcinoma (RCC) has historically been refractory to cytotoxic and hormonal agents; only interleukin 2 and interferon alpha provide response in a minority of patients." | 2.43 | Targeted therapy for metastatic renal cell carcinoma. ( Chaganti, RS; Motzer, RJ; Patel, PH, 2006) |
| "Inflammation has been demonstrated to promote cancer metastasis." | 1.56 | Nicaraven Attenuates Postoperative Systemic Inflammatory Responses-Induced Tumor Metastasis. ( Goto, S; Guo, CY; Kawabata, T; Li, TS; Liu, KX; Moriwaki, T; Zhang, X, 2020) |
| " We retrospectively analyzed the clinical efficacy between SU/SO combined with DC-CIK and SU/SO monotherapy in treating renal cell carcinoma (RCC) patients with metastasis after radical nephrectomy." | 1.48 | Retrospective analysis on the efficacy of sunitinib/sorafenib in combination with dendritic cells-cytokine-induced killer in metastasis renal cell carcinoma after radical nephrectomy. ( Chen, LJ; Li, BT; Mai, HX; Mei, GH; Tang, YY; Xu, XJ; Zhang, B; Zhao, FL, 2018) |
| " Considering the critical role of VEGF signaling in the homeostasis of the cardiovascular system, we speculated that the long-term use of axitinib and sorafenib directly influenced the initiation of aortic dissection and cardiac dysfunction." | 1.48 | Aortic Dissection and Cardiac Dysfunction Emerged Coincidentally During the Long-Term Treatment with Angiogenesis Inhibitors for Metastatic Renal Cell Carcinoma. ( Fujita, M; Kuroda, T; Mukai, M; Nakai, Y; Nishimura, K; Oka, T; Shioyama, W; Takada, M; Yasui, T, 2018) |
| "Metastatic renal cell carcinoma (MRCC) exhibits primary resistance to both chemotherapy and radiotherapy." | 1.46 | Combination of sorafenib and cytokine-induced killer cells in metastatic renal cell carcinoma: a potential regimen. ( Gao, Q; Lin, H; Song, Y; Yang, Y; Zhao, L, 2017) |
| "Sorafenib has comparable efficacy and lower toxicity profile than sunitinib as first-line therapy for mRCC." | 1.46 | Comparison of efficacy, safety, and quality of life between sorafenib and sunitinib as first-line therapy for Chinese patients with metastatic renal cell carcinoma. ( Cai, W; Chen, Y; Dong, B; Huang, J; Huang, Y; Kong, W; Xue, W; Zhang, J; Zhou, L, 2017) |
| "Sorafenib treatment had no effect on tumor growth in a 4T1 mouse model of breast cancer, but induced M2 macrophage polarization in tumors." | 1.43 | Inhibition of tumor growth and metastasis by photoimmunotherapy targeting tumor-associated macrophage in a sorafenib-resistant tumor model. ( Cai, Y; Gao, D; Gao, L; Jia, B; Lai, J; Liu, H; Liu, Z; Wang, F; Zhang, C, 2016) |
| " Most common adverse events were hand-foot skin reaction and thrombocytopenia which were manageable." | 1.43 | Efficacy and safety of sorafenib versus sunitinib as first-line treatment in patients with metastatic renal cell carcinoma: largest single-center retrospective analysis. ( Chi, Z; Cui, C; Guo, J; Li, S; Lian, B; Mao, L; Sheng, X; Si, L; Tang, B; Wang, X; Yan, X, 2016) |
| "Sorafenib was the first-line treatment in 15% of patients." | 1.42 | Prognostic factors in renal cell carcinoma patients treated with sorafenib: results from the Czech registry. ( Bortlicek, Z; Buchler, T; Kubackova, K; Linke, Z; Melichar, B; Pavlik, T; Pokorna, P; Prausova, J; Vyzula, R, 2015) |
| "In head and neck squamous cell carcinoma (HNSCC), the role of sprouty2 in tumorigenesis and clinical implication remains elusive." | 1.42 | Sprouty2 protein is downregulated in human squamous cell carcinoma of the head and neck and suppresses cell proliferation in vitro. ( Chang, CH; Chiang, WF; Feng, LY; Feng, YH; Hsiao, JR; Hsieh, JL; Huang, WT; Lin, CL; Liu, SY; Tsao, CJ; Tung, CL, 2015) |
| "Sorafenib was generally well tolerated and provided clinical benefit in a large, diverse population of patients with advanced RCC treated in routine clinical practice." | 1.42 | Sorafenib treatment of advanced renal cell carcinoma patients in daily practice: the large international PREDICT study. ( Ahn, H; Böckenhoff, A; Escudier, B; Guo, J; Jäger, D; Korbenfeld, E; Leonhartsberger, N; Ma, JH; Mardiak, J; Stauch, K; Ye, DW; Yu, J; Zemanova, M, 2015) |
| "Sorafenib has been evaluated in several Phase II and III studies in patients with locally advanced/metastatic radioactive iodine-refractory differentiated thyroid carcinomas (DTCs), reporting partial responses, stabilization of the disease and improvement of progression-free survival." | 1.42 | Sorafenib in the treatment of thyroid cancer. ( Antonelli, A; Baldini, E; Fallahi, P; Ferrari, SM; Materazzi, G; Miccoli, P; Politti, U; Spisni, R; Ulisse, S, 2015) |
| "Sorafenib was administered at a dose of 400 mg twice daily, and continued until disease progression, at which point the dose was increased to 600 or 800 mg twice daily, or the onset of an intolerable adverse drug event (ADE) that required dose reduction or temporary suspension of treatment." | 1.42 | Retrospective Analysis of the Efficacy and Safety of Sorafenib in Chinese Patients With Metastatic Renal Cell Carcinoma and Prognostic Factors Related to Overall Survival. ( Fang, D; Guo, G; Huang, L; Li, X; Song, Y; Yu, X; Zhang, C; Zhang, X; Zhou, L, 2015) |
| "The aim of the study is to evaluate the relationship between the adverse events and efficacy of sorafenib in patients with metastatic renal cell carcinoma (mRCC), with a purpose to guide the judgment of efficacy in sorafenib treatment." | 1.42 | The Relationship Between the Adverse Events and Efficacy of Sorafenib in Patients With Metastatic Renal Cell Carcinoma: A Multicenter Retrospective Study from Northwest China. ( Chen, P; Li, P; Lu, J; Lu, X; Wang, F; Wang, J; Wang, Q; Wang, Y; Wang, Z; Wu, G; Yuan, J; Zhang, L; Zheng, Y, 2015) |
| "Melanoma is highly metastatic, but the mechanism of melanoma cell migration is still unclear." | 1.40 | SIRT1 regulates lamellipodium extension and migration of melanoma cells. ( Hayashi, T; Hirobe, T; Hisahara, S; Horimoto, K; Horio, Y; Jimbow, K; Kunimoto, R; Sato, M; Sugino, T; Tanimura, A; Yamashita, T, 2014) |
| "A total of 77 patients had synchronous metastasis (48." | 1.40 | [Systemic treatment of metastatic renal cell carcinoma: change of paradigms after introduction of targeted therapy]. ( Bögemann, M; Herrmann, E; Hertle, L; Hoffmeister, I; Krabbe, LM; Moritz, R; Papavassilis, P; Thielen, B, 2014) |
| " Herein, we report a lipid-coated nanodiamond (ND) system loading water-insoluble sorafenib (SND) to improve the bioavailability and efficacy on suppression of cancer metastasis." | 1.40 | The use of lipid-coated nanodiamond to improve bioavailability and efficacy of sorafenib in resisting metastasis of gastric cancer. ( Bao, X; Chen, J; He, X; Li, Y; Niu, B; Yu, H; Zhang, Z; Zhu, J, 2014) |
| "Fifteen patients presented with metastases at the time of diagnosis." | 1.40 | Sorafenib in advanced, heavily pretreated patients with soft tissue sarcomas. ( Bauernhofer, T; Brämswig, K; Brodowicz, T; Girschikofsky, M; Hilbe, W; Hochreiner, G; Kühr, T; Leitgeb, C; Martel, A; Mlineritsch, B; Petzer, A; Ploner, F; Ressler, S; Romeder, F; Seebacher, V; Stöger, H; Wöll, E, 2014) |
| "Tumor growth and intrahepatic metastasis were assessed, and immunohistochemistry was applied to analyze the activation of the PI3K/Akt/Snail-dependent pathway." | 1.40 | Activation of phosphatidylinositol 3-kinase/Akt signaling mediates sorafenib-induced invasion and metastasis in hepatocellular carcinoma. ( Chi, H; Meng, Z; Wang, H; Wang, P; Xu, L; Zhu, X, 2014) |
| "Kinase inhibitor therapy may be used to treat thyroid carcinoma that is symptomatic and/or progressive and not amenable to treatment with radioactive iodine." | 1.40 | Thyroid carcinoma, version 2.2014. ( Ball, DW; Byrd, D; Dickson, P; Duh, QY; Ehya, H; Haddad, RI; Haymart, M; Hoffmann, KG; Hoh, C; Hughes, M; Hunt, JP; Iagaru, A; Kandeel, F; Kopp, P; Lamonica, DM; Lydiatt, WM; McCaffrey, J; Moley, JF; Parks, L; Raeburn, CD; Ridge, JA; Ringel, MD; Scheri, RP; Shah, JP; Sherman, SI; Sturgeon, C; Tuttle, RM; Waguespack, SG; Wang, TN; Wirth, LJ, 2014) |
| "We retrospectively analyzed metastatic renal cell carcinoma (RCC) patients treated with 3 targeted agents." | 1.39 | Prolonged exposure to tyrosine kinase inhibitors or early use of everolimus in metastatic renal cell carcinoma: are the two options alike? ( Calvani, N; Chiuri, V; Cinieri, S; Fedele, P; Gnoni, A; Lorusso, V; Maiello, E; Morelli, F; Orlando, L; Scavelli, C, 2013) |
| "Recurrence and chemoresistance of liver cancer has been attributed to the existence of liver tumor-initiating cells (T-ICs)." | 1.39 | Cyclin G1 expands liver tumor-initiating cells by Sox2 induction via Akt/mTOR signaling. ( Cao, D; Chen, C; Chen, SZ; Ding, J; Feng, GS; Han, T; Huang, L; Sun, W; Tang, L; Wang, HY; Wang, X; Wen, W; Wu, MC; Xiang, DM, 2013) |
| "We report a case of metastatic renal cell carcinoma (RCC) treated with cytoreductive nephrectomy, cytokine therapy, and molecular targeted therapy followed by metastasectomy." | 1.39 | [A case of metastatic renal cell carcinoma with no evidence of disease for a long term after a favorable response to molecular-targeted therapy followed by metastasectomy]. ( Ikehata, Y; Kitamura, H; Masumori, N; Takahashi, S; Tsukamoto, T, 2013) |
| "Sorafenib is an orally administered active multikinase inhibitor for metastatic renal cell carcinoma that is now considered a standard agent." | 1.39 | Stevens-Johnson syndrome induced by sorafenib for metastatic renal cell carcinoma. ( Amoh, Y; Fujita, T; Ikeda, M; Iwamura, M; Matsumoto, K; Mii, S, 2013) |
| " Previously, we reported on the development of LY2801653: a novel, orally bioavailable oncokinase inhibitor with MET as one of its targets." | 1.39 | Inhibition of tumor growth and metastasis in non-small cell lung cancer by LY2801653, an inhibitor of several oncokinases, including MET. ( Bi, C; Credille, KM; Donoho, GP; Manro, JR; Peek, VL; Walgren, RA; Wijsman, JA; Wu, W; Yan, L; Yan, SB, 2013) |
| "Considering the crucial role of EMT in breast cancer metastasis, a better understanding of this process may provide new therapeutic options." | 1.39 | Comparative proteome profiling of breast tumor cell lines by gel electrophoresis and mass spectrometry reveals an epithelial mesenchymal transition associated protein signature. ( Acierno, R; Alberti, S; del Boccio, P; Giannelli, G; Maffia, M; Pieragostino, D; Sacchetta, P; Salzet, M; Simeone, P; Tinelli, A; Toto, C; Vergara, D, 2013) |
| " The mean starting dose for patients who initiated on sorafenib (n = 16) was 725 mg and for temsirolimus (n = 15) was 25 mg: their study samples were insufficient for further, meaningful dosing analyses." | 1.39 | Treatment patterns: targeted therapies indicated for first-line management of metastatic renal cell carcinoma in a real-world setting. ( Borker, R; Fonseca, E; Hess, G, 2013) |
| "The overall survival of patients with hepatocellular carcinoma (HCC) remains poor, and the molecular pathogenesis remains incompletely defined in HCC." | 1.39 | αB-crystallin complexes with 14-3-3ζ to induce epithelial-mesenchymal transition and resistance to sorafenib in hepatocellular carcinoma. ( Ding, ZB; Fan, J; Huang, XY; Ke, AW; Qiu, SJ; Shi, GM; Shi, YH; Wang, XY; Xiao, YS; Yan, J; Zhang, C; Zhang, X; Zhou, J, 2013) |
| "Sorafenib was well tolerated, with mostly grade 1/2 adverse events and no treatment-related deaths." | 1.38 | Sequential treatment with sorafenib and sunitinib in metastatic renal cell carcinoma: clinical outcomes from a retrospective clinical study. ( Andreadis, C; Bamias, A; Dimopoulos, M; Karadimou, A; Kontovinis, L; Laschos, K; Papazisis, K; Paraskevopoulos, P, 2012) |
| "Treatment with sorafenib resulted in more than 7 months of progression-free survival." | 1.38 | A rare case of metastatic pancreatic hepatoid carcinoma treated with sorafenib. ( Barbara, C; Barni, S; Cabiddu, M; Colombo, S; Corti, D; Elia, S; Ghilardi, M; Petrelli, F; Stringhi, E, 2012) |
| " Rates of adverse events (AEs) and treatment modifications were analyzed; reasons for treatment modifications were examined." | 1.38 | Safety and treatment patterns of angiogenesis inhibitors in patients with metastatic renal cell carcinoma: evidence from US community oncology clinics. ( Duh, MS; Feinberg, BA; Fortner, B; Gilmore, J; Jolly, P; Neary, MP; Scott, J; Wang, ST, 2012) |
| "Using a highly invasive hepatoma SK-Hep-1 cell line, we investigated the possible synergistic anti-metastatic efficacy of a combination of sorafenib (SF), a multi-kinase inhibitor, and β-ionone (BI), a precursor of carotenoids." | 1.38 | Synergistic effects of the combination of β-ionone and sorafenib on metastasis of human hepatoma SK-Hep-1 cells. ( Hu, ML; Huang, CS; Lyu, SC, 2012) |
| " Their baseline characteristics, radiologic response, adverse events, and survival status were assessed." | 1.38 | Efficacy and safety of vascular endothelial growth factor receptor tyrosine kinase inhibitors in patients with metastatic renal cell carcinoma and poor risk features. ( Ahn, H; Ahn, JH; Ahn, S; Ahn, Y; Hong, JH; Kim, CS; Kim, TW; Lee, JL; Park, I; Park, K; Park, S; Song, C, 2012) |
| "Although thyroid cancer usually has an excellent prognosis, few therapeutic options are available in the refractory setting." | 1.38 | Sorafenib in metastatic thyroid cancer. ( Capdevila, J; Corral, J; Grande, E; Grau, JJ; Halperin, I; Iglesias, L; Martínez-Trufero, J; Obiols, G; Segura, A; Tabernero, J; Vaz, MÁ, 2012) |
| "Here we present a man with pancreatic metastases from PTC, report our experience with sorafenib therapy, and discuss the role of endoscopic ultrasound (EUS)-guided biopsy in its diagnosis." | 1.38 | Pancreatic metastasis arising from a BRAF(V600E)-positive papillary thyroid cancer: the role of endoscopic ultrasound-guided biopsy and response to sorafenib therapy. ( Abalkhail, H; Al Sohaibani, F; Almanea, H; AlQaraawi, A; Alzahrani, AS, 2012) |
| "A retrospective, registry-based analysis to assess the outcomes of metastatic renal cell cancer (mRCC) patients treated with sunitinib and sorafenib who developed dermatologic adverse events was performed." | 1.38 | Skin toxicity and efficacy of sunitinib and sorafenib in metastatic renal cell carcinoma: a national registry-based study. ( Abrahamova, J; Bortlicek, Z; Buchler, T; Dusek, L; Melichar, B; Pavlik, T; Poprach, A; Puzanov, I; Vyzula, R, 2012) |
| "Thymoma and thymic carcinoma are rare neoplasms of the mediastinum, arising from the epithelial cells of the thymus." | 1.38 | Long lasting efficacy of sorafenib in a heavily pretreated patient with thymic carcinoma. ( Luyken, J; Neuhaus, T, 2012) |
| "Sorafenib is an orally administered multikinase inhibitor that blocks intracellular kinases in the Raf/MEK/ERK pathway involved in tumor proliferation, and also kinases responsible for angiogenesis, including VEGFr-2, VEGFr-3, Flt-3, PDGFr-β and c-KIT." | 1.37 | Sustained response following sorafenib therapy in an older adult patient with advanced renal cancer on hemodialysis: a case report. ( Bigatti, GL; Castagneto, B; Cosimi, MF; Giorcelli, L; Montefiore, F; Pisacco, P; Stevani, I, 2011) |
| "Surgical resection is the first-line treatment for hepatocellular carcinoma (HCC) patients with well-preserved liver function." | 1.37 | Sorafenib suppresses postsurgical recurrence and metastasis of hepatocellular carcinoma in an orthotopic mouse model. ( Cheng, SQ; Deng, YZ; Feng, YX; Guan, DX; Li, JJ; Li, N; Qin, Y; Wang, H; Wang, HY; Wang, T; Wang, XF; Wu, MC; Xie, D; Yang, P; Yao, F; Zhu, YQ, 2011) |
| "Temsirolimus appears to be an effective and well-tolerated substance in the treatment of patients with a good performance status, low MSKCC score and stable disease under previous antiangiogenic treatment in advanced renal cell cancer." | 1.37 | Efficacy of temsirolimus after previous treatment with sunitinib, sorafenib or everolimus in advanced renal cell cancer. ( Greil, R; Grundbichler, M; Kappacher, A; Mlineritsch, B; Moik, M; Ressler, S; Rosenlechner, S, 2011) |
| "Sorafenib was effective in Japanese patients with advanced renal cell carcinoma in general clinical practice and was tolerated although most patients required dose reduction or interruption of therapy." | 1.37 | Clinical outcome and prognostic factors of sorafenib in Japanese patients with advanced renal cell carcinoma in general clinical practice. ( Hara, T; Kajikawa, J; Kawashima, A; Meguro, N; Miyoshi, S; Nishimura, K; Nonomura, N; Oka, T; Takayama, H; Tanigawa, G; Yamaguchi, S; Yosioka, T, 2011) |
| "Sorafenib is a multikinase inhibitor that blocks tumor cell proliferation and angiogenesis and is used for the treatment of advanced renal cell carcinoma, unresectable hepatocellular carcinoma, and other solid tumors." | 1.36 | Sorafenib-induced psoriasiform eruption in a patient with metastatic thyroid carcinoma. ( Chon, SY; Diamantis, ML, 2010) |
| "Sorafenib was used in 13 and sunitinib in two, including one patient who failed prior sorafenib therapy." | 1.36 | Treatment with tyrosine kinase inhibitors for patients with differentiated thyroid cancer: the M. D. Anderson experience. ( Bronstein, Y; Busaidy, NL; Cabanillas, ME; Feng, L; Hernandez, M; Lopez, A; Sherman, SI; Waguespack, SG; Williams, MD, 2010) |
| "IKKbeta signaling in ovarian cancer regulated the transcription of genes involved in a wide range of cellular effects known to increase the aggressive nature of the cells." | 1.36 | Activation of NF-kappaB signaling by inhibitor of NF-kappaB kinase beta increases aggressiveness of ovarian cancer. ( Annunziata, CM; Birrer, MJ; Davidson, B; Hernandez, L; Hsu, SC; Kohn, EC, 2010) |
| "Patients with metastatic clear cell renal cell carcinoma with available baseline tumor samples who received vascular endothelial growth factor targeted therapy were included in analysis." | 1.35 | von Hippel-Lindau gene status and response to vascular endothelial growth factor targeted therapy for metastatic clear cell renal cell carcinoma. ( Bhalla, IP; Bukowski, RM; Choueiri, TK; Elson, P; Ganapathi, R; Golshayan, AR; Jaeger, E; Rini, BI; Sein, N; Sercia, L; Simko, J; Small, EJ; Vaziri, SA; Waldman, FM; Weinberg, V; Wood, L; Zhou, M, 2008) |
| "Metastatic renal cell carcinoma (mRCC) with sarcomatoid differentiation is an aggressive disease that is associated with poor outcomes to chemotherapy or immunotherapy." | 1.35 | Metastatic sarcomatoid renal cell carcinoma treated with vascular endothelial growth factor-targeted therapy. ( Aydin, H; Bukowski, RM; Elson, P; Garcia, JA; George, S; Golshayan, AR; Heng, DY; Mekhail, TM; Rini, BI; Wood, LS; Zhou, M, 2009) |
| "In this renal cell carcinoma population sorafenib followed by sunitinib was associated with longer survival than sunitinib followed by sorafenib." | 1.35 | Sequential sorafenib and sunitinib for renal cell carcinoma. ( Balleyguier, C; Celier, C; Escudier, B; Gautier, J; Medioni, J; Negrier, S; Oudard, S; Ravaud, A; Sablin, MP, 2009) |
| " The medication dosed at 400 mg twice daily is both efficacious and safe in the treatment of metastatic renal cell carcinoma in Chinese patients." | 1.35 | Efficacy of sorafenib on metastatic renal cell carcinoma in Asian patients: results from a multicenter study. ( Dai, B; Dong, B; Huang, Y; Lu, JJ; Shen, Y; Yao, X; Ye, D; Zhang, H; Zhang, S; Zhu, Y, 2009) |
| "Sorafenib is an oral Raf kinase inhibitor, approved for the treatment of advanced renal cancer." | 1.35 | Safety and efficacy of sorafenib therapy in patients with metastatic kidney cancer with impaired renal function. ( Heilbrun, L; Parsa, V; Sethi, A; Smith, D; Vaishampayan, U, 2009) |
| "Sorafenib is able to inhibit their signal transduction, both in vitro and in vivo, displaying anti-tumoural activity, anti-angiogenic effects, and reducing metastatic colony formation in lungs." | 1.35 | Sorafenib blocks tumour growth, angiogenesis and metastatic potential in preclinical models of osteosarcoma through a mechanism potentially involving the inhibition of ERK1/2, MCL-1 and ezrin pathways. ( Aglietta, M; Alberghini, M; Bottos, A; Bruno, S; Bussolino, F; Camussi, G; Cavalloni, G; Fagioli, F; Ferrari, S; Gammaitoni, L; Grignani, G; Migliardi, G; Motta, M; Picci, P; Pignochino, Y; Tapparo, M; Torchio, B, 2009) |
| "Malignant schwannomas or malignant peripheral nerve sheath tumors (MPNST) represent approximately 10% of all soft tissue sarcomas." | 1.35 | Metastatic chest wall malignant schwannoma responding to sorafenib: case report and literature review. ( Fenning, R; Gudena, V; Kizziah, M; Montero, AJ; Post, G; Verma, N, 2008) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 3 (1.20) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 42 (16.80) | 29.6817 |
| 2010's | 200 (80.00) | 24.3611 |
| 2020's | 5 (2.00) | 2.80 |
| Authors | Studies |
|---|---|
| Zhang, X | 3 |
| Moriwaki, T | 1 |
| Kawabata, T | 1 |
| Goto, S | 1 |
| Liu, KX | 1 |
| Guo, CY | 1 |
| Li, TS | 1 |
| Marafi, F | 1 |
| Sasikumar, A | 1 |
| Alfeeli, M | 1 |
| Thuruthel, S | 1 |
| Soeda, F | 2 |
| Watabe, T | 2 |
| Kato, H | 2 |
| Uemura, M | 2 |
| Nonomura, N | 3 |
| Naka, S | 1 |
| Ujike, T | 1 |
| Hatano, K | 1 |
| Sasaki, H | 1 |
| Kamiya, T | 1 |
| Shimosegawa, E | 1 |
| Cardinale, J | 1 |
| Tateishi, U | 1 |
| Giesel, FL | 1 |
| Ji, X | 1 |
| Wang, L | 6 |
| Lin, J | 1 |
| Tang, K | 1 |
| Cai, W | 3 |
| Zhang, J | 4 |
| Chen, Y | 5 |
| Kong, W | 3 |
| Huang, Y | 5 |
| Huang, J | 3 |
| Zhou, L | 4 |
| Gill, DM | 1 |
| Agarwal, N | 1 |
| Vaishampayan, U | 2 |
| Ishihara, H | 1 |
| Kondo, T | 1 |
| Tanabe, K | 1 |
| Yang, Y | 1 |
| Lin, H | 1 |
| Zhao, L | 1 |
| Song, Y | 2 |
| Gao, Q | 2 |
| Buchler, T | 4 |
| Poprach, A | 3 |
| Bortlicek, Z | 4 |
| Lakomy, R | 2 |
| Chloupková, R | 1 |
| Vyzula, R | 4 |
| Zemanova, M | 2 |
| Kopeckova, K | 1 |
| Svoboda, M | 2 |
| Slaby, O | 1 |
| Kiss, I | 2 |
| Studentova, H | 1 |
| Hornova, J | 1 |
| Fiala, O | 1 |
| Kopecky, J | 1 |
| Finek, J | 1 |
| Dusek, L | 3 |
| Melichar, B | 5 |
| Decker, T | 1 |
| Overkamp, F | 1 |
| Rösel, S | 1 |
| Nusch, A | 1 |
| Göhler, T | 1 |
| Indorf, M | 1 |
| Sahlmann, J | 1 |
| Trarbach, T | 1 |
| Dong, B | 3 |
| Xue, W | 2 |
| Bettinger, D | 1 |
| Spode, R | 1 |
| Glaser, N | 1 |
| Buettner, N | 1 |
| Boettler, T | 1 |
| Neumann-Haefelin, C | 1 |
| Brunner, TB | 1 |
| Gkika, E | 1 |
| Maruschke, L | 1 |
| Thimme, R | 1 |
| Schultheiss, M | 1 |
| Blomberg, M | 1 |
| He, SY | 1 |
| Harwood, C | 1 |
| Arron, ST | 1 |
| Demehri, S | 1 |
| Green, A | 1 |
| Asgari, MM | 1 |
| Zhang, K | 1 |
| Sun, X | 1 |
| Xie, F | 1 |
| Jian, W | 1 |
| Li, C | 2 |
| Zhu, H | 1 |
| Ma, X | 1 |
| Zhao, Y | 1 |
| Duo, J | 1 |
| Mai, HX | 1 |
| Mei, GH | 1 |
| Zhao, FL | 1 |
| Li, BT | 1 |
| Tang, YY | 1 |
| Zhang, B | 1 |
| Xu, XJ | 1 |
| Chen, LJ | 1 |
| Moreira, GA | 1 |
| Lima, GDA | 1 |
| Siqueira, RP | 1 |
| Barros, MVA | 1 |
| Adjanohoun, ALM | 1 |
| Santos, VC | 1 |
| Barbosa, ÉAA | 1 |
| Loterio, RK | 1 |
| Paiva, JC | 1 |
| Gonçalves, VHS | 1 |
| Viol, LCS | 1 |
| Marques-da-Silva, EA | 1 |
| Júnior, AS | 1 |
| Almeida, MR | 1 |
| Fietto, JLR | 1 |
| Machado-Neves, M | 1 |
| Ferreira, RS | 1 |
| Teixeira, RR | 1 |
| Bressan, GC | 1 |
| Takada, M | 1 |
| Yasui, T | 1 |
| Oka, T | 2 |
| Shioyama, W | 1 |
| Kuroda, T | 1 |
| Nakai, Y | 1 |
| Nishimura, K | 2 |
| Mukai, M | 1 |
| Fujita, M | 1 |
| Eckert, MA | 1 |
| Coscia, F | 1 |
| Chryplewicz, A | 1 |
| Chang, JW | 1 |
| Hernandez, KM | 1 |
| Pan, S | 1 |
| Tienda, SM | 1 |
| Nahotko, DA | 1 |
| Li, G | 1 |
| Blaženović, I | 1 |
| Lastra, RR | 1 |
| Curtis, M | 1 |
| Yamada, SD | 1 |
| Perets, R | 1 |
| McGregor, SM | 1 |
| Andrade, J | 1 |
| Fiehn, O | 1 |
| Moellering, RE | 1 |
| Mann, M | 1 |
| Lengyel, E | 1 |
| Procopio, G | 3 |
| Pignata, S | 1 |
| Altavilla, A | 1 |
| Attademo, L | 1 |
| De Lisi, D | 1 |
| Verzoni, E | 2 |
| De Giorgi, U | 2 |
| Santini, D | 1 |
| Zhang, QB | 4 |
| Sun, HC | 3 |
| Zhang, KZ | 2 |
| Jia, QA | 1 |
| Bu, Y | 1 |
| Wang, M | 1 |
| Chai, ZT | 2 |
| Wang, WQ | 3 |
| Kong, LQ | 3 |
| Zhu, XD | 3 |
| Lu, L | 3 |
| Wu, WZ | 3 |
| Tang, ZY | 3 |
| Levy, A | 1 |
| Menard, J | 1 |
| Albiges, L | 1 |
| Loriot, Y | 2 |
| Di Palma, M | 2 |
| Fizazi, K | 2 |
| Escudier, B | 7 |
| Shah, CH | 1 |
| Viktorsson, K | 1 |
| Sherif, A | 1 |
| Kanter, L | 1 |
| Grybäck, P | 1 |
| Lewensohn, R | 1 |
| Sandström, P | 1 |
| Nilsson, S | 1 |
| Ullén, A | 1 |
| Park, SJ | 1 |
| Lee, JL | 4 |
| Park, I | 3 |
| Park, K | 2 |
| Ahn, Y | 2 |
| Ahn, JH | 3 |
| Lee, DH | 2 |
| Ahn, S | 2 |
| Song, C | 3 |
| Hong, JH | 3 |
| Kim, CS | 3 |
| Ahn, H | 4 |
| Calvani, N | 1 |
| Morelli, F | 1 |
| Chiuri, V | 1 |
| Gnoni, A | 1 |
| Scavelli, C | 1 |
| Fedele, P | 1 |
| Orlando, L | 1 |
| Maiello, E | 1 |
| Lorusso, V | 1 |
| Cinieri, S | 1 |
| Zhang, W | 6 |
| Zhang, YY | 1 |
| Ao, JY | 1 |
| Li, JQ | 1 |
| Al-Marrawi, MY | 1 |
| Saroya, BS | 1 |
| Brennan, MC | 1 |
| Yang, Z | 1 |
| Dykes, TM | 1 |
| El-Deiry, WS | 1 |
| Antoun, S | 1 |
| Lanoy, E | 1 |
| Iacovelli, R | 2 |
| Albiges-Sauvin, L | 1 |
| Merad-Taoufik, M | 1 |
| Baracos, VE | 1 |
| Wen, W | 1 |
| Han, T | 1 |
| Chen, C | 1 |
| Huang, L | 2 |
| Sun, W | 2 |
| Wang, X | 3 |
| Chen, SZ | 1 |
| Xiang, DM | 1 |
| Tang, L | 1 |
| Cao, D | 1 |
| Feng, GS | 1 |
| Wu, MC | 2 |
| Ding, J | 1 |
| Wang, HY | 2 |
| Mina, LA | 1 |
| Yu, M | 1 |
| Johnson, C | 1 |
| Burkhardt, C | 1 |
| Miller, KD | 1 |
| Zon, R | 1 |
| Ikehata, Y | 1 |
| Takahashi, S | 1 |
| Kitamura, H | 1 |
| Masumori, N | 1 |
| Tsukamoto, T | 2 |
| Ikeda, M | 1 |
| Fujita, T | 1 |
| Amoh, Y | 1 |
| Mii, S | 1 |
| Matsumoto, K | 1 |
| Iwamura, M | 1 |
| Wu, W | 1 |
| Bi, C | 1 |
| Credille, KM | 1 |
| Manro, JR | 1 |
| Peek, VL | 1 |
| Donoho, GP | 1 |
| Yan, L | 2 |
| Wijsman, JA | 1 |
| Yan, SB | 1 |
| Walgren, RA | 1 |
| Nakamura, M | 1 |
| Yao, M | 1 |
| Sano, F | 1 |
| Sakata, R | 1 |
| Tatenuma, T | 1 |
| Makiyama, K | 1 |
| Nakaigawa, N | 1 |
| Kubota, Y | 1 |
| Stenzinger, A | 1 |
| Endris, V | 1 |
| Klauschen, F | 1 |
| Sinn, B | 1 |
| Lorenz, K | 1 |
| Warth, A | 1 |
| Goeppert, B | 1 |
| Ehemann, V | 1 |
| Muckenhuber, A | 1 |
| Kamphues, C | 1 |
| Bahra, M | 1 |
| Neuhaus, P | 1 |
| Weichert, W | 1 |
| Lee, S | 2 |
| Kim, BK | 1 |
| Kim, SU | 1 |
| Park, Y | 1 |
| Chang, S | 1 |
| Park, JY | 1 |
| Kim, DY | 1 |
| Ahn, SH | 1 |
| Chon, CY | 1 |
| Han, KH | 1 |
| Guy, L | 1 |
| Bay, JO | 1 |
| Bastide, C | 1 |
| Mahammedi, H | 1 |
| Bruyere, F | 1 |
| Karsenty, G | 1 |
| Chow, AK | 1 |
| Ng, L | 1 |
| Lam, CS | 1 |
| Wong, SK | 1 |
| Wan, TM | 1 |
| Cheng, NS | 1 |
| Yau, TC | 1 |
| Poon, RT | 2 |
| Pang, RW | 1 |
| Pavlik, T | 3 |
| Kubackova, K | 2 |
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| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| Randomised Phase II Study of Paclitaxel Alone Versus Paclitaxel Plus Sorafenib in Second- or Third-line Treatment of Patients With Metastatic Breast Cancer[NCT01320111] | Phase 2 | 59 participants (Actual) | Interventional | 2010-07-01 | Completed | ||
| A Prospective Randomized Control Trial of the Effect of Sorafenib Combined With Aspirin in Preventing the Recurrence in High-risk Patients With Hepatocellular Carcinoma[NCT02748304] | 52 participants (Actual) | Interventional | 2016-04-30 | Terminated (stopped due to The enrollment of this study was slow. With the approval of lenvatinib in HCC,many patients choose the new drug, so subsequent enrollment may be more difficult.) | |||
| A Phase II Study of Combined VEGF Inhibitor (Bevacizumab + Sorafenib) in Patients With Metastatic Breast Cancer: Hoosier Oncology Group BRE06-109[NCT00632541] | Phase 2 | 18 participants (Actual) | Interventional | 2007-10-31 | Terminated (stopped due to Significant Toxicities Experienced) | ||
| Phase I/II Vinorelbine and Sorafenib as Salvage Therapy in Metastatic Breast Cancer[NCT00828074] | Phase 1/Phase 2 | 46 participants (Actual) | Interventional | 2008-11-30 | Completed | ||
| An Open-label, Randomized, Multi-center, Phase III Study to Compare the Safety and Efficacy of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma After Failure of Anti-angiogenic (VEGF-targeted and mTOR Inhibitor) Therapies[NCT01223027] | Phase 3 | 564 participants (Actual) | Interventional | 2011-03-31 | Completed | ||
| A Randomized, Open-label, Multi-center Phase II Study to Compare Bevacizumab Plus Sorafenib Versus Sorafenib for the Third-line Treatment of Patients With Metastatic Renal Cell Carcinoma[NCT02330783] | Phase 2 | 106 participants (Anticipated) | Interventional | 2014-12-31 | Recruiting | ||
| Evaluation of Cognitive Function of Patients Treated With Sunitinib or Sorafenib[NCT01246843] | 50 participants (Anticipated) | Observational | 2009-07-31 | Completed | |||
| A Phase II Trial of BAY86-9766 Plus Sorafenib as First Line Systemic Treatment for Hepatocellular Carcinoma (HCC)[NCT01204177] | Phase 2 | 70 participants (Actual) | Interventional | 2010-12-31 | Completed | ||
| Phase II Trial of Sorafenib for Patients With Metastatic or Recurrent Esophageal and Gastroesophageal Junction Cancer[NCT00917462] | Phase 2 | 35 participants (Actual) | Interventional | 2009-06-30 | Completed | ||
| Sorafenib Plus Capecitabine Efficacy Assessment in Patients With Advanced Pre-treated Colorectal Cancer[NCT01290926] | Phase 2 | 97 participants (Actual) | Interventional | 2011-02-28 | Completed | ||
| Randomized, Double-blind Phase 2 Study Of Axitinib (Ag-013736) With Or Without Dose Titration In Patients With Metastatic Renal Cell Carcinoma[NCT00835978] | Phase 2 | 213 participants (Actual) | Interventional | 2009-08-31 | Completed | ||
| Phase II Study Of Single-Agent SU011248 In The Second-Line Treatment Of Patients With Metastatic Renal Cell Carcinoma[NCT00054886] | Phase 2 | 63 participants | Interventional | 2003-01-31 | Completed | ||
| AG-013736 (AXITINIB) FOR THE TREATMENT OF METASTATIC RENAL CELL CANCER[NCT00920816] | Phase 3 | 492 participants (Actual) | Interventional | 2009-08-25 | Completed | ||
| A Phase 2 Efficacy And Safety Study Of SU011248 Administered In A Continuous Daily Regimen In Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma[NCT00137423] | Phase 2 | 107 participants (Actual) | Interventional | 2005-05-31 | Completed | ||
| Phase 3b, Randomized, Open-Label Study Of Bevacizumab + Temsirolimus Vs. Bevacizumab + Interferon-Alfa As First-Line Treatment In Subjects With Advanced Renal Cell Carcinoma[NCT00631371] | Phase 3 | 791 participants (Actual) | Interventional | 2008-04-30 | Completed | ||
| AXITINIB (AG-013736) AS SECOND LINE THERAPY FOR METASTATIC RENAL CELL CANCER: AXIS TRIAL[NCT00678392] | Phase 3 | 723 participants (Actual) | Interventional | 2008-09-03 | Completed | ||
| A Phase II Efficacy And Safety Study Of Sunitinib Malate (SU011248) Administered In A Continuous Daily Regimen In Patients With Advanced (First-Line) Renal Cell Cancer[NCT00338884] | Phase 2 | 120 participants (Actual) | Interventional | 2006-09-30 | Completed | ||
| A Randomized Trial Of Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced Renal Cell Carcinoma Who Have Failed First-Line Sunitinib Therapy[NCT00474786] | Phase 3 | 512 participants (Actual) | Interventional | 2007-09-30 | Completed | ||
| A Randomized Phase II Study Of The Efficacy And Safety Of Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (Renal EFFECT Trial)[NCT00267748] | Phase 2 | 317 participants (Actual) | Interventional | 2005-12-31 | Completed | ||
| A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma[NCT00077974] | Phase 2 | 106 participants (Actual) | Interventional | 2004-02-29 | Completed | ||
| A Phase 3, Randomized Study Of SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma[NCT00083889] | Phase 3 | 750 participants (Actual) | Interventional | 2004-08-31 | Completed | ||
| A Phase 3, Three-Arm, Randomized, Open-Label Study Of Interferon Alfa Alone, CCI-779 Alone, And The Combination Of Interferon Alfa And CCI-779 In First-Line Poor-Prognosis Subjects With Advanced Renal Cell Carcinoma.[NCT00065468] | Phase 3 | 626 participants (Actual) | Interventional | 2003-07-31 | Completed | ||
| An Open-label, Prospective Study of Tumor Response Time of Palbociclib in Combination With AI in Real-world First-line Treatment of Postmenopausal Chinese Patients With ER (+) HER2 (-) Metastatic Breast Cancer[NCT04858997] | Phase 2 | 150 participants (Anticipated) | Interventional | 2021-04-22 | Recruiting | ||
| A Prospective Cohort Study of Single Agent Memantine in Patients With Child-Pugh Score ≥ B7 Cirrhosis and Hepatocellular Carcinoma[NCT06007846] | Phase 2/Phase 3 | 12 participants (Anticipated) | Interventional | 2023-07-31 | Recruiting | ||
| Phase I/II Randomized Trial of Sorafenib and Bevacizumab as First-Line Therapy in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma[NCT00867321] | Phase 1/Phase 2 | 24 participants (Actual) | Interventional | 2009-04-30 | Completed | ||
| A Phase IB/II Trial of Combination of Vinorelbine With Sorafenib (BAY 43-9006) as First-Line Treatment in Patients With Metastatic Breast Cancer[NCT00764972] | Phase 1/Phase 2 | 36 participants (Anticipated) | Interventional | 2007-10-31 | Recruiting | ||
| A Phase II Study of BAY 43-9006 (Sorafenib) in Metastatic, Androgen-Independent Prostate Cancer[NCT00090545] | Phase 2 | 46 participants (Actual) | Interventional | 2004-09-01 | Completed | ||
| A Randomised, Open-label, Multi-centre Phase II Study of BAY43-9006 (Sorafenib) Versus Standard Treatment With Interferon Alpha-2a in Patients With Unresectable and/or Metastatic Renal Cell Carcinoma.[NCT00117637] | Phase 2 | 189 participants (Actual) | Interventional | 2005-06-30 | Completed | ||
| A Phase II Multicenter Uncontrolled Trial of BAY43-9006 in Subjects With Metastatic Breast Cancer.[NCT00101400] | Phase 2 | 54 participants (Actual) | Interventional | 2004-02-29 | Completed | ||
| Clinical Evaluation of Neoadjuvant Chemotherapy for Primary Malignant Sarcomas That Originate in Bone: a Multi-center Retrospective Study for Standardization and Modification of Response Evaluation Criteria[NCT03742063] | 190 participants (Actual) | Observational | 2017-06-01 | Completed | |||
| A Phase II Study to Evaluate Overall Response Rate of BAY 43-9006 (Sorafenib) Combined With Docetaxel and Cisplatin or Oxaliplatin in the Treatment of Metastatic or Advanced Unresectable Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma[NCT00253370] | Phase 2 | 44 participants (Actual) | Interventional | 2005-10-31 | Completed | ||
| Pazopanib With 5-Fluorouracil, Leucovorin and Oxaliplatin (FLO) as 1st-line Treatment in Advanced Gastric Cancer; a Randomized Phase-II-study of the Arbeitsgemeinschaft Internistische Onkologie[NCT01503372] | Phase 2 | 75 participants (Actual) | Interventional | 2011-11-30 | Completed | ||
| A Randomized, Multicenter, Open-label, Phase II Study of the Optimal Scheme of Administration of Pazopanib in Thyroid Carcinoma[NCT01813136] | Phase 2 | 168 participants (Actual) | Interventional | 2013-03-31 | Completed | ||
| Cabozantinib in Patients With Advanced Penile Squamous Cell Carcinoma (PSCC): an Open-label, Single-center, Phase 2, Single-arm Trial (CaboPen)[NCT03943602] | Phase 2 | 37 participants (Anticipated) | Interventional | 2019-08-01 | Recruiting | ||
| A Phase II Study of BAY 43-9006 (NSC 724772) in Unresectable Stage III and IV Melanoma (IND 69,869)[NCT00119249] | Phase 2 | 74 participants (Anticipated) | Interventional | 2005-06-30 | Completed | ||
| A Randomized Phase 2 Trial of Double-Blind, Placebo Controlled AMG 706 in Combination With Paclitaxel, or Open-Label Bevacizumab in Combination With Paclitaxel, as First Line Therapy in Women With HER2 Negative Locally Recurrent or Metastatic Breast Cance[NCT00356681] | Phase 2 | 282 participants (Actual) | Interventional | 2006-12-31 | Terminated (stopped due to Sponsor decision to close study) | ||
| A Phase II, Multi-center, Open-label, Uncontrolled Study to Evaluate the Efficacy and Safety of BAY 43-9006 Given Daily in Combination With Repeated 21-Day Cycles of Dacarbazine (DTIC) Chemotherapy in Subjects With Advanced Metastatic Melanoma.[NCT00492297] | Phase 2 | 83 participants (Actual) | Interventional | 2005-04-30 | Completed | ||
| A Double-Blind Randomized Phase III Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer[NCT00984282] | Phase 3 | 417 participants (Actual) | Interventional | 2009-10-15 | Completed | ||
| An Exploratory Study of Sorafenib Plus Toripalimab for Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus[NCT04069949] | Phase 1/Phase 2 | 39 participants (Anticipated) | Interventional | 2019-12-01 | Not yet recruiting | ||
| A Randomized, Double-blinded, Placebo-controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma[NCT00492752] | Phase 3 | 226 participants (Actual) | Interventional | 2005-10-31 | Completed | ||
| Phase II Trial of BAY 43-9006 (Sorafenib; NSC-724772) in Combination With Carboplatin and Paclitaxel in Patients With Metastatic Uveal Melanoma[NCT00329641] | Phase 2 | 25 participants (Actual) | Interventional | 2011-02-28 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
The primary objective was to assess the Progression-Free Survival of sorafenib combined with bevacizumab in patients with metastatic breast cancer. Progression is defined by RECIST as a 20% increase in the sum of the longest diameters of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) or by the appearance of a new lesion. (NCT00632541)
Timeframe: From the start of the treatment until the criteria for disease progression is met (or death occurs) maximum of 24 months
| Intervention | months (Median) |
|---|---|
| Single Arm A | 2.8 |
Dose Limiting Toxicity (DLT) defined as any treatment-related grade 3 or greater non-hematologic toxicity (excluding alopecia, controllable nausea and vomiting, and serum triglycerides < 1,500 mg/dL which recover within 1 week), grade 4 or greater thrombocytopenia, grade 4 or greater febrile neutropenia requiring hospitalization, or treatment delay of > 2 weeks as a result of unresolved toxicity during the first cycle of therapy. (NCT00828074)
Timeframe: 4 weeks from start of treatment, up to 2 years
| Intervention | participants with DLTs (Number) |
|---|---|
| Phase I: Dose Level 1 - Vinorelbine at 20mg/m^2 | 0 |
| Phase I: Dose Level 2 - Vinorelbine at 25mg/m^2 | 3 |
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response Rate defined as percentage of patients achieving a Best Response of either CR or PR. (NCT00828074)
Timeframe: After 2 cycles of treatment, up to 2 years.
| Intervention | percentage of participants (Number) |
|---|---|
| Dose Level II - Vinorelbine 20 mg/m^2 | 10 |
Estimated using the product-limit method of Kaplan and Meier. (NCT00828074)
Timeframe: Until death from any cause, up to 5 years.
| Intervention | Months (Median) |
|---|---|
| Dose Level II - Vinorelbine 20 mg/m^2 | 15.4 |
Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT00828074)
Timeframe: Until disease progression, up to 5 years.
| Intervention | Months (Median) |
|---|---|
| Dose Level II - Vinorelbine 20 mg/m^2 | 4.1 |
Estimated using the product-limit method of Kaplan and Meier.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT00828074)
Timeframe: 4 months following the last course of treatment
| Intervention | percentage of participants (Number) |
|---|---|
| Dose Level II - Vinorelbine I.V. 20 mg/m^2 | 44 |
The maximum tolerated dose (MTD) of Vinorelbine is based on toxicities observed during the first cycle and is defined as the highest dose tested in which fewer than 33% of patients experience an attributable DLT to the study drug, when at least 6 patients are treated at that dose and are evaluable for toxicity. Dose escalations proceeded according to a standard 3+3 design. (NCT00828074)
Timeframe: 4 weeks from start of treatment, up to 2 years
| Intervention | mg/m^2 (Number) |
|---|---|
| Phase I | 20 |
Number of Participants with Treatment-Related Grade 3 & 4 Toxicities for Sorafenib and Vinorelbine Combination (NCT00828074)
Timeframe: 28 days following the last course of treatment
| Intervention | participants (Number) | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Anemia | Leukopenia | Neutropenia | Thrombocytopenia | Alkalosis | Cellulitis | Cough | Diarrhea | Fatigue | Genital abscess | Hand-foot toxicity | Hiccups | High glucose level | Hypertension | Hypokalemia | Hyponatremia | Infection (NOS) | Low phosphate | Pulmonary embolus | Myalgia | Pain (NOS) | Phlebitis | Sensory neuropathy | Somnolence | Transaminases/alkaline | Urinary tract infection | |
| Phase I & II | 2 | 16 | 16 | 1 | 1 | 1 | 1 | 3 | 5 | 1 | 7 | 1 | 1 | 3 | 1 | 2 | 1 | 3 | 1 | 1 | 3 | 1 | 1 | 1 | 1 | 1 |
Overall survival (OS) was the key secondary endpoint and was defined as the time from date of randomization to the date of death due to any cause. If a patient was not known to have died, survival was censored on the date of last contact. (NCT01223027)
Timeframe: until at least 386 deaths are documented in the clinical database.
| Intervention | Months (Median) |
|---|---|
| Dovitinib + Best Supportive Care (BSC) | 11.1 |
| Sorafenib + BSC | 11.0 |
The EORTC QLQ-C30 contains 30 items and is composed of both multi-item scales and single-item measures. These include five functional scales (physical, role, emotional, social and cognitive functioning), three symptom scales (fatigue, pain, nausea, and vomiting), a global health status/QoL scale, and six single items (dyspnea, diarrhea, constipation, anorexia, insomnia and financial impact). Each of the multiitem scales includes a different set of items - no item occurs in more than one scale. Each item in the EORTC QLQ-C30 has 4 response categories (1=Not at all, 2= A little, 3= Quite a bit, 4= Very much) with the higher number representing a worse outcome. (NCT01223027)
Timeframe: from date of randomization
| Intervention | Months (Median) |
|---|---|
| Dovitinib + Best Supportive Care (BSC) | 3.8 |
| Sorafenib + BSC | 5.6 |
The EORTC QLQ-C30 contains 30 items and is composed of both multi-item scales and single-item measures. These include five functional scales (physical, role, emotional, social and cognitive functioning), three symptom scales (fatigue, pain, nausea, and vomiting), a global health status/QoL scale, and six single items (dyspnea, diarrhea, constipation, anorexia, insomnia and financial impact). Each of the multiitem scales includes a different set of items - no item occurs in more than one scale. Each item in the EORTC QLQ-C30 has 4 response categories (1=Not at all, 2= A little, 3= Quite a bit, 4= Very much) with the higher number representing a worse outcome. (NCT01223027)
Timeframe: from date of randomization
| Intervention | Months (Median) |
|---|---|
| Dovitinib + Best Supportive Care (BSC) | 3.7 |
| Sorafenib + BSC | 4.5 |
The Kidney Cancer Symptom Index - Disease Related Symptoms (FKSI-DRS) is a validated symptom scale used in studies of patients with kidney cancer. It includes 9-items that assess pain, bone pain, fatigue, lack of energy, shortness of breath, fevers, weight loss, coughing, and blood in urine and responses to each question are answered on a 5-point Likert-type scale ranging from 0 to 4 (e.g., 0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). FKSI-DRS scores range from 0 to 36, where higher scores correspond to better outcomes (eg, fewer symptoms). (NCT01223027)
Timeframe: from date of randomization, at least 2 score units
| Intervention | Months (Median) |
|---|---|
| Dovitinib + Best Supportive Care (BSC) | 4.9 |
| Sorafenib + BSC | 6.4 |
Overall response rate (ORR) was defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR). Best overall esponse (BOR) for each patient was determined from the sequence of overall (lesion) responses according to the following rules: CR = at least two determinations of CR at least 4 weeks apart before progression where confirmation required or one determination of CR prior to progression where confirmation not required. CR = at least two determinations of CR at least 4 weeks apart before progression where confirmation required or one determination of CR prior to progression where confirmation not required. SD = at least one SD assessment (or better) > 6 weeks after randomization (and not qualifying for CR or PR). PD = progression ≤ 17 weeks after randomization (and not qualifying for CR, PR or SD). (NCT01223027)
Timeframe: Until disease progression or discontinuation of treatment due to unacceptable toxicity
| Intervention | Percentage of Participants (Number) |
|---|---|
| Dovitinib + Best Supportive Care (BSC) | 3.9 |
| Sorafenib + BSC | 3.8 |
Assessed according to RECIST 1.1. PFS was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause. If a patient had not progressed or died, on the date of the analysis cut-off or when he/she received any further anti-neoplastic therapy, PFS was censored on the date of last tumor assessment before the cutoff date or the anti-neoplastic therapy date. The distribution of PFS was estimated using the Kaplan-Meier method. The median PFS along with 95% confidence intervals was presented by treatment group. (NCT01223027)
Timeframe: Until disease progression or discontinuation of treatment due to unacceptable toxicity up to 30-Jun-2014 (discontinuation)
| Intervention | Months (Median) |
|---|---|
| Dovitinib + Best Supportive Care (BSC) | 3.7 |
| Sorafenib + BSC | 3.6 |
PFS was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause. The primary analysis for PFS (based on central review) was also to be repeated on FAS considering the Investigator assessments and using the same analytical conventions as the primary analysis. (NCT01223027)
Timeframe: Until disease progression or discontinuation of treatment due to unacceptable toxicity
| Intervention | Months (Median) |
|---|---|
| Dovitinib + Best Supportive Care (BSC) | 3.9 |
| Sorafenib + BSC | 3.9 |
Time to definitive worsening of Karnofsky performance status (KPS) was defined as the time from date of randomization to the date of definitive worsening of KPS or to the date of death whichever occurred earlier. Definitive worsening was defined as a definitive decrease in performance status by at least one Karnofsky category (i.e. at least 10 points less) compared to Baseline. Worsening was considered definitive if no later increase above the defined threshold was observed within the course of the study. A single measure reporting a decrease in Karnofsky performance status was sufficient to consider it as definitive only if it was the last one available for this patient. Time to definitive worsening of KPS was analyzed at the time of the final analysis for PFS. (NCT01223027)
Timeframe: from date of randomization to the date of definitive worsening of KPS or to the date of death whichever occurred earlier
| Intervention | Months (Median) |
|---|---|
| Dovitinib + Best Supportive Care (BSC) | 5.1 |
| Sorafenib + BSC | 5.7 |
Predose concentrations of dovitinib were summarized by visit using PAS. All concentration data was listed by patient and time point using FAS. Mean pre-dose concentrations along with standard deviation (SD) was plotted over time if appropriate. (NCT01223027)
Timeframe: Week 2 Day 5, Week 4 Day 5, Week 6 Day 5
| Intervention | ng/ml (Mean) | ||
|---|---|---|---|
| Week 2 Day 5 (n: 205) | Week 4 Day 5 (n: 202) | Week 6 Day 5 (n: 170) | |
| Dovitinib + Best Supportive Care (BSC) | 128.06 | 114.08 | 118.27 |
(NCT00917462)
Timeframe: every week while on study
| Intervention | Participants (Count of Participants) |
|---|---|
| Sorafenib | 35 |
(NCT00917462)
Timeframe: anytime prior to enrollment or during protocol therapy
| Intervention | % of tumors with high pERK expression (Number) |
|---|---|
| Sorafenib | 65 |
Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Clearance is defined as the volume of blood from which drug can be completely removed per unit of time. CL/F for steady-state axitinib was evaluated on Cycle 2 Day 15. (NCT00835978)
Timeframe: C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose
| Intervention | L/hr (Geometric Mean) |
|---|---|
| Active Titration Arm | 54.15 |
| Placebo Titration Arm | 61.93 |
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vz/F is influenced by the fraction absorbed. Vz/F for steady-state axitinb was evaluated on Cycle 2 Day 15. (NCT00835978)
Timeframe: C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose
| Intervention | L (Geometric Mean) |
|---|---|
| Active Titration Arm | 158.18 |
| Placebo Titration Arm | 216.62 |
Area under the plasma concentration time-curve from zero 24 hours[AUC(0-24). AUC(0-24) for steady-state axitinib was evaluated on Cycle 2 Day 15. Results were normalized to axitinib 7 mg dose for active titration arm and axitinib 5 mg dose for placebo titration arm. (NCT00835978)
Timeframe: C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose
| Intervention | ng.hr/mL (Geometric Mean) |
|---|---|
| Active Titration Arm | 258.68 |
| Placebo Titration Arm | 161.38 |
Area under the plasma concentration time-curve from zero to the last measurable concentration (AUClast). AUClast for steady-state axitinib was evaluated on Cycle 2 Day 15. Results were normalized to axitinib 7 mg dose for active titration arm and axitinib 5 mg dose for placebo titration arm. (NCT00835978)
Timeframe: C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose
| Intervention | ng.hr/mL (Geometric Mean) |
|---|---|
| Active Titration Arm | 105.33 |
| Placebo Titration Arm | 78.44 |
DR was defined as the time from the first documentation of objective tumor response (complete response - CR or Partial response - PR) to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. The median values were estimated based on Kaplan-Meier method. 95% confidence interval was based on the Brookmeyer and Crowley method. (NCT00835978)
Timeframe: Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks
| Intervention | Months (Median) |
|---|---|
| Active Titration Arm | NA |
| Placebo Titration Arm | 21.2 |
| Non-randomized Arm | 23.3 |
Cmax for steady-state axitinib was evaluated on Cycle 2 Day 15. Results were normalized to axitinib 7 mg dose for active titration arm and axitinib 5 mg dose for placebo titration arm. Results were normalized to axitinib 7 mg dose for active titration arm and axitinib 5 mg dose for placebo titration arm. (NCT00835978)
Timeframe: Cycle 2 Day 15 (C2D15): pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose
| Intervention | ng/mL (Geometric Mean) |
|---|---|
| Active Titration Arm | 31.74 |
| Placebo Titration Arm | 23.05 |
ORR was defined as the proportion of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as complete disappearance of all target lesions and non-target disease. No new lesions. PR was defined as >=30% decrease on study under baseline of the sum of longest diameters of all target lesions. No unequivocal progression of non-target disease. No new lesions. (NCT00835978)
Timeframe: Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks.
| Intervention | Percentage of Participants (Number) |
|---|---|
| Active Titration Arm | 53.6 |
| Placebo Titration Arm | 33.9 |
| Non-randomized Arm | 59.3 |
| All Participants | 48.4 |
OS was defined as the time from date of the first dose of the study medication to date of death due to any cause. For participants who did not die, their survival times were to be censored at the last date they were known to be alive. (NCT00835978)
Timeframe: Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks.
| Intervention | Months (Median) |
|---|---|
| Active Titration Arm (FA Population) | 42.7 |
| Placebo Titration Arm (FA Population) | 30.4 |
| Non-randomized Arm (SA Population) | 41.6 |
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Plasma decay half life for steady-state axitinib was evaluated on Cycle 2 Day 15. (NCT00835978)
Timeframe: C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose
| Intervention | hr (Mean) |
|---|---|
| Active Titration Arm | 2.48 |
| Placebo Titration Arm | 2.81 |
The time from first dose administration to first documentation of objective tumor progression or to death due to any cause. PFS in each arm was assessed using the Kaplan-Meier method and estimates of the PFS curves from the Kaplan-Meier method were presented. (NCT00835978)
Timeframe: Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks.
| Intervention | Months (Median) |
|---|---|
| Active Titration Arm | 14.5 |
| Placebo Titration Arm | 15.7 |
| Non-randomized Arm | 16.6 |
| All Participants | 14.6 |
Tmax for steady-state axitinib was evaluated on Cycle 2 Day 15. (NCT00835978)
Timeframe: C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose
| Intervention | hrs (Median) |
|---|---|
| Active Titration Arm | 2.04 |
| Placebo Titration Arm | 2.00 |
Value at respective visit minus value at baseline. (NCT00835978)
Timeframe: At screening (D-14 to D-1); lead-in period: Cycle 1 - Day 1 and Day 15; Cycle 2 - Day 1 and Day 15; Cycle 3 & subsequent cycles Day 1; end of study and follow-up 28 days after last dose.
| Intervention | mmHg (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Cycle 1 Day 1 (n=52,51,73) | Cycle 1 Day 15 (n=56,56,91) | Cycle 2 Day 1 (n=56,56,91) | Cycle 2 Day 15 (n=55,55,86) | Cycle 3 Day 1 (n=48,49,84) | Cycle 4 Day 1 (n=45,48,79) | End of treatment (n=35,44,51) | Follow-up (n=16,25,36) | |
| Active Titration Arm | -1.6 | 4.8 | 4.2 | 5.5 | 6.6 | 7.4 | 0.6 | -4.5 |
| Non-randomized Arm | 0.5 | 11.5 | 10.5 | 9.7 | 9.1 | 8.7 | 3.0 | 1.8 |
| Placebo Titration Arm | -2.6 | 3.0 | 3.5 | 4.4 | 5.9 | 4.6 | 3.5 | -1.3 |
Value at respective visit minus value at baseline (NCT00835978)
Timeframe: At screening (D-14 to D-1); lead-in period: Cycle 1 - Day 1 and Day 15; Cycle 2 - Day 1 and Day 15; Cycle 3 & subsequent cycles Day 1; end of study and follow-up 28 days after last dose.
| Intervention | mmHg (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Cycle 1 Day 1 (n=52,51,73) | Cycle 1 Day 15 (n=56,56,91) | Cycle 2 Day 1 (n=56,56,91) | Cycle 2 Day 15 (n=55,55,86) | Cycle 3 Day 1 (n=48,49,84) | Cycle 4 Day 1 (n=45,48,79) | End of treatment (n=35,44,51) | Follow-up (n=16,25,36) | |
| Active Titration Arm | -4.3 | 3.8 | 1.9 | 3.6 | 3.5 | 4.3 | 2.4 | -3.6 |
| Non-randomized Arm | -1.8 | 11.5 | 9.9 | 5.9 | 5.2 | 5.5 | -2.8 | -0.6 |
| Placebo Titration Arm | -2.9 | 4.1 | 0.9 | 2.7 | 8.4 | 3.5 | 1.7 | -0.4 |
CECs are noninvasive marker of vascular damage, remodeling, and dysfunction. Samples were collected and following proteins were analyzed: CD31+/CD146+ CECs, CD31+/CD146+ MFI PDGFR-beta, CD31+/CD146+ MFI pPDGFR-beta, CD31+/CD146+ pVEGFR, CD31+/CD146+ MFI VEGFR. The ratio of plasma levels of the biomarkers at the selected time point vs baseline is reported. (NCT00835978)
Timeframe: At baseline - Beginning of the lead-in period (Cycle 1 Day 1)
| Intervention | Fluorescent Intensity Unit (FIU) (Mean) | ||||
|---|---|---|---|---|---|
| Baseline CECs Count (n=17,22,20) | Baseline MFI PDGFR-BETA (n=17,21,20) | Baseline MFI pPDGFR-BETA (n=17,21,20) | Baseline MFI pVEGFR (n=17,22,20) | Baseline MFI VEGFR (n=17,22,20) | |
| Active Titration Arm | 74668 | 333760 | 380139 | 385617 | 330333 |
| Non-randomized Arm | 77437 | 442642 | 383202 | 380184 | 359097 |
| Placebo Titration Arm | 76258 | 380886 | 355441 | 352644 | 401909 |
CECs are noninvasive marker of vascular damage, remodeling, and dysfunction. Samples were collected and following proteins were analyzed: CD146+/CD105+ CECs, CD146+/CD105+ mean fluorescence intensity (MFI) platelet derived growth factor receptor (PDGFR)-beta, CD146+/CD105+ MFI phospho-PDGFR (pPDGFR)-beta, CD146+/CD105+ phospho-Vascular endothelial growth factor receptor (pVEGFR), CD146+/CD105+ MFI VEGFR. The ratio of plasma levels of the biomarkers at the selected time point vs baseline is reported. (NCT00835978)
Timeframe: At baseline - Beginning of the lead-in period (Cycle 1 Day 1)
| Intervention | Fluorescent Intensity Unit (FIU) (Mean) | ||||
|---|---|---|---|---|---|
| Baseline CECs Count (n=17,22,20) | Baseline MFI PDGFR-BETA (n=17,22,20) | Baseline MFI pPDGFR-BETA (n=17,22,20) | Baseline MFI pVEGFR (n=16,22,20) | Baseline MFI VEGFR (n=16,22,20) | |
| Active Titration Arm | 23584 | 346815 | 401226 | 456086 | 367799 |
| Non-randomized Arm | 29663 | 327567 | 397672 | 398754 | 359092 |
| Placebo Titration Arm | 28544 | 455238 | 395509 | 436197 | 473290 |
CECs are noninvasive marker of vascular damage, remodeling, and dysfunction. Samples were collected and following proteins were analyzed: CD31+/CD146+ CECs, CD31+/CD146+ MFI PDGFR-beta, CD31+/CD146+ MFI pPDGFR-beta, CD31+/CD146+ pVEGFR, CD31+/CD146+ MFI VEGFR. The ratio of plasma levels of the biomarkers at the selected time point vs baseline is reported. (NCT00835978)
Timeframe: At end of the lead-in period (Cycle 1 Day 15), Cycle 2 Day 15 and End of therapy (EOT)
| Intervention | Ratio (Mean) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C1D15:C1D1 CECs Count (n=11,18,14) | C2D15:C1D1 CECs Count (n=13,16,11) | EOT:C1D1 CECs COUNT (n=7,9,4) | C1D15:C1D1 MFI PDGFRBETA (n=11,15,13) | C2D15:C1D1 MFI PDGFRBETA (n=13,14,11) | EOT:C1D1 MFI PDGFRBETA (n=6,8,4) | C1D15:C1D1 MFI pPDGFR-BETA (n=11,15,13) | C2D15:C1D1 MFI pPDGFR-BETA (n=13,14,11) | EOT:C1D1 MFI pPDGFRBETA (n=6,8,4) | C1D15:C1D1 MFI pVEGFR (n=11,18,14) | C2D15:C1D1 MFI pVEGFR (n=13,16,10) | EOT:C1D1 MFI pVEGFR (n=7,9,4) | C1D15:C1D1 MFI VEGFR (n=11,18,14) | C2D15:C1D1 MFI VEGFR n=13,16,10) | EOT:C1D1 MFI VEGFR (n=7,9,4) | |
| Active Titration Arm | 2.7 | 1.4 | 1.5 | 1.2 | 1.4 | 1.2 | 1.2 | 1.2 | 0.7 | 1.1 | 1.2 | 0.7 | 1.3 | 1.5 | 1.2 |
| Non-randomized Arm | 1.5 | 2.5 | 0.6 | 0.8 | 2.2 | 1.7 | 1.0 | 1.1 | 3.0 | 1.2 | 1.3 | 3.1 | 1.0 | 2.1 | 1.5 |
| Placebo Titration Arm | 1.6 | 2.2 | 1.4 | 1.3 | 1.1 | 0.6 | 1.4 | 0.8 | 0.8 | 1.4 | 0.9 | 1.1 | 1.3 | 1.2 | 1.1 |
CECs are noninvasive marker of vascular damage, remodeling, and dysfunction. Samples were collected and following proteins were analyzed: CD146+/CD105+ CECs, CD146+/CD105+ MFI platelet derived growth factor receptor (PDGFR)-beta, CD146+/CD105+ MFI phospho-PDGFR (pPDGFR)-beta, CD146+/CD105+ phospho-VEGFR (pVEGFR), CD146+/CD105+ MFI VEGFR. The ratio of plasma levels of the biomarkers at the selected time point vs baseline is reported. (NCT00835978)
Timeframe: At end of the lead-in period (Cycle 1 Day 15), Cycle 2 Day 15 and End of therapy (EOT)
| Intervention | Ratio (Mean) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C1D15:C1D1 CECs Count (n=11,18,14) | C2D15:C1D1 CECs Count (n=13,16,11) | EOT:C1D1 CECs Count (n=7,9,4) | C1D15:C1D1 MFI PDGFRBETA (n=11,17,13) | C2D15:C1D1 MFI PDGFRBETA (n=13,16,11) | EOT:C1D1 MFI PDGFRBETA (n=7,9,4) | C1D15:C1D1 MFI pPDGFR-BETA (n=11,17,13) | C2D15:C1D1 MFI pPDGFR-BETA (n=13,16,11) | EOT:C1D1 MFI pPDGFRBETA (n=7,9,4) | C1D15:C1D1 MFI pVEGFR (n=10,18,14) | C2D15:C1D1 MFI pVEGFR (n=12,16,11) | EOT:C1D1 MFI pVEGFR (n=7,9,4) | C1D15:C1D1 MFI VEGFR (n=10,18,14) | C2D15:C1D1 MFI VEGFR (n=12,16,11) | EOT:C1D1 MFI VEGFR (n=7,9,4) | |
| Active Titration Arm | 2.3 | 1.3 | 2.8 | 1.3 | 1.4 | 1.5 | 1.1 | 1.0 | 0.8 | 1.0 | 1.0 | 0.8 | 1.4 | 1.5 | 1.1 |
| Non-randomized Arm | 2.2 | 1.3 | 1.2 | 1.1 | 2.2 | 1.2 | 1.0 | 1.2 | 1.9 | 1.2 | 1.2 | 3.0 | 1.0 | 2.1 | 1.9 |
| Placebo Titration Arm | 3.7 | 4.4 | 8.9 | 1.5 | 1.1 | 0.6 | 1.2 | 0.8 | 0.8 | 1.2 | 0.9 | 1.3 | 1.3 | 1.3 | 0.7 |
ORR, defined as proportion of participants with CR or PR according to RECIST, in subgroups that were defined by VEGFA or VEGFR3 polymorphisms. (NCT00835978)
Timeframe: At baseline - Beginning of the lead-in period (Cycle 1 Day 1)
| Intervention | Percentage of participants (Number) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| VEGFA/rs699947 Genotype: A/A (n = 7, 9, 14) | VEGFA/rs699947 Genotype: A/C (n = 22, 20, 41) | VEGFA/rs699947 Genotype: C/C (n = 14, 14, 24) | VEGFA/rs1570360 Genotype: G/G (n = 22, 23, 43) | VEGFA/rs1570360 Genotype: G/A (n = 19, 16, 29) | VEGFA/rs1570360 Genotype: A/A (n = 2, 4, 7) | VEGFR3/rs448012 Genotype: G/G (n = 16, 15, 28) | VEGFR3/rs448012 Genotype: G/C (n = 22, 22, 35) | VEGFR3/rs448012 Genotype: C/C (n = 5, 6, 16) | VEGFR3/rs307826 Genotype: A/A (n = 36, 39, 79) | VEGFR3/rs307826 Genotype: A/G (n = 6, 4, 9) | VEGFR3/rs307826 Genotype: G/G (n = 1, 0, 0) | VEGFR3/rs307821 Genotype: G/G (n = 36, 38, 79) | VEGFR3/rs307821 Genotype: G/T (n = 6, 5, 10) | VEGFR3/rs307821 Genotype: T/T (n = 1, 0, 0) | |
| Active Titration Arm | 85.7 | 54.5 | 50.0 | 59.1 | 57.9 | 50.0 | 81.3 | 45.5 | 40.0 | 58.3 | 50.0 | 100.0 | 55.6 | 66.7 | 100.0 |
| Non-randomized Arm | 42.9 | 65.9 | 66.7 | 67.4 | 58.6 | 42.9 | 60.7 | 57.1 | 75.0 | 64.3 | 44.4 | 0 | 65.2 | 40.0 | 0 |
| Placebo Titration Arm | 22.2 | 35.0 | 35.7 | 39.1 | 18.8 | 50.0 | 53.3 | 18.2 | 33.3 | 30.8 | 50.0 | 0 | 28.9 | 60.0 | 0 |
PFS, defined as the time from randomization to first documentation of objective tumor progression or to death due to any cause, in subgroups that were defined by VEGFA or VEGFR3 polymorphisms. Estimates of the PFS curves from the Kaplan-Meier method were presented. (NCT00835978)
Timeframe: At baseline - Beginning of the lead-in period (Cycle 1 Day 1)
| Intervention | Months (Median) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| VEGFA/rs699947 Genotype: A/A (n = 7, 9, 14) | VEGFA/rs699947 Genotype: A/C (n = 22, 20, 41) | VEGFA/rs699947 Genotype: C/C (n = 14, 14, 41) | VEGFA/rs1570360 Genotype: G/G (n = 22, 23, 43) | VEGFA/rs1570360 Genotype: G/A (n = 19, 16, 29) | VEGFA/rs1570360 Genotype: A/A (n = 2, 4, 29) | VEGFR3/rs448012 Genotype: G/G (n = 16, 15, 28) | VEGFR3/rs448012 Genotype: G/C (n = 22, 22, 35) | VEGFR3/rs448012 Genotype: C/C (n = 5, 6, 16) | VEGFR3/rs307826 Genotype: A/A (n = 36, 39, 70) | VEGFR3/rs307826 Genotype: A/G (n = 6, 4, 9) | VEGFR3/rs307826 Genotype: G/G (n = 0, 0, 0) | VEGFR3/rs307821 Genotype: G/G (n = 36, 38, 69) | VEGFR3/rs307821 Genotype: G/T (n = 36, 38, 10) | VEGFR3/rs307821 Genotype: T/T (n = 1, 0, 0) | |
| Active Titration Arm | NA | 11.07 | 18.74 | 14.62 | 12.78 | NA | 17.44 | 9.18 | 11.07 | 13.73 | 16.52 | NA | 12.78 | 24.80 | NA |
| Non-randomized Arm | 7.33 | 16.59 | 25.13 | 25.13 | 13.90 | 8.57 | 22.54 | 13.83 | NA | 16.56 | 16.26 | NA | 16.59 | 13.86 | NA |
| Placebo Titration Arm | 11.50 | 9.67 | 24.64 | 19.42 | 8.34 | 10.04 | 19.42 | 8.31 | 15.67 | 15.67 | 7.93 | NA | 15.67 | 8.34 | NA |
Time in months from the first documentation of objective tumor response that is subsequently confirmed to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response. (NCT00920816)
Timeframe: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)
| Intervention | months (Median) |
|---|---|
| Axitinib (First-line Participants) | 14.7 |
| Sorafenib (First-line Participants) | 14.3 |
Time in months from the first documentation of objective tumor response that is subsequently confirmed to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response. (NCT00920816)
Timeframe: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)
| Intervention | months (Median) |
|---|---|
| Axitinib (Second-line Participants) | NA |
| Sorafenib (Second-line Participants) | 8.7 |
Time in months from date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). (NCT00920816)
Timeframe: Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)
| Intervention | months (Median) |
|---|---|
| Axitinib (First-line Participants) | NA |
| Sorafenib (First-line Participants) | NA |
Time in months from date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). (NCT00920816)
Timeframe: Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)
| Intervention | months (Median) |
|---|---|
| Axitinib (Second-line Participants) | 17.2 |
| Sorafenib (Second-line Participants) | 18.1 |
Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent. (NCT00920816)
Timeframe: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)
| Intervention | percentage of participants (Number) |
|---|---|
| Axitinib (First-line Participants) | 32.3 |
| Sorafenib (First-line Participants) | 14.6 |
Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent. (NCT00920816)
Timeframe: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)
| Intervention | percentage of participants (Number) |
|---|---|
| Axitinib (Second-line Participants) | 23.7 |
| Sorafenib (Second-line Participants) | 10.1 |
"Time in months from randomization to first documentation of objective tumor progression or death due to any cause. PFS calculated as (first event date minus date of randomization plus 1)/30.4. Tumor progression determined from oncologic assessment data (where it meets criteria for progressive disease [PD]), or from adverse event (AE) data (where outcome was Death). Progression using Response Evaluation Criteria in Solid Tumors (RECIST) is >= 20 percent (%) increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions." (NCT00920816)
Timeframe: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)
| Intervention | months (Median) |
|---|---|
| Axitinib (First-line Participants) | 10.1 |
| Sorafenib (First-line Participants) | 6.5 |
"Time in months from randomization to first documentation of objective tumor progression or death due to any cause. PFS calculated as (first event date minus date of randomization plus 1)/30.4. Tumor progression determined from oncologic assessment data (where it meets criteria for progressive disease [PD]), or from adverse event (AE) data (where outcome was Death). Progression using Response Evaluation Criteria in Solid Tumors (RECIST) is >= 20 percent (%) increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions." (NCT00920816)
Timeframe: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)
| Intervention | months (Median) |
|---|---|
| Axitinib (Second-line Participants) | 6.5 |
| Sorafenib (Second-line Participants) | 4.8 |
"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state." (NCT00920816)
Timeframe: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)
| Intervention | units on a scale (Mean) | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C1 D1 | C2 D1 | C3 D1 | C4 D1 | C5 D1 | C6 D1 | C7 D1 | C8 D1 | C9 D1 | C10 D1 | C11 D1 | C12 D1 | C13 D1 | C14 D1 | C15 D1 | C16 D1 | C17 D1 | C18 D1 | C19 D1 | C20 D1 | C21 D1 | C22 D1 | C23 D1 | End of treatment | Follow-up | |
| Axitinib (First-line Participants) | 0.710 | 0.709 | 0.694 | 0.696 | 0.708 | 0.683 | 0.685 | 0.678 | 0.704 | 0.682 | 0.698 | 0.708 | 0.708 | 0.703 | 0.689 | 0.702 | 0.706 | 0.699 | 0.713 | 0.699 | 0.712 | 0.737 | 0.736 | 0.635 | 0.545 |
| Sorafenib (First-line Participants) | 0.712 | 0.693 | 0.687 | 0.668 | 0.673 | 0.641 | 0.676 | 0.717 | 0.729 | 0.723 | 0.748 | 0.742 | 0.761 | 0.731 | 0.755 | 0.775 | 0.738 | 0.777 | 0.762 | 0.710 | 0.702 | 0.774 | 0.789 | 0.588 | 0.618 |
"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state." (NCT00920816)
Timeframe: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)
| Intervention | units on a scale (Mean) | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C1 D1 | C2 D1 | C3 D1 | C4 D1 | C5 D1 | C6 D1 | C7 D1 | C8 D1 | C9 D1 | C10 D1 | C11 D1 | C12 D1 | C13 D1 | C14 D1 | C15 D1 | C16 D1 | C17 D1 | C18 D1 | C19 D1 | C20 D1 | C21 D1 | End of treatment | Follow-up | |
| Axitinib (Second-line Participants) | 0.812 | 0.769 | 0.772 | 0.737 | 0.780 | 0.767 | 0.762 | 0.758 | 0.796 | 0.768 | 0.792 | 0.797 | 0.786 | 0.833 | 0.819 | 0.811 | 0.834 | 0.830 | 0.830 | 0.832 | 0.859 | 0.582 | 0.429 |
| Sorafenib (Second-line Participants) | 0.831 | 0.754 | 0.755 | 0.759 | 0.768 | 0.753 | 0.768 | 0.733 | 0.794 | 0.820 | 0.848 | 0.837 | 0.814 | 0.871 | 0.829 | 0.828 | 0.865 | 0.829 | 0.861 | 0.923 | 0.852 | 0.623 | 0.418 |
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0: worst imaginable health state to 100: best imaginable health state; higher scores indicate a better health state. (NCT00920816)
Timeframe: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)
| Intervention | units on a scale (Mean) | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C1 D1 | C2 D1 | C3 D1 | C4 D1 | C5 D1 | C6 D1 | C7 D1 | C8 D1 | C9 D1 | C10 D1 | C11 D1 | C12 D1 | C13 D1 | C14 D1 | C15 D1 | C16 D1 | C17 D1 | C18 D1 | C19 D1 | C20 D1 | C21 D1 | C22 D1 | C23 D1 | End of treatment | Follow-up | |
| Axitinib (First-line Participants) | 71.181 | 71.714 | 72.006 | 72.179 | 72.451 | 71.574 | 71.050 | 71.031 | 72.690 | 72.910 | 72.763 | 73.610 | 73.030 | 73.147 | 74.494 | 73.878 | 73.090 | 73.817 | 72.089 | 74.244 | 75.694 | 78.000 | 77.143 | 67.254 | 69.195 |
| Sorafenib (First-line Participants) | 72.362 | 72.422 | 71.241 | 72.086 | 73.615 | 69.944 | 73.923 | 73.183 | 73.780 | 72.400 | 72.271 | 75.295 | 75.432 | 75.108 | 74.405 | 75.818 | 74.333 | 75.571 | 75.125 | 74.190 | 70.500 | 73.917 | 72.571 | 67.048 | 64.885 |
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0: worst imaginable health state to 100: best imaginable health state; higher scores indicate a better health state. (NCT00920816)
Timeframe: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)
| Intervention | units on a scale (Mean) | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C1 D1 | C2 D1 | C3 D1 | C4 D1 | C5 D1 | C6 D1 | C7 D1 | C8 D1 | C9 D1 | C10 D1 | C11 D1 | C12 D1 | C13 D1 | C14 D1 | C15 D1 | C16 D1 | C17 D1 | C18 D1 | C19 D1 | C20 D1 | C21 D1 | End of treatment | Follow-up | |
| Axitinib (Second-line Participants) | 82.799 | 81.102 | 80.895 | 81.138 | 83.018 | 82.222 | 82.900 | 83.382 | 84.171 | 83.041 | 84.136 | 84.305 | 82.927 | 86.520 | 85.841 | 87.579 | 88.424 | 86.586 | 89.500 | 90.333 | 90.313 | 75.568 | 58.154 |
| Sorafenib (Second-line Participants) | 82.058 | 78.231 | 80.534 | 81.245 | 80.250 | 80.829 | 80.868 | 81.000 | 83.788 | 82.778 | 83.000 | 83.500 | 83.300 | 86.667 | 86.462 | 86.083 | 84.300 | 83.125 | 82.143 | 86.000 | 84.167 | 74.741 | 64.333 |
FKSI-DRS: subset of FKSI which is FACT-Kidney Symptom Index questionnaire used to assess QoL for participants diagnosed with renal cell cancer. FKSI contains 15 questions and FKSI-DRS 9 questions (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, hematuria) each ranging from 0 (not at all) to 4 (very much). FKSI-DRS total score 0 to 36; higher scores associated with better health states (Individual questions may be reversed coded, as appropriate). (NCT00920816)
Timeframe: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)
| Intervention | units on a scale (Mean) | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C1 D1 | C2 D1 | C3 D1 ( | C4 D1 | C5 D1 | C6 D1 | C7 D1 | C8 D1 | C9 D1 | C10 D1 | C11 D1 | C12 D1 | C13 D1 | C14 D1 | C15 D1 | C16 D1 | C17 D1 | C18 D1 | C19 D1 | C20 D1 | C21 D1 | C22 D1 | C23 D1 | End of treatment | Follow-up | |
| Axitinib (First-line Participants) | 28.691 | 28.728 | 29.171 | 28.577 | 29.020 | 28.574 | 28.568 | 28.557 | 28.817 | 29.057 | 29.146 | 29.648 | 29.545 | 29.579 | 29.859 | 29.683 | 29.564 | 29.380 | 29.737 | 29.844 | 30.889 | 31.696 | 31.357 | 26.556 | 26.805 |
| Sorafenib (First-line Participants) | 29.653 | 29.963 | 29.750 | 29.642 | 30.255 | 29.153 | 29.523 | 30.296 | 30.186 | 30.364 | 30.688 | 30.727 | 31.483 | 31.027 | 30.730 | 31.515 | 31.567 | 31.107 | 31.417 | 30.762 | 30.056 | 31.000 | 31.143 | 26.786 | 26.769 |
FKSI-DRS: subset of FKSI which is FACT-Kidney Symptom Index questionnaire used to assess QoL for participants diagnosed with renal cell cancer. FKSI contains 15 questions and FKSI-DRS 9 questions (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, hematuria) each ranging from 0 (not at all) to 4 (very much). FKSI-DRS total score 0 to 36; higher scores associated with better health states (Individual questions may be reversed coded, as appropriate). (NCT00920816)
Timeframe: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)
| Intervention | units on a scale (Mean) | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C1 D1 | C2 D1 | C3 D1 | C4 D1 | C5 D1 | C6 D1 | C7 D1 | C8 D1 | C9 D1 | C10 D1 | C11 D1 | C12 D1 | C13 D1 | C14 D1 | C15 D1 | C16 D1 | C17 D1 | C18 D1 | C19 D1 | C20 D1 | C21 D1 | End of treatment | Follow-up | |
| Axitinib (Second-line Participants) | 31.020 | 30.600 | 30.645 | 30.103 | 30.676 | 30.731 | 30.920 | 30.966 | 31.012 | 30.986 | 31.212 | 31.356 | 31.418 | 32.100 | 32.000 | 31.921 | 32.061 | 31.931 | 32.364 | 31.905 | 33.125 | 28.216 | 24.692 |
| Sorafenib (Second-line Participants) | 31.489 | 30.682 | 30.965 | 30.679 | 31.063 | 31.439 | 30.632 | 30.703 | 30.667 | 30.926 | 32.045 | 32.000 | 32.100 | 32.800 | 32.769 | 33.167 | 32.800 | 32.625 | 32.429 | 33.500 | 33.500 | 29.519 | 27.500 |
FKSI-15 questionnaires (lack of energy, side effects, pain, weight loss, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria, sleep) was used to assess quality of life (QoL) for those diagnosed with renal cell cancer. Questions answered on 5-point Likert scale: 0 to 4 (0= not at all, 1= little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score 0 to 60; higher scores=better health states (Individual questions may be reversed coded, as appropriate). (NCT00920816)
Timeframe: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)
| Intervention | units on a scale (Mean) | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C1 D1 | C2 D1 | C3 D1 | C4 D1 | C5 D1 | C6 D1 | C7 D1 | C8 D1 | C9 D1 | C10 D1 | C11 D1 | C12 D1 | C13 D1 | C14 D1 | C15 D1 | C16 D1 | C17 D1 | C18 D1 | C19 D1 | C20 D1 | C21 D1 | C22 D1 | C23 D1 | End of treatment | Follow-up | |
| Axitinib (First-line Participants) | 43.869 | 43.328 | 43.366 | 42.932 | 43.211 | 42.787 | 42.474 | 42.534 | 42.778 | 43.120 | 43.264 | 43.962 | 44.141 | 43.789 | 44.176 | 44.232 | 43.897 | 43.761 | 43.737 | 43.733 | 45.417 | 47.000 | 47.571 | 39.052 | 39.683 |
| Sorafenib (First-line Participants) | 43.865 | 43.969 | 43.345 | 42.926 | 44.022 | 42.344 | 43.446 | 44.077 | 44.051 | 44.018 | 45.000 | 45.318 | 45.787 | 45.459 | 45.514 | 46.000 | 46.400 | 45.357 | 45.583 | 44.333 | 43.500 | 45.833 | 45.714 | 39.524 | 40.038 |
FKSI-15 questionnaires (lack of energy, side effects, pain, weight loss, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria, sleep) was used to assess quality of life (QoL) for those diagnosed with renal cell cancer. Questions answered on 5-point Likert scale: 0 to 4 (0= not at all, 1= little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score 0 to 60; higher scores=better health states (Individual questions may be reversed coded, as appropriate). (NCT00920816)
Timeframe: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)
| Intervention | units on a scale (Mean) | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C1 D1 | C2 D1 | C3 D1 | C4 D1 | C5 D1 | C6 D1 | C7 D1 | C8 D1 | C9 D1 | C10 D1 | C11 D1 | C12 D1 | C13 D1 | C14 D1 | C15 D1 | C16 D1 | C17 D1 | C18 D1 | C19 D1 | C20 D1 | C21 D1 | End of treatment | Follow-up | |
| Axitinib (Second-line Participants) | 46.753 | 46.217 | 45.968 | 45.060 | 45.775 | 45.407 | 45.709 | 45.169 | 45.829 | 45.608 | 45.833 | 45.797 | 46.727 | 47.740 | 48.023 | 48.184 | 47.909 | 48.138 | 48.636 | 48.810 | 50.188 | 41.432 | 35.385 |
| Sorafenib (Second-line Participants) | 47.470 | 45.045 | 45.684 | 45.792 | 46.125 | 46.341 | 45.053 | 45.676 | 45.970 | 46.148 | 47.227 | 48.091 | 47.600 | 49.133 | 49.308 | 50.500 | 49.000 | 49.125 | 48.571 | 50.500 | 50.000 | 42.889 | 38.583 |
Using RECIST criteria: date of 1st objective tumor response (CR or PR) subsequently confirmed to date of 1st objective tumor progression or to death due to any cause within 28 days after last dose of study medication, whichever was first. Censored on day after the date of the last oncologic assessment documenting no tumor progression. (NCT00137423)
Timeframe: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up
| Intervention | weeks (Median) |
|---|---|
| AM Dose Sunitinib Malate (SU011248) | 24.0 |
| PM Dose Sunitinib Malate (SU011248) | 32.0 |
Confirmed objective responses using RECIST criteria defined as responses persisting on repeat imaging study for 2 assessments with at least 4 weeks between, and evaluating all target and non-target sites followed since baseline. Two PRs separated by an SD or NE visit in between was considered a confirmed response if the 2 PRs were > 4 weeks apart. CR=disappearance of all target lesions. PR is a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. (NCT00137423)
Timeframe: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up
| Intervention | participants (Number) |
|---|---|
| AM Dose Sunitinib Malate (SU011248) | 15 |
| PM Dose Sunitinib Malate (SU011248) | 6 |
Overall survival is time from the date of first dose of medication to the date of death due to any cause (NCT00137423)
Timeframe: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up
| Intervention | weeks (Median) |
|---|---|
| AM Dose Sunitinib Malate (SU011248) | 91.4 |
| PM Dose Sunitinib Malate (SU011248) | 76.4 |
Using RECIST criteria: Time from date 1st dose study medication to date 1st documentation of objective tumor progression or death due to any cause occurring on treatment including within 28 days after last dose, whichever occurred 1st. Censored on day following the date of last oncologic assessment documenting absence of tumor progression. PFS based on the number of subjects with measurable disease at baseline, the correct histological cancer type, and had disease that was refractory to prior cytokine-based therapy(105 in total group). (NCT00137423)
Timeframe: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up
| Intervention | weeks (Median) |
|---|---|
| AM Dose Sunitinib Malate (SU011248) | 35.7 |
| PM Dose Sunitinib Malate (SU011248) | 35.3 |
Time from date of first dose of study medication to date of first documentation of objective tumor progression using RECIST criteria that occurred on treatment including within 28 days after the last dose of study medication. TTP censored on the day following the date of last oncologic assessment documenting absence of tumor progression. TTP based on the number of subjects with measurable disease at baseline, the correct histological cancer type, and had disease that was refractory to prior cytokine-based therapy(105 in total group). (NCT00137423)
Timeframe: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up
| Intervention | weeks (Median) |
|---|---|
| AM Dose Sunitinib Malate (SU011248) | 35.7 |
| PM Dose Sunitinib Malate (SU011248) | 35.9 |
EQ-5D health status in 5 dimensions (mobility, self-care, pain / discomfort, anxiety / depression, usual activities) with a weighted health index based on general population values where 0.0=death and 1.0 = perfect health. Change: median index score at observation minus median index score at baseline. (NCT00137423)
Timeframe: Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year.
| Intervention | score on scale (Median) | |
|---|---|---|
| Maximum Increase | Maximum Decrease | |
| AM Dose Sunitinib Malate (SU011248) | 0.0 | 0.0 |
| PM Dose Sunitinib Malate (SU011248) | 0.0 | -0.1 |
"EQ-VAS score on the self-rated thermometer indicated the patient's own assessment of their health status from 0 (worst) to 100 (best) imaginable health state. Change: median score at observation minus median score at baseline. Maximum changes (increase or decrease from baseline)." (NCT00137423)
Timeframe: Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year.
| Intervention | score on scale (Median) | |
|---|---|---|
| Maximum Increase | Maximum Decrease | |
| AM Dose Sunitinib Malate (SU011248) | 0.0 | -10.0 |
| PM Dose Sunitinib Malate (SU011248) | 0.0 | -9.0 |
FACIT Fatigue Scale: Overall score from 13-questionnaire, which measures fatigue / asthenia for patients with chronic, life-threatening illnesses. For each question, a patient rates his / her condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Higher scores always represent less fatigue / asthenia. Outcome based on completed questionnaires. (NCT00137423)
Timeframe: Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year.
| Intervention | score on scale (Mean) | ||
|---|---|---|---|
| Baseline Score n=52,52 | Maximum Post-Baseline Score n=53,52 | Minimum Post-Baseline Score n=53,52 | |
| AM Dose Sunitinib Malate | 39.5 | 43.4 | 28.0 |
| PM Dose Sunitinib Malate | 39.6 | 42.7 | 29.4 |
OS was defined as the time from randomization to death due to any cause, censored at the last date known alive. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). (NCT00631371)
Timeframe: Baseline until death due to any cause, assessed every 8 weeks (up to cut-off date: 19 April 2012)
| Intervention | months (Median) |
|---|---|
| Bevacizumab+Temsirolimus | 25.8 |
| Bevacizumab+ Interferon-Alfa | 25.5 |
Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30% decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent. (NCT00631371)
Timeframe: Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)
| Intervention | percentage of participants (Number) |
|---|---|
| Bevacizumab+Temsirolimus | 27.0 |
| Bevacizumab+ Interferon-Alfa | 27.4 |
PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by independent imaging reviewers using Response Evaluation Criteria in Solid Tumors (RECIST) criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions. (NCT00631371)
Timeframe: Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)
| Intervention | months (Median) |
|---|---|
| Bevacizumab+Temsirolimus | 9.1 |
| Bevacizumab+ Interferon-Alfa | 9.3 |
PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by investigator imaging reviewers using RECIST criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions. (NCT00631371)
Timeframe: Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)
| Intervention | months (Median) |
|---|---|
| Bevacizumab+Temsirolimus | 9.1 |
| Bevacizumab+ Interferon-Alfa | 10.8 |
DR: time from first documentation of objective tumor response (CR or PR), that was subsequently confirmed, to the first documentation of PD or to death due to any cause, whichever occurred first as per RECIST version 1.0, a) CR: disappearance of all target, non target lesions and no appearance of new lesions, documented on 2 occasions separated by at least 4 weeks, b) PR: at least 30 % decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non target lesions, no appearance of new lesions, c) PD: >=20% increase in sum of LD of the target lesions taking as a reference smallest sum of LD recorded since the start of treatment or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Occurrence of pleural effusion or ascites if demonstrated by cytological investigation, not previously documented. New bone lesions not previously documented if confirmed by computed tomography/magnetic resonance imaging or X-ray. (NCT00678392)
Timeframe: From initiation of treatment up to follow-up period (up to 3 years)
| Intervention | Months (Median) |
|---|---|
| Axitinib 5 mg | 11.0 |
| Sorafenib 400 mg | 10.6 |
ORR = percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0 recorded from first dose of study treatment until PD or death due to any cause. CR: disappearance of all target, non target lesions and no appearance of new lesions, documented on 2 occasions separated by at least 4 weeks. PR: at least 30 % decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non target lesions, no appearance of new lesions. PD: >=20% increase in sum of LD of the target lesions taking as a reference smallest sum of LD recorded since the start of treatment or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Occurrence of pleural effusion or ascites if demonstrated by cytological investigation, not previously documented. New bone lesions not previously documented if confirmed by computed tomography/magnetic resonance imaging or X-ray. (NCT00678392)
Timeframe: From initiation of treatment up to follow-up period (up to 3 years)
| Intervention | Percentage of participants (Number) |
|---|---|
| Axitinib 5 mg | 19.4 |
| Sorafenib 400 mg | 9.4 |
OS was defined as the duration from start of study treatment to date of death due to any cause. OS was calculated as (months) = (date of death minus the date of first dose of study medication plus 1) divided by 30.4. For participants who were alive, overall survival was censored on last date the participants were known to be alive. (NCT00678392)
Timeframe: From initiation of treatment up to follow-up period (up to 3 years)
| Intervention | Months (Median) |
|---|---|
| Axitinib 5 mg | 20.1 |
| Sorafenib 400 mg | 19.2 |
PFS was defined as the time in months from start of study treatment to the first documentation of objective tumor progression of disease (PD) or to death due to any cause, whichever occurs first. PD was assessed by response evaluation criteria in solid tumors (RECIST) version 1.0. PD: >=20 percent (%) increase in the sum of the longest dimensions (LD) of the target lesions taking as a reference the smallest sum of the LD recorded since the start of treatment or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. Occurrence of a pleural effusion or ascites was also considered PD if demonstrated by cytological investigation and it was not previously documented. New bone lesions not previously documented were considered PD if confirmed by computed tomography/magnetic resonance imaging or X-ray. (NCT00678392)
Timeframe: From initiation of treatment up to follow-up period (up to 3 years)
| Intervention | Months (Median) |
|---|---|
| Axitinib 5 mg | 6.7 |
| Sorafenib 400 mg | 4.7 |
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility or index score. Health state profile component assesses level of health for 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain was rated on a 3-point response scale (1= no problems, 2= some/moderate problems and 3= extreme problems). Scoring formula developed by EuroQol Group assigned a utility value for each domain in the profile. Score were transformed and resulted in a total score range of 0 to 1, with higher scores indicating better health. (NCT00678392)
Timeframe: Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)
| Intervention | Units on a scale (Mean) | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (n =347, 341) | Cycle 2/Day1 (n =326, 307) | Cycle 3/Day1 (n =287, 248) | Cycle 4/Day1 (n =262, 226) | Cycle 5/Day1 (n =244, 207) | Cycle 6/Day1 (n =221, 178) | Cycle 7/Day1 (n =213, 163) | Cycle 8/Day1 (n =181, 136) | Cycle 9/Day1 (n =169, 120) | Cycle 10/Day1 (n =151, 98) | Cycle 11/Day1 (n =126, 87) | Cycle 12/Day1 (n =110, 73) | Cycle 13/Day1 (n =96, 61) | Cycle 14/Day1 (n =80, 57) | Cycle 15/Day1 (n =63, 41) | Cycle 16/Day1 (n =54, 37) | Cycle 17/Day1 (n =48, 29) | Cycle 18/Day1 (n =37, 20) | Cycle 19/Day1 (n =29, 14) | Cycle 20/Day1 (n =21, 12) | Cycle 21/Day1 (n =16, 7) | End of Treatment (n =169, 196) | Follow up (n =76, 106) | |
| Axitinib 5 mg | 0.732 | 0.716 | 0.722 | 0.730 | 0.730 | 0.734 | 0.718 | 0.756 | 0.760 | 0.734 | 0.764 | 0.744 | 0.760 | 0.723 | 0.730 | 0.749 | 0.779 | 0.755 | 0.734 | 0.794 | 0.700 | 0.608 | 0.682 |
| Sorafenib 400 mg | 0.731 | 0.696 | 0.709 | 0.716 | 0.711 | 0.704 | 0.728 | 0.702 | 0.730 | 0.730 | 0.724 | 0.734 | 0.753 | 0.752 | 0.758 | 0.785 | 0.764 | 0.755 | 0.804 | 0.771 | 0.771 | 0.612 | 0.666 |
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. VAS component: participants rated their current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health. (NCT00678392)
Timeframe: Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)
| Intervention | Units on a scale (Mean) | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (n =341, 339) | Cycle 2/Day1 (n =317, 302) | Cycle 3/Day1 (n =280, 250) | Cycle 4/Day1 (n =261, 224) | Cycle 5/Day1 (n =244, 205) | Cycle 6/Day1 (n =220, 178) | Cycle 7/Day1 (n =209, 163) | Cycle 8/Day1 (n =180, 139) | Cycle 9/Day1 (n =168, 121) | Cycle 10/Day1 (n =151, 98) | Cycle 11/Day1 (n =126, 87) | Cycle 12/Day1 (n =111, 73) | Cycle 13/Day1 (n =94, 61) | Cycle 14/Day1 (n =81, 58) | Cycle 15/Day1 (n =62, 42) | Cycle 16/Day1 (n =52, 37) | Cycle 17/Day1 (n =48, 30) | Cycle 18/Day1 (n =37, 23) | Cycle 19/Day1 (n =29, 14) | Cycle 20/Day1 (n =21, 12) | Cycle 21/Day1 (n =16, 7) | End of Treatment (n =166, 197) | Follow up (n =76, 109) | |
| Axitinib 5 mg | 70.560 | 69.003 | 69.843 | 69.180 | 69.705 | 69.900 | 69.919 | 70.756 | 70.667 | 70.629 | 72.103 | 71.730 | 70.723 | 69.420 | 73.016 | 70.269 | 71.375 | 70.459 | 71.034 | 73.143 | 74.563 | 61.759 | 64.382 |
| Sorafenib 400 mg | 70.351 | 67.606 | 69.712 | 70.759 | 71.888 | 71.365 | 72.282 | 71.475 | 73.380 | 75.102 | 74.586 | 73.959 | 75.693 | 75.362 | 75.357 | 73.676 | 73.767 | 73.870 | 70.571 | 66.917 | 64.714 | 61.690 | 66.037 |
FKSI was used to assess quality of life (QoL) for those diagnosed with renal cell cancer and consisted of 15 items (lack of energy, side effects, pain, losing weight, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria and sleep). Each of the 15 items was answered on a 5-point Likert-type scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score = sum of the 15 item scores; total range: 0 - 60; 0 (no symptoms) to 60 (very much); higher scores indicate greater presence of symptoms. (NCT00678392)
Timeframe: Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)
| Intervention | Units on a scale (Mean) | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (n =346, 342) | Cycle 2/Day1 (n =319, 296) | Cycle 3/Day1 (n =279, 246) | Cycle 4/Day1 (n =257, 221) | Cycle 5/Day1 (n =238, 203) | Cycle 6/Day1 (n =213, 179) | Cycle 7/Day1 (n =206, 158) | Cycle 8/Day1 (n =177, 136) | Cycle 9/Day1 (n =163, 118) | Cycle 10/Day1 (n =146, 96) | Cycle 11/Day1 (n =122, 85) | Cycle 12/Day1 (n =110, 70) | Cycle 13/Day1 (n =92, 58) | Cycle 14/Day1 (n =81, 54) | Cycle 15/Day1 (n =61, 38) | Cycle 16/Day1 (n =52, 34) | Cycle 17/Day1 (n =47, 28) | Cycle 18/Day1 (n =36, 22) | Cycle 19/Day1 (n =29, 14) | Cycle 20/Day1 (n =20, 12) | Cycle 21/Day1 (n =15, 7) | End of treatment (n=163, 191) | Follow up (n =80, 110) | |
| Axitinib 5 mg | 43.199 | 42.351 | 42.590 | 42.791 | 42.968 | 42.949 | 42.747 | 43.580 | 43.191 | 43.312 | 44.119 | 44.517 | 44.492 | 44.485 | 45.291 | 45.217 | 45.242 | 44.861 | 45.379 | 47.050 | 45.850 | 38.328 | 41.919 |
| Sorafenib 400 mg | 43.339 | 41.668 | 42.424 | 43.424 | 42.907 | 43.057 | 43.578 | 44.074 | 44.518 | 44.771 | 44.438 | 44.357 | 45.261 | 44.898 | 45.053 | 44.445 | 44.438 | 44.182 | 45.026 | 44.780 | 44.494 | 38.457 | 40.028 |
FKSI-DRS was used to assess quality of life for those diagnosed with renal cell cancer and consisted of 9 items (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria). Each of the 9 items was answered on a 5-point Likert-type scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptoms) to 36 (very much); higher scores indicate greater presence of symptoms. (NCT00678392)
Timeframe: Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)
| Intervention | Units on a scale (Mean) | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (n =346, 341) | Cycle 2/Day1 (n =319, 295) | Cycle 3/Day1 (n =279, 244) | Cycle 4/Day1 (n =257, 220) | Cycle 5/Day1 (n =238, 202) | Cycle 6/Day1 (n =213, 178) | Cycle 7/Day1 (n =206, 157) | Cycle 8/Day1 (n =177, 135) | Cycle 9/Day1 (n =163, 117) | Cycle 10/Day1 (n =146, 96) | Cycle 11/Day1 (n =122, 85) | Cycle 12/Day1 (n =110, 70) | Cycle 13/Day1 (n =92, 58) | Cycle 14/Day1 (n =81, 54) | Cycle 15/Day1 (n =61, 38) | Cycle 16/Day1 (n =52, 34) | Cycle 17/Day1 (n =47, 28) | Cycle 18/Day1 (n =36, 22) | Cycle 19/Day1 (n =29, 14) | Cycle 20/Day1 (n =20, 12) | Cycle 21/Day1 (n =15, 7) | End of Treatment (n =163, 191) | Follow up (n =80, 110) | |
| Axitinib 5 mg | 28.874 | 28.211 | 28.640 | 28.822 | 28.869 | 29.159 | 29.042 | 29.520 | 29.194 | 29.343 | 29.762 | 29.764 | 29.594 | 29.711 | 30.324 | 30.430 | 30.551 | 30.194 | 30.130 | 31.300 | 31.067 | 26.288 | 28.263 |
| Sorafenib 400 mg | 28.975 | 28.399 | 28.640 | 29.130 | 29.007 | 29.098 | 29.361 | 29.619 | 29.884 | 29.604 | 29.366 | 29.257 | 29.666 | 29.820 | 29.500 | 29.474 | 28.737 | 29.045 | 29.286 | 29.250 | 30.143 | 26.517 | 27.516 |
Biochemistry laboratory test included parameters: alanine aminotransferase, alkaline phosphatase, amylase, aspartate aminotransferase, bicarbonate, bilirubin, creatinine, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, hypophosphatemia and lipase. Abnormalities were assessed by CTCAE Grade Version 2 for severity: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. (NCT00678392)
Timeframe: From initiation of treatment up to follow-up period (up to 3 years)
| Intervention | Participants (Number) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alanine aminotransferase: Grade 1 (n =331, 313) | Alanine aminotransferase: Grade 2 (n =331, 313) | Alanine aminotransferase: Grade 3 (n =331, 313) | Alanine aminotransferase: Grade 4 (n =331, 313) | Alkaline phosphatase: Grade 1 (n =336, 319) | Alkaline phosphatase: Grade 2 (n =336, 319) | Alkaline phosphatase: Grade 3 (n =336, 319) | Alkaline phosphatase: Grade 4 (n =336, 319) | Amylase: Grade 1 (n =338, 319) | Amylase: Grade 2 (n =338, 319) | Amylase: Grade 3 (n =338, 319) | Amylase: Grade 4 (n =338, 319) | Aspartate aminotransferase: Grade 1 (n =331, 311) | Aspartate aminotransferase: Grade 2 (n =331, 311) | Aspartate aminotransferase: Grade 3 (n =331, 311) | Aspartate aminotransferase: Grade 4 (n =331, 311) | Bicarbonate: Grade 1 (n =314, 291) | Bicarbonate: Grade 2 (n =314, 291) | Bicarbonate: Grade 3 (n =314, 291) | Bicarbonate: Grade 4 (n =314, 291) | Bilirubin: Grade 1 (n =336, 318) | Bilirubin: Grade 2 (n =336, 318) | Bilirubin: Grade 3 (n =336, 318) | Bilirubin: Grade 4 (n =336, 318) | Creatinine: Grade 1 (n =336, 318) | Creatinine: Grade 2 (n =336, 318) | Creatinine: Grade 3 (n =336, 318) | Creatinine: Grade 4 (n =336, 318) | Hypercalcemia: Grade 1 (n =336, 319) | Hypercalcemia: Grade 2 (n =336, 319) | Hypercalcemia: Grade 3 (n =336, 319) | Hypercalcemia: Grade 4 (n =336, 319) | Hyperglycemia: Grade 1 (n =336, 319) | Hyperglycemia: Grade 2 (n =336, 319) | Hyperglycemia: Grade 3 (n =336, 319) | Hyperglycemia: Grade 4 (n =336, 319) | Hyperkalemia: Grade 1 (n =333, 314) | Hyperkalemia: Grade 2 (n =333, 314) | Hyperkalemia: Grade 3 (n =333, 314) | Hyperkalemia: Grade 4 (n =333, 314) | Hypernatremia: Grade 1 (n =338, 319) | Hypernatremia: Grade 2 (n =338, 319) | Hypernatremia: Grade 3 (n =338, 319) | Hypernatremia: Grade 4 (n =338, 319) | Hypoalbuminemia: Grade 1 (n =337, 319) | Hypoalbuminemia: Grade 2 (n =337, 319) | Hypoalbuminemia: Grade 3 (n =337, 319) | Hypoalbuminemia: Grade 4 (n =337, 319) | Hypocalcemia: Grade 1 (n =336, 319) | Hypocalcemia: Grade 2 (n =336, 319) | Hypocalcemia: Grade 3 (n =336, 319) | Hypocalcemia: Grade 4 (n =336, 319) | Hypoglycemia: Grade 1 (n =336, 319) | Hypoglycemia: Grade 2 (n =336, 319) | Hypoglycemia: Grade 3 (n =336, 319) | Hypoglycemia: Grade 4 (n =336, 319) | Hypokalemia: Grade 1 (n =333, 314) | Hypokalemia: Grade 2 (n =333, 314) | Hypokalemia: Grade 3 (n =333, 314) | Hypokalemia: Grade 4 (n =333, 314) | Hyponatremia: Grade 1 (n =338, 319) | Hyponatremia: Grade 2 (n =338, 319) | Hyponatremia: Grade 3 (n =338, 319) | Hyponatremia: Grade 4 (n =338, 319) | Hypophosphatemia: Grade 1 (n =336, 318) | Hypophosphatemia: Grade 2 (n =336, 318) | Hypophosphatemia: Grade 3 (n =336, 318) | Hypophosphatemia: Grade 4 (n =336, 318) | Lipase: Grade 1 (n =338, 319) | Lipase: Grade 2 (n =338, 319) | Lipase: Grade 3 (n =338, 319) | Lipase: Grade 4 (n =338, 319) | |
| Axitinib 5 mg | 65 | 8 | 1 | 0 | 88 | 8 | 4 | 0 | 64 | 12 | 7 | 0 | 59 | 5 | 1 | 0 | 127 | 11 | 0 | 1 | 16 | 8 | 1 | 0 | 155 | 30 | 0 | 0 | 92 | 8 | 1 | 0 | 41 | 45 | 7 | 0 | 0 | 42 | 9 | 0 | 34 | 19 | 3 | 0 | 37 | 11 | 1 | 0 | 25 | 4 | 2 | 1 | 23 | 12 | 1 | 0 | 22 | 0 | 0 | 0 | 33 | 0 | 11 | 1 | 4 | 33 | 6 | 0 | 53 | 22 | 14 | 2 |
| Sorafenib 400 mg | 57 | 6 | 2 | 3 | 92 | 15 | 3 | 0 | 76 | 21 | 6 | 1 | 67 | 7 | 4 | 0 | 115 | 10 | 0 | 0 | 12 | 2 | 1 | 0 | 121 | 9 | 1 | 0 | 22 | 1 | 0 | 0 | 28 | 37 | 7 | 0 | 0 | 22 | 8 | 0 | 23 | 14 | 1 | 2 | 25 | 31 | 2 | 0 | 67 | 18 | 2 | 2 | 9 | 16 | 1 | 0 | 21 | 0 | 5 | 0 | 27 | 0 | 6 | 1 | 8 | 99 | 51 | 0 | 76 | 25 | 40 | 7 |
Hematology laboratory test included hemoglobin, platelet count, white blood cells count, neutrophils and lymphocytes. Abnormalities were assessed by CTCAE Grade Version 2 for severity: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. (NCT00678392)
Timeframe: From initiation of treatment up to follow-up period (up to 3 years)
| Intervention | Participants (Number) | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hemoglobin: Grade 1 (n =320, 316) | Hemoglobin: Grade 2 (n =320, 316) | Hemoglobin: Grade 3 (n =320, 316) | Hemoglobin: Grade 4 (n =320, 316) | Lymphocytes: Grade 1 (n =317, 309) | Lymphocytes: Grade 2 (n =317, 309) | Lymphocytes: Grade 3 (n =317, 309) | Lymphocytes: Grade 4 (n =317, 309) | Neutrophils: Grade 1 (n =316, 308) | Neutrophils: Grade 2 (n =316, 308) | Neutrophils: Grade 3 (n =316, 308) | Neutrophils: Grade 4 (n =316, 308) | Platelets: Grade 1 (n =312, 310) | Platelets: Grade 2 (n =312, 310) | Platelets: Grade 3 (n =312, 310) | Platelets: Grade 4 (n =312, 310) | White Blood Cells: Grade 1 (n =320, 315) | White Blood Cells: Grade 2 (n =320, 315) | White Blood Cells: Grade 3 (n =320, 315) | White Blood Cells: Grade 4 (n =320, 315) | |
| Axitinib 5 mg | 93 | 19 | 1 | 0 | 7 | 89 | 10 | 0 | 13 | 4 | 2 | 0 | 47 | 0 | 1 | 0 | 32 | 4 | 0 | 0 |
| Sorafenib 400 mg | 112 | 41 | 11 | 1 | 7 | 93 | 11 | 0 | 20 | 4 | 2 | 0 | 41 | 3 | 0 | 0 | 36 | 12 | 1 | 0 |
Urinalysis included urine blood/ hemoglobin, glucose and protein. Abnormalities were assessed by CTCAE Grade Version 2 for severity: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. (NCT00678392)
Timeframe: From initiation of treatment up to follow-up period (up to 3 years)
| Intervention | Participants (Number) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Urine blood/ hemoglobin: Grade 1 (n =304, 272) | Urine blood/ hemoglobin: Grade 2 (n =304, 272) | Urine blood/ hemoglobin: Grade 3 (n =304, 272) | Urine blood/ hemoglobin: Grade 4 (n =304, 272) | Urine glucose: Grade 1 (n =322, 286) | Urine glucose: Grade 2 (n =322, 286) | Urine glucose: Grade 3 (n =322, 286) | Urine glucose: Grade 4 (n =322, 286) | Urine protein: Grade 1 (n =326, 289) | Urine protein: Grade 2 (n =326, 289) | Urine protein: Grade 3 (n =326, 289) | Urine protein: Grade 4 (n =326, 289) | |
| Axitinib 5 mg | 45 | 1 | 0 | 0 | 12 | 0 | 0 | 1 | 105 | 31 | 27 | 9 |
| Sorafenib 400 mg | 35 | 0 | 0 | 0 | 13 | 3 | 0 | 1 | 91 | 27 | 21 | 7 |
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of the AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grade 1= mild; Grade 2= moderate; Grade 3= severe; Grade 4= life-threatening or disabling; Grade 5= death related to AE. (NCT00678392)
Timeframe: From initiation of treatment up to follow-up period (up to 3 years)
| Intervention | Percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 | |
| Axitinib 5 mg | 3.9 | 20.1 | 47.6 | 10.6 | 13.9 |
| Sorafenib 400 mg | 3.1 | 21.7 | 52.4 | 11.5 | 9.3 |
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life- threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious AEs. (NCT00678392)
Timeframe: From initiation of treatment up to follow-up period (up to 3 years)
| Intervention | Percentage of participants (Number) | |
|---|---|---|
| AEs | SAEs | |
| Axitinib 5 mg | 96.1 | 40.7 |
| Sorafenib 400 mg | 98.0 | 35.8 |
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life -threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious and non -serious AEs. (NCT00678392)
Timeframe: From initiation of treatment up to follow-up period (up to 3 years)
| Intervention | Percentage of participants (Number) | |
|---|---|---|
| AEs | SAEs | |
| Axitinib 5 mg | 92.2 | 15.3 |
| Sorafenib 400 mg | 95.2 | 13.8 |
One year survival rate defined as the probability that a subject was alive 1 year after the date of first study treatment. (NCT00338884)
Timeframe: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter up until 1 year
| Intervention | percent chance of survival (Median) |
|---|---|
| Sunitinib | 67.8 |
Time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death due to to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as [the end date for DR minus first CR or PR that was subsequently confirmed +1]/7. (NCT00338884)
Timeframe: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death due to any cause
| Intervention | months (Mean) |
|---|---|
| Sunitinib | 7.14 |
OR = subjects with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) persisting > = 4 weeks after initial documentation of response. A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. (NCT00338884)
Timeframe: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter
| Intervention | participants (Number) |
|---|---|
| Sunitinib | 41 |
Time from start of study medication to first documentation of objective tumor progression or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS (in months) was calculated as (first event date minus first dose date +1)/7. (NCT00338884)
Timeframe: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death
| Intervention | months (Median) |
|---|---|
| Sunitinib | 9.0 |
(NCT00338884)
Timeframe: Baseline
| Intervention | pg/mL (Mean) |
|---|---|
| Sunitinib | 9163.4 |
Time from date of first dose of study medication to first documentation of objective tumor progression. The 50% quartile point estimate is provided. The criteria for tumor progression was according to RECIST. (NCT00338884)
Timeframe: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter
| Intervention | months (Median) |
|---|---|
| Sunitinib | 10.0 |
(NCT00338884)
Timeframe: Baseline
| Intervention | picograms (pg)/mL (Mean) |
|---|---|
| Sunitinib | 154.8 |
FACT-Advanced Kidney Cancer Symptom Index (FKSI) Questionnaire: subscale designed to be a stand-alone instrument to measure symptoms and quality of life in patients with advanced kidney cancer. Contains 15 questions. Each question was answered on a 5-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Total FKSI score = sum score of the 15 item scores; total range: 0 - 60; 0 (most severe symptoms and concerns) to 60 (no symptoms or concerns). End of treatment assessment was for subjects who completed the study only. (NCT00338884)
Timeframe: Baseline (Day 1, Week 1), Day 1 of Weeks 3, 5, 7, 9, 11, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, Week 53 (End of Treatment)
| Intervention | scores on a scale (Mean) | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (n=109) | Week 3 (n=104) | Week 5 (n=101) | Week 7 (n=97) | Week 9 (n=88) | Week 11 (n=84) | Week 13 (n=81) | Week 17 (n=72) | Week 21 (n=63) | Week 25 (n=55) | Week 29 (n=55) | Week 33 (n=50) | Week 37 (n=47) | Week 41 (n=45) | Week 45 (n=37) | Week 49 (n=36) | Week 53 (End of Treatment) (n=35) | |
| Sunitinib | 44.68 | 43.69 | 42.71 | 43.69 | 44.11 | 43.26 | 43.49 | 44.21 | 45.51 | 45.42 | 44.64 | 44.06 | 45.23 | 44.71 | 46.73 | 45.92 | 45.94 |
Ctrough = the concentration prior to study drug administration. (NCT00338884)
Timeframe: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
| Intervention | ng/mL (Mean) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1, Week 1 (n=111) | Day 1, Week 3 (n=108) | Day 1, Week 5 (n=106) | Day 1, Week 7 (n=104) | Day 1, Week 9 (n=97) | Day 1, Week 13 (n=93) | Day 1, Week 17 (n=82) | Day 1, Week 21 (n=73) | Day 1, Week 25 (n=70) | Day 1, Week 29 (n=58) | Day 1, Week 33 (n=58) | Day 1, Week 37 (n=50) | Day 1, Week 41 (n=49) | Day 1, Week 45 (n=44) | Day 1, Week 49 (n=40) | Day 1, Week 53 (n=33) | |
| Sunitinib | 2.62 | 20.27 | 20.25 | 20.41 | 21.18 | 20.01 | 19.76 | 17.13 | 17.30 | 17.38 | 16.55 | 15.71 | 16.50 | 15.61 | 16.57 | 13.81 |
Ctrough = the concentration prior to study drug administration. (NCT00338884)
Timeframe: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
| Intervention | ng/mL (Mean) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1, Week 1 (n=111) | Day 1, Week 3 (n=108) | Day 1, Week 5 (n=106) | Day 1, Week 7 (n=104) | Day 1, Week 9 (n=97) | Day 1, Week 13 (n=93) | Day 1, Week 17 (n=82) | Day 1, Week 21 (n=73) | Day 1, Week 25 (n=70) | Day 1, Week 29 (n=58) | Day 1, Week 33 (n=58) | Day 1, Week 37 (n=50) | Day 1, Week 41 (n=49) | Day 1, Week 45 (n=44) | Day 1, Week 49 (n=40) | Day 1, Week 53 (n=33) | |
| Sunitinib | 9.77 | 75.04 | 65.89 | 66.76 | 68.72 | 61.31 | 61.41 | 53.09 | 53.69 | 55.39 | 50.27 | 51.74 | 49.83 | 51.82 | 53.07 | 46.91 |
Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented. (NCT00338884)
Timeframe: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
| Intervention | ng/mL (Median) | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1, Week 1 (CR or PR, n=39) | Day 1, Week 3 (CR or PR, n=40) | Day 1, Week 5 (CR or PR, n=38) | Day 1, Week 7 (CR or PR, n=40) | Day 1, Week 9 (CR or PR, n=38) | Day 1, Week 13 (CR or PR, n=41) | Day 1, Week 17 (CR or PR, n=38) | Day 1, Week 21 (CR or PR, n=38) | Day 1, Week 25 (CR or PR, n=37) | Day 1, Week 29 (CR or PR, n=32) | Day 1, Week 33 (CR or PR, n=33) | Day 1, Week 37 (CR or PR, n=28) | Day 1, Week 41 (CR or PR, n=28) | Day 1, Week 45 (CR or PR, n=29) | Day 1, Week 49 (CR or PR, n=26) | Day 1, Week 53 (CR or PR, n=21) | Day 1, Week 1 (PD, n=16) | Day 1, Week 3 (PD, n=15) | Day 1, Week 5 (PD, n=15) | Day 1, Week 7 (PD, n=13) | Day 1, Week 9 (PD, n=8) | Day 1, Week 13 (PD, n=1) | Day 1, Week 17 (PD, n=1) | Day 1, Week 21 (PD, n=1) | Day 1, Week 25 (PD, n=1) | Day 1, Week 29 (PD, n=1) | Day 1, Week 33 (PD, n=1) | |
| Sunitinib | 0.000 | 18.250 | 16.650 | 17.300 | 15.100 | 15.900 | 14.300 | 12.600 | 14.500 | 12.850 | 12.800 | 14.350 | 14.000 | 13.400 | 14.700 | 11.600 | 0.000 | 20.000 | 18.800 | 14.300 | 16.550 | 9.710 | 12.600 | 23.400 | 29.400 | 13.700 | 4.360 |
Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented. (NCT00338884)
Timeframe: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
| Intervention | ng/mL (Median) | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1, Week 1 (CR or PR, n=39) | Day 1, Week 3 (CR or PR, n=40) | Day 1, Week 5 (CR or PR, n=38) | Day 1, Week 7 (CR or PR, n=40) | Day 1, Week 9 (CR or PR, n=38) | Day 1, Week 13 (CR or PR, n=41) | Day 1, Week 17 (CR or PR, n=38) | Day 1, Week 21 (CR or PR, n=38) | Day 1, Week 25 (CR or PR, n=37) | Day 1, Week 29 (CR or PR, n=32) | Day 1, Week 33 (CR or PR, n=33) | Day 1, Week 37 (CR or PR, n=28) | Day 1, Week 41 (CR or PR, n=28) | Day 1, Week 45 (CR or PR, n=29) | Day 1, Week 49 (CR or PR, n=26) | Day 1, Week 53 (CR or PR, n=21) | Day 1, Week 1 (PD, n=16) | Day 1, Week 3 (PD, n=15) | Day 1, Week 5 (PD, n=15) | Day 1, Week 7 (PD, n=13) | Day 1, Week 9 (PD, n=8) | Day 1, Week 13 (PD, n=1) | Day 1, Week 17 (PD, n=1) | Day 1, Week 21 (PD, n=1) | Day 1, Week 25 (PD, n=1) | Day 1, Week 29 (PD, n=1) | Day 1, Week 33 (PD, n=1) | |
| Sunitinib | 0.000 | 76.950 | 65.900 | 66.100 | 65.150 | 57.600 | 55.660 | 47.370 | 50.700 | 50.650 | 46.000 | 49.750 | 43.365 | 45.200 | 49.975 | 41.000 | 0.000 | 69.000 | 64.700 | 50.200 | 55.850 | 34.810 | 40.800 | 71.100 | 52.100 | 37.400 | 13.880 |
Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented. (NCT00338884)
Timeframe: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
| Intervention | ng/mL (Median) | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1, Week 1 (CR or PR, n=39) | Day 1, Week 3 (CR or PR, n=40) | Day 1, Week 5 (CR or PR, n=38) | Day 1, Week 7 (CR or PR, n=40) | Day 1, Week 9 (CR or PR, n=38) | Day 1, Week 13 (CR or PR, n=41) | Day 1, Week 17 (CR or PR, n=38) | Day 1, Week 21 (CR or PR, n=38) | Day 1, Week 25 (CR or PR, n=37) | Day 1, Week 29 (CR or PR, n=32) | Day 1, Week 33 (CR or PR, n=33) | Day 1, Week 37 (CR or PR, n=28) | Day 1, Week 41 (CR or PR, n=28) | Day 1, Week 45 (CR or PR, n=29) | Day 1, Week 49 (CR or PR, n=26) | Day 1, Week 53 (CR or PR, n=21) | Day 1, Week 1 (PD, n=16) | Day 1, Week 3 (PD, n=15) | Day 1, Week 5 (PD, n=15) | Day 1, Week 7 (PD, n=13) | Day 1, Week 9 (PD, n=8) | Day 1, Week 13 (PD, n=1) | Day 1, Week 17 (PD, n=1) | Day 1, Week 21 (PD, n=1) | Day 1, Week 25 (PD, n=1) | Day 1, Week 29 (PD, n=1) | Day 1, Week 33 (PD, n=1) | |
| Sunitinib | 0.000 | 57.900 | 45.000 | 45.400 | 46.250 | 40.000 | 41.350 | 34.400 | 34.200 | 34.450 | 33.000 | 35.350 | 30.900 | 34.000 | 36.250 | 28.600 | 0.000 | 50.200 | 45.600 | 35.600 | 39.050 | 25.100 | 28.200 | 47.700 | 22.700 | 23.700 | 9.520 |
Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented. (NCT00338884)
Timeframe: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
| Intervention | ng/mL (Median) | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1, Week 1 (CR or PR or SD, n=83) | Day 1, Week 3 (CR or PR or SD, n=83) | Day 1, Week 5 (CR or PR or SD, n=83) | Day 1, Week 7 (CR or PR or SD, n=86) | Day 1, Week 9 (CR or PR or SD, n=85) | Day 1, Week 13 (CR or PR or SD, n=88) | Day 1, Week 17 (CR or PR or SD, n=79) | Day 1, Week 21 (CR or PR or SD, n=71) | Day 1, Week 25 (CR or PR or SD, n=68) | Day 1, Week 29 (CR or PR or SD, n=56) | Day 1, Week 33 (CR or PR or SD, n=56) | Day 1, Week 37 (CR or PR or SD, n=49) | Day 1, Week 41 (CR or PR or SD, n=49) | Day 1, Week 45 (CR or PR or SD, n=44) | Day 1, Week 49 (CR or PR or SD, n=40) | Day 1, Week 53 (CR or PR or SD, n=32) | Day 1, Week 1 (PD, n=16) | Day 1, Week 3 (PD, n=15) | Day 1, Week 5 (PD, n=15) | Day 1, Week 7 (PD, n=13) | Day 1, Week 9 (PD, n=8) | Day 1, Week 13 (PD, n=1) | Day 1, Week 17 (PD, n=1) | Day 1, Week 21 (PD, n=1) | Day 1, Week 25 (PD, n=1) | Day 1, Week 29 (PD, n=1) | Day 1, Week 33 (PD, n=1) | |
| Sunitinib | 0.000 | 18.800 | 17.300 | 17.900 | 18.700 | 16.350 | 14.600 | 14.100 | 14.950 | 14.900 | 14.050 | 15.500 | 15.400 | 13.700 | 14.700 | 11.450 | 0.000 | 20.000 | 18.800 | 14.300 | 16.550 | 9.710 | 12.600 | 23.400 | 29.400 | 13.700 | 4.360 |
Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented. (NCT00338884)
Timeframe: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
| Intervention | ng/mL (Median) | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1, Week 1 (CR or PR or SD, n=83) | Day 1, Week 3 (CR or PR or SD, n=83) | Day 1, Week 5 (CR or PR or SD, n=83) | Day 1, Week 7 (CR or PR or SD, n=86) | Day 1, Week 9 (CR or PR or SD, n=85) | Day 1, Week 13 (CR or PR or SD, n=88) | Day 1, Week 17 (CR or PR or SD, n=79) | Day 1, Week 21 (CR or PR or SD, n=71) | Day 1, Week 25 (CR or PR or SD, n=68) | Day 1, Week 29 (CR or PR or SD, n=56) | Day 1, Week 33 (CR or PR or SD, n=56) | Day 1, Week 37 (CR or PR or SD, n=49) | Day 1, Week 41 (CR or PR or SD, n=49) | Day 1, Week 45 (CR or PR or SD, n=44) | Day 1, Week 49 (CR or PR or SD, n=40) | Day 1, Week 53 (CR or PR or SD, n=32) | Day 1, Week 1 (PD, n=16) | Day 1, Week 3 (PD, n=15) | Day 1, Week 5 (PD, n=15) | Day 1, Week 7 (PD, n=13) | Day 1, Week 9 (PD, n=8) | Day 1, Week 13 (PD, n=1) | Day 1, Week 17 (PD, n=1) | Day 1, Week 21 (PD, n=1) | Day 1, Week 25 (PD, n=1) | Day 1, Week 29 (PD, n=1) | Day 1, Week 33 (PD, n=1) | |
| Sunitinib | 0.000 | 75.000 | 63.300 | 66.400 | 70.600 | 57.600 | 58.100 | 49.860 | 51.150 | 53.500 | 50.050 | 50.800 | 48.000 | 50.500 | 54.885 | 42.160 | 0.000 | 69.000 | 64.700 | 50.200 | 55.850 | 34.810 | 40.800 | 71.100 | 52.100 | 37.400 | 13.880 |
Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented. (NCT00338884)
Timeframe: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
| Intervention | ng/mL (Median) | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1, Week 1 (CR or PR or SD, n=83) | Day 1, Week 3 (CR or PR or SD, n=83) | Day 1, Week 5 (CR or PR or SD, n=83) | Day 1, Week 7 (CR or PR or SD, n=86) | Day 1, Week 9 (CR or PR or SD, n=85) | Day 1, Week 13 (CR or PR or SD, n=88) | Day 1, Week 17 (CR or PR or SD, n=79) | Day 1, Week 21 (CR or PR or SD, n=71) | Day 1, Week 25 (CR or PR or SD, n=68) | Day 1, Week 29 (CR or PR or SD, n=56) | Day 1, Week 33 (CR or PR or SD, n=56) | Day 1, Week 37 (CR or PR or SD, n=49) | Day 1, Week 41 (CR or PR or SD, n=49) | Day 1, Week 45 (CR or PR or SD, n=44) | Day 1, Week 49 (CR or PR or SD, n=40) | Day 1, Week 53 (CR or PR or SD, n=32) | Day 1, Week 1 (PD, n=16) | Day 1, Week 3 (PD, n=15) | Day 1, Week 5 (PD, n=15) | Day 1, Week 7 (PD, n=13) | Day 1, Week 9 (PD, n=8) | Day 1, Week 13 (PD, n=1) | Day 1, Week 17 (PD, n=1) | Day 1, Week 21 (PD, n=1) | Day 1, Week 25 (PD, n=1) | Day 1, Week 29 (PD, n=1) | Day 1, Week 33 (PD, n=1) | |
| Sunitinib | 0.000 | 55.300 | 44.600 | 46.750 | 49.500 | 39.550 | 42.300 | 36.500 | 35.500 | 37.250 | 34.400 | 35.300 | 33.200 | 35.950 | 37.250 | 31.100 | 0.000 | 50.200 | 45.600 | 35.600 | 39.050 | 25.100 | 28.200 | 47.700 | 22.700 | 23.700 | 9.520 |
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale: Overall score from 13-question questionnaire (measures fatigue/asthenia for patients with chronic, life-threatening illnesses). For each question, patient rates condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Total FACIT-Fatigue score = sum score of the 13 question scores; total range: 0 - 52; higher total score represents less fatigue. End of treatment assessment was for subjects who completed the study only. (NCT00338884)
Timeframe: Baseline (Day 1, Week 1), Day 1 of Weeks 3, 5, 7, 9, 11, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, Week 53 (End of Treatment)
| Intervention | scores on a scale (Mean) | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (n=118) | Week 3 (n=113) | Week 5 (n=110) | Week 7 (n=106) | Week 9 (n=97) | Week 11 (n=93) | Week 13 (n=90) | Week 17 (n=80) | Week 21 (n=71) | Week 25 (n=62) | Week 29 (n=60) | Week 33 (n=55) | Week 37 (n=52) | Week 41 (n=50) | Week 45 (n=42) | Week 49 (n=41) | Week 53 (End of Treatment) (n=40) | |
| Sunitinib | 39.29 | 36.98 | 35.44 | 36.54 | 36.82 | 35.94 | 36.58 | 37.44 | 38.42 | 38.05 | 36.77 | 36.00 | 37.88 | 36.96 | 38.71 | 39.32 | 39.05 |
Summary statistics of sVEGFR2 at baseline by group (CR or PR or SD versus PD) are presented. (NCT00338884)
Timeframe: Baseline (Cycle 1, Day 1)
| Intervention | pg/mL (Median) | |
|---|---|---|
| Cycle 1, Day 1 (CR or PR or SD, n=85) | Cycle 1, Day 1 (PD, n=16) | |
| Sunitinib | 9772.500 | 8342.750 |
Summary statistics of sVEGFR2 at baseline by group (CR or PR versus PD) are presented. (NCT00338884)
Timeframe: Baseline (Cycle 1, Day 1)
| Intervention | pg/mL (Median) | |
|---|---|---|
| Cycle 1, Day 1 (CR or PR, n=40) | Cycle 1, Day 1 (PD, n=16) | |
| Sunitinib | 9968.000 | 8342.750 |
sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline). (NCT00338884)
Timeframe: Baseline to Day 1 of Weeks 3 through 53
| Intervention | ratio (Mean) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1, Week 3 (n=106) | Day 1, Week 5 (n=104) | Day 1, Week 7 (n=101) | Day 1, Week 9 (n=95) | Day 1, Week 13 (n=91) | Day 1, Week 17 (n=79) | Day 1, Week 21 (n=69) | Day 1, Week 25 (n=68) | Day 1, Week 29 (n=55) | Day 1, Week 33 (n=55) | Day 1, Week 37 (n=50) | Day 1, Week 41 (n=48) | Day 1, Week 45 (n=42) | Day 1, Week 49 (n=38) | Day 1, Week 53 (n=31) | |
| Sunitinib | 0.7 | 0.6 | 0.6 | 0.6 | 0.6 | 0.6 | 0.6 | 0.6 | 0.6 | 0.6 | 0.6 | 0.6 | 0.6 | 0.6 | 0.7 |
Median sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 12 weeks] versus PD). (NCT00338884)
Timeframe: Baseline to Day 1 of Weeks 3 through 53
| Intervention | ratio (Median) | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1, Week 3 (CR or PR or SD, n=81) | Day 1, Week 3 (PD, n=15) | Day 1, Week 5 (CR or PR or SD, n=81) | Day 1, Week 5 (PD, n=15) | Day 1, Week 7 (CR or PR or SD, n=84) | Day 1, Week 7 (PD, n=13) | Day 1, Week 9 (CR or PR or SD, n=83) | Day 1, Week 9 (PD, n=8) | Day 1, Week 13 (CR or PR or SD, n=85) | Day 1, Week 13 (PD, n=2) | Day 1, Week 17 (CR or PR or SD, n=77) | Day 1, Week 17 (PD, n=1) | Day 1, Week 21 (CR or PR or SD, n=67) | Day 1, Week 21 (PD, n=1) | Day 1, Week 25 (CR or PR or SD, n=66) | Day 1, Week 25 (PD, n=1) | Day 1, Week 29 (CR or PR or SD, n=53) | Day 1, Week 29 (PD, n=1) | Day 1, Week 33 (CR or PR or SD, n=54) | Day 1, Week 33 (PD, n=1) | Day 1, Week 37 (CR or PR or SD, n=49) | Day 1, Week 41 (CR or PR or SD, n=48) | Day 1, Week 45 (CR or PR or SD, n=42) | Day 1, Week 49 (CR or PR or SD, n=38) | Day 1, Week 53 (CR or PR or SD, n=30) | |
| Sunitinib | 0.691 | 0.653 | 0.625 | 0.531 | 0.599 | 0.574 | 0.563 | 0.603 | 0.534 | 0.529 | 0.524 | 0.687 | 0.548 | 0.540 | 0.570 | 0.509 | 0.556 | 0.671 | 0.569 | 0.610 | 0.559 | 0.572 | 0.538 | 0.569 | 0.638 |
Median sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR versus PD). (NCT00338884)
Timeframe: Baseline to Day 1 of Weeks 3 through 53
| Intervention | ratio (Median) | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1, Week 3 (CR or PR, n=39) | Day 1, Week 3 (PD, n=15) | Day 1, Week 5 (CR or PR, n=38) | Day 1, Week 5 (PD, n=15) | Day 1, Week 7 (CR or PR, n=40) | Day 1, Week 7 (PD, n=13) | Day 1, Week 9 (CR or PR, n=38) | Day 1, Week 9 (PD, n=8) | Day 1, Week 13 (CR or PR, n=40) | Day 1, Week 13 (PD, n=2) | Day 1, Week 17 (CR or PR, n=37) | Day 1, Week 17 (PD, n=1) | Day 1, Week 21 (CR or PR, n=36) | Day 1, Week 21 (PD, n=1) | Day 1, Week 25 (CR or PR, n=36) | Day 1, Week 25 (PD, n=1) | Day 1, Week 29 (CR or PR, n=30) | Day 1, Week 29 (PD, n=1) | Day 1, Week 33 (CR or PR, n=32) | Day 1, Week 33 (PD, n=1) | Day 1, Week 37 (CR or PR, n=29) | Day 1, Week 41 (CR or PR, n=29) | Day 1, Week 45 (CR or PR, n=28) | Day 1, Week 49 (CR or PR, n=25) | Day 1, Week 53 (CR or PR, n=20) | |
| Sunitinib | 0.704 | 0.653 | 0.638 | 0.531 | 0.596 | 0.574 | 0.562 | 0.603 | 0.555 | 0.529 | 0.545 | 0.687 | 0.566 | 0.540 | 0.564 | 0.509 | 0.564 | 0.671 | 0.547 | 0.610 | 0.554 | 0.561 | 0.535 | 0.555 | 0.630 |
Ctrough = the concentration prior to study drug administration. (NCT00338884)
Timeframe: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
| Intervention | nanograms (ng)/milliliter (mL) (Mean) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1, Week 1 (n=111) | Day 1, Week 3 (n=108) | Day 1, Week 5 (n=106) | Day 1, Week 7 (n=104) | Day 1, Week 9 (n=97) | Day 1, Week 13 (n=93) | Day 1, Week 17 (n=82) | Day 1, Week 21 (n=73) | Day 1, Week 25 (n=70) | Day 1, Week 29 (n=58) | Day 1, Week 33 (n=58) | Day 1, Week 37 (n=50) | Day 1, Week 41 (n=49) | Day 1, Week 45 (n=44) | Day 1, Week 49 (n=40) | Day 1, Week 53 (n=33) | |
| Sunitinib | 7.15 | 54.78 | 45.64 | 46.35 | 47.54 | 41.29 | 41.65 | 35.95 | 36.39 | 38.01 | 33.72 | 36.04 | 33.33 | 36.20 | 36.49 | 33.10 |
Summary statistics of VEGF at baseline by group (CR or PR or SD versus PD) are presented. (NCT00338884)
Timeframe: Baseline (Cycle 1, Day 1)
| Intervention | pg/mL (Median) | |
|---|---|---|
| Cycle 1, Day 1 (CR or PR or SD, n=85) | Cycle 1, Day 1 (PD, n=16) | |
| Sunitinib | 86.400 | 109.300 |
Summary statistics of VEGF at baseline by group (CR or PR versus PD) are presented. (NCT00338884)
Timeframe: Baseline (Cycle 1, Day 1)
| Intervention | pg/mL (Median) | |
|---|---|---|
| Cycle 1, Day 1 (CR or PR, n=39) | Cycle 1, Day 1 (PD, n=16) | |
| Sunitinib | 73.600 | 109.300 |
VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline). (NCT00338884)
Timeframe: Baseline to Day 1 of Weeks 3 through 53
| Intervention | ratio (Mean) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1, Week 3 (n=108) | Day 1, Week 5 (n=104) | Day 1, Week 7 (n=101) | Day 1, Week 9 (n=95) | Day 1, Week 13 (n=91) | Day 1, Week 17 (n=78) | Day 1, Week 21 (n=70) | Day 1, Week 25 (n=67) | Day 1, Week 29 (n=55) | Day 1, Week 33 (n=54) | Day 1, Week 37 (n=49) | Day 1, Week 41 (n=48) | Day 1, Week 45 (n=41) | Day 1, Week 49 (n=37) | Day 1, Week 53 (n=30) | |
| Sunitinib | 2.9 | 2.6 | 2.6 | 3.4 | 3.2 | 2.8 | 2.6 | 3 | 2.5 | 2.3 | 2.7 | 5.5 | 2.9 | 2.8 | 3.2 |
Median VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 12 weeks] versus PD). (NCT00338884)
Timeframe: Baseline to Day 1 of Weeks 3 through 53
| Intervention | ratio (Median) | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1, Week 3 (CR or PR or SD, n=83) | Day 1, Week 3 (PD, n=15) | Day 1, Week 5 (CR or PR or SD, n=81) | Day 1, Week 5 (PD, n=15) | Day 1, Week 7 (CR or PR or SD, n=84) | Day 1, Week 7 (PD, n=13) | Day 1, Week 9 (CR or PR or SD, n=83) | Day 1, Week 9 (PD, n=8) | Day 1, Week 13 (CR or PR or SD, n=85) | Day 1, Week 13 (PD, n=2) | Day 1, Week 17 (CR or PR or SD, n=76) | Day 1, Week 17 (PD, n=1) | Day 1, Week 21 (CR or PR or SD, n=68) | Day 1, Week 21 (PD, n=1) | Day 1, Week 25 (CR or PR or SD, n=65) | Day 1, Week 25 (PD, n=1) | Day 1, Week 29 (CR or PR or SD, n=53) | Day 1, Week 29 (PD, n=1) | Day 1, Week 33 (CR or PR or SD, n=53) | Day 1, Week 33 (PD, n=1) | Day 1, Week 37 (CR or PR or SD, n=48) | Day 1, Week 41 (CR or PR or SD, n=48) | Day 1, Week 45 (CR or PR or SD, n=41) | Day 1, Week 49 (CR or PR or SD, n=37) | Day 1, Week 53 (CR or PR or SD, n=29) | |
| Sunitinib | 2.127 | 1.948 | 1.574 | 2.471 | 1.798 | 1.405 | 2.481 | 1.176 | 1.890 | 3.921 | 2.070 | 0.988 | 1.972 | 1.510 | 1.906 | 1.433 | 1.831 | 1.929 | 2.200 | 1.063 | 2.201 | 1.859 | 2.484 | 2.329 | 2.431 |
Median VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR versus PD). (NCT00338884)
Timeframe: Baseline to Day 1 of Weeks 3 through 53
| Intervention | ratio (Median) | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1, Week 3 (CR or PR, n=38) | Day 1, Week 3 (PD, n=15) | Day 1, Week 5 (CR or PR, n=37) | Day 1, Week 5 (PD, n=15) | Day 1, Week 7 (CR or PR, n=39) | Day 1, Week 7 (PD, n=13) | Day 1, Week 9 (CR or PR, n=37) | Day 1, Week 9 (PD, n=8) | Day 1, Week 13 (CR or PR, n=39) | Day 1, Week 13 (PD, n=2) | Day 1, Week 17 (CR or PR, n=36) | Day 1, Week 17 (PD, n=1) | Day 1, Week 21 (CR or PR, n=36) | Day 1, Week 21 (PD, n=1) | Day 1, Week 25 (CR or PR, n=35) | Day 1, Week 25 (PD, n=1) | Day 1, Week 29 (CR or PR, n=30) | Day 1, Week 29 (PD, n=1) | Day 1, Week 33 (CR or PR, n=31) | Day 1, Week 33 (PD, n=1) | Day 1, Week 37 (CR or PR, n=28) | Day 1, Week 41 (CR or PR, n=28) | Day 1, Week 45 (CR or PR, n=27) | Day 1, Week 49 (CR or PR, n=24) | Day 1, Week 53 (CR or PR, n=19) | |
| Sunitinib | 1.999 | 1.948 | 1.383 | 2.471 | 1.761 | 1.405 | 2.215 | 1.176 | 1.753 | 3.921 | 2.012 | 0.988 | 1.523 | 1.510 | 1.809 | 1.433 | 1.805 | 1.929 | 2.248 | 1.063 | 2.179 | 1.864 | 2.240 | 2.707 | 2.863 |
Duration of response as defined by the time from CR or PR (whichever status recorded first) until the date of death or PD was objectively documented. Median and its 95 percent confidence interval (95% CI) were estimated using Kaplan-Meier method. (NCT00474786)
Timeframe: Baseline up to 24 Months
| Intervention | months (Median) |
|---|---|
| Temsirolimus | 8.26 |
| Sorafenib | 6.96 |
Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact. (NCT00474786)
Timeframe: Baseline to date of death from any cause (up to 24 months)
| Intervention | months (Median) |
|---|---|
| Temsirolimus | 12.27 |
| Sorafenib | 16.64 |
Percentage of participants with tumor response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST and evaluated by independent central review. CR/PR persisted on repeat imaging study at least 4 weeks after initial documentation of response. PR had at least 30 percent decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. (NCT00474786)
Timeframe: Baseline up to 24 Months
| Intervention | percentage of participants (Number) |
|---|---|
| Temsirolimus | 7.7 |
| Sorafenib | 7.9 |
Interval from date of randomization until documentation of PD by an investigator tumor assessment, symptomatic deterioration, or death for any reason whichever occurred first. (NCT00474786)
Timeframe: Baseline up to 24 Months
| Intervention | months (Median) |
|---|---|
| Temsirolimus | 5.43 |
| Sorafenib | 4.14 |
Interval from date of randomization until documentation of progressive disease (PD) by an independent tumor assessment according to Response Evaluation Criteria in Solid Tumor (RECIST) or death for any reason whichever occurred first. (NCT00474786)
Timeframe: Baseline up to 24 Months
| Intervention | months (Median) |
|---|---|
| Temsirolimus | 4.28 |
| Sorafenib | 3.91 |
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. (NCT00474786)
Timeframe: Baseline up to 24 months
| Intervention | participants (Number) | |
|---|---|---|
| Serious AE | Any AE | |
| Sorafenib | 86 | 251 |
| Temsirolimus | 103 | 248 |
PFS: Interval from date of randomization until documentation of PD by an independent tumor assessment according to RECIST or death for any reason whichever occurred first. PFS calculated as (Weeks)=(randomization date minus first dose date plus 1) divided by 7. (NCT00474786)
Timeframe: Weeks 12, 24, and 36
| Intervention | percentage of participants (Number) | ||
|---|---|---|---|
| Baseline to Week 12 | Week 13 to Week 24 | Week 25 to Week 36 | |
| Sorafenib | 36.7 | 20.1 | 11.2 |
| Temsirolimus | 31.2 | 20.9 | 12.3 |
Time from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for the subgroup of participants with a confirmed objective tumor response. (NCT00267748)
Timeframe: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
| Intervention | Months (Median) |
|---|---|
| Sunitinib 50 mg (Schedule 4/2) | 12.5 |
| Sunitinib 37.5 mg | 8.7 |
"FKSI-DRS is a subset of FKSI which is a questionnaire for Functional Assessment of Cancer Therapy -Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer.~The FKSI contained 15 questions and the FKSI-DRS consisted of 9 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI-DRS ranged between 0-36. Since the questions could be reversed coded, as appropriate, before calculating FKSI-DRS, 0 and 36 could be considered the worst and best health states based on the 9 questions comprising FKSI-DRS." (NCT00267748)
Timeframe: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
| Intervention | Units on scale (Mean) |
|---|---|
| Sunitinib 50 mg (Schedule 4/2) | 28.3 |
| Sunitinib 37.5 mg | 27.2 |
FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population.FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL(HRQoL):Physical Well-being(PWB),Social/Family Well-Being (SWB),Emotional Well-Being (EWB) and Functional Well-Being (FWB);each ranging from 0 (not at all) to 4 (very much) so that FACT-G ranged between 0-108.Since questions could be reversed coded, as appropriate, before calculating FACT-G,0 and 108 could be considered worst and best health states. (NCT00267748)
Timeframe: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
| Intervention | Units on a scale (Mean) |
|---|---|
| Sunitinib 50 mg (Schedule 4/2) | 78.0 |
| Sunitinib 37.5 mg | 77.0 |
Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with atleast 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. (NCT00267748)
Timeframe: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
| Intervention | Percentage of participants (Number) |
|---|---|
| Sunitinib 50 mg (Schedule 4/2) | 32.2 |
| Sunitinib 37.5 mg | 28.1 |
MSKCC Prognostic Factor Model assessed as low (0), intermediate (1-2) or high (=>3) based upon number of criteria present. Criteria as follows: Karnofsky performance status < 80 %, Lactate dehydrogenase > 1.5 * Upper limit of Normal, Hemoglobin < lower limit of normal for local lab, Corrected serum calcium > 10 mg/dL; Time from first diagnosis of renal cell carcinoma to start of systemic therapy of < 1 year. OS was defined as time from date of start of treatment to date of death due to any cause. OS, in months, was calculated as (event date -start of treatment date + 1)/30.44. (NCT00267748)
Timeframe: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
| Intervention | Months (Median) | ||
|---|---|---|---|
| High Risk (equal or more than 3) | Intermediate Risk (1-2) | Low Risk (0) | |
| Sunitinib 37.5 mg | 6.1 | 21.8 | 28.9 |
| Sunitinib 50 mg (Schedule 4/2) | 3.5 | 19.3 | NA |
MSKCC Prognostic Factor Model assessed as low(0),intermediate(1-2) or high(=>3) based on number of criteria present such as Karnofsky performance status < 80 %, Lactate dehydrogenase > 1.5 * Upper limit of Normal,Hemoglobin < lower limit of normal, serum calcium > 10 mg/dL;Time from first diagnosis of renal cell carcinoma to start of systemic therapy of < 1 year.TTP was time from start of study treatment to first documentation of objective tumor progression or death due to cancer.TTP was calculated as (first event date minus date of first dose of study medication plus 1) divided by 30.44. (NCT00267748)
Timeframe: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
| Intervention | Months (Median) | |||
|---|---|---|---|---|
| Stratified analysis : High Risk (=>3) | Stratified analysis : Intermediate Risk (1-2) | Stratified analysis : Low Risk (0) | Overall unstratified analysis | |
| Sunitinib 37.5 mg | 4.4 | 7.1 | 8.4 | 7.1 |
| Sunitinib 50 mg (Schedule 4/2) | 3.1 | 8.0 | 20.7 | 9.9 |
"Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7.~DR was calculated for the subgroup of patients with a confirmed objective tumor response." (NCT00077974)
Timeframe: Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death due to cancer
| Intervention | weeks (Median) |
|---|---|
| Sunitinib Malate | 60.4 |
Overall confirmed objective response = confirmed Complete Response (CR) or confirmed Partial Response (PR) according to RECIST. CR defined as disappearance of all target lesions. PR defined as >= 30 percent decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. (NCT00077974)
Timeframe: From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter
| Intervention | participants (Number) |
|---|---|
| Sunitinib Malate | 35 |
Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the subject current status was death). (NCT00077974)
Timeframe: From start of study treatment until death
| Intervention | weeks (Median) |
|---|---|
| Sunitinib Malate | 104.1 |
"Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)." (NCT00077974)
Timeframe: From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death
| Intervention | weeks (Median) |
|---|---|
| Sunitinib Malate | 38.0 |
Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]). (NCT00077974)
Timeframe: From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter
| Intervention | weeks (Median) |
|---|---|
| Sunitinib Malate | 46.3 |
Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib. Dose-corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date. (NCT00077974)
Timeframe: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
| Intervention | nanograms per milliliter (Mean) | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cycle 1 Day 28 (n = 33) | Cycle 2 Day 28 (n = 26) | Cycle 3 Day 28 (n = 20) | Cycle 4 Day 28 (n = 25) | Cycle 5 Day 1 (n = 28) | Cycle 6 Day 1 (n = 41) | Cycle 7 Day 1 (n = 35) | Cycle 8 Day 1 (n = 32) | Cycle 9 Day 1 (n = 32) | Cycle 10 Day 1 (n = 32) | Cycle 11 Day 1 (n = 25) | Cycle 12 Day 1 (n = 28) | Cycle 13 Day 1 (n = 23) | Cycle 14 Day 1 (n = 24) | Cycle 15 Day 1 (n = 16) | Cycle 16 Day 1 (n = 18) | Cycle 17 Day 1 (n = 17) | Cycle 18 Day 1 (n = 14) | Cycle 19 Day 1 (n = 11) | Cycle 20 Day 1 (n = 11) | Cycle 21 Day 1 (n = 8) | Cycle 22 Day 1 (n = 9) | Cycle 23 Day 1 (n = 6) | Cycle 24 Day 1 (n = 6) | Cycle 25 Day 1 (n = 5) | Cycle 26 Day 1 (n = 5) | Cycle 27 Day 1 (n = 5) | Cycle 28 Day 1 (n = 4) | Cycle 29 Day 1 (n = 4) | Cycle 30 Day 1 (n = 3) | |
| Sunitinib Malate | 53.64 | 55.94 | 69.44 | 64.33 | 1.94 | 2.15 | 2.04 | 2.32 | 2.07 | 2.68 | 3.42 | 1.94 | 2.23 | 2.41 | 1.58 | 2.42 | 2.23 | 3.05 | 1.92 | 5.09 | 3.41 | 3.91 | 4.53 | 3.82 | 3.14 | 4.09 | 2.12 | 2.97 | 4.02 | 1.36 |
Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib metabolite (SU012662). Dose-corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date. (NCT00077974)
Timeframe: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
| Intervention | nanograms per milliliter (Mean) | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cycle 1 Day 28 (n = 33) | Cycle 2 Day 28 (n = 26) | Cycle 3 Day 28 (n = 20) | Cycle 4 Day 28 (n = 25) | Cycle 5 Day 1 (n = 28) | Cycle 6 Day 1 (n = 41) | Cycle 7 Day 1 (n = 35) | Cycle 8 Day 1 (n = 32) | Cycle 9 Day 1 (n = 32) | Cycle 10 Day 1 (n = 32) | Cycle 11 Day 1 (n = 25) | Cycle 12 Day 1 (n = 28) | Cycle 13 Day 1 (n = 23) | Cycle 14 Day 1 (n = 24) | Cycle 15 Day 1 (n = 16) | Cycle 16 Day 1 (n = 18) | Cycle 17 Day 1 (n = 17) | Cycle 18 Day 1 (n = 14) | Cycle 19 Day 1 (n = 11) | Cycle 20 Day 1 (n = 11) | Cycle 21 Day 1 (n = 8) | Cycle 22 Day 1 (n = 9) | Cycle 23 Day 1 (n = 6) | Cycle 24 Day 1 (n = 6) | Cycle 25 Day 1 (n = 5) | Cycle 26 Day 1 (n = 5) | Cycle 27 Day 1 (n = 5) | Cycle 28 Day 1 (n = 4) | Cycle 29 Day 1 (n = 4) | Cycle 30 Day 1 (n = 3) | |
| Sunitinib Malate | 31.85 | 28.15 | 40.53 | 38.04 | 2.99 | 3.35 | 3.11 | 3.37 | 3.45 | 3.61 | 4.37 | 3.24 | 3.68 | 3.54 | 2.80 | 3.40 | 2.55 | 2.59 | 2.93 | 4.53 | 3.97 | 5.31 | 4.26 | 3.62 | 3.00 | 4.49 | 2.36 | 2.94 | 3.32 | 1.18 |
Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib plus its metabolite (SU012662). Dose-corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date. (NCT00077974)
Timeframe: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
| Intervention | nanograms per milliliter (Mean) | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cycle 1 Day 28 (n = 33) | Cycle 2 Day 28 (n = 26) | Cycle 3 Day 28 (n = 20) | Cycle 4 Day 28 (n = 25) | Cycle 5 Day 1 (n = 28) | Cycle 6 Day 1 (n = 41) | Cycle 7 Day 1 (n = 35) | Cycle 8 Day 1 (n = 32) | Cycle 9 Day 1 (n = 32) | Cycle 10 Day 1 (n = 32) | Cycle 11 Day 1 (n = 25) | Cycle 12 Day 1 (n = 28) | Cycle 13 Day 1 (n = 23) | Cycle 14 Day 1 (n = 24) | Cycle 15 Day 1 (n = 16) | Cycle 16 Day 1 (n = 18) | Cycle 17 Day 1 (n = 17) | Cycle 18 Day 1 (n = 14) | Cycle 19 Day 1 (n = 11) | Cycle 20 Day 1 (n = 11) | Cycle 21 Day 1 (n = 8) | Cycle 22 Day 1 (n = 9) | Cycle 23 Day 1 (n = 6) | Cycle 24 Day 1 (n = 6) | Cycle 25 Day 1 (n = 5) | Cycle 26 Day 1 (n = 5) | Cycle 27 Day 1 (n = 5) | Cycle 28 Day 1 (n = 4) | Cycle 29 Day 1 (n = 4) | Cycle 30 Day 1 (n = 3) | |
| Sunitinib Malate | 85.49 | 84.09 | 109.97 | 102.37 | 4.93 | 5.50 | 5.15 | 5.69 | 5.52 | 6.29 | 7.78 | 5.19 | 5.91 | 5.95 | 4.39 | 5.82 | 4.78 | 5.64 | 4.85 | 9.63 | 7.38 | 9.23 | 8.79 | 7.44 | 6.13 | 8.58 | 4.48 | 5.90 | 7.34 | 2.54 |
Observed plasma trough (predose) (Cmin) concentrations of sunitinib (NCT00077974)
Timeframe: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
| Intervention | nanograms per milliliter (Mean) | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cycle 1 Day 28 (n = 103) | Cycle 2 Day 28 (n = 81) | Cycle 3 Day 28 (n = 73) | Cycle 4 Day 28 (n = 66) | Cycle 5 Day 1 (n = 63) | Cycle 6 Day 1 (n = 59) | Cycle 7 Day 1 (n = 52) | Cycle 8 Day 1 (n = 48) | Cycle 9 Day 1 (n = 46) | Cycle 10 Day 1 (n = 41) | Cycle 11 Day 1 (n = 38) | Cycle 12 Day 1 (n = 34) | Cycle 13 Day 1 (n = 30) | Cycle 14 Day 1 (n = 30) | Cycle 15 Day 1 (n = 24) | Cycle 16 Day 1 (n = 24) | Cycle 17 Day 1 (n = 19) | Cycle 18 Day 1 (n = 16) | Cycle 19 Day 1 (n = 14) | Cycle 20 Day 1 (n = 12) | Cycle 21 Day 1 (n = 11) | Cycle 22 Day 1 (n = 11) | Cycle 23 Day 1 (n = 7) | Cycle 24 Day 1 (n = 7) | Cycle 25 Day 1 (n = 6) | Cycle 26 Day 1 (n = 6) | Cycle 27 Day 1 (n = 6) | Cycle 28 Day 1 (n = 4) | Cycle 29 Day 1 (n = 5) | Cycle 30 Day 1 (n = 4) | |
| Sunitinib Malate | 46.82 | 50.13 | 49.36 | 53.18 | 1.55 | 1.44 | 1.51 | 1.60 | 1.60 | 1.69 | 2.05 | 1.72 | 1.74 | 1.60 | 1.56 | 1.46 | 1.42 | 2.20 | 1.34 | 2.96 | 2.53 | 2.18 | 3.14 | 2.75 | 1.99 | 2.46 | 1.20 | 1.75 | 2.93 | 1.02 |
Observed plasma trough (predose) (Cmin) concentrations of sunitinib metabolite (SU012662) (NCT00077974)
Timeframe: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
| Intervention | nanograms per milliliter (Mean) | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cycle 1 Day 28 (n = 103) | Cycle 2 Day 28 (n = 81) | Cycle 3 Day 28 (n = 73) | Cycle 4 Day 28 (n = 66) | Cycle 5 Day 1 (n = 63) | Cycle 6 Day 1 (n = 59) | Cycle 7 Day 1 (n = 52) | Cycle 8 Day 1 (n = 48) | Cycle 9 Day 1 (n = 46) | Cycle 10 Day 1 (n = 41) | Cycle 11 Day 1 (n = 38) | Cycle 12 Day 1 (n = 34) | Cycle 13 Day 1 (n = 30) | Cycle 14 Day 1 (n = 30) | Cycle 15 Day 1 (n = 24) | Cycle 16 Day 1 (n = 24) | Cycle 17 Day 1 (n = 19) | Cycle 18 Day 1 (n = 16) | Cycle 19 Day 1 (n = 14) | Cycle 20 Day 1 (n = 12) | Cycle 21 Day 1 (n = 11) | Cycle 22 Day 1 (n = 11) | Cycle 23 Day 1 (n = 7) | Cycle 24 Day 1 (n = 7) | Cycle 25 Day 1 (n = 6) | Cycle 26 Day 1 (n = 6) | Cycle 27 Day 1 (n = 6) | Cycle 28 Day 1 (n = 4) | Cycle 29 Day 1 (n = 5) | Cycle 30 Day 1 (n = 4) | |
| Sunitinib Malate | 26.44 | 28.21 | 28.32 | 28.54 | 2.50 | 2.64 | 2.64 | 2.66 | 2.81 | 2.54 | 2.78 | 2.67 | 2.77 | 2.49 | 2.51 | 2.30 | 1.83 | 2.16 | 2.06 | 2.92 | 3.13 | 3.24 | 3.10 | 2.64 | 1.99 | 2.60 | 1.36 | 1.81 | 2.43 | 1.10 |
Observed plasma trough (predose) concentrations of sunitinib plus its metabolite (SU012662) (NCT00077974)
Timeframe: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
| Intervention | nanograms per milliliter (Mean) | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cycle 1 Day 28 (n = 103) | Cycle 2 Day 28 (n = 81) | Cycle 3 Day 28 (n = 73) | Cycle 4 Day 28 (n = 66) | Cycle 5 Day 1 (n = 63) | Cycle 6 Day 1 (n = 59) | Cycle 7 Day 1 (n = 52) | Cycle 8 Day 1 (n = 48) | Cycle 9 Day 1 (n = 46) | Cycle 10 Day 1 (n = 41) | Cycle 11 Day 1 (n = 38) | Cycle 12 Day 1 (n = 34) | Cycle 13 Day 1 (n = 30) | Cycle 14 Day 1 (n = 30) | Cycle 15 Day 1 (n = 24) | Cycle 16 Day 1 (n = 24) | Cycle 17 Day 1 (n = 19) | Cycle 18 Day 1 (n = 16) | Cycle 19 Day 1 (n = 14) | Cycle 20 Day 1 (n = 12) | Cycle 21 Day 1 (n = 11) | Cycle 22 Day 1 (n = 11) | Cycle 23 Day 1 (n = 7) | Cycle 24 Day 1 (n = 7) | Cycle 25 Day 1 (n = 6) | Cycle 26 Day 1 (n = 6) | Cycle 27 Day 1 (n = 6) | Cycle 28 Day 1 (n = 4) | Cycle 29 Day 1 (n = 5) | Cycle 30 Day 1 (n = 4) | |
| Sunitinib Malate | 73.26 | 78.34 | 77.68 | 81.71 | 4.04 | 4.08 | 4.15 | 4.26 | 4.41 | 4.23 | 4.83 | 4.39 | 4.52 | 4.09 | 4.07 | 3.75 | 3.25 | 4.35 | 3.40 | 5.88 | 5.66 | 5.43 | 6.24 | 5.39 | 3.97 | 5.06 | 2.55 | 3.56 | 5.36 | 2.13 |
Probability of survival 1 year and 2 years after the first dose of study treatment (NCT00077974)
Timeframe: From start of study treatment until death
| Intervention | percent chance of survival (Number) | |
|---|---|---|
| 1 year | 2 years | |
| Sunitinib Malate | 67.2 | 50.2 |
Duration of response (DR) = time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause. DR data were censored on the day following the date of the last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects without objective tumor progression who did not die due to any cause while on treatment or who were given anti-tumor treatment other than study treatment prior to observing tumor progression. (NCT00083889)
Timeframe: Day 28 of each cycle: duraton of treatment phase
| Intervention | weeks (Median) |
|---|---|
| SU011248 | 52.9 |
| IFN-α | 64.9 |
Duration of response (DR) = time from the first documentation of objective tumor response to the first documentaion of objective tumor progression or to death due to any cause. DR data were censored on the day following the date of the last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects without objective tumor progression who did not die due to any cause while on treatment or who were given anti-tumor treatment other than study treatment prior to observing tumor progression. (NCT00083889)
Timeframe: Day 28 of each cycle: duration of treatment phase
| Intervention | weeks (Median) |
|---|---|
| SU011248 | 56.3 |
| IFN-α | 48.1 |
Incremental cost effectiveness ratio (ICER) of sunitinib compared to IFN-a as first-line treatment for MRCC, defined as the ratio of the incremental cost of treatment over the incremental effectiveness; effectiveness measured as quality adjusted life year (QALY) gain. This objective was not addressed in the clinical study report, but an interim analysis of cost-effectiveness was presented separately. These results were not available for inclusion at the time of this posting. (NCT00083889)
Timeframe: post study measurement
| Intervention | ratio (Number) |
|---|---|
| SU011248 | 0 |
| IFN-α | 0 |
Objective response (OR) = the number of patients with confirmed complete response (CR) and confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, relative to all randomized patients. CR was defined as the disappearance of all target lesions. PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Confirmed responses (CR or PR) = those that persisted on repeat imaging study >= 4 weeks after initial documentation of response. (NCT00083889)
Timeframe: Day 28 of each 6-week cycle: duration of treatment phase
| Intervention | participants (Number) |
|---|---|
| SU011248 | 145 |
| IFN-α | 29 |
Objective response (OR) = the number of patients with confirmed complete response (CR) and confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, relative to all randomized patients. CR was defined as the disappearance of all target lesions. PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Confirmed responses = those that persist on repeat imaging study >= 4 weeks after initial documentation of response. (NCT00083889)
Timeframe: Day 28 of each 6-week cycle: duration of treatment phase
| Intervention | participants (Number) |
|---|---|
| SU011248 | 171 |
| IFN-α | 45 |
Overall survival (OS) = time from date of randomization to date of death due to any cause. For patients not expiring, survival time was censored at the last date they were known to be alive. Patients lacking data beyond randomization had their survival times censored at the date of randomization with a duration of 1 day. (NCT00083889)
Timeframe: Clinic visit or telephone contact every 2 months until death
| Intervention | weeks (Median) |
|---|---|
| SU011248 | 114.6 |
| IFN-α | 94.9 |
Progression-free survival (PFS) = time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occured first. If tumor progression data included more than 1 date, the first date was used. PFS = first event date minus the date of randomization + 1. On study included treatment plus 28-day follow-up periods. (NCT00083889)
Timeframe: Day 28 of each 6-week cycle: duration of treatment phase
| Intervention | weeks (Median) |
|---|---|
| SU011248 | 48.3 |
| IFN-α | 22.1 |
Progression-free survival = time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occured first. PFS = first event date minus the date of randomization + 1). On study included treatment plus 28-day follow-up periods. (NCT00083889)
Timeframe: Day 28 of each 6-week cycle: duration of treatment phase
| Intervention | weeks (Median) |
|---|---|
| SU011248 | 47.7 |
| IFN-α | 22.1 |
TTP = time from randomization to first documentation of objective tumor progression. TTP data were censored on the day following the date of last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects who did not have objective tumor progression while on treatment or who were given anti-tumor treatment other than study treatment prior to documentation of objective tumor progression. Subjects with no tumor assessments after randomization had TTP censored on the date of randomization with a duration of 1 day. (NCT00083889)
Timeframe: Randomization to first documentation of tumor progression: duration of treatment phase
| Intervention | weeks (Median) |
|---|---|
| SU011248 | 49.1 |
| IFN-α | 22.4 |
TTP = time from randomization to first documentation of objective tumor progression. TTP data were censored on the day following the date of last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects who did not have objective tumor progression while on treatment or who were given anti-tumor treatment other than the study treatment prior to documentation of objective tumor progression. Subjects with no tumor assessments after randomization had TTP censored on the date of randomization with a duration of 1 day. (NCT00083889)
Timeframe: Randomization to first documentation of tumor progression: duration of treatment phase
| Intervention | weeks (Median) |
|---|---|
| SU011248 | 49.0 |
| IFN-α | 22.3 |
Subject observed Ctrough (trough drug) concentrations of active metabolite SU012662 per cycle and study day determined by plasma trough samples collected from a subset of patients. Steady-state observed trough concentrations were dose corrected to the starting dose (reference dose) where appropriate. Concentrations below the limits of quantitation (BLQ) were set to 0. Ctrough = minimum (trough) plasma concentration (nanograms per milliliter [ng/mL]). (NCT00083889)
Timeframe: Day 28 of Cycle 1 to Cycle 4
| Intervention | ng/mL (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Cycle 1, Day 28 (n=31) | Cycle 2, Day 28 (n=36) | Cycle 3, Day 28 (n=36) | Cycle 4, Day 28 (n=32) | Dose-Corrected: Cycle 1, Day 28 (n=24) | Dose-Corrected: Cycle 2, Day 28 (n=28) | Dose-Corrected: Cycle 3, Day 28 (n=27) | Dose-Corrected: Cycle 4, Day 28 (n=26) | |
| SU012662 | 27.10 | 27.35 | 26.11 | 22.11 | 28.21 | 28.32 | 29.04 | 25.99 |
Subject observed Ctrough (trough drug) concentrations of SU011248 per cycle and study day determined by plasma trough samples collected from a subset of patients. Steady-state observed trough concentrations were dose corrected to the starting dose (reference dose) where appropriate. Concentrations below the limits of quantitation (BLQ) were set to 0. Ctrough = minimum (trough) plasma concentration (nanograms per milliliter [ng/mL]). (NCT00083889)
Timeframe: Day 28 of Cycle 1 to Cycle 4
| Intervention | ng/mL (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Cycle 1, Day 28 (n=31) | Cycle 2, Day 28 (n=36) | Cycle 3, Day 28 (n=36) | Cycle 4, Day 28 (n=32) | Dose-Corrected: Cycle 1, Day 28 (n=24) | Dose-Corrected: Cycle 2, Day 28 (n=28) | Dose-Corrected: Cycle 3, Day 28 (n=27) | Dose-Corrected: Cycle 4, Day 28 (n=26) | |
| SU011248 | 57.26 | 57.59 | 50.26 | 45.05 | 64.22 | 59.90 | 58.45 | 54.31 |
Subject observed Ctrough (trough drug) concentrations of total drug (SU011248 and its active metabolite SU012662) per cycle and study day determined by plasma trough samples collected from a subset of patients. Steady-state observed trough concentrations were dose corrected to the starting dose (reference dose) where appropriate. Concentrations below the limits of quantitation (BLQ) were set to 0. Ctrough = minimum (trough) plasma concentration (nanograms per milliliter [ng/mL]). (NCT00083889)
Timeframe: Day 28 of Cycle 1 to Cycle 4
| Intervention | ng/mL (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Cycle 1, Day 28 (n=31) | Cycle 2, Day 28 (n=36) | Cycle 3, Day 28 (n=36) | Cycle 4, Day 28 (n=32) | Dose-Corrected: Cycle 1, Day 28 (n=24) | Dose-Corrected: Cycle 2, Day 28 (n=28) | Dose-Corrected: Cycle 3, Day 28 (n=27) | Dose-Corrected: Cycle 4, Day 28 (n=27) | |
| Total Drug: SU011248 and SU012662 | 84.36 | 84.94 | 76.37 | 67.15 | 92.43 | 88.22 | 87.49 | 80.30 |
EQ-VAS: overall self-rating rating of the patient's current health state using a 20 cm Visual Analog Scale (EQ-VAS), also called the health state thermometer) is a metric measurement (in 2 mm interval) from the visual analog scale which ranges between 0 (worse imaginable health state) and 100 (best imaginable health state). (NCT00083889)
Timeframe: Day 1 & 28 of each cycle: duration of treatment phase
| Intervention | scores on scale (Mean) | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (n=365, 352) | Cycle 1 Day 28 (n=347, 315) | Cycle 2 Day 1 (n=323, 247) | Cycle 2 Day 28 (n=314, 237) | Cycle 3 Day 1 (n=293, 198) | Cycle 3 Day 28 (n=287, 193) | Cycle 4 Day 1 (n=270, 152) | Cycle 4 Day 28 (n=264, 139) | Cycle 5 Day 1 (n=248, 118) | Cycle 5 Day 28 (n=240, 104) | Cycle 6 Day 1 (n=237, 99) | Cycle 6 Day 28 (n=223, 98) | Cycle 7 Day 1 (n=209, 77) | Cycle 7 Day 28 (n=201, 74) | Cycle 8 Day 1 (n=192, 67) | Cycle 8 Day 28 (n=191, 60) | Cycle 9 Day 1 (n=172, 50) | Cycle 9 Day 28 (n=168, 46) | Cycle 10 Day 1 (n=160, 50) | Cycle 10 Day 28 (n=154, 45) | Cycle 11 Day 1 (n=138, 34) | Cycle 11 Day 28 (n=141, 33) | Cycle 12 Day 1 (n=130, 31) | Cycle 12 Day 28 (n=128, 31) | Cycle 13 Day 1 (n=114, 27) | Cycle 13 Day 28 (n=115, 27) | Cycle 14 Day 1 (n=114, 26) | Cycle 14 Day 28 (n=107, 25) | Cycle 15 Day 1 (n=101, 21) | Cycle 15 Day 28 (n=96, 20) | Cycle 16 Day 1 (n=96, 19) | Cycle 16 Day 28 (n=92, 18) | Cycle 17 Day 1 (n=84, 17) | Cycle 17 Day 28 (n=82, 14) | Cycle 18 Day 1 (n=78, 12) | Cycle 18 Day 28 (n=70, 11) | Cycle 19 Day 1 (n=70, 11) | Cycle 19 Day 28 (n=62, 11) | Cycle 20 Day 1 (n=65, 9) | Cycle 20 Day 28 (n=54, 9) | |
| IFN-α | 71.43 | 67.66 | 70.45 | 70.70 | 72.68 | 71.45 | 72.74 | 72.20 | 73.44 | 72.57 | 73.68 | 72.26 | 73.80 | 73.46 | 74.27 | 74.33 | 77.66 | 76.57 | 76.64 | 76.69 | 75.06 | 72.21 | 75.19 | 73.84 | 77.52 | 73.56 | 76.69 | 76.44 | 76.62 | 76.50 | 74.84 | 73.11 | 76.94 | 72.86 | 74.42 | 73.82 | 79.27 | 68.55 | 76.00 | 75.44 |
| SU011248 | 73.80 | 69.35 | 75.05 | 72.06 | 76.23 | 72.33 | 77.46 | 75.15 | 79.83 | 75.13 | 78.83 | 76.81 | 79.39 | 76.09 | 81.34 | 77.53 | 80.08 | 76.24 | 79.18 | 76.44 | 79.72 | 76.81 | 80.84 | 76.71 | 80.59 | 77.22 | 80.39 | 76.53 | 80.50 | 76.51 | 79.85 | 75.51 | 80.74 | 77.10 | 80.40 | 77.76 | 81.47 | 77.05 | 81.10 | 76.85 |
EQ-5D Health State Index: a brief, self-administered generic health status instrument. Respondents were asked to describe their current health state on each of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety or depression) on a three-level scale (1=no problem, 2=some problem, and 3=extreme problem). A maximum score of 1 can be derived from these 5 dimensions by score conversion; range: -0.39 (worst health state)to 1.00 (best health state). This descriptive system classifies respondents into one of 243 possible distinct health states (EQ-5D descriptive system). (NCT00083889)
Timeframe: Day 1 & 28 of each cycle: duration of treatment phase
| Intervention | scores on scale (Mean) | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (n=363, 352) | Cycle 1 Day 28 (346, 315) | Cycle 2 Day 1 (326, 244) | Cycle 2 Day 28 (311, 233) | Cycle 3 Day 1 (287, 200) | Cycle 3 Day 28 (283, 195) | Cycle 4 Day 1 (269, 150) | Cycle 4 Day 28 (261, 142) | Cycle 5 Day 1 (247, 120) | Cycle 5 Day 28 (240, 106) | Cycle 6 Day 1 (240, 98) | Cycle 6 Day 28 (224, 100) | Cycle 7 Day 1 (205, 79) | Cycle 7 Day 28 (204, 74) | Cycle 8 Day 1 (192, 68) | Cycle 8 Day 28 (190, 61) | Cycle 9 Day 1 (170, 51) | Cycle 9 Day 28 (168, 45) | Cycle 10 Day 1 (161, 50) | Cycle 10 Day 28 (153, 46) | Cycle 11 Day 1 (138, 34) | Cycle 11 Day 28 (138, 32) | Cycle 12 Day 1 (132, 31) | Cycle 12 Day 28 (127, 31) | Cycle 13 Day 1 (114, 26) | Cycle 13 Day 28 (115, 27) | Cycle 14 Day 1 (114, 25) | Cycle 14 Day 28 (107, 24) | Cycle 15 Day 1 (100, 21) | Cycle 15 Day 28 (95, 20) | Cycle 16 Day 1 (96, 19) | Cycle 16 Day 28 (93, 18) | Cycle 17 Day 1 (84, 15) | Cycle 17 Day 28 (82, 14) | Cycle 18 Day 1 (80, 12) | Cycle 18 Day 28 (71, 10) | Cycle 19 Day 1 (69, 11) | Cycle 19 Day 28 (62, 11) | Cycle 20 Day 1 (63, 8) | Cycle 20 Day 28 (54, 9) | |
| IFN-α | 0.76 | 0.70 | 0.75 | 0.74 | 0.76 | 0.75 | 0.80 | 0.79 | 0.79 | 0.78 | 0.80 | 0.80 | 0.80 | 0.81 | 0.82 | 0.81 | 0.84 | 0.84 | 0.85 | 0.82 | 0.85 | 0.84 | 0.82 | 0.85 | 0.83 | 0.82 | 0.86 | 0.87 | 0.88 | 0.88 | 0.84 | 0.83 | 0.88 | 0.83 | 0.86 | 0.84 | 0.88 | 0.72 | 0.85 | 0.86 |
| SU011248 | 0.76 | 0.72 | 0.78 | 0.73 | 0.78 | 0.75 | 0.80 | 0.76 | 0.80 | 0.76 | 0.80 | 0.77 | 0.81 | 0.77 | 0.82 | 0.77 | 0.80 | 0.78 | 0.81 | 0.78 | 0.80 | 0.75 | 0.81 | 0.77 | 0.81 | 0.77 | 0.81 | 0.75 | 0.80 | 0.75 | 0.79 | 0.76 | 0.79 | 0.77 | 0.81 | 0.76 | 0.81 | 0.78 | 0.81 | 0.77 |
FACT-Kidney Symptom Index (FKSI) subscale designed to be a stand-alone instrument to measure symptoms and quality of life in patients with advanced kidney cancer. Contains 15 questions; some questions overlap with the FACT-G questions. Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Total FKSI score = sum score of the 15 item scores; total range: 0 - 60; 0 (most severe symptoms and concerns) to 60 (no symptoms or concerns). (NCT00083889)
Timeframe: Day 1 & 28 of each cycle: duration of treatment phase
| Intervention | scores on scale (Mean) | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (n=369, 351) | Cycle 1 Day 28 (n=348, 317) | Cycle 2 Day 1 (n=327, 246) | Cycle 2 Day 28 (n=315, 238) | Cycle 3 Day 1 (n=294, 198) | Cycle 3 Day 28 (n=285, 195) | Cycle 4 Day 1 (n=272, 151) | Cycle 4 Day 28 (n=264, 142) | Cycle 5 Day 1 (n=248, 119) | Cycle 5 Day 28 (n=242, 109) | Cycle 6 Day 1 (n=240, 99) | Cycle 6 Day 28 (n=223, 99) | Cycle 7 Day 1 (n=208, 79) | Cycle 7 Day 28 (n=203, 75) | Cycle 8 Day 1 (n=192, 68) | Cycle 8 Day 28 (n=190, 62) | Cycle 9 Day 1 (n=172, 51) | Cycle 9 Day 28 (n=166, 46) | Cycle 10 Day 1 (n=161, 50) | Cycle 10 Day 28 (n=155, 46) | Cycle 11 Day 1 (n=138, 35) | Cycle 11 Day 28 (n=141, 33) | Cycle 12 Day 1 (n=132, 31) | Cycle 12 Day 28 (n=128, 31) | Cycle 13 Day 1 (n=113, 27) | Cycle 13 Day 28 (n=114, 27) | Cycle 14 Day 1 (n=114, 26) | Cycle 14 Day 28 (n=105, 25) | Cycle 15 Day 1 (n=100, 22) | Cycle 15 Day 28 (n=94, 20) | Cycle 16 Day 1 (n=96, 19) | Cycle 16 Day 28 (n=90, 18) | Cycle 17 Day 1 (n=85, 17) | Cycle 17 Day 28 (n=81, 14) | Cycle 18 Day 1 (n=80, 12) | Cycle 18 Day 28 (n=70, 11) | Cycle 19 Day 1 (n=71, 11) | Cycle 19 Day 28 (n=61, 10) | Cycle 20 Day 1 (n=65, 9) | Cycle 20 Day 28 (n=53, 9) | |
| IFN-α | 46.09 | 40.93 | 42.33 | 42.01 | 43.64 | 43.13 | 44.78 | 44.03 | 44.82 | 44.41 | 45.38 | 44.07 | 45.09 | 44.65 | 45.38 | 45.10 | 46.88 | 46.16 | 46.22 | 45.16 | 46.26 | 45.46 | 46.08 | 46.00 | 46.25 | 45.84 | 46.08 | 46.10 | 45.62 | 45.30 | 43.64 | 43.46 | 45.59 | 43.64 | 44.92 | 45.27 | 46.64 | 44.47 | 45.00 | 46.00 |
| SU011248 | 46.45 | 42.71 | 45.98 | 43.75 | 46.60 | 44.01 | 46.99 | 45.08 | 47.99 | 44.99 | 47.61 | 45.40 | 47.84 | 45.39 | 48.24 | 45.83 | 48.31 | 45.79 | 47.90 | 45.70 | 47.90 | 45.28 | 47.90 | 45.67 | 48.02 | 45.65 | 47.90 | 45.10 | 48.26 | 45.37 | 47.75 | 45.95 | 48.07 | 46.27 | 47.47 | 45.36 | 47.70 | 46.07 | 48.88 | 46.26 |
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) subscale of the FKSI to measure advanced kidney cancer disease related symptoms. Includes 9 items: lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria. Each question was answered on a five-point Likert-type scale ranging from 0 (not at all) to 4 (very much). Score = the sum score of the item scores in the subscale; total range: 0 to 36. A score greater than 0 indicates the difference favored sunitinib. (NCT00083889)
Timeframe: Day 1 & 28 of each cycle: duration of treatment phase
| Intervention | scores on scale (Mean) | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (n=368, 351) | Cycle 1 Day 28 (n=348, 317) | Cycle 2 Day 1 (n=327, 246) | Cycle 2 Day 28 (n= 315, 237) | Cycle 3 Day 1 (n=294, 198) | Cycle 3 Day 28 (n=285, 195) | Cycle 4 Day 1 (n=272, 151) | Cycle 4 Day 28 (n=264, 142) | Cycle 5 Day 1 (n=248, 119 ) | Cycle 5 Day 28 (n=242, 109) | Cycle 6 Day 1 (n=240, 99) | Cycle 6 Day 28 (n=223, 99) | Cycle 7 Day 1 (n=208, 79) | Cycle 7 Day 28 (n=203, 75 ) | Cycle 8 Day 1 (n=192, 68) | Cycle 8 Day 28 (n=190, 62) | Cycle 9 Day 1 (n=172, 51) | Cycle 9 Day 28 (n=166, 46) | Cycle 10 Day 1 (n=161, 50) | Cycle 10 Day 28 (n=155, 46) | Cycle 11 Day 1 (n=138, 35) | Cycle 11 Day 28 (n=141, 33) | Cycle 12 Day 1 (n=132, 31) | Cycle 12 Day 28 (n=128, 31) | Cycle 13 Day 1 (113, 27) | Cycle 13 Day 28 (n=114, 27) | Cycle 14 Day 1 (n=114, 26) | Cycle 14 Day 28 (n=105, 25) | Cycle 15 Day 1 (n=100, 22) | Cycle 15 Day 28 (n=94, 20) | Cycle 16 Day 1 (n=96, 19) | Cycle 16 Day 28 (n=90, 18) | Cycle 17 Day 1 (n=85, 17) | Cycle 17 Day 28 (n=81, 14) | Cycle 18 Day 1 (n=80, 12) | Cycle 18 Day 28 (n=70, 11) | Cycle 19 Day 1 (n=71, 11) | Cycle 19 Day 28 (n=61, 10) | Cycle 20 Day 1 (n=65, 9) | Cycle 20 Day 28 (n=53, 9) | |
| IFN-α | 29.55 | 26.68 | 27.59 | 27.22 | 28.20 | 27.81 | 28.85 | 28.30 | 28.57 | 28.37 | 29.12 | 28.44 | 28.99 | 28.50 | 28.76 | 28.67 | 29.86 | 29.36 | 29.43 | 29.03 | 29.89 | 29.24 | 29.54 | 29.48 | 29.81 | 29.63 | 29.35 | 29.23 | 29.18 | 28.89 | 27.79 | 28.28 | 29.26 | 27.94 | 28.83 | 28.73 | 29.64 | 28.65 | 28.44 | 29.22 |
| SU011248 | 29.74 | 27.73 | 29.66 | 28.49 | 29.93 | 28.72 | 30.25 | 29.43 | 30.87 | 29.43 | 30.80 | 29.62 | 30.93 | 29.73 | 31.03 | 29.76 | 31.24 | 29.72 | 30.73 | 29.78 | 30.72 | 29.34 | 30.76 | 29.63 | 30.58 | 29.30 | 30.58 | 28.94 | 30.87 | 29.26 | 30.63 | 29.51 | 30.69 | 29.73 | 30.24 | 29.15 | 30.11 | 29.48 | 31.07 | 29.44 |
Functional Assessment of Cancer Therapy-General (FACT-G): core questionnaire of the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system that has been validated in a variety of cancer populations. 27 questions grouped into 4 domains that measure a patient's physical, functional, social and family, and emotional well-being. Five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = sum score of item scores in the subscale; total range: 0 to 108 with higher score indicating better quality of life. (NCT00083889)
Timeframe: Day 1 & 28 of each cycle: duration of treatment phase
| Intervention | scores on scale (Mean) | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (n=368, 346) | Cycle 1 Day 28 (n=345, 316) | Cycle 2 Day 1 (n=328, 247) | Cycle 2 Day 28 (n=314, 237) | Cycle 3 Day 1 (n=293, 199) | Cycle 3 Day 28 (n=285, 193) | Cycle 4 Day 1 (n=269, 149) | Cycle 4 Day 28 (n=263, 142) | Cycle 5 Day 1 (n=247, 119) | Cycle 5 Day 28 (n=240, 106) | Cycle 6 Day 1 (n=238, 98) | Cycle 6 Day 28 (n=222, 97) | Cycle 7 Day 1 (n=206, 78) | Cycle 7 Day 28 (n=200, 75) | Cycle 8 Day 1 (n=192, 66) | Cycle 8 Day 28 (n=189, 61) | Cycle 9 Day 1 (n=170, 51) | Cycle 9 Day 28 (n=166, 46) | Cycle 10 Day 1 (n=158, 49) | Cycle 10 Day 28 (n=150, 45) | Cycle 11 Day 1 (n=134, 35) | Cycle 11 Day 28 (n=139, 32) | Cycle 12 Day 1 (n=130, 29) | Cycle 12 Day 28 (n=126, 31) | Cycle 13 Day 1 (n=113, 27) | Cycle 13 Day 28 (n=114, 27) | Cycle 14 Day 1 (n=112, 26) | Cycle 14 Day 28 (n=107, 24) | Cycle 15 Day 1 (n=101, 20) | Cycle 15 Day 28 (n=96, 20) | Cycle 16 Day 1 (n=94, 19) | Cycle 16 Day 28 (n=89, 18) | Cycle 17 Day 1 (n=84, 16) | Cycle 17 Day 28 (n=80, 14) | Cycle 18 Day 1 (n=79, 12) | Cycle 18 Day 28 (n=70, 11) | Cycle 19 Day 1 (n=71, 11) | Cycle 19 Day 28 (n=61, 10) | Cycle 20 Day 1 (n=63, 9) | Cycle 20 Day 28 (n=52, 8) | |
| IFN-α | 81.22 | 74.91 | 77.02 | 77.05 | 79.35 | 78.42 | 80.86 | 80.46 | 81.96 | 80.60 | 81.97 | 79.70 | 80.39 | 81.06 | 81.25 | 81.31 | 84.50 | 83.14 | 84.03 | 81.79 | 81.60 | 80.20 | 80.99 | 81.73 | 81.18 | 80.67 | 81.22 | 81.57 | 81.66 | 80.88 | 78.20 | 78.38 | 81.80 | 78.96 | 82.24 | 82.27 | 82.48 | 79.63 | 81.70 | 79.54 |
| SU011248 | 82.30 | 78.75 | 82.88 | 80.51 | 84.24 | 80.59 | 85.32 | 82.08 | 86.40 | 82.23 | 84.90 | 82.54 | 85.01 | 82.16 | 86.83 | 83.05 | 85.81 | 82.71 | 85.32 | 82.14 | 84.75 | 81.91 | 85.31 | 82.43 | 85.50 | 83.61 | 85.24 | 82.34 | 86.24 | 82.64 | 84.77 | 83.38 | 86.78 | 84.42 | 85.74 | 83.51 | 87.16 | 84.54 | 87.96 | 84.62 |
Emotional well-being (EWB)subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 24; lower score indicates better emotional well-being. (NCT00083889)
Timeframe: Day 1 & 28 of each cycle: duration of treatment phase
| Intervention | scores on scale (Mean) | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (370, 352) | Cycle 1 Day 28 (n=347, 318) | Cycle 2 Day 1 (n=328, 249) | Cycle 2 Day 28 (n=316, 237) | Cycle 3 Day 1 (n=294, 200) | Cycle 3 Day 28 (n=287, 196) | Cycle 4 Day 1 (n=272, 152) | Cycle 4 Day 28 (n=265, 142) | Cycle 5 Day 1 (n=249, 120) | Cycle 5 Day 28 (n=241, 109) | Cycle 6 Day 1 (n=240, 99) | Cycle 6 Day 28 (n=222, 99) | Cycle 7 Day 1 (n=208, 77) | Cycle 7 Day 28 (n=204, 75) | Cycle 8 Day 1 (n=192, 67) | Cycle 8 Day 28 (n=189, 62) | Cycle 9 Day 1 (n=171, 51) | Cycle 9 Day 28 (n=167, 46) | Cycle 10 Day 1 (n=161, 50) | Cycle 10 Day 28 (n=154, 45) | Cycle 11 Day 1 (n=138, 35) | Cycle 11 Day 28 (n=141, 33) | Cycle 12 Day 1 (n=132, 30) | Cycle 12 Day 28 (n=128, 31) | Cycle 13 Day 1 (n=114, 27) | Cycle 13 Day 28 (n=114, 27) | Cycle 14 Day 1 (n=114, 26) | Cycle 14 Day 28 (n=107, 25) | Cycle 15 Day 1 (n=101, 21) | Cycle 15 Day 28 (n=96, 20) | Cycle 16 Day 1 (n=96, 19) | Cycle 16 Day 28 (n=91, 18) | Cycle 17 Day 1 (n=84, 17) | Cycle 17 Day 28 (n=81, 14) | Cycle 18 Day 1 (n=80, 12) | Cycle 18 Day 28 (n=71, 11) | Cycle 19 Day 1 (n=71, 11) | Cycle 19 Day 28 (n=61, 10) | Cycle 20 Day 1 (n=65, 9) | Cycle 20 Day 28 (n=53, 9) | |
| IFN-α | 17.06 | 17.40 | 17.52 | 17.73 | 18.13 | 18.17 | 18.80 | 18.39 | 19.00 | 18.70 | 18.60 | 18.14 | 18.08 | 18.55 | 18.54 | 18.55 | 18.98 | 18.76 | 18.92 | 18.36 | 18.97 | 18.52 | 18.87 | 19.45 | 18.63 | 18.97 | 18.05 | 18.76 | 18.24 | 18.75 | 17.26 | 16.83 | 18.28 | 18.00 | 19.62 | 19.55 | 19.09 | 18.20 | 18.67 | 18.67 |
| SU011248 | 17.15 | 17.76 | 18.46 | 18.46 | 18.82 | 18.53 | 19.04 | 18.76 | 19.18 | 18.63 | 18.99 | 18.73 | 19.08 | 18.69 | 19.33 | 18.98 | 19.25 | 18.93 | 19.32 | 18.71 | 18.92 | 19.10 | 19.14 | 19.06 | 19.38 | 19.39 | 19.55 | 19.23 | 19.57 | 19.41 | 19.54 | 19.33 | 19.95 | 19.66 | 19.64 | 19.34 | 19.94 | 19.61 | 20.00 | 19.75 |
Functional well-being (FWB) subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 28; higher score indicates greater functional well-being. (NCT00083889)
Timeframe: Day 1 & 28 of each cycle: duration of treatment phase
| Intervention | scores on scale (Mean) | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (n=371, 353) | Cycle 1 Day 28 (n=347, 318) | Cycle 2 Day 1 (n=328, 249) | Cycle 2 Day 28 (n=315, 238) | Cycle 3 Day 1 (n=294, 200) | Cycle 3 Day 28 (n=287, 195) | Cycle 4 Day 1 (n=272, 152) | Cycle 4 Day 28 (n=265, 142) | Cycle 5 Day 1 (n=249, 120) | Cycle 5 Day 28 (n=241, 109) | Cycle 6 Day 1 (n=239, 99) | Cycle 6 Day 28 (n=222, 99) | Cycle 7 Day 1 (n=208, 79) | Cycle 7 Day 28 (n=204, 75) | Cycle 8 Day 1 (n=192, 67) | Cycle 8 Day 28 (n=190, 62) | Cycle 9 Day 1 (n=170, 51) | Cycle 9 Day 28 (n=167, 46) | Cycle 10 Day 1 (n=161, 50) | Cycle 10 Day 28 (n=154, 46) | Cycle 11 Day 1 (n=137, 35) | Cycle 11 Day 28 (n=140, 33) | Cycle 12 Day 1 (n=132, 30) | Cycle 12 Day 28 (n=128, 31) | Cycle 13 Day 1 (n=114, 27) | Cycle 13 Day 28 (n=114, 27) | Cycle 14 Day 1 (n=114, 26) | Cycle 14 Day 28 (n=107, 25) | Cycle 15 Day 1 (n=101, 21) | Cycle 15 Day 28 (n=96, 20) | Cycle 16 Day 1 (n=96, 19) | Cycle 16 Day 28 (n=91, 18) | Cycle 17 Day 1 (n=85, 17) | Cycle 17 Day 28 (n=81, 14) | Cycle 18 Day 1 (n=80, 12) | Cycle 18 Day 28 (n=71, 11) | Cycle 19 Day 1 (n=71, 11) | Cycle 19 Day 28 (n=61, 10) | Cycle 20 Day 1 (n=65, 9) | Cycle 20 Day 28 (n=53, 9) | |
| IFN-α | 18.51 | 16.37 | 17.08 | 17.18 | 17.92 | 17.56 | 18.40 | 18.37 | 18.81 | 18.47 | 19.02 | 18.24 | 18.45 | 18.76 | 19.22 | 19.10 | 20.20 | 20.04 | 19.88 | 19.40 | 18.89 | 18.81 | 18.80 | 19.13 | 19.63 | 18.59 | 19.62 | 19.72 | 19.86 | 19.83 | 18.89 | 18.61 | 19.35 | 18.71 | 19.08 | 19.00 | 19.64 | 19.10 | 20.00 | 20.22 |
| SU011248 | 18.93 | 17.92 | 18.78 | 18.37 | 19.51 | 18.58 | 19.93 | 18.86 | 20.27 | 19.02 | 19.74 | 19.21 | 19.69 | 19.12 | 20.29 | 19.33 | 19.87 | 19.27 | 19.95 | 19.22 | 19.81 | 19.12 | 19.98 | 19.42 | 20.02 | 19.65 | 20.04 | 19.07 | 20.13 | 19.24 | 19.80 | 19.53 | 20.20 | 19.67 | 19.76 | 19.47 | 20.18 | 19.59 | 20.50 | 20.15 |
Physical well-being (PWB) subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 28; lower score indicates better physical well-being. (NCT00083889)
Timeframe: Day 1 & 28 of each cycle: duration of treatment phase
| Intervention | scores on scale (Mean) | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (n=369, 348) | Cycle 1 Day 28 (n=348, 318) | Cycle 2 Day 1 (n=329, 247) | Cycle 2 Day 28 (n=316, 239) | Cycle 3 Day 1 (n=294, 200) | Cycle 3 Day 28 (n=286, 195) | Cycle 4 Day 1 (n=270, 150) | Cycle 4 Day 28 (n=264, 142) | Cycle 5 Day 1 (n=248, 120) | Cycle 5 Day 28 (n=241, 106) | Cycle 6 Day 1 (n=239, 99) | Cycle 6 Day 28 (n=224, 97) | Cycle 7 Day 1 (n=207, 79) | Cycle 7 Day 28 (n=201, 75) | Cycle 8 Day 1 (n=193, 67) | Cycle 8 Day 28 (n=189, 61) | Cycle 9 Day 1 (n=172, 51) | Cycle 9 Day 28 (n=166, 46) | Cycle 10 Day 1 (n=159, 49) | Cycle 10 Day 28 (n=151, 46) | Cycle 11 Day 1 (n=135, 35) | Cycle 11 Day 28 (n=140, 32) | Cycle 12 Day 1 (n=131, 30) | Cycle 12 Day 28 (n=127, 31) | Cycle 13 Day 1 (n=114, 27) | Cycle 13 Day 28 (n=114, 27) | Cycle 14 Day 1 (n=112, 26) | Cycle 14 Day 28 (n=107, 24) | Cycle 15 Day 1 (n=101, 21) | Cycle 15 Day 28 (n=96, 20) | Cycle 16 Day 1 (n=94, 19) | Cycle 16 Day 28 (n=90, 18) | Cycle 17 Day 1 (n=85, 16) | Cycle 17 Day 28 (n=80, 14) | Cycle 18 Day 1 (n=79, 12) | Cycle 18 Day 28 (n=70, 11) | Cycle 19 Day 1 (n=71, 11) | Cycle 19 Day 28 (n=61, 10) | Cycle 20 Day 1 (n=63, 9) | Cycle 20 Day 28 (n=52, 9) | |
| IFN-α | 22.70 | 18.85 | 20.05 | 19.84 | 20.87 | 20.63 | 21.56 | 21.31 | 21.84 | 21.23 | 21.70 | 20.96 | 21.67 | 21.66 | 21.94 | 21.40 | 22.58 | 22.38 | 22.60 | 21.83 | 22.23 | 21.88 | 22.60 | 21.90 | 21.99 | 21.80 | 22.05 | 22.75 | 22.33 | 22.07 | 20.63 | 21.42 | 21.81 | 20.50 | 21.83 | 22.45 | 22.45 | 21.60 | 21.78 | 22.33 |
| SU011248 | 23.14 | 19.43 | 22.22 | 20.34 | 22.45 | 20.18 | 22.72 | 21.00 | 23.24 | 20.91 | 22.99 | 21.22 | 23.05 | 21.22 | 23.58 | 21.51 | 23.41 | 21.29 | 22.94 | 21.21 | 23.16 | 20.98 | 23.03 | 20.87 | 23.05 | 21.26 | 23.02 | 20.80 | 23.26 | 20.95 | 22.60 | 21.31 | 22.99 | 21.68 | 22.85 | 20.89 | 23.20 | 21.82 | 23.68 | 21.81 |
Social/family well-being (SWB)subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 28; lower score indicates less social/family well-being. (NCT00083889)
Timeframe: Day 1 & 28 of each cycle: duration of treatment phase
| Intervention | scores on scale (Mean) | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (n=370, 349) | Cycle 1 Day 28 (n=348, 319) | Cycle 2 Day 1 (n=328, 247) | Cycle 2 Day 28 (n=315, 238) | Cycle 3 Day 1 (n=292, 200) | Cycle 3 Day 28 (n=284, 194) | Cycle 4 Day 1 (n=269, 150) | Cycle 4 Day 28 (n=263, 142) | Cycle 5 Day 1 (n=247, 120) | Cycle 5 Day 28 (n=241, 107) | Cycle 6 Day 1 (n=238, 98) | Cycle 6 Day 28 (n=224, 97) | Cycle 7 Day 1 (n=207, 79) | Cycle 7 Day 28 (n=200, 75) | Cycle 8 Day 1 (n=193, 67) | Cycle 8 Day 28 (n=189, 61) | Cycle 9 Day 1 (n=172, 51) | Cycle 9 Day 28 (n=166, 46) | Cycle 10 Day 1 (n=158, 49) | Cycle 10 Day 28 (n=151, 46) | Cycle 11 Day 1 (n=135, 35) | Cycle 11 Day 28 (n=140, 32) | Cycle 12 Day 1 (n=131, 30) | Cycle 12 Day 28 (n=127, 31) | Cycle 13 Day 1 (n=114, 27) | Cycle 13 Day 28 (n=114, 27) | Cycle 14 Day 1 (n=112, 26) | Cycle 14 Day 28 (n=107, 24) | Cycle 15 Day 1 (n=101, 21) | Cycle 15 Day 28 (n=96, 20) | Cycle 16 Day 1 (n=94, 19) | Cycle 16 Day 28 (n=89, 18) | Cycle 17 Day 1 (n=85, 16) | Cycle 17 Day 28 (n=80, 14) | Cycle 18 Day 1 (n=79, 12) | Cycle 18 Day 28 (n=70, 11) | Cycle 19 Day 1 (n=71, 11) | Cycle 19 Day 28 (n=61, 10) | Cycle 20 Day 1 (n=63, 9) | Cycle 20 Day 28 (n=52, 8) | |
| IFN-α | 22.94 | 22.20 | 22.31 | 22.22 | 22.42 | 22.12 | 22.26 | 22.38 | 22.35 | 22.36 | 22.56 | 22.33 | 22.46 | 22.10 | 21.95 | 22.17 | 22.74 | 21.96 | 22.45 | 22.06 | 21.51 | 21.09 | 20.79 | 21.25 | 20.93 | 21.30 | 21.51 | 20.32 | 20.35 | 20.23 | 21.41 | 21.52 | 22.25 | 21.75 | 21.71 | 21.27 | 21.30 | 20.73 | 21.26 | 20.67 |
| SU011248 | 23.14 | 23.60 | 23.50 | 23.40 | 23.51 | 23.44 | 23.73 | 23.36 | 23.53 | 23.68 | 23.35 | 23.40 | 23.29 | 23.13 | 23.67 | 23.26 | 23.26 | 23.26 | 23.08 | 23.03 | 23.05 | 22.71 | 23.23 | 23.07 | 23.15 | 23.31 | 22.82 | 23.24 | 23.28 | 23.04 | 23.11 | 23.41 | 23.42 | 23.50 | 23.53 | 23.70 | 23.85 | 23.53 | 23.60 | 22.93 |
Plasma concentrations of soluble proteins that may be associated with tumor proliferation or angiogenesis collected from a subset of patients were analyzed by enzyme-linked immunosorbent assay (ELISA) analysis. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio = plasma concentration of soluble protein (picograms per milliliter [pg/ml]) at timepoint / concentration of soluble protein (pg/ml) at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded. (NCT00083889)
Timeframe: Day 1 & Day 28, Cycle 1 to Cycle 4
| Intervention | pg/ml and ratio to Baseline (Mean) | ||||
|---|---|---|---|---|---|
| PLASMA bFGF: C2D28:C1D1 (n=14, 0) | PLASMA bFGF: C3D1:C1D1 (n=12, 0) | PLASMA bFGF: C3D28:C1D1 (n=12, 0) | PLASMA bFGF: C4D1:C1D1 (n=14, 0) | PLASMA bFGF: C4:D28:C1D1 (n=10, 0) | |
| SU011248 | 0.760 | 1.582 | 1.671 | 2.895 | 0.803 |
Plasma concentrations of soluble proteins that may be associated with tumor proliferation or angiogenesis collected from a subset of patients were analyzed by enzyme-linked immunosorbent assay (ELISA) analysis. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio = plasma concentration of soluble protein (picograms per milliliter [pg/ml]) at timepoint / concentration of soluble protein (pg/ml) at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded. (NCT00083889)
Timeframe: Day 1 & Day 28, Cycle 1 to Cycle 4
| Intervention | pg/ml and ratio to Baseline (Mean) | ||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Plasma VEGF-A: Baseline (n=33, 31) | Plasma VEGF-A: C1D28: C1D1 (n=31, 26) | Plasma VEGF-A: C2D1: C1D1 (n=32, 21) | Plasma VEGF-A: C2D28: C1D1 (n=31, 20) | Plasma VEGF-A: C3D1: C1D1 (n=27, 15) | Plasma VEGF-A: C3D28: C1D1 (n=28, 15) | Plasma VEGF-A: C4D1: C1D1 (n=27, 12) | Plasma VEGF-A: C4D28: C1D1 (n=25, 11) | Plasma VEGF-C: Baseline (n=35, 31) | Plasma VEGF-C: C1D28: C1D1 (n=31, 26) | Plasma VEGF-C: C2D1:C1D1 (n=30, 21) | Plasma VEGF-C: C2D28:C1D1 (n=31, 19) | Plasma VEGF-C: C3D1:C1D1 (n=28, 15) | Plasma VEGF-C: C3D28:C1D1 (n=28, 15) | Plasma VEGF-C: C4D1:C1D1 (n=28, 12) | Plasma VEGF-C: C4:D28:C1D1 (n=26, 11) | PLASMA sVEGFR-3: Baseline (n=29, 30) | PLASMA sVEGFR-3: C1D28:C1D1 (n=27, 25) | PLASMA sVEGFR-3: C2D1:C1D1 (n=28, 20) | PLASMA sVEGFR-3: C2D28:C1D1 (n=28, 19) | PLASMA sVEGFR-3: C3D1:C1D1 (n=25, 14) | PLASMA sVEGFR-3: C3D28:C1D1 (n=25, 14) | PLASMA sVEGFR-3: C4D1:C1D1 (n=24, 11) | PLASMA sVEGFR-3: C4:D28:C1D1 (n=23, 10) | PLASMA IL-8: Baseline (n=31, 29) | PLASMA IL-8: C1D28:C1D1 (n=29, 25) | PLASMA IL-8: C2D1:C1D1 (n=29, 20) | PLASMA IL-8: C2D28:C1D1 (n=29, 19) | PLASMA IL-8: C3D1:C1D1 (n=26, 15) | PLASMA IL-8: C3D28:C1D1 (n=26, 14) | PLASMA IL-8: C4D1:C1D1 (n=26, 12) | PLASMA IL-8: C4:D28:C1D1 (n=25, 11) | PLASMA bFGF: Baseline (n=21, 2) | PLASMA bFGF: C1D28:C1D1 (n=15, 1) | PLASMA bFGF: C2D1:C1D1 (n=13, 1) | |
| IFN-α | 109.0 | 1.134 | 1.171 | 1.153 | 1.253 | 1.149 | 1.209 | 1.008 | 651.2 | 1.165 | 1.177 | 1.081 | 1.174 | 1.054 | 1.382 | 1.139 | 40317.7 | 1.068 | 1.075 | 1.150 | 1.015 | 1.042 | 1.183 | 1.044 | 18.6 | 2.297 | 1.579 | 1.858 | 1.531 | 1.999 | 1.662 | 2.492 | 13.6 | 0.429 | 0.157 |
| SU011248 | 101.9 | 4.280 | 1.161 | 5.851 | 1.630 | 5.236 | 1.486 | 4.924 | 556.4 | 0.945 | 1.045 | 0.871 | 1.159 | 1.043 | 1.243 | 1.207 | 44049.3 | 0.473 | 0.787 | 0.407 | 0.800 | 0.427 | 0.846 | 0.486 | 10.1 | 2.815 | 1.716 | 2.423 | 2.788 | 2.574 | 1.934 | 2.549 | 13.1 | 2.762 | 1.370 |
DR: Time from first documentation of objective tumor response to first date that recurrence or progressive disease (PD) was objectively documented, taking as a reference for PD, the smallest sum LD recorded since randomization. (NCT00065468)
Timeframe: Baseline, every month until tumor progression or death (up to Month 80)
| Intervention | months (Median) |
|---|---|
| Interferon Alfa | 7.4 |
| Temsirolimus | 11.1 |
| Interferon Alfa and Temsirolimus | 9.3 |
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. EQ-5D index measured 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Range of EQ-5D index score = -0.594 to 1 where higher scores indicated a better health state. (NCT00065468)
Timeframe: Baseline
| Intervention | units on a scale (Median) |
|---|---|
| Interferon Alfa | 0.656 |
| Temsirolimus | 0.689 |
| Interferon Alfa and Temsirolimus | 0.689 |
Overall survival is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact. (NCT00065468)
Timeframe: Baseline up to Month 80
| Intervention | months (Median) |
|---|---|
| Interferon Alfa | 7.3 |
| Temsirolimus | 10.9 |
| Interferon Alfa and Temsirolimus | 8.4 |
Clinical benefit: confirmed CR or PR or had stable disease (SD) lasting at least 24 weeks. CR was the disappearance of all target lesions and non target lesions. PR was at least a 30% decrease in sum of the LD of target lesions, taking as reference the baseline sum LD. SD was having neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. (NCT00065468)
Timeframe: Baseline, every 2 months until tumor progression or death (up to Month 80)
| Intervention | percentage of participants (Number) |
|---|---|
| Interferon Alfa | 16.4 |
| Temsirolimus | 34.0 |
| Interferon Alfa and Temsirolimus | 30.0 |
Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was the disappearance of all target lesions and non target lesions. PR was at least a 30 percent (%) decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. (NCT00065468)
Timeframe: Baseline, every 2 months until tumor progression or death (up to Month 80)
| Intervention | percentage of participants (Number) |
|---|---|
| Interferon Alfa | 5.3 |
| Temsirolimus | 9.1 |
| Interferon Alfa and Temsirolimus | 9.5 |
PFS based on Independent Central Review Assessment. The period from randomization until disease progression, death or date of last contact. (NCT00065468)
Timeframe: Baseline, monthly until tumor progression or death (up to Month 80)
| Intervention | months (Median) |
|---|---|
| Interferon Alfa | 3.2 |
| Temsirolimus | 5.6 |
| Interferon Alfa and Temsirolimus | 4.9 |
"The Q-Twist is not a score calculated for each participant but is defined only on a by treatment group basis. For each treatment group, it is the weighted sum of the mean durations of the health states Tox, Twist, and Relapse. Tox is defined as time with severe toxicity related to treatment; Twist: time without symptoms or toxic side effects; and Relapse: time after relapse/progression. The mean duration of each health state is calculated based on the area under the Kaplan Meier curve pertaining to that health state. There is no direct method for calculating the dispersion of Q-Twist, and it is typically done using bootstrap method for purposes of inference (see, e.g., Glasziou PP, Simes RJ, Gelber RD. Quality adjusted survival analysis. Stat Med 1990; 9: 1259-76). In practice, as apparently in the case with this study, the intermediate values resulting from the bootstrap exercise were not displayed." (NCT00065468)
Timeframe: Baseline to Month 80
| Intervention | months (Number) |
|---|---|
| Interferon Alfa | 6.9083 |
| Temsirolimus | 8.3707 |
| Interferon Alfa and Temsirolimus | 7.4821 |
TTF is defined as the time from the date of randomization to the date of PD or death, withdrawal from treatment due to an adverse event (AE), withdrawal of voluntary consent, or lost to follow-up, whichever occurred first, censored at the date of the conclusion of treatment phase. (NCT00065468)
Timeframe: Baseline, every month until tumor progression or death (up to Month 80)
| Intervention | months (Median) |
|---|---|
| Interferon Alfa | 1.9 |
| Temsirolimus | 3.7 |
| Interferon Alfa and Temsirolimus | 2.5 |
MTD is defined as the dose level below the lowest dose that induces dose limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients). If dose level (-1) is not tolerable, but dose (-3) or (-2) is below or at MTD, testing of alternate dose levels (-2a, -3a, -3b) will occur as outlined in the table. The number of dose limiting toxicities will be reported here. (NCT00867321)
Timeframe: From baseline up to 3 years post treatment
| Intervention | Participants (Count of Participants) |
|---|---|
| Phase I: Dose Level 0 | 2 |
| Phase I: Dose Level -1 | 3 |
| Phase I: Dose Level -2a (Maximum Tolerated Dose) | 0 |
| Phase I: Dose Level -2 | 0 |
Overall survival (OS) is defined as the length of time from date of registration to a) date of death due to any cause or b) last follow-up. Kaplan-Meier survival curves will be used to estimate the distribution of OS. (NCT00867321)
Timeframe: Up to 3 years post treatment
| Intervention | Months (Median) |
|---|---|
| All Patients | 13.3 |
Time to progression is defined to be the length of time from study registration to a) date of disease progression as defined by section 11.0, or b) last follow-up. If a patient dies without documentation of disease progression, the patient will be considered to have had a tumor progression at the time of death unless there is sufficient documented evidence to conclude no progression occurred prior to death. Kaplan-Meier survival curves will be used to estimate the distribution of TTP. (NCT00867321)
Timeframe: From baseline up to 3 years post treatment
| Intervention | years (Median) |
|---|---|
| Arm I (Phase II) | 8.6 |
| Arm II (Phase II) | 13.3 |
Geometric mean exposure for sorafenib. (NCT00090545)
Timeframe: 0, 0.25, 0.50, 1, 2, 4, 6, 8, 12, and 24 hours post-dose
| Intervention | mg/L.h (Geometric Mean) |
|---|---|
| First Stage - Disease Progression | 9.76 |
| Second Stage - Increased Accrual | 18.63 |
Plasma concentration-time profile for sorafenib. (NCT00090545)
Timeframe: 0, 0.25, 0.50, 1, 2, 4, 6, 8, 12, AND 24 hours post dose
| Intervention | mg/L (Mean) |
|---|---|
| First Stage - Disease Progression | 1.28 |
| Second Stage - Increased Accrual | 2.57 |
Time from treatment start date until date of death or date last known alive. (NCT00090545)
Timeframe: Time from treatment start date until date of death or date last known alive, approximately 18.3 months.
| Intervention | Months (Median) |
|---|---|
| First Stage - Disease Progression | 18 |
| Second Stage - Increased Accrual | 18.3 |
Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module. (NCT00090545)
Timeframe: Date treatment consent signed to date off study, approximately 49 months.
| Intervention | Participants (Count of Participants) |
|---|---|
| First Stage - Disease Progression | 22 |
| Second Stage - Increased Accrual | 23 |
Determine whether BAY 43-9006 when used to treat metastatic prostate cancer is associated with having 50% of Patients Progression Free at 4 Months by clinical, radiographic, and prostatic specific antigen (PSA)criteria. (NCT00090545)
Timeframe: 4 months
| Intervention | months (Median) |
|---|---|
| First Stage - Disease Progression | 1.83 |
| Second Stage - Increased Accrual | 3.7 |
Time to maximum concentration for sorafenib. (NCT00090545)
Timeframe: 0, 0.25, 0.50, 1, 2, 4, 6, 8, 12, and 24 hours post-dose
| Intervention | hours (Median) |
|---|---|
| First Stage - Disease Progression | 0.68 |
| Second Stage - Increased Accrual | 8 |
Overall response was evaluated by the RECIST. Complete Response (CR) is the disappearance of all target lesions. Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. (NCT00090545)
Timeframe: Every 2 cycles (1 cycle = 28 days)
| Intervention | Participants (Count of Participants) | |||
|---|---|---|---|---|
| Complete Response | Partial Response | Progressive Disease | Stable Disease | |
| First Stage - Disease Progression | 0 | 0 | 8 | 0 |
| Second Stage - Increased Accrual | 0 | 1 | 13 | 10 |
The FACT-BRM comprises 40 questions within 6 domains (physical well being, social/family well being, emotional well being, additional concern: physical, and additional concern: emotional). Each question was answered on a five point scale from 0 (not at all) to 4 (very much). The total score range is from 0 to 160 with higher scores indicating better QoL. (NCT00117637)
Timeframe: From randomization of the first subject until 15 months later, assessed every 8 weeks
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Sorafenib 400 mg in Period 1 | 104 |
| Interferon Therapy in Period 1 | 93 |
The FACT-BRM comprises 40 questions within 6 domains (physical well being, social/family well being, emotional well being, additional concern: physical, and additional concern: emotional). Each question was answered on a five point scale from 0 (not at all) to 4 (very much). The total score range is from 0 to 160 with higher scores indicating better QoL. (NCT00117637)
Timeframe: From randomization of the first subject until 15 months later, assessed every 8 weeks
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Sorafenib 600 mg (as Dose Escalation After 400 mg) | 89.7 |
| Sorafenib 400 mg (After Interferon Therapy) | 108.4 |
"The FKSI questionnaire comprises 15 questions dispatched within 4 domains (respiratory, pain, general symptoms and overall Quality of Life (QoL)) plus 2 individual items. Each question was answered on a five point scale from 0 (not at all) to 4 (very much) indicating the severity of symptoms. The total score range was from 0 to 60 with higher scores indicating subjects reported fewer kidney cancer related symptoms and concerns. The respiratory domain of the FKSI comprises 2 questions: I have been short in breath and I have been coughing; its score ranges from 0 to 8." (NCT00117637)
Timeframe: From randomization of the first subject until 15 months later, assessed every 8 weeks
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Sorafenib 400 mg in Period 1 | 6.4 |
| Interferon Therapy in Period 1 | 5.1 |
"The FKSI questionnaire comprises 15 questions dispatched within 4 domains (respiratory, pain, general symptoms and overall Quality of Life (QoL)) plus 2 individual items. Each question was answered on a five point scale from 0 (not at all) to 4 (very much) indicating the severity of symptoms. The total score range was from 0 to 60 with higher scores indicating subjects reported fewer kidney cancer related symptoms and concerns. The respiratory domain of the FKSI comprises 2 questions: I have been short in breath and I have been coughing; its score ranges from 0 to 8." (NCT00117637)
Timeframe: From randomization of the first subject until 15 months later, assessed every 8 weeks
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Sorafenib 600 mg (as Dose Escalation After 400 mg) | 5.7 |
| Sorafenib 400 mg (After Interferon Therapy) | 6.4 |
The FKSI questionnaire comprises 15 questions dispatched within 4 domains (respiratory, pain, general symptoms and overall Quality of Life (QoL)) plus 2 individual items. Each question was answered on a five point scale from 0 (not at all) to 4 (very much) indicating the severity of symptoms. The total score range was from 0 to 60 with higher scores indicating subjects reported fewer kidney cancer related symptoms and concerns. (NCT00117637)
Timeframe: From randomization of the first subject until 15 months later, assessed every 8 weeks
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Sorafenib 400 mg in Period 1 | 40.5 |
| Interferon Therapy in Period 1 | 34.6 |
The FKSI questionnaire comprises 15 questions dispatched within 4 domains (respiratory, pain, general symptoms and overall Quality of Life (QoL)) plus 2 individual items. Each question was answered on a five point scale from 0 (not at all) to 4 (very much) indicating the severity of symptoms. The total score range was from 0 to 60 with higher scores indicating subjects reported fewer kidney cancer related symptoms and concerns. (NCT00117637)
Timeframe: From randomization of the first subject until 15 months later, assessed every 8 weeks
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Sorafenib 600 mg (as Dose Escalation After 400 mg) | 34.6 |
| Sorafenib 400 mg (After Interferon Therapy) | 42.3 |
The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated. (NCT00117637)
Timeframe: From randomization of the first subject until 15 months later, assessed every 8 weeks
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Sorafenib 400 mg in Period 1 | 82 |
| Interferon Therapy in Period 1 | 66 |
The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated. (NCT00117637)
Timeframe: From randomization of the first subject until 15 months later, assessed every 8 weeks
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Sorafenib 600 mg (as Dose Escalation After 400 mg) | 86.5 |
| Sorafenib 400 mg (After Interferon Therapy) | 82.5 |
The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated. (NCT00117637)
Timeframe: From randomization of the first subject until 15 months later, assessed every 8 weeks
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Sorafenib 400 mg in Period 1 | 52 |
| Interferon Therapy in Period 1 | 42 |
The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated. (NCT00117637)
Timeframe: From randomization of the first subject until 15 months later, assessed every 8 weeks
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Sorafenib 600 mg (as Dose Escalation After 400 mg) | 56.9 |
| Sorafenib 400 mg (After Interferon Therapy) | 40.3 |
The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated. (NCT00117637)
Timeframe: From randomization of the first subject until 15 months later, assessed every 8 weeks
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Sorafenib 400 mg in Period 1 | 60 |
| Interferon Therapy in Period 1 | 46 |
The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated. (NCT00117637)
Timeframe: From randomization of the first subject until 15 months later, assessed every 8 weeks
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Sorafenib 600 mg (as Dose Escalation After 400 mg) | 39.9 |
| Sorafenib 400 mg (After Interferon Therapy) | 35.4 |
The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated. (NCT00117637)
Timeframe: From randomization of the first subject until 15 months later, assessed every 8 weeks
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Sorafenib 400 mg in Period 1 | 63 |
| Interferon Therapy in Period 1 | 46 |
The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated. (NCT00117637)
Timeframe: From randomization of the first subject until 15 months later, assessed every 8 weeks
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Sorafenib 600 mg (as Dose Escalation After 400 mg) | 61.3 |
| Sorafenib 400 mg (After Interferon Therapy) | 57.6 |
Plasma samples were collected prior to dosing every 4 weeks after the patient reached steady-state (at least 10 days at 400 mg BID). (NCT00117637)
Timeframe: From start of treatment of the first subject until 15 months later assessed every 4 weeks.
| Intervention | 100*mg/L (Geometric Mean) |
|---|---|
| First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600mg | 93.9 |
Duration of Response was defined as the time from date of first response (Complete Response (CR) or Partial Response (PR)) to the date when Progressive Disease (PD) is first documented or to the date of death, whichever occurs first. Subjects still having CR or PR at the time of analysis were censored at their last date of last contact (NCT00117637)
Timeframe: From randomization of the first subject until 15 months later, assessed every 8 weeks
| Intervention | months (Median) |
|---|---|
| First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg | 7.5 |
| First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg | 7.7 |
Duration of Response was defined as the time from date of first response (Complete Response (CR) or Partial Response (PR)) to the date when Progressive Disease (PD) is first documented or to the date of death, whichever occurs first. Subjects still having CR or PR at the time of analysis were censored at their last date of last contact (NCT00117637)
Timeframe: From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks
| Intervention | months (Median) |
|---|---|
| First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg | 4.4 |
| First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg | 9.2 |
Duration of Response was defined as the time from date of first response (Complete Response (CR) or Partial Response (PR)) to the date when Progressive Disease (PD) is first documented or to the date of death, whichever occurs first. Subjects still having CR or PR at the time of analysis were censored at their last date of last contact (NCT00117637)
Timeframe: From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks
| Intervention | months (Median) |
|---|---|
| First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg | 5.5 |
Overall Survival was defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact (NCT00117637)
Timeframe: From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks
| Intervention | months (Median) |
|---|---|
| First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg | 14.8 |
| First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg | 26.9 |
Progression-free Survival (PFS) was defined as the time from date of randomization to disease progression (radiological or clinical or death due to any cause, whichever occurs first). Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation (NCT00117637)
Timeframe: From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks
| Intervention | months (Median) |
|---|---|
| First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg | 4.5 |
| First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg | 5.5 |
Progression-free Survival (PFS) was defined as the time from date of randomization to disease progression (radiological or clinical or death due to any cause, whichever occurs first). Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation (NCT00117637)
Timeframe: From randomization of the first subject until 15 months later, assessed every 8 weeks
| Intervention | months (Median) |
|---|---|
| First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg | 5.7 |
| First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg | 5.6 |
Progression-free Survival (PFS) was defined as the time from date of randomization to disease progression (radiological or clinical or death due to any cause, whichever occurs first). Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation (NCT00117637)
Timeframe: From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks
| Intervention | months (Median) |
|---|---|
| First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg | 5.6 |
| First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg | 7.0 |
Plasma samples were collected prior to dosing every 4 weeks after the patient reached steady-state (at least 10 days at 400 mg BID (bis in die, twice daily)) to assess any potential trends in trough concentration over time. (NCT00117637)
Timeframe: From start of treatment of the first subject until 15 months later assessed every 4 weeks.
| Intervention | 100*(mg/L/cycle) (Mean) |
|---|---|
| First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600mg | -8.3 |
Time to Response (TTR) for subjects who achieved a response (Complete Response (CR) or Partial Response (PR) with confirmation was defined as the time from date of randomization to the earliest date that the response was first documented (NCT00117637)
Timeframe: From randomization of the first subject until 15 months later, assessed every 8 weeks
| Intervention | months (Median) |
|---|---|
| First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg | 1.8 |
| First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg | 5.4 |
Time to Response (TTR) for subjects who achieved a response (Complete Response (CR) or Partial Response (PR) with confirmation was defined as the time from date of randomization to the earliest date that the response was first documented (NCT00117637)
Timeframe: From randomization of the first subject until 3 years and 9 months later, assessed every 4 weeks
| Intervention | months (Median) |
|---|---|
| First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg | 3.5 |
| First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg | 5.4 |
Time to Response (TTR) for subjects who achieved a response (Complete Response (CR) or Partial Response (PR) with confirmation) was defined as the time from date of randomization to the earliest date that the response was first documented (NCT00117637)
Timeframe: From randomization of the first subject until 3 years and 9 months later, assessed every 4 weeks
| Intervention | months (Median) |
|---|---|
| First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg | 1.7 |
Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale that measures how cancer affects the daily life of a patient on an ordinal scale from grade 0 (best) to grade 5 (worst). (NCT00117637)
Timeframe: From randomization of the first subject until 3 years and 9 months later, assessed every 4 weeks
| Intervention | participants (Number) | |||||
|---|---|---|---|---|---|---|
| 0= Fully active without restriction | 1= Restricted in physically strenuous activity | 2= Ambulatory, capable of all selfcare | 3= Capable of limited selfcare | 4= Completely disabled | 5= Dead | |
| Interferon Therapy in Period 1 | 19 | 42 | 21 | 5 | 2 | 0 |
| Sorafenib 400 mg in Period 1 | 20 | 48 | 20 | 5 | 1 | 1 |
Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale that measures how cancer affects the daily life of a patient on an ordinal scale from grade 0 (best) to grade 5 (worst). (NCT00117637)
Timeframe: From randomization of the first subject until 3 years and 9 months later, assessed every 4 weeks
| Intervention | participant s (Number) | |||||
|---|---|---|---|---|---|---|
| 0= Fully active without restriction | 1= Restricted in physically strenuous activity | 2= Ambulatory, capable of all selfcare | 3= Capable of limited selfcare | 4= Completely disabled | 5= Dead | |
| Sorafenib 400 mg (After Interferon Therapy) | 16 | 26 | 10 | 5 | 1 | 0 |
| Sorafenib 600 mg (as Dose Escalation After 400 mg) | 5 | 25 | 10 | 4 | 1 | 0 |
Disease Control (DC) was defined as the total number of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating). CR: disappearance of tumor lesions (TL); PR: a decrease of at least 30% in the sum of TL sizes; SD: steady state of disease; PD: an increase of at least 20% in the sum of TL sizes. (NCT00117637)
Timeframe: From randomization of the first subject until 15 months later, assessed every 8 weeks
| Intervention | participants (Number) | ||
|---|---|---|---|
| disease control (CR or PR or SD) | no disease control | Unknown | |
| First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg | 59 | 24 | 9 |
| First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg | 77 | 10 | 10 |
Disease Control (DC) was defined as the total number of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating). CR: disappearance of tumor lesions (TL); PR: a decrease of at least 30% in the sum of TL sizes; SD: steady state of disease; PD: an increase of at least 20% in the sum of TL sizes. (NCT00117637)
Timeframe: From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks
| Intervention | participants (Number) | ||
|---|---|---|---|
| disease control (CR or PR or SD) | no disease control | Unknown | |
| First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg | 62 | 24 | 6 |
| First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg | 83 | 7 | 7 |
Disease Control (DC) was defined as the total number of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating). CR: disappearance of tumor lesions (TL); PR: a decrease of at least 30% in the sum of TL sizes; SD: steady state of disease; PD: an increase of at least 20% in the sum of TL sizes. (NCT00117637)
Timeframe: From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks
| Intervention | participants (Number) | ||
|---|---|---|---|
| disease control (CR or PR or SD) | no disease control | Unknown | |
| First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg | 49 | 6 | 6 |
| First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg | 25 | 16 | 8 |
Tumor Response (= Best Overall Response) of a subject was defined as the best tumor response (confirmed Complete Response (CR), confirmed Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, SD was defined as steady state of disease, PD was defined as an increase of at least 20% in the sum of tumor lesions sizes. (NCT00117637)
Timeframe: From randomization of the first subject until 15 months later, assessed every 8 weeks
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| Complete Response (CR) | Partial Response (PR) | Stable Disease (SD) | Progressive Disease (PD) | Not Evaluated | |
| First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg | 1 | 7 | 51 | 24 | 9 |
| First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg | 0 | 5 | 72 | 10 | 10 |
Tumor Response (= Best Overall Response) of a subject was defined as the best tumor response (confirmed Complete Response (CR), confirmed Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, SD was defined as steady state of disease, PD was defined as an increase of at least 20% in the sum of tumor lesions sizes (NCT00117637)
Timeframe: From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| Complete Response (CR) | Partial Response (PR) | Stable Disease (SD) | Progressive Disease (PD) | Not Evaluated | |
| First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg | 1 | 13 | 48 | 24 | 6 |
| First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg | 0 | 21 | 62 | 7 | 7 |
Tumor Response (= Best Overall Response) of a subject was defined as the best tumor response (confirmed Complete Response (CR), confirmed Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, SD was defined as steady state of disease, PD was defined as an increase of at least 20% in the sum of tumor lesions sizes (NCT00117637)
Timeframe: From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| Complete Response (CR) | Partial Response (PR) | Stable Disease (SD) | Progressive Disease (PD) | Not Evaluated | |
| First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg | 1 | 11 | 37 | 6 | 6 |
| First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg | 0 | 0 | 25 | 16 | 8 |
Number of subjects who had not responded to treatment but had stable disease up to cycle 4. (NCT00101400)
Timeframe: Until 30 days after termination of active therapy
| Intervention | participants (Number) |
|---|---|
| Sorafenib (Nexavar, BAY43-9006) | 12 |
Overall response duration was defined only for subjects achieving confirmed objective response (PR or CR). It was measured from start of treatment to the date when progressive disease was first objectively documented. (NCT00101400)
Timeframe: Time from PR or CR to progression
| Intervention | days (Number) |
|---|---|
| Sorafenib (Nexavar, BAY43-9006) | 256 |
After the end of treatment visit (30 days after the last dose), the subjects were monitored every 3 months for survival (visits/phone calls). (NCT00101400)
Timeframe: Start of treatment to death
| Intervention | days (Median) |
|---|---|
| Sorafenib (Nexavar, BAY43-9006) | 259 |
Defined only for subjects achieving objective tumor response from start of treatment to the date when confirmed PR or CR was first documented according to the Modified WHO Tumor Response Criteria. (NCT00101400)
Timeframe: Until objective response occurs
| Intervention | days (Number) |
|---|---|
| Sorafenib (Nexavar, BAY43-9006) | 145 |
Time from start of treatment until progression was first documented. (NCT00101400)
Timeframe: Until progression occurs
| Intervention | days (Median) |
|---|---|
| Sorafenib (Nexavar, BAY43-9006) | 58 |
Number of subjects with metastatic breast cancer treated with single agent BAY43-9006 who had best overall response assessed as complete response (CR) or partial response (PR) as per Modified World Health Organization (WHO) Tumor Response Criteria. (NCT00101400)
Timeframe: Until 30 days after termination of active therapy
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| Complete response (CR) | Partial response (PR) | Stable disease (SD) | Progressive disease (PD) | Not evaluated | |
| Sorafenib (Nexavar, BAY43-9006) | 0 | 1 | 20 | 31 | 2 |
Overall survival was defined as the time from registration to death from any cause. (NCT00253370)
Timeframe: Assessed every 3 months if patient is < 2 years from study entry; then every 6 months if patient is 2-3 years from study entry.
| Intervention | Months (Median) |
|---|---|
| BAY 43-9006, Docetaxel, Cisplatin | 13.6 |
"Progression-free survival was defined as the shorter of:~The time from registration to progression. or~The time from registration to death without documentation of progression given that the death occurs within 4 months of the last disease assessment without progression (or registration, whichever is more recent).~Therefore, cases not meeting either of the criteria for a PFS event are censored at the date of last disease assessment without progression (or registration, whichever is more recent).~Progression is defined as at least 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing non-target lesions." (NCT00253370)
Timeframe: Assessed every 6 weeks until disease progression or up to 3 years
| Intervention | Months (Median) |
|---|---|
| BAY 43-9006, Docetaxel, Cisplatin | 5.8 |
Response was evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria. Per RECIST criteria, complete response (CR) = disappearance of all target and non-target lesions. Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR. (NCT00253370)
Timeframe: Assessed every 6 weeks until disease progression or up to 3 years
| Intervention | Proportion of patients (Number) |
|---|---|
| BAY 43-9006, Docetaxel, Cisplatin | 0.409 |
Duration of complete response was the number of days from the date that a complete response was first documented to the date that recurrent or progressive disease was first objectively documented (if patient progressed then censored=no) or to last observation (if patient did not progress then censored=yes). (NCT00492297)
Timeframe: from confirmed CR until PD (median 259 days)
| Intervention | days (Number) |
|---|---|
| Sorafenib + Dacarbazine | 420 |
Duration of partial response was the number of days from the date that a partial response was first documented to the date that recurrent or progressive disease was first objectively documented (if patient progressed then censored=no) or to last observation (if patient did not progress then censored=yes). (NCT00492297)
Timeframe: from confirmed PR until PD (median 259 days)
| Intervention | days (Median) |
|---|---|
| Sorafenib + Dacarbazine | 255 |
Duration of Response was assessed in subjects who showed a Partial Response (PR) or Complete Response (CR). It was defined as the time from the first documented objective response to Progressive Disease (PD), or death if before documented progression. Duration of response for subjects who have not progressed or died at the time of analysis was censored at the date of last tumor assessment. (NCT00492297)
Timeframe: from confirmed Complete Response (CR) or Partial Response (PR) until Progressive Disease (PD) (median 259 days)
| Intervention | days (Median) |
|---|---|
| Sorafenib + Dacarbazine | 327 |
Duration of Stable Disease (DSD), defined as the time from the first documented objective evidence of Stable Disease (SD) to disease progression (DP) or death if death occurred before DP, was assessed in subjects who showed SD as best response. DSD for subjects who had not progressed or died was censored at the date of last tumor assessment. (NCT00492297)
Timeframe: from start of therapy to PD, only in non-responders (median 259 days)
| Intervention | days (Median) |
|---|---|
| Sorafenib + Dacarbazine | 93 |
Overall Survival was the number of days from the date that combination treatment started until the date of death. (NCT00492297)
Timeframe: from start of treatment until death (median 259 days)
| Intervention | days (Median) |
|---|---|
| Sorafenib + Dacarbazine | 259 |
Progression-free Survival (PFS) was the time from the first dose of combination therapy to disease progression (radiological or clinical, whichever is earlier) or death (if death occurs before progression is documented). PFS for subjects without tumor progression or death at the time of analysis were censored at the date of last tumor evaluation. (NCT00492297)
Timeframe: from start of treatment until progression or death before progression (median 259 days)
| Intervention | days (Median) |
|---|---|
| Sorafenib + Dacarbazine | 102 |
Time to Progression was the number of days from the start of therapy to progression (if patient progressed then censored=no) or to the last observation at which the patient was known to have not progressed, that is, the last observation with a best response of CR, PR, or SD. (NCT00492297)
Timeframe: From start of treatment until progression (median 259 days)
| Intervention | days (Median) |
|---|---|
| Sorafenib + Dacarbazine | 102 |
Time to Response in subjects who achieved an objective response (PR or CR with confirmation) was measured from the date of starting study combination treatment until the earliest date that the response was first documented. (NCT00492297)
Timeframe: start of therapy to confirmed CR or PR (median 259 days)
| Intervention | days (Median) |
|---|---|
| Sorafenib + Dacarbazine | 48 |
DC was defined as the total number of subjects whose best response was not progressive disease (PD) (total number of CRs + total number of PRs + total number of Stable Diseases (SD)). The DC at specific time points could also be calculated as the total number of subjects whose response was not PD at that time point. (NCT00492297)
Timeframe: after start of treatment, at 6 months and 12 months
| Intervention | participants (Number) | ||
|---|---|---|---|
| DC based on overall best response | DC at 6 months | DC at 12 months | |
| Sorafenib + Dacarbazine | 41 | 38 | 38 |
Best Overall Response (BOR): Best tumor response achieved during or within 30 days after active therapy confirmed according to the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR): The disappearance of all target and non-target lesions. Partial response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. SD was defined as steady state of disease, PD was defined as an increase of at least 20% increase in the sum of the LD of target lesions or appearance of new lesions. (NCT00492297)
Timeframe: during or within 30 days after active therapy
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| Overall response (CR+PR) | Complete response (CR) | Partial response (PR) | Stable disease (SD) | Progressive disease (PD) | |
| Sorafenib + Dacarbazine | 10 | 1 | 9 | 31 | 34 |
Progression-free Survival (PFS) was the time from the first dose of combination therapy to disease progression (radiological or clinical, whichever is earlier) or death (if death occurs before progression is documented). PFS for subjects without tumor progression or death at the time of analysis were censored at the date of last tumor evaluation. (NCT00492297)
Timeframe: from start of treatment until progression or death before progression after 3, 6 and 12 months
| Intervention | percentage of participants (Number) | ||
|---|---|---|---|
| PFS at month 3 | PFS at month 6 | PFS at month 12 | |
| Sorafenib + Dacarbazine | 56.63 | 33.73 | 10.84 |
Sorafenib AUC(0-12h),ss (area under the concentration time curve from time 0 to 12 hours at steady state) was estimated from the steady state plasma concentration. (NCT00984282)
Timeframe: A single pharmacokinetic plasma sample was collected at steady state (after 14 days of uninterrupted, unmodified sorafenib dosing)
| Intervention | mg*h/L (Geometric Mean) |
|---|---|
| Sorafenib (Nexavar, BAY43-9006) | 75.4 |
Disease control rate was defined as the proportion of subjects whose best response was complete response (CR), partial response (PR), or stable disease (SD). Per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, CR and PR were to be confirmed by another scan at least 4 weeks later; SD had to be documented at least 4 weeks after date of randomization. CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). PR = At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum. SD = steady state of disease which is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. (NCT00984282)
Timeframe: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
| Intervention | Percentage of participants (Number) |
|---|---|
| Sorafenib (Nexavar, BAY43-9006) | 86.2 |
| Placebo | 74.6 |
Duration of response was defined as the time from the first documented objective response of PR or CR, whichever was noted earlier, to disease progression or death (if death occurred before progression was documented). CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). PR = At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum. (NCT00984282)
Timeframe: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
| Intervention | Days (Median) |
|---|---|
| Sorafenib (Nexavar, BAY43-9006) | 309 |
| Placebo | NA |
Overall survival was defined as the time (days) from date of randomization to date of death due to any cause. Subjects still alive at the time of analysis were censored at their date of last contact. Since the median value could not be estimated due to censored data, the percentage of participants who died is presented. (NCT00984282)
Timeframe: From randomization of the first subject until the database cut-off (30 AUG 2017), study duration approximately eight years
| Intervention | Percentage of participants (Number) |
|---|---|
| Sorafenib (Nexavar, BAY43-9006) | 52.7 |
| Placebo | 54.8 |
PFS=time from randomization to first observed disease progression (radiological according to central assessment or clinical due to bone irradiation, whichever is earlier), or death due to any cause, if death occurred before progression. Progression was assessed by RECIST criteria, version 1.0, modified for bone lesions. PFS for participants without disease progression or death at the time of analysis or unblinding were censored at the last date of tumor assessment before unblinding. Participants with no tumor evaluation after baseline were censored at Day 1. PD (Progression Disease)=At least a 20% increase in sum of longest diameters (LD) of measured lesions taking as reference the smallest sum LD on study since the treatment started or the appearance of 1 or more new lesions. New lesions also constituted PD. In exceptional circumstances, unequivocal progression of a nonmeasured lesion may have been accepted as evidence of disease progression in participants with measurable disease. (NCT00984282)
Timeframe: Final analysis to be performed when approximately 267 progression-free survival events (centrally assessed) had occurred, study duration approximately three years
| Intervention | Days (Median) |
|---|---|
| Sorafenib (Nexavar, BAY43-9006) | 329 |
| Placebo | 175 |
Response rate was defined as the proportion of subjects whose best response was CR or PR. Per RECIST, CR and PR was to be confirmed by another scan at least 4 weeks later. CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). PR = At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum. (NCT00984282)
Timeframe: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
| Intervention | Percentage of participants (Number) |
|---|---|
| Sorafenib (Nexavar, BAY43-9006) | 12.24 |
| Placebo | 0.5 |
Time to progression was defined at the time (days) from randomization to progression (based on central assessment [radiological and clinical progression due to bone irradiation]) (NCT00984282)
Timeframe: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
| Intervention | Days (Median) |
|---|---|
| Sorafenib (Nexavar, BAY43-9006) | 337 |
| Placebo | 175 |
The magnitude of change from baseline in target lesion size in evaluable participants with scans was determined. (NCT00984282)
Timeframe: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
| Intervention | Percentage of participants (Number) | |||||
|---|---|---|---|---|---|---|
| Reduction ≥ 30% | Reduction ≥ 20% but < 30% | Reduction ≥ 10% but < 20% | Reduction > 0% but < 10% | Growth ≥ 0% | Not assessed | |
| Placebo | 1.0 | 1.5 | 3.5 | 21.9 | 62.7 | 9.5 |
| Sorafenib (Nexavar, BAY43-9006) | 17.3 | 15.3 | 22.4 | 22.4 | 12.8 | 9.7 |
The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. A plot of concentration vs time after dosing is created, and the area under this curve is calculated by standard methods (eg, trapezoidal rule) to provide a measure of how much drug was in the bloodstream following dosing. (NCT00492752)
Timeframe: PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1
| Intervention | mg*h/L (Geometric Mean) |
|---|---|
| Sorafenib (Nexavar, BAY43-9006) | 35.7 |
Duration of Response was defined as the time from date of first response (Complete Response (CR) or Partial Response (PR)) to the date when Progressive Disease (PD) is first documented, or to the date of death, whichever occurs first. Subjects still having CR or PR at the time of analysis were censored at their last tumor assessment. (NCT00492752)
Timeframe: From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization
| Intervention | days (Median) |
|---|---|
| Sorafenib (Nexavar, BAY43-9006) | 210 |
| Placebo | 252 |
Cmax refers to the highest plasma concentration of drug reached after dosing. It is obtained by collecting a series of blood samples after dosing, and analyzing them for drug content by a sensitive and specific analytical method. The highest measured concentration is referred to as the Cmax. (NCT00492752)
Timeframe: PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1
| Intervention | mg/L (Geometric Mean) |
|---|---|
| Sorafenib (Nexavar, BAY43-9006) | 4.44 |
The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. A plot of concentration vs time after dosing is created, and the area under this curve is calculated by standard methods (eg, trapezoidal rule) to provide a measure of how much drug was in the bloodstream following dosing. (NCT00492752)
Timeframe: PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1
| Intervention | g*h/L (Geometric Mean) |
|---|---|
| Sorafenib (Nexavar, BAY43-9006) | 6.6 |
Cmaxnorm refers to the maximum plasma concentration of Sorafenib corrected for dose and body weight (Cmaxnorm = Cmax/(mg/kg)). (NCT00492752)
Timeframe: PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1
| Intervention | g/mL (Geometric Mean) |
|---|---|
| Sorafenib (Nexavar, BAY43-9006) | 0.66 |
Overall Survival (OS) was defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact. (NCT00492752)
Timeframe: From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization
| Intervention | days (Median) |
|---|---|
| Sorafenib (Nexavar, BAY43-9006) | 198 |
| Placebo | 127 |
Tmax refers to the time after dosing when a drug attains its maximum concentration in the blood. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content. The time corresponding to the highest measurable concentration (Cmax) is referred to as Tmax. (NCT00492752)
Timeframe: PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1
| Intervention | hours (Median) |
|---|---|
| Sorafenib (Nexavar, BAY43-9006) | 4.0 |
Time to progression (TTP) was defined as the time from date of randomization to radiologically documented disease progression. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation。 (NCT00492752)
Timeframe: From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization
| Intervention | days (Median) |
|---|---|
| Sorafenib (Nexavar, BAY43-9006) | 84 |
| Placebo | 41.5 |
Time to Response (TTR) for subjects who achieved a response (Complete Response (CR) or Partial Response (PR) ) was defined as the time from date of randomization to the earliest date that the response was first documented. (NCT00492752)
Timeframe: From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization
| Intervention | days (Median) |
|---|---|
| Sorafenib (Nexavar, BAY43-9006) | 84 |
| Placebo | 42 |
Time to Symptomatic Progression (TTSP) was defined as the time from date of randomization to symptomatic progression. Subjects without symptomatic progression at the time of analysis were censored at their last date of tumor evaluation. (NCT00492752)
Timeframe: From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization
| Intervention | days (Median) |
|---|---|
| Sorafenib (Nexavar, BAY43-9006) | 105 |
| Placebo | 103 |
The FHSI-8 questionnaire was completed at baseline and every 3 weeks during treatment and at the end of treatment visit only for subjects who withdrew for reasons other than symptomatic progression. Patient reported outcome was measured using the FHSI-8 score changes from baseline throughout the study period. FHSI-8 assesses hepatobiliary cancer symptoms with total score ranges from 0 to 32 (0 = the best quality of life; 32 = the worst quality of life with severe symptoms).. (NCT00492752)
Timeframe: Baseline up to Cycle 1 and Cycle 3. From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization
| Intervention | scores on a scale (Mean) | |
|---|---|---|
| cycle 1 | cycle 3 | |
| Placebo | 26 | 25 |
| Sorafenib (Nexavar, BAY43-9006) | 26 | 24 |
"The FACT-Hep questionnaire was also completed to assess patient reported outcome. The FACT-Hep assesses hepatobiliary cancer-related quality of life. FACT-Hep total score ranges from 0 to 180 (0=All questions answered Not at all; 180=All questions answered Very much)." (NCT00492752)
Timeframe: Baseline up to Cycle 3 and end of treatment. From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization
| Intervention | scores on a scale (Mean) | |
|---|---|---|
| cycle 3 | end of treatment | |
| Placebo | -3 | -23 |
| Sorafenib (Nexavar, BAY43-9006) | -10 | -25 |
Disease Control (DC) was defined as the total number of subjects whose best response was not Progressive Disease (PD: an increase in the sum of tumor lesions sizes) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR: disappearance of tumor lesions) + total number of Partial Response (PR: a decrease of at least 30% in the sum of tumor lesion sizes) + total number of Stable Disease (SD: steady state of disease); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating). (NCT00492752)
Timeframe: From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization
| Intervention | participants (Number) | |
|---|---|---|
| Yes | No | |
| Placebo | 12 | 64 |
| Sorafenib (Nexavar, BAY43-9006) | 53 | 97 |
Tumor Response (= Best Overall Response) of a subject was defined as the best tumor response (confirmed Complete Response (CR: disappearance of tumor lesions), confirmed* Partial Response (PR: a decrease of at least 30% in the sum of tumor lesion sizes), Stable Disease (SD: steady state of disease), or Progressive Disease (PD: an increase in the sum of tumor lesions sizes)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. (NCT00492752)
Timeframe: From randomization/start of treatment of the first subject until approximately 23 months after randomization when the subjects on placebo were offered the option to crossover to sorafenib treatment
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| Complete Response (CR) | Partial Response (PR) | Stable Disease (SD) | Progressive Disease (PD) | Not assessable | |
| Placebo | 0 | 1 | 21 | 41 | 13 |
| Sorafenib (Nexavar, BAY43-9006) | 0 | 5 | 81 | 46 | 18 |
Measured from the date of registration to the first of progression or death due to any cause with patients last known to be alive and progression-free censored at the date of last contact (NCT00329641)
Timeframe: Every 6 weeks for the first 8 cycles of therapy, and then every 9 weeks until disease progression for up to 3 years after registration or until death
| Intervention | Percent of population (Number) |
|---|---|
| Sorafenib, Carboplatin, Paclitaxel | 29 |
Measured from date of registration to study until death due to any caused with observations last known to be alive censored at the date of last contact (NCT00329641)
Timeframe: Every 6-9 weeks until progression, after progression every six months for first two years and annually thereafter up to 3 for up to 3 years after registration or until death
| Intervention | Percentage of population (Number) |
|---|---|
| Sorafenib, Carboplatin, Paclitaxel | 42 |
Complete response corresponds to complete disappearance of all measurable and non-measurable lesions with no new lesions. Partial response corresponds to greater than or equal to 30fi decrease of sum of longest diameter of all target measurable lesions with no new lesion and non unequivocal progression of non-measurable disease. (NCT00329641)
Timeframe: Every 6 weeks for the first 8 cycles of therapy, then every three cycles (9 weeks) until progression
| Intervention | participants (Number) |
|---|---|
| Sorafenib, Carboplatin, Paclitaxel | 0 |
Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event (NCT00329641)
Timeframe: Weekly during the first cycle of therapy, then prior to each cycle (one cycle = 3 weeks)
| Intervention | Participants with a given type of AE (Number) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Calcium, serum-low (hypocalcemia) | Cataract | Diarrhea | Fatigue (asthenia, lethargy, malaise) | Febrile neutropenia | Hemoglobin | Infec w/ Gr 3/4 neut-Urinary tract | Leukocytes (total WBC) | Lymphopenia | Mucositis/stomatitis (func/symp) - Pharynx | Neuropathy: sensory | Neutrophils/granulocytes (ANC/AGC) | Platelets | Pruritus/itching | Rash/desquamation | Vision-blurred vision | |
| Intervention | 1 | 1 | 2 | 1 | 1 | 2 | 1 | 4 | 2 | 1 | 2 | 10 | 4 | 1 | 5 | 1 |
32 reviews available for niacinamide and Metastase
| Article | Year |
|---|---|
Evolving Treatment Paradigm in Metastatic Renal Cell Carcinoma.
Topics: Carcinoma, Renal Cell; Cell Proliferation; Gene Expression Regulation, Neoplastic; Humans; Indoles; | 2017 |
Research gaps in the management and prevention of cutaneous squamous cell carcinoma in organ transplant recipients.
Topics: Antimetabolites, Antineoplastic; Capecitabine; Carcinoma, Squamous Cell; Health Behavior; Humans; Im | 2017 |
Role and relevance of quality indicators in the selection of first-line treatment of patients with metastatic renal cell carcinoma: a position paper of the MeetURO Group.
Topics: Carcinoma, Renal Cell; Humans; Indazoles; Indoles; Kidney Neoplasms; Neoplasm Metastasis; Niacinamid | 2019 |
[Medical treatment of renal cell carcinoma].
Topics: Angiogenesis Inhibitors; Antibodies, Monoclonal, Humanized; Antineoplastic Agents; Bevacizumab; Carc | 2013 |
Sorafenib in metastatic thyroid cancer: a systematic review.
Topics: Antineoplastic Agents; Clinical Trials, Phase II as Topic; Disease Progression; Female; Humans; Male | 2014 |
New insights in the treatment of radioiodine refractory differentiated thyroid carcinomas: to lenvatinib and beyond.
Topics: Antineoplastic Agents; Clinical Trials, Phase II as Topic; Humans; Iodine Radioisotopes; Mutation; N | 2015 |
Aggressive thyroid cancer: targeted therapy with sorafenib.
Topics: Angiogenesis Inhibitors; Antineoplastic Agents; Humans; Neoplasm Metastasis; Niacinamide; Phenylurea | 2017 |
Efficacy and Safety of Sorafenib Therapy on Metastatic Renal Cell Carcinoma in Korean Patients: Results from a Retrospective Multicenter Study.
Topics: Antineoplastic Agents; Carcinoma, Renal Cell; Disease-Free Survival; Female; Humans; Kidney Neoplasm | 2015 |
Real-World Effectiveness of Everolimus Subsequent to Different First Targeted Therapies for the Treatment of Metastatic Renal Cell Carcinoma: Synthesis of Retrospective Chart Reviews.
Topics: Aged; Antineoplastic Agents; Carcinoma, Renal Cell; Everolimus; Female; Humans; Indazoles; Indoles; | 2016 |
A decade of pharmacogenomics research on tyrosine kinase inhibitors in metastatic renal cell cancer: a systematic review.
Topics: Antineoplastic Agents; Biomarkers, Pharmacological; Carcinoma, Renal Cell; Gene Expression; Humans; | 2016 |
First-line therapy for treatment-naive patients with advanced/metastatic renal cell carcinoma: a systematic review of published randomized controlled trials.
Topics: Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; Carcin | 2016 |
Challenges of advanced hepatocellular carcinoma.
Topics: Antineoplastic Combined Chemotherapy Protocols; Biomarkers, Tumor; Carcinoma, Hepatocellular; Clinic | 2016 |
Effects and Side Effects of Using Sorafenib and Sunitinib in the Treatment of Metastatic Renal Cell Carcinoma.
Topics: Angiogenesis Inhibitors; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Renal Cell; Dise | 2017 |
An update on the medical therapy of advanced metastatic renal cell carcinoma.
Topics: Antineoplastic Agents; Benzenesulfonates; Carcinoma, Renal Cell; Clinical Trials as Topic; Drug Ther | 2008 |
Exploring the role of novel agents in the treatment of renal cell carcinoma.
Topics: Aged; Aged, 80 and over; Angiogenesis Inhibitors; Antibodies, Monoclonal; Antibodies, Monoclonal, Hu | 2008 |
Targeted therapies in metastatic renal cancer in 2009.
Topics: Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic Agents; Axitinib; Benzenes | 2009 |
[Current advances in molecular targeted therapy of primary hepatocellular carcinoma].
Topics: Antineoplastic Agents; Benzenesulfonates; Carcinoma, Hepatocellular; Cell Adhesion; Cell Proliferati | 2009 |
Sorafenib reveals efficacy in sequential treatment of metastatic renal cell cancer.
Topics: Antineoplastic Combined Chemotherapy Protocols; Benzenesulfonates; Carcinoma, Renal Cell; Clinical T | 2009 |
Metastatic renal cell carcinoma: current standards of care.
Topics: Antineoplastic Agents; Benzenesulfonates; Carcinoma, Renal Cell; Combined Modality Therapy; Everolim | 2009 |
Sorafenib therapy for metastatic renal carcinoma in patients with low cardiac ejection fraction: report of two cases and literature review.
Topics: Aged; Antineoplastic Agents; Benzenesulfonates; Carcinoma, Renal Cell; Female; Heart Diseases; Human | 2010 |
Update on systemic therapies of metastatic renal cell carcinoma.
Topics: Algorithms; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic Agents; Benzen | 2010 |
[Treatment of metastatic renal cell carcinoma].
Topics: Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic Agents; Benzenesulfonates; | 2011 |
Multikinase inhibitors in metastatic renal cell carcinoma: indirect comparison meta-analysis.
Topics: Antineoplastic Agents; Benzenesulfonates; Carcinoma, Renal Cell; Humans; Indazoles; Indoles; Kidney | 2011 |
Systemic therapy for metastatic non-clear-cell renal cell carcinoma: recent progress and future directions.
Topics: Benzenesulfonates; Carcinoma, Renal Cell; Clinical Trials as Topic; Humans; Indazoles; Indoles; Kidn | 2011 |
Developments in metastatic pancreatic cancer: is gemcitabine still the standard?
Topics: Antimetabolites, Antineoplastic; Antineoplastic Combined Chemotherapy Protocols; Benzenesulfonates; | 2012 |
Hypothyroidism during treatment with tyrosine kinase inhibitors.
Topics: Carcinoma, Renal Cell; Dose-Response Relationship, Drug; Gastrointestinal Neoplasms; Humans; Indoles | 2012 |
Targeted therapy for metastatic renal cell carcinoma.
Topics: Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Benzenesulfonates; Bevacizumab; Carcinoma | 2006 |
VEGF-targeted therapy in renal cell carcinoma: active drugs and active choices.
Topics: Angiogenesis Inhibitors; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic A | 2006 |
New treatment approaches in metastatic renal cell carcinoma.
Topics: Angiogenesis Inhibitors; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic A | 2006 |
Safety, pharmacokinetics, and preliminary antitumor activity of sorafenib: a review of four phase I trials in patients with advanced refractory solid tumors.
Topics: Antineoplastic Agents; Benzenesulfonates; Clinical Trials, Phase I as Topic; Humans; Neoplasm Metast | 2007 |
Playing only one instrument may be not enough: limitations and future of the antiangiogenic treatment of cancer.
Topics: Angiogenesis Inhibitors; Antibodies, Monoclonal; Antineoplastic Agents; Benzenesulfonates; Carcinoma | 2007 |
[Angiogenesis inhibitors for the systemic treatment of metastatic renal cell carcinoma: sunitinib, sorafenib, bevacizumab and temsirolimus].
Topics: Angiogenesis Inhibitors; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic A | 2008 |
52 trials available for niacinamide and Metastase
| Article | Year |
|---|---|
Association of post-treatment hypoalbuminemia and survival in Chinese patients with metastatic renal cell carcinoma.
Topics: Adult; Aged; Aged, 80 and over; Carcinoma, Renal Cell; Disease-Free Survival; Female; Humans; Hypoal | 2017 |
A randomized phase II study of paclitaxel alone versus paclitaxel plus sorafenib in second- and third-line treatment of patients with HER2-negative metastatic breast cancer (PASO).
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Breast Neoplasms; Disease-Free Survival; Femal | 2017 |
A phase II study of combined VEGF inhibitor (bevacizumab+sorafenib) in patients with metastatic breast cancer: Hoosier Oncology Group Study BRE06-109.
Topics: Adult; Aged; Angiogenesis Inhibitors; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Che | 2013 |
Prognostic value of the proliferation marker Ki-67 in laryngeal carcinoma: results of the accelerated radiotherapy with carbogen breathing and nicotinamide phase III randomized trial.
Topics: Administration, Inhalation; Adult; Aged; Aged, 80 and over; Antigens, Neoplasm; Carbon Dioxide; Carb | 2015 |
Phase I/II trial of vinorelbine and sorafenib in metastatic breast cancer.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Breast Neoplasms; Female; Follow-Up Stu | 2014 |
Dovitinib versus sorafenib for third-line targeted treatment of patients with metastatic renal cell carcinoma: an open-label, randomised phase 3 trial.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Benzimidazoles; Carcinoma, Renal | 2014 |
Dovitinib versus sorafenib for third-line targeted treatment of patients with metastatic renal cell carcinoma: an open-label, randomised phase 3 trial.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Benzimidazoles; Carcinoma, Renal | 2014 |
Dovitinib versus sorafenib for third-line targeted treatment of patients with metastatic renal cell carcinoma: an open-label, randomised phase 3 trial.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Benzimidazoles; Carcinoma, Renal | 2014 |
Dovitinib versus sorafenib for third-line targeted treatment of patients with metastatic renal cell carcinoma: an open-label, randomised phase 3 trial.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Benzimidazoles; Carcinoma, Renal | 2014 |
Sorafenib dose escalation is not uniformly associated with blood pressure elevations in normotensive patients with advanced malignancies.
Topics: Adult; Aged; Blood Pressure; Dose-Response Relationship, Drug; Female; Humans; Male; Middle Aged; Ne | 2014 |
Impairment of cognitive functioning during Sunitinib or Sorafenib treatment in cancer patients: a cross sectional study.
Topics: Adult; Aged; Aged, 80 and over; Carcinoma, Renal Cell; Cognition; Cognition Disorders; Cross-Section | 2014 |
Safety and efficacy of sorafenib in the treatment of advanced hepatocellular carcinoma: a single center experience.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Carcinoma, Hepatocellular; Disease Progressio | 2014 |
A phase II study of the efficacy and safety of the combination therapy of the MEK inhibitor refametinib (BAY 86-9766) plus sorafenib for Asian patients with unresectable hepatocellular carcinoma.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Asian People; Biomarkers; Carcinoma, He | 2014 |
A randomized phase II efficacy and correlative studies of cetuximab with or without sorafenib in recurrent and/or metastatic head and neck squamous cell carcinoma.
Topics: Adult; Aged; Antineoplastic Agents; Carcinoma, Squamous Cell; Cetuximab; Female; Head and Neck Neopl | 2015 |
Effects of Adjuvant Sorafenib and Sunitinib on Cardiac Function in Renal Cell Carcinoma Patients without Overt Metastases: Results from ASSURE, ECOG 2805.
Topics: Adult; Aged; Antineoplastic Agents; Carcinoma, Renal Cell; Cardiovascular Diseases; Chemotherapy, Ad | 2015 |
Phase I study of FOLFIRI plus pimasertib as second-line treatment for KRAS-mutated metastatic colorectal cancer.
Topics: Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Camptothecin; Colorectal Ne | 2015 |
Phase II Trial of Sorafenib in Patients with Chemotherapy Refractory Metastatic Esophageal and Gastroesophageal (GE) Junction Cancer.
Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Agents; Disease-Free Survival; Drug Resistance, Neoplasm | 2015 |
The Prognostic Significance of Metabolic Response Heterogeneity in Metastatic Colorectal Cancer.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Capecitabine; Colore | 2015 |
Phase II clinical trial of sorafenib plus interferon-alpha treatment for patients with metastatic renal cell carcinoma in Japan.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Renal Cell; Female; Humans; | 2015 |
A phase II study of sorafenib in recurrent and/or metastatic salivary gland carcinomas: Translational analyses and clinical impact.
Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Agents; Carcinoma, Adenoid Cystic; Carcinoma, Mucoepider | 2016 |
Phase I/II Randomized Trial of Sorafenib and Bevacizumab as First-Line Therapy in Patients with Locally Advanced or Metastatic Hepatocellular Carcinoma: North Central Cancer Treatment Group Trial N0745 (Alliance).
Topics: Adolescent; Adult; Aged; Antineoplastic Agents; Bevacizumab; Carcinoma, Hepatocellular; Female; Huma | 2017 |
Phase I/II Trial of Sorafenib in Combination with Vinorelbine as First-Line Chemotherapy for Metastatic Breast Cancer.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Breast Neoplasms; Drug Administration S | 2016 |
Patterns of Care and Clinical Outcomes in Patients With Metastatic Renal Cell Carcinoma-Results From a Tertiary Cancer Center in India.
Topics: Adult; Aged; Antineoplastic Agents; Carcinoma, Renal Cell; Everolimus; Female; Humans; Indazoles; In | 2017 |
Final analysis of a phase II trial using sorafenib for metastatic castration-resistant prostate cancer.
Topics: Aged; Aged, 80 and over; Antineoplastic Agents; Benzenesulfonates; Bone Neoplasms; Disease-Free Surv | 2009 |
Randomized phase II trial of first-line treatment with sorafenib versus interferon Alfa-2a in patients with metastatic renal cell carcinoma.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Benzenesulfonates; Carcinoma, Ren | 2009 |
Evaluation of sorafenib treatment in metastatic renal cell carcinoma with 2-fluoro-2-deoxyglucose positron emission tomography and computed tomography.
Topics: Aged; Benzenesulfonates; Carcinoma, Renal Cell; Female; Fluorodeoxyglucose F18; Humans; Male; Middle | 2009 |
Phase II multicenter, uncontrolled trial of sorafenib in patients with metastatic breast cancer.
Topics: Adult; Aged; Antineoplastic Agents; Benzenesulfonates; Biomarkers, Tumor; Breast Neoplasms; ErbB Rec | 2009 |
A phase II trial of sorafenib in first-line metastatic urothelial cancer: a study of the PMH Phase II Consortium.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Benzenesulfonates; Female; Humans; Male; Midd | 2011 |
Phase II study of sorafenib in combination with docetaxel and cisplatin in the treatment of metastatic or advanced gastric and gastroesophageal junction adenocarcinoma: ECOG 5203.
Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Benzenesulfonates; Cisp | 2010 |
Phase II study of sorafenib in combination with docetaxel and cisplatin in the treatment of metastatic or advanced gastric and gastroesophageal junction adenocarcinoma: ECOG 5203.
Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Benzenesulfonates; Cisp | 2010 |
Phase II study of sorafenib in combination with docetaxel and cisplatin in the treatment of metastatic or advanced gastric and gastroesophageal junction adenocarcinoma: ECOG 5203.
Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Benzenesulfonates; Cisp | 2010 |
Phase II study of sorafenib in combination with docetaxel and cisplatin in the treatment of metastatic or advanced gastric and gastroesophageal junction adenocarcinoma: ECOG 5203.
Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Benzenesulfonates; Cisp | 2010 |
Phase II evaluation of sorafenib in advanced and metastatic squamous cell carcinoma of the head and neck: Southwest Oncology Group Study S0420.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Benzenesulfonates; Carcinoma, Squamous Cell; | 2010 |
Sorafenib in patients with metastatic renal cell carcinoma refractory to either sunitinib or bevacizumab.
Topics: Aged; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic Agents; Benzenesulfo | 2010 |
A phase II trial of sorafenib in metastatic melanoma with tissue correlates.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Benzenesulfonates; Cyclin D1; DNA Mutational | 2010 |
Phase I trial of sorafenib in combination with interferon-alpha in Japanese patients with unresectable or metastatic renal cell carcinoma.
Topics: Adult; Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Asian People; Be | 2012 |
A randomized phase II of gemcitabine and sorafenib versus sorafenib alone in patients with metastatic pancreatic cancer.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Benzenesulfonates; C | 2012 |
Motesanib, or open-label bevacizumab, in combination with paclitaxel, as first-line treatment for HER2-negative locally recurrent or metastatic breast cancer: a phase 2, randomised, double-blind, placebo-controlled study.
Topics: Adult; Aged; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chem | 2011 |
Sorafenib with interleukin-2 vs sorafenib alone in metastatic renal cell carcinoma: the ROSORC trial.
Topics: Aged; Algorithms; Antineoplastic Combined Chemotherapy Protocols; Benzenesulfonates; Carcinoma, Rena | 2011 |
Baseline patient-reported kidney cancer-specific symptoms as an indicator for median survival in sorafenib-refractory metastatic renal cell carcinoma.
Topics: Adult; Aged; Antineoplastic Agents; Benzenesulfonates; Carcinoma, Renal Cell; Drug Resistance, Neopl | 2011 |
An adjusted indirect comparison of everolimus and sorafenib therapy in sunitinib-refractory metastatic renal cell carcinoma patients using repeated matched samples.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Benzenesulfonates; Carcinoma, Renal Cell; Dis | 2011 |
Multikinase inhibitors in metastatic renal cell carcinoma: indirect comparison meta-analysis.
Topics: Antineoplastic Agents; Benzenesulfonates; Carcinoma, Renal Cell; Humans; Indazoles; Indoles; Kidney | 2011 |
SWOG 0514: a phase II study of sorafenib in patients with unresectable or metastatic gallbladder carcinoma and cholangiocarcinoma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Benzenesulfonates; Cholangiocarcinoma; Diseas | 2012 |
Sorafenib and dacarbazine as first-line therapy for advanced melanoma: phase I and open-label phase II studies.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Benzenesulfonates; Dacarbazine; Disease | 2011 |
Rationale and design of decision: a double-blind, randomized, placebo-controlled phase III trial evaluating the efficacy and safety of sorafenib in patients with locally advanced or metastatic radioactive iodine (RAI)-refractory, differentiated thyroid ca
Topics: Antineoplastic Agents; Benzenesulfonates; Clinical Protocols; Double-Blind Method; Drug Administrati | 2011 |
Treatment of everolimus-resistant metastatic renal cell carcinoma with VEGF-targeted therapies.
Topics: Adult; Aged; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocols; Benz | 2011 |
Paclitaxel in combination with sorafenib and bevacizumab in patients with locally advanced or metastatic solid tumors.
Topics: Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocols; Benzenesulfonates | 2012 |
Phase II escalation study of sorafenib in patients with metastatic renal cell carcinoma who have been previously treated with anti-angiogenic treatment.
Topics: Adult; Aged; Aged, 80 and over; Benzenesulfonates; Biomarkers, Tumor; Carcinoma, Renal Cell; Diarrhe | 2012 |
Phase I study of the combination of sorafenib and temsirolimus in patients with metastatic melanoma.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Benzenesulfonates; Female; Humans; Male | 2012 |
Randomized phase II trial of sorafenib with temsirolimus or tipifarnib in untreated metastatic melanoma (S0438).
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Benzenesulfonates; F | 2012 |
Efficacy and safety of sorafenib in patients with advanced hepatocellular carcinoma according to baseline status: subset analyses of the phase III Sorafenib Asia-Pacific trial.
Topics: Adult; Benzenesulfonates; Carcinoma, Hepatocellular; China; Female; Humans; Liver Neoplasms; Male; M | 2012 |
Efficacy and safety of sorafenib in patients with advanced hepatocellular carcinoma according to baseline status: subset analyses of the phase III Sorafenib Asia-Pacific trial.
Topics: Adult; Benzenesulfonates; Carcinoma, Hepatocellular; China; Female; Humans; Liver Neoplasms; Male; M | 2012 |
Efficacy and safety of sorafenib in patients with advanced hepatocellular carcinoma according to baseline status: subset analyses of the phase III Sorafenib Asia-Pacific trial.
Topics: Adult; Benzenesulfonates; Carcinoma, Hepatocellular; China; Female; Humans; Liver Neoplasms; Male; M | 2012 |
Efficacy and safety of sorafenib in patients with advanced hepatocellular carcinoma according to baseline status: subset analyses of the phase III Sorafenib Asia-Pacific trial.
Topics: Adult; Benzenesulfonates; Carcinoma, Hepatocellular; China; Female; Humans; Liver Neoplasms; Male; M | 2012 |
Phase I study of sorafenib in combination with docetaxel and prednisone in chemo-naïve patients with metastatic castration-resistant prostate cancer.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Benzenesulfonates; D | 2012 |
A double-blind, randomised, placebo-controlled, phase 2b study evaluating sorafenib in combination with paclitaxel as a first-line therapy in patients with HER2-negative advanced breast cancer.
Topics: Antineoplastic Combined Chemotherapy Protocols; Breast Neoplasms; Disease-Free Survival; Double-Blin | 2013 |
Phase II study of sorafenib in combination with cisplatin and 5-fluorouracil to treat recurrent or metastatic nasopharyngeal carcinoma.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma; Cisplatin; Disease-Free Surv | 2013 |
Phase II trial of sorafenib in combination with carboplatin and paclitaxel in patients with metastatic uveal melanoma: SWOG S0512.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Biomarkers, Pharmacological; Carboplatin; Dise | 2012 |
Phase II trial of sequential subcutaneous interleukin-2 plus interferon alpha followed by sorafenib in renal cell carcinoma (RCC).
Topics: Adult; Aged; Aged, 80 and over; Carcinoma, Renal Cell; Combined Modality Therapy; Disease Progressio | 2013 |
Sorafenib for metastatic renal cancer: the Princess Margaret experience.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Benzenesulfonates; Drug-Related Side Effects and Adverse | 2008 |
Evaluation of 6-aminonicotinamide (NSC-21206) in the treatment of metastatic hypernephroma.
Topics: Adenocarcinoma; Adult; Aged; Clinical Trials as Topic; Evaluation Studies as Topic; Female; Follow-U | 1970 |
167 other studies available for niacinamide and Metastase
| Article | Year |
|---|---|
Nicaraven Attenuates Postoperative Systemic Inflammatory Responses-Induced Tumor Metastasis.
Topics: Animals; Cytokines; Inflammation; Lung; Lung Neoplasms; Male; Mice; Mice, Inbred C57BL; Neoplasm Met | 2020 |
18F-PSMA 1007 Uptake in a Man With Metastatic Breast Cancer.
Topics: Aged; Breast Neoplasms, Male; Fluorine Radioisotopes; Humans; Male; Neoplasm Metastasis; Niacinamide | 2020 |
Duodenal Adenocarcinoma Mimicking Metastasis of Prostate Cancer on 18F-Prostate-Specific Membrane Antigen-1007 PET/CT.
Topics: Adenocarcinoma; Aged; Diagnosis, Differential; Duodenal Neoplasms; Humans; Male; Neoplasm Grading; N | 2021 |
High detection rate in [
Topics: Aged; Bone Neoplasms; Diagnostic Imaging; Humans; Male; Middle Aged; Neoplasm Metastasis; Neoplasm R | 2021 |
Detection of Diffuse Peritoneal and Omental Metastases From Prostate Cancer With 18F-PSMA-1007 PET/CT.
Topics: Aged, 80 and over; Humans; Male; Neoplasm Metastasis; Niacinamide; Oligopeptides; Peritoneum; Positr | 2022 |
Evaluation of First-Line Sorafenib Treatment for Metastatic Renal Cell Carcinoma in Kidney Transplant Patients: A Single-Center Experience With Four Cases.
Topics: Aged; Antineoplastic Agents; Carcinoma, Renal Cell; Humans; Kidney Neoplasms; Kidney Transplantation | 2017 |
Combination of sorafenib and cytokine-induced killer cells in metastatic renal cell carcinoma: a potential regimen.
Topics: Carcinoma, Renal Cell; Cytokine-Induced Killer Cells; Humans; Immunotherapy; Kidney Neoplasms; Male; | 2017 |
Outcomes of Patients With Long-Term Treatment Response to Vascular Endothelial Growth Factor-Targeted Therapy for Metastatic Renal Cell Cancer.
Topics: Adult; Aged; Aged, 80 and over; Angiogenesis Inhibitors; Bevacizumab; Carcinoma, Renal Cell; Disease | 2017 |
Comparison of efficacy, safety, and quality of life between sorafenib and sunitinib as first-line therapy for Chinese patients with metastatic renal cell carcinoma.
Topics: Adult; Aged; Aged, 80 and over; Carcinoma, Renal Cell; China; Disease-Free Survival; Drug-Related Si | 2017 |
Survival benefit of transarterial chemoembolization in patients with metastatic hepatocellular carcinoma: a single center experience.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Carcinoma, Hepatocellular; Chemoembolization, | 2017 |
Effectiveness and the strategy to treat the side effects of sorafenib administration after transarterial chemoembolization in advanced hepatocellular carcinoma patients.
Topics: Adult; Aftercare; Aged; Aged, 80 and over; Antineoplastic Agents; Carcinoma, Hepatocellular; Chemoem | 2018 |
The excellent antitumor effect of apatinib alone as second-line therapy in a patient with sorafenib-refractory hepatocellular carcinoma: A case report.
Topics: Adult; Carcinoma, Hepatocellular; Chemoembolization, Therapeutic; Disease Progression; Fatal Outcome | 2018 |
Retrospective analysis on the efficacy of sunitinib/sorafenib in combination with dendritic cells-cytokine-induced killer in metastasis renal cell carcinoma after radical nephrectomy.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Cancer Vaccines; Carcinoma, Renal Cell; | 2018 |
Antimetastatic effect of the pharmacological inhibition of serine/arginine-rich protein kinases (SRPK) in murine melanoma.
Topics: Animals; Antineoplastic Agents; Cell Adhesion; Cell Movement; Drug Screening Assays, Antitumor; Fema | 2018 |
Aortic Dissection and Cardiac Dysfunction Emerged Coincidentally During the Long-Term Treatment with Angiogenesis Inhibitors for Metastatic Renal Cell Carcinoma.
Topics: Aged; Angiogenesis Inhibitors; Aortic Dissection; Axitinib; Carcinoma, Renal Cell; Heart Diseases; H | 2018 |
Proteomics reveals NNMT as a master metabolic regulator of cancer-associated fibroblasts.
Topics: Cancer-Associated Fibroblasts; Cell Line, Tumor; Cells, Cultured; Disease Progression; DNA Methylati | 2019 |
Suppression of natural killer cells by sorafenib contributes to prometastatic effects in hepatocellular carcinoma.
Topics: Animals; Antigens, CD; Antigens, Differentiation, T-Lymphocyte; Antineoplastic Agents; Carcinoma, He | 2013 |
Second line treatment of metastatic renal cell carcinoma: The Institut Gustave Roussy experience with targeted therapies in 251 consecutive patients.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Analysis of Variance; Antibodies, Monoclonal, Humanized; | 2013 |
Clinical activity of sorafenib in a previously treated advanced urothelial cancer patient.
Topics: Antineoplastic Agents; Carcinoma, Renal Cell; Disease-Free Survival; Humans; Kidney Neoplasms; Male; | 2013 |
Comparative efficacy of sunitinib versus sorafenib as first-line treatment for patients with metastatic renal cell carcinoma.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Carcinoma, Renal Cell; Disease-Fr | 2012 |
Prolonged exposure to tyrosine kinase inhibitors or early use of everolimus in metastatic renal cell carcinoma: are the two options alike?
Topics: Adult; Aged; Antineoplastic Agents; Carcinoma, Renal Cell; Disease-Free Survival; Everolimus; Female | 2013 |
Aspirin minimized the pro-metastasis effect of sorafenib and improved survival by up-regulating HTATIP2 in hepatocellular carcinoma.
Topics: Acetyltransferases; Animals; Aspirin; Carcinoma, Hepatocellular; Cell Line, Tumor; Cell Proliferatio | 2013 |
Off-label use of cetuximab plus sorafenib and panitumumab plus regorafenib to personalize therapy for a patient with V600E BRAF-mutant metastatic colon cancer.
Topics: Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Prot | 2013 |
Skeletal muscle density predicts prognosis in patients with metastatic renal cell carcinoma treated with targeted therapies.
Topics: Aged; Antineoplastic Agents; Body Composition; Carcinoma, Renal Cell; Clinical Trials as Topic; Dise | 2013 |
Cyclin G1 expands liver tumor-initiating cells by Sox2 induction via Akt/mTOR signaling.
Topics: Animals; Apoptosis; Carcinoma, Hepatocellular; Cell Line, Tumor; Cisplatin; Cyclin G1; Drug Resistan | 2013 |
[A case of metastatic renal cell carcinoma with no evidence of disease for a long term after a favorable response to molecular-targeted therapy followed by metastasectomy].
Topics: Adrenalectomy; Carcinoma, Renal Cell; Humans; Kidney Neoplasms; Male; Middle Aged; Molecular Targete | 2013 |
Sorafenib makes headway on metastatic thyroid cancer.
Topics: Humans; Neoplasm Metastasis; Niacinamide; Phenylurea Compounds; Randomized Controlled Trials as Topi | 2013 |
Stevens-Johnson syndrome induced by sorafenib for metastatic renal cell carcinoma.
Topics: Aged; Betamethasone; Carcinoma, Renal Cell; Fatal Outcome; Humans; Kidney Neoplasms; Male; Neoplasm | 2013 |
Inhibition of tumor growth and metastasis in non-small cell lung cancer by LY2801653, an inhibitor of several oncokinases, including MET.
Topics: Animals; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Non-Small | 2013 |
[A case of metastatic renal cell carcinoma associated with Birt-Hogg-Dubé syndrome treated with molecular-targeting agents].
Topics: Animals; Antineoplastic Agents; Birt-Hogg-Dube Syndrome; Carcinoma, Renal Cell; Everolimus; Humans; | 2013 |
High SIRT1 expression is a negative prognosticator in pancreatic ductal adenocarcinoma.
Topics: Aged; Aged, 80 and over; Carcinoma, Pancreatic Ductal; Cell Cycle; Cell Line, Tumor; Cell Proliferat | 2013 |
Efficacy of sorafenib monotherapy versus sorafenib-based loco-regional treatments in advanced hepatocellular carcinoma.
Topics: alpha-Fetoproteins; Carcinoma, Hepatocellular; Cohort Studies; Disease-Free Survival; Female; Humans | 2013 |
The Enhanced metastatic potential of hepatocellular carcinoma (HCC) cells with sorafenib resistance.
Topics: Animals; Antineoplastic Agents; ATP-Binding Cassette Transporters; Carcinoma, Hepatocellular; Cell L | 2013 |
Clinical and laboratory prognostic factors in patients with metastatic renal cell carcinoma treated with sunitinib and sorafenib after progression on cytokines.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Renal Cell; Cytokines; Disea | 2014 |
SIRT1 regulates lamellipodium extension and migration of melanoma cells.
Topics: Animals; Cell Movement; Female; Gene Expression Regulation, Neoplastic; Melanoma; Melanoma, Experime | 2014 |
[Systemic treatment of metastatic renal cell carcinoma: change of paradigms after introduction of targeted therapy].
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Carcinoma, Renal Cell; Combined Modality Ther | 2014 |
The use of lipid-coated nanodiamond to improve bioavailability and efficacy of sorafenib in resisting metastasis of gastric cancer.
Topics: Administration, Oral; Animals; Antineoplastic Agents; Biological Availability; Drug Carriers; Humans | 2014 |
Role of salvage targeted therapy in differentiated thyroid cancer patients who failed first-line sorafenib.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Papillary, Follicular; Chemo | 2014 |
Sorafenib in advanced, heavily pretreated patients with soft tissue sarcomas.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Female; Humans; Leiomyosarcoma; Male; Middle | 2014 |
The relevance of testing the efficacy of anti-angiogenesis treatments on cells derived from primary tumors: a new method for the personalized treatment of renal cell carcinoma.
Topics: Angiogenesis Inhibitors; Animals; Antineoplastic Agents; Basic Helix-Loop-Helix Leucine Zipper Trans | 2014 |
[Metastasized renal cell carcinoma - research subjects needed!].
Topics: Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Renal Cell; Drug Administration Schedule; | 2014 |
(99m)Tc-labeled-rhTSH analogue (TR1401) for imaging poorly differentiated metastatic thyroid cancer.
Topics: Animals; Cattle; Cell Differentiation; Cell Separation; CHO Cells; Cricetinae; Cricetulus; Dogs; Flo | 2014 |
Inhibition of the vacuolar ATPase induces Bnip3-dependent death of cancer cells and a reduction in tumor burden and metastasis.
Topics: Animals; Antineoplastic Agents; Apoptosis; Breast Neoplasms; Butadienes; Cell Hypoxia; Enzyme Inhibi | 2014 |
Blocking lipid synthesis overcomes tumor regrowth and metastasis after antiangiogenic therapy withdrawal.
Topics: Angiogenesis Inhibitors; Animals; Cell Line, Tumor; Disease Progression; Fatty Acid Synthases; Homeo | 2014 |
Activation of phosphatidylinositol 3-kinase/Akt signaling mediates sorafenib-induced invasion and metastasis in hepatocellular carcinoma.
Topics: Angiogenesis Inhibitors; Animals; Carcinoma, Hepatocellular; Epithelial-Mesenchymal Transition; Fema | 2014 |
Sorafenib-associated psoriasiform eruption in a patient with hepatocellular carcinoma.
Topics: Administration, Oral; Aged; Antineoplastic Agents; Carcinoma, Hepatocellular; Drug Eruptions; Humans | 2014 |
Prognostic factors in renal cell carcinoma patients treated with sorafenib: results from the Czech registry.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Carcinoma, Renal Cell; Czech Republic; Databa | 2015 |
Second-line sunitinib as a feasible approach for iodine-refractory differentiated thyroid cancer after the failure of first-line sorafenib.
Topics: Antineoplastic Agents; Disease Progression; Drug Resistance, Neoplasm; Female; Humans; Indoles; Iodi | 2015 |
Sprouty2 protein is downregulated in human squamous cell carcinoma of the head and neck and suppresses cell proliferation in vitro.
Topics: Antineoplastic Agents; Carcinoma, Squamous Cell; Cell Line, Tumor; Cell Proliferation; Down-Regulati | 2015 |
Sorafenib treatment of advanced renal cell carcinoma patients in daily practice: the large international PREDICT study.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Ambulatory Care Facilities; Antineoplastic Agents; Carci | 2015 |
Thyroid carcinoma, version 2.2014.
Topics: Adenocarcinoma; Anilides; Carcinoma, Neuroendocrine; Guidelines as Topic; Humans; Neoplasm Metastasi | 2014 |
Health economic changes as a result of implementation of targeted therapy for metastatic renal cell carcinoma: national results from DARENCA study 2.
Topics: Adult; Aged; Aged, 80 and over; Ambulatory Care; Angiogenesis Inhibitors; Antineoplastic Agents; Bev | 2015 |
Sorafenib in the treatment of thyroid cancer.
Topics: Animals; Antineoplastic Agents; Disease-Free Survival; Humans; Neoplasm Metastasis; Niacinamide; Phe | 2015 |
CXCR4-targeted lipid-coated PLGA nanoparticles deliver sorafenib and overcome acquired drug resistance in liver cancer.
Topics: Animals; Carcinoma, Hepatocellular; Cell Death; Cell Line, Tumor; Cell Proliferation; Drug Delivery | 2015 |
Retrospective Analysis of the Efficacy and Safety of Sorafenib in Chinese Patients With Metastatic Renal Cell Carcinoma and Prognostic Factors Related to Overall Survival.
Topics: Antineoplastic Agents; Carcinoma, Renal Cell; China; Disease-Free Survival; Dose-Response Relationsh | 2015 |
Early Tumor Shrinkage Under Treatment with First-line Tyrosine Kinase Inhibitors as a Predictor of Overall Survival in Patients with Metastatic Renal Cell Carcinoma: a Retrospective Multi-Institutional Study in Japan.
Topics: Adult; Aged; Aged, 80 and over; Angiogenesis Inhibitors; Carcinoma, Renal Cell; Disease-Free Surviva | 2016 |
Sorafenib for the treatment of advanced hepatocellular carcinoma with extrahepatic metastasis: a prospective multicenter cohort study.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Carcinoma, Hepatocellular; Female; Humans; Ka | 2015 |
Down-regulation of SDF1-α expression in tumor microenvironment is associated with aspirin-mediated suppression of the pro-metastasis effect of sorafenib in hepatocellular carcinoma.
Topics: Animals; Aspirin; Benzylamines; Carcinoma, Hepatocellular; Cell Proliferation; Chemokine CXCL12; Cyc | 2015 |
The Relationship Between the Adverse Events and Efficacy of Sorafenib in Patients With Metastatic Renal Cell Carcinoma: A Multicenter Retrospective Study from Northwest China.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Carcinoma, Renal Cell; China; Disease Progres | 2015 |
Long-term outcomes of tyrosine kinase inhibitor discontinuation in patients with metastatic renal cell carcinoma.
Topics: Adult; Aged; Antineoplastic Agents; Carcinoma, Renal Cell; Disease Progression; Disease-Free Surviva | 2016 |
Metformin inhibits the prometastatic effect of sorafenib in hepatocellular carcinoma by upregulating the expression of TIP30.
Topics: Acetyltransferases; Animals; Carcinoma, Hepatocellular; Cell Line, Tumor; Cell Proliferation; Gene E | 2016 |
Inhibition of tumor growth and metastasis by photoimmunotherapy targeting tumor-associated macrophage in a sorafenib-resistant tumor model.
Topics: Animals; Breast Neoplasms; Cell Death; Cell Line, Tumor; Cell Proliferation; Disease Models, Animal; | 2016 |
[Efficacy of Sorafenib for Extrahepatic Recurrence of Hepatocellular Carcinoma after Liver Resection].
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Carcinoma, Hepatocellular; Female; Hepatectom | 2015 |
Efficacy and safety of sorafenib versus sunitinib as first-line treatment in patients with metastatic renal cell carcinoma: largest single-center retrospective analysis.
Topics: Antineoplastic Agents; Carcinoma, Renal Cell; Diarrhea; Disease-Free Survival; Fatigue; Female; Huma | 2016 |
Metformin sensitizes sorafenib to inhibit postoperative recurrence and metastasis of hepatocellular carcinoma in orthotopic mouse models.
Topics: Acetyltransferases; Animals; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; | 2016 |
Fuhrman Grade and Neutrophil-To-Lymphocyte Ratio Influence on Survival in Patients With Metastatic Renal Cell Carcinoma Treated With First-Line Tyrosine Kinase Inhibitors.
Topics: Adult; Aged; Aged, 80 and over; Carcinoma, Renal Cell; Disease-Free Survival; Female; Humans; Indazo | 2016 |
Hepatocellular carcinoma cases with high levels of c-Raf-1 expression may benefit from postoperative adjuvant sorafenib after hepatic resection even with high risk of recurrence.
Topics: Adult; Biomarkers, Tumor; Carcinoma, Hepatocellular; Chemotherapy, Adjuvant; Disease-Free Survival; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Axitinib; Bevacizumab; | 2016 |
Model-based prediction of progression-free survival in patients with first-line renal cell carcinoma using week 8 tumor size change from baseline.
Topics: Antineoplastic Agents; Axitinib; Carcinoma, Renal Cell; Clinical Trials, Phase II as Topic; Clinical | 2016 |
A retrospective study of predictive factors for unexpectedly prolonged or shortened progression-free survival and overall survival among patients with metastatic renal cell carcinoma who received first-line targeted therapy.
Topics: Aged; Antineoplastic Agents; Carcinoma, Renal Cell; Disease-Free Survival; Female; Humans; Indazoles | 2016 |
68Ga DOTATATE PET/CT in Differentiated Thyroid Carcinoma With Fibular Metastasis and Mixed Response to Sorafenib.
Topics: Female; Humans; Middle Aged; Neoplasm Metastasis; Niacinamide; Organometallic Compounds; Phenylurea | 2016 |
Circulating vascular endothelial growth factor (VEGF) as predictive factor of progression-free survival in patients with advanced chordoma receiving sorafenib: an analysis from a phase II trial of the french sarcoma group (GSF/GETO).
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Biomarkers, Tumor; Chordoma; Clinical Trials, | 2016 |
Eosinophil percentage elevation as a prognostic factor for overall survival in patients with metastatic renal cell carcinoma treated with tyrosine kinase inhibitor.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Carcinoma, Renal Cell; Enzyme Inhibitors; Eos | 2016 |
Clinical significance of sunitinib-associated macrocytosis in metastatic renal cell carcinoma.
Topics: Angiogenesis Inhibitors; Antineoplastic Agents; Carcinoma, Renal Cell; Erythrocyte Indices; Erythroc | 2016 |
Prognostic role of N-Acetylgalactosaminyltransferase 10 in metastatic renal cell carcinoma.
Topics: Antineoplastic Combined Chemotherapy Protocols; Biomarkers, Tumor; Carcinoma, Renal Cell; Female; Fo | 2017 |
Pretreatment Serum Prealbumin as an Independent Prognostic Indicator in Patients With Metastatic Renal Cell Carcinoma Using Tyrosine Kinase Inhibitors as First-Line Target Therapy.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Carcinoma, Renal Cell; Disease-Free Survival; | 2017 |
The effects of 1,4-dimethylpyridine in metastatic prostate cancer in mice.
Topics: Animals; Antineoplastic Combined Chemotherapy Protocols; Cyclophosphamide; Disease Models, Animal; D | 2017 |
von Hippel-Lindau gene status and response to vascular endothelial growth factor targeted therapy for metastatic clear cell renal cell carcinoma.
Topics: Aged; Angiogenesis Inhibitors; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineopla | 2008 |
[Antiangiogenics: new therapeutic standards in metastatic kidney cancer].
Topics: Angiogenesis Inhibitors; Benzenesulfonates; Humans; Indoles; Kidney Neoplasms; Neoplasm Metastasis; | 2008 |
Cardiac toxicity of sunitinib and sorafenib in patients with metastatic renal cell carcinoma.
Topics: Aged; Aged, 80 and over; Benzenesulfonates; Biomarkers; Carcinoma, Renal Cell; Cardiovascular Diseas | 2008 |
Editorial comment on: Can tyrosine kinase inhibitors be discontinued in patients with metastatic renal cell carcinoma and a complete response to treatment? A multicentre, retrospective analysis.
Topics: Antineoplastic Agents; Benzenesulfonates; Carcinoma, Renal Cell; Chemotherapy, Adjuvant; Female; Fol | 2009 |
Can tyrosine kinase inhibitors be discontinued in patients with metastatic renal cell carcinoma and a complete response to treatment? A multicentre, retrospective analysis.
Topics: Aged; Antineoplastic Agents; Benzenesulfonates; Carcinoma, Renal Cell; Chemotherapy, Adjuvant; Dose- | 2009 |
Wild-type BRAF is required for response to panitumumab or cetuximab in metastatic colorectal cancer.
Topics: Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineopl | 2008 |
[Vascular and renal effects of anti-angiogenic therapy].
Topics: Angiogenesis Inhibitors; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic A | 2008 |
Metastatic sarcomatoid renal cell carcinoma treated with vascular endothelial growth factor-targeted therapy.
Topics: Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineopl | 2009 |
[Medical treatment of metastatic renal cell carcinoma after the approval and market entry of multitargeted tyrosine kinase inhibitors in Germany].
Topics: Aged; Aged, 80 and over; Angiogenesis Inhibitors; Antineoplastic Agents; Benzenesulfonates; Carcinom | 2009 |
[Interdisciplinary recommendations for the treatment of metastatic renal cell carcinoma].
Topics: Angiogenesis Inhibitors; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic A | 2009 |
Recommendations from the Spanish Oncology Genitourinary Group for the treatment of metastatic renal cancer.
Topics: Algorithms; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic Agents; Benzen | 2009 |
Sequential sorafenib and sunitinib for renal cell carcinoma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Benzenesulfonates; C | 2009 |
VEGF inhibition and metastasis: possible implications for antiangiogenic therapy.
Topics: Angiogenesis Inhibitors; Animals; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Benzene | 2009 |
Efficacy of sorafenib on metastatic renal cell carcinoma in Asian patients: results from a multicenter study.
Topics: Aged; Antineoplastic Agents; Benzenesulfonates; Carcinoma, Renal Cell; China; Female; Follow-Up Stud | 2009 |
Safety and efficacy of sorafenib therapy in patients with metastatic kidney cancer with impaired renal function.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Benzenesulfonates; Female; Humans; Kidney; Ki | 2009 |
Effect of the UK postcode lottery on survival of patients with metastatic renal cancer: an audit of outcomes in patients with metastatic renal cancer suitable for treatment with tyrosine kinase inhibitors.
Topics: Angiogenesis Inhibitors; Benzenesulfonates; Carcinoma, Renal Cell; Female; Humans; Indoles; Kidney; | 2009 |
Sorafenib induces partial response in metastatic medullary thyroid carcinoma.
Topics: Adult; Antineoplastic Agents; Benzenesulfonates; Bone Neoplasms; Carcinoma, Neuroendocrine; Humans; | 2010 |
VEGFR TKI 'resistance' or transient clinical insensitivity to VEGFR TKI in metastatic renal cell carcinoma.
Topics: Antineoplastic Agents; Benzenesulfonates; Carcinoma, Renal Cell; Drug Administration Schedule; Drug | 2010 |
Sorafenib blocks tumour growth, angiogenesis and metastatic potential in preclinical models of osteosarcoma through a mechanism potentially involving the inhibition of ERK1/2, MCL-1 and ezrin pathways.
Topics: Animals; Antineoplastic Agents; Apoptosis; Benzenesulfonates; Cell Division; Cell Line, Tumor; Cytos | 2009 |
Assessing tumor response and detecting recurrence in metastatic renal cell carcinoma on targeted therapy: importance of size and attenuation on contrast-enhanced CT.
Topics: Adult; Aged; Analysis of Variance; Benzenesulfonates; Carcinoma, Renal Cell; Contrast Media; Disease | 2010 |
Sunitinib and sorafenib in metastatic renal cell carcinoma patients with renal insufficiency.
Topics: Aged; Antineoplastic Agents; Benzenesulfonates; Carcinoma, Renal Cell; Female; Humans; Indoles; Kidn | 2010 |
High-contrast PET of melanoma using (18)F-MEL050, a selective probe for melanin with predominantly renal clearance.
Topics: Animals; Autoradiography; Cell Line, Tumor; Cell Transformation, Neoplastic; Contrast Media; Female; | 2010 |
Sorafenib-induced psoriasiform eruption in a patient with metastatic thyroid carcinoma.
Topics: Antineoplastic Agents; Benzenesulfonates; Drug Eruptions; Humans; Male; Middle Aged; Neoplasm Metast | 2010 |
Clinical outcomes of sorafenib treatment in patients with metastatic hepatocellular carcinoma who had been previously treated with fluoropyrimidine plus platinum-based chemotherapy.
Topics: Adult; Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Benzenesulfonate | 2011 |
Association of percentage of tumour burden removed with debulking nephrectomy and progression-free survival in patients with metastatic renal cell carcinoma treated with vascular endothelial growth factor-targeted therapy.
Topics: Adult; Aged; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chem | 2010 |
Clinical responses observed with imatinib or sorafenib in melanoma patients expressing mutations in KIT.
Topics: Adult; Aged; Antineoplastic Agents; Benzamides; Benzenesulfonates; Female; Humans; Imatinib Mesylate | 2010 |
Treatment with tyrosine kinase inhibitors for patients with differentiated thyroid cancer: the M. D. Anderson experience.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Benzenesulfonates; Disease Progression; Disea | 2010 |
Activation of NF-kappaB signaling by inhibitor of NF-kappaB kinase beta increases aggressiveness of ovarian cancer.
Topics: Biomarkers, Tumor; Blotting, Western; Carbolines; Cell Adhesion; Cell Movement; Cell Proliferation; | 2010 |
Morphology, Attenuation, Size, and Structure (MASS) criteria: assessing response and predicting clinical outcome in metastatic renal cell carcinoma on antiangiogenic targeted therapy.
Topics: Adult; Aged; Angiogenesis Inhibitors; Benzenesulfonates; Carcinoma, Renal Cell; Contrast Media; Dise | 2010 |
Harvesting the low-hanging fruit: kinase inhibitors for therapy of advanced medullary and nonmedullary thyroid cancer.
Topics: Adenocarcinoma, Follicular; Antineoplastic Agents; Benzenesulfonates; Biomarkers, Tumor; Carcinoma, | 2010 |
Sustained response following sorafenib therapy in an older adult patient with advanced renal cancer on hemodialysis: a case report.
Topics: Aged; Antineoplastic Agents; Benzenesulfonates; Carcinoma, Renal Cell; Humans; Kidney Neoplasms; Mal | 2011 |
Sustained treatment response of metastatic hepatocellular carcinoma with bevacizumab and sorafenib.
Topics: Angiogenesis Inhibitors; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic A | 2010 |
Hypothyroidism in patients with renal cell carcinoma: blessing or curse?
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Benzenesulfonates; Carcinoma, Renal Cell; Dis | 2011 |
Feasibility of (125)I brachytherapy combined with sorafenib treatment in patients with multiple lung metastases after liver transplantation for hepatocellular carcinoma.
Topics: Adult; Antineoplastic Agents; Benzenesulfonates; Brachytherapy; Carcinoma, Hepatocellular; Cause of | 2010 |
Impressive efficacy of sorafenib in a patient with an hepatocellular carcinoma and a portal vein thrombosis associated with a metastatic ENT cancer.
Topics: Benzenesulfonates; Carcinoma, Hepatocellular; Head and Neck Neoplasms; Humans; Liver Neoplasms; Male | 2011 |
Feasibility and activity of sorafenib and sunitinib in advanced penile cancer: a preliminary report.
Topics: Adult; Antigens, CD34; Antineoplastic Agents; Benzenesulfonates; Carcinoma, Squamous Cell; Humans; I | 2010 |
Regional squamous cell carcinomas following systemic sorafenib therapy and isolated limb infusion for regionally advanced metastatic melanoma of the limb.
Topics: Aged; Antineoplastic Agents; Benzenesulfonates; Carcinoma, Squamous Cell; Drug Administration Routes | 2010 |
Sorafenib suppresses postsurgical recurrence and metastasis of hepatocellular carcinoma in an orthotopic mouse model.
Topics: Animals; Antineoplastic Agents; Apoptosis; Benzenesulfonates; Carcinoma, Hepatocellular; Cell Line, | 2011 |
Sequential treatment with sorafenib and sunitinib in metastatic renal cell carcinoma: clinical outcomes from a retrospective clinical study.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Benzenesulfonates; C | 2012 |
A rare case of metastatic pancreatic hepatoid carcinoma treated with sorafenib.
Topics: Adult; Antineoplastic Agents; Benzenesulfonates; Humans; Male; Neoplasm Metastasis; Niacinamide; Pan | 2012 |
Prognostic prediction in patients with metastatic renal cell carcinoma treated with sorafenib based on expression levels of potential molecular markers in radical nephrectomy specimens.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Biomarkers, Tumor; Bone Neoplasms; Carcinoma, | 2013 |
Anti-angiogenic therapies in metastatic breast cancer-an unfulfilled dream.
Topics: Angiogenesis Inhibitors; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic C | 2011 |
Safety and treatment patterns of multikinase inhibitors in patients with metastatic renal cell carcinoma at a tertiary oncology center in Italy.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Benzenesulfonates; C | 2011 |
Safety and treatment patterns of angiogenesis inhibitors in patients with metastatic renal cell carcinoma: evidence from US community oncology clinics.
Topics: Adult; Aged; Aged, 80 and over; Angiogenesis Inhibitors; Benzenesulfonates; Cancer Care Facilities; | 2012 |
Efficacy of temsirolimus after previous treatment with sunitinib, sorafenib or everolimus in advanced renal cell cancer.
Topics: Aged; Aged, 80 and over; Anemia; Angiogenesis Inhibitors; Antineoplastic Combined Chemotherapy Proto | 2011 |
An investigation of the effect of sorafenib on tumour growth and recurrence after liver cancer resection in nude mice independent of phosphorylated extracellular signal-regulated kinase levels.
Topics: Animals; Antineoplastic Agents; Benzenesulfonates; Biomarkers, Tumor; Cell Growth Processes; Cell Li | 2011 |
Sequential therapy with sunitinib and sorafenib in metastatic hepatocellular carcinoma.
Topics: Adult; Aged; Antineoplastic Agents; Benzenesulfonates; Carcinoma, Hepatocellular; Disease Progressio | 2012 |
Intrinsic resistance to tyrosine kinase inhibitors is associated with poor clinical outcome in metastatic renal cell carcinoma.
Topics: Adult; Aged; Antineoplastic Agents; Benzenesulfonates; Carcinoma, Renal Cell; Drug Resistance, Neopl | 2011 |
Synergistic effects of the combination of β-ionone and sorafenib on metastasis of human hepatoma SK-Hep-1 cells.
Topics: Antineoplastic Combined Chemotherapy Protocols; Benzenesulfonates; Carcinoma, Hepatocellular; Cell A | 2012 |
Prognostic model for survival in patients with metastatic renal cell carcinoma: results from the international kidney cancer working group.
Topics: Antibodies, Monoclonal, Humanized; Benzenesulfonates; Bevacizumab; Carcinoma, Renal Cell; Databases, | 2011 |
The urokinase plasminogen activator system in metastatic papillary thyroid carcinoma: a potential therapeutic target.
Topics: Antineoplastic Agents; Benzenesulfonates; Carcinoma, Papillary; Humans; Iodine Radioisotopes; Neopla | 2011 |
Course of size and density of metastatic renal cell carcinoma lesions in the early follow-up of molecular targeted therapy.
Topics: Aged; Aged, 80 and over; Carcinoma, Renal Cell; Female; Follow-Up Studies; Humans; Kaplan-Meier Esti | 2012 |
Polymeric nanoparticle-encapsulated hedgehog pathway inhibitor HPI-1 (NanoHHI) inhibits systemic metastases in an orthotopic model of human hepatocellular carcinoma.
Topics: Adult; Aged; Animals; Antineoplastic Agents; Benzenesulfonates; Carcinoma, Hepatocellular; Cell Line | 2012 |
Utilizing pre-therapy clinical schema and initial CT changes to predict progression-free survival in patients with metastatic renal cell carcinoma on VEGF-targeted therapy: a preliminary analysis.
Topics: Adult; Aged; Antineoplastic Agents; Carcinoma, Renal Cell; Disease-Free Survival; Female; Humans; In | 2013 |
Clinical outcome and prognostic factors of sorafenib in Japanese patients with advanced renal cell carcinoma in general clinical practice.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Asian People; Benzenesulfonates; Carcinoma, R | 2011 |
Sorafenib inhibits growth and metastasis of hepatocellular carcinoma by blocking STAT3.
Topics: Animals; Antineoplastic Agents; Benzenesulfonates; Carcinoma, Hepatocellular; Cell Line, Tumor; Enzy | 2011 |
Third-line sunitinib following sequential use of cytokine therapy and sorafenib in Japanese patients with metastatic renal cell carcinoma.
Topics: Aged; Antineoplastic Agents; Carcinoma, Renal Cell; Disease-Free Survival; Drug-Related Side Effects | 2013 |
[Our experience of the treatment with sorafenib for unresectable hepatocellular carcinoma].
Topics: Aged; Antineoplastic Agents; Benzenesulfonates; Carcinoma, Hepatocellular; Female; Humans; Liver Neo | 2011 |
[Three cases of hepatocellular carcinoma without distant metastasis effectively treated by sorafenib].
Topics: Aged; Antineoplastic Agents; Benzenesulfonates; Carcinoma, Hepatocellular; Humans; Liver Neoplasms; | 2011 |
Efficacy and safety of vascular endothelial growth factor receptor tyrosine kinase inhibitors in patients with metastatic renal cell carcinoma and poor risk features.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Benzenes | 2012 |
Pericyte depletion results in hypoxia-associated epithelial-to-mesenchymal transition and metastasis mediated by met signaling pathway.
Topics: Animals; Antineoplastic Agents; Benzamides; Benzenesulfonates; Breast Neoplasms; Cell Hypoxia; Cell | 2012 |
Sorafenib in metastatic thyroid cancer.
Topics: Adult; Antineoplastic Agents; Benzenesulfonates; Calcitonin; Carcinoembryonic Antigen; Disease-Free | 2012 |
Use of tyrosine kinase inhibitors in patients with metastatic kidney cancer receiving haemodialysis: a retrospective Italian survey.
Topics: Aged; Aged, 80 and over; Antineoplastic Agents; Benzenesulfonates; Contraindications; Female; Humans | 2012 |
Pancreatic metastasis arising from a BRAF(V600E)-positive papillary thyroid cancer: the role of endoscopic ultrasound-guided biopsy and response to sorafenib therapy.
Topics: Benzenesulfonates; Biopsy; Carcinoma; Carcinoma, Papillary; Disease Progression; Endoscopy; Fatal Ou | 2012 |
Hyperthyroidism and thyroid autoimmunity induced by sorafenib in metastatic renal cell cancer.
Topics: Antineoplastic Agents; Carcinoma, Renal Cell; Humans; Hyperthyroidism; Kidney Neoplasms; Male; Middl | 2012 |
Differential drug class-specific metastatic effects following treatment with a panel of angiogenesis inhibitors.
Topics: Angiogenesis Inhibitors; Animals; Antibodies, Monoclonal; Antineoplastic Agents; Benzamides; Benzene | 2012 |
Thyroid dysfunction in patients treated with tyrosine kinase inhibitors, sunitinib, sorafenib and axitinib, for metastatic renal cell carcinoma.
Topics: Adult; Aged; Antineoplastic Agents; Axitinib; Benzenesulfonates; Carcinoma, Renal Cell; Female; Huma | 2012 |
Skin toxicity and efficacy of sunitinib and sorafenib in metastatic renal cell carcinoma: a national registry-based study.
Topics: Aged; Angiogenesis Inhibitors; Antineoplastic Agents; Carcinoma, Renal Cell; Disease-Free Survival; | 2012 |
Targeting angiogenesis in metastatic breast cancer.
Topics: Angiogenesis Inhibitors; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Pro | 2012 |
The effect of sorafenib treatment on the diabetic status of patients with renal cell or hepatocellular carcinoma.
Topics: Antineoplastic Agents; Benzenesulfonates; Carcinoma, Hepatocellular; Carcinoma, Renal Cell; Comorbid | 2012 |
Sorafenib down-regulates expression of HTATIP2 to promote invasiveness and metastasis of orthotopic hepatocellular carcinoma tumors in mice.
Topics: Angiogenesis Inhibitors; Animals; Carcinoma, Hepatocellular; Cell Line, Tumor; Disease Models, Anima | 2012 |
The placental growth factor as a target against hepatocellular carcinoma in a diethylnitrosamine-induced mouse model.
Topics: Animals; Antibodies, Monoclonal; Antineoplastic Agents; Carcinoma, Hepatocellular; Diethylnitrosamin | 2013 |
Long lasting efficacy of sorafenib in a heavily pretreated patient with thymic carcinoma.
Topics: Antineoplastic Agents; Disease-Free Survival; Drug Resistance, Neoplasm; Female; Humans; Middle Aged | 2012 |
Conditional survival of patients with metastatic renal-cell carcinoma.
Topics: Carcinoma, Renal Cell; Humans; Indoles; Neoplasm Metastasis; Niacinamide; Phenylurea Compounds; Prog | 2012 |
Concomitant oral tyrosine kinase inhibitors and bisphosphonates in advanced renal cell carcinoma with bone metastases.
Topics: Antineoplastic Combined Chemotherapy Protocols; Bone Density Conservation Agents; Bone Neoplasms; Ca | 2012 |
Carbonic anhydrase IX as a potential biomarker of efficacy in metastatic clear-cell renal cell carcinoma patients receiving sorafenib or placebo: analysis from the treatment approaches in renal cancer global evaluation trial (TARGET).
Topics: Adult; Aged; Aged, 80 and over; Antigens, Neoplasm; Biomarkers, Tumor; Carbonic Anhydrase IX; Carbon | 2013 |
Comparative proteome profiling of breast tumor cell lines by gel electrophoresis and mass spectrometry reveals an epithelial mesenchymal transition associated protein signature.
Topics: Antineoplastic Agents; Breast Neoplasms; Cell Adhesion; Cell Line, Tumor; Cell Movement; Cell Prolif | 2013 |
Spontaneous regression of metastatic papillary renal cell cancer after cessation of treatment with sorafenib.
Topics: Aged; Antineoplastic Agents; Carcinoma, Renal Cell; Humans; Kidney Neoplasms; Male; Neoplasm Metasta | 2013 |
Treatment patterns: targeted therapies indicated for first-line management of metastatic renal cell carcinoma in a real-world setting.
Topics: Angiogenesis Inhibitors; Antibodies, Monoclonal, Humanized; Antineoplastic Agents; Bevacizumab; Carc | 2013 |
αB-crystallin complexes with 14-3-3ζ to induce epithelial-mesenchymal transition and resistance to sorafenib in hepatocellular carcinoma.
Topics: 14-3-3 Proteins; alpha-Crystallin B Chain; Antineoplastic Agents; Carcinoma, Hepatocellular; Cell Li | 2013 |
Leukocytoclastic vasculitis masquerading as hand-foot syndrome in a patient treated with sorafenib.
Topics: Aged; Antineoplastic Agents; Benzenesulfonates; Carcinoma, Non-Small-Cell Lung; Diagnosis, Different | 2006 |
Keratoacanthomas associated with sorafenib therapy.
Topics: Aged; Antineoplastic Agents; Arm; Benzenesulfonates; Facial Dermatoses; Female; Humans; Keratoacanth | 2007 |
Newly approved therapies for RCC and their effect on the standard of care.
Topics: Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Benzenesulfonates; Bevacizumab; Carcinoma | 2007 |
Sorafenib-induced pancreatitis.
Topics: Antineoplastic Agents; Benzenesulfonates; Carcinoma, Renal Cell; Female; Humans; Kidney Neoplasms; M | 2007 |
Radiation therapy and sorafenib: clinical data and rationale for the combination in metastatic renal cell carcinoma.
Topics: Aged; Antineoplastic Agents; Benzenesulfonates; Carcinoma, Renal Cell; Combined Modality Therapy; Fe | 2007 |
[Interdisciplinary recommendations on targeted therapy in the treatment of renal cell carcinoma].
Topics: Antineoplastic Agents; Benzenesulfonates; Carcinoma, Renal Cell; Controlled Clinical Trials as Topic | 2007 |
Thyroid function test abnormalities in patients with metastatic renal cell carcinoma treated with sorafenib.
Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Benzenesulfonates; Carcinoma, Renal Cell; Chem | 2008 |
Metastatic chest wall malignant schwannoma responding to sorafenib: case report and literature review.
Topics: Adult; Antineoplastic Agents; Benzenesulfonates; Brain Neoplasms; Female; Humans; Lung Neoplasms; Ma | 2008 |
The inhibitory effect of B-group vitamins on the incidence of tumour metastases.
Topics: Animals; Lung Neoplasms; Mammary Neoplasms, Experimental; Mice; Neoplasm Metastasis; Niacinamide; Ox | 1971 |
Notes on streptozotocin in metastatic insulinoma.
Topics: Adenoma, Islet Cell; Adult; Antibiotics, Antineoplastic; Autopsy; Blood Glucose; Bone Marrow; Brain; | 1971 |