Page last updated: 2024-10-27

fluorouracil and Febrile Neutropenia

fluorouracil has been researched along with Febrile Neutropenia in 24 studies

Fluorouracil: A pyrimidine analog that is an antineoplastic antimetabolite. It interferes with DNA synthesis by blocking the THYMIDYLATE SYNTHETASE conversion of deoxyuridylic acid to thymidylic acid.
5-fluorouracil : A nucleobase analogue that is uracil in which the hydrogen at position 5 is replaced by fluorine. It is an antineoplastic agent which acts as an antimetabolite - following conversion to the active deoxynucleotide, it inhibits DNA synthesis (by blocking the conversion of deoxyuridylic acid to thymidylic acid by the cellular enzyme thymidylate synthetase) and so slows tumour growth.

Febrile Neutropenia: Fever accompanied by a significant reduction in the number of NEUTROPHILS.

Research Excerpts

ExcerptRelevanceReference
"Docetaxel + cisplatin + 5-fluorouracil (DCF) therapy, a frequently prescribed regimen for esophageal cancer, is associated with a high risk of febrile neutropenia (FN)."8.31Low pretherapy skeletal muscle mass index is associated with an increased risk of febrile neutropenia in patients with esophageal cancer receiving docetaxel + cisplatin + 5-fluorouracil (DCF) therapy. ( Kawasaki, K; Nara, K; Sato, Y; Seto, Y; Suzuki, H; Takada, T; Toriumi, T; Yagi, K; Yamamoto, T, 2023)
"Nedaplatin (NDP)/5-fluorouracil (5-FU) combination therapy frequently causes severe neutropenia and febrile neutropenia (FN)."8.31Poor Renal Function and a High Modified Glasgow Prognostic Score Are Predictive Factors for Nedaplatin/5-Fluorouracil Combination Therapy-induced Febrile Neutropenia. ( Harasawa, H; Hashizume, J; Kodama, Y; Nakagawa, H; Nambu, M, 2023)
"The efficacy of primary prophylactic granulocyte colony-stimulating factor (G-CSF) in preventing febrile neutropenia (FN) in patients treated with docetaxel, cisplatin, and 5-fluorouracil (TPF) chemotherapy remains controversial."7.88Primary prophylactic granulocyte colony-stimulating factor according to ASCO guidelines has no preventive effect on febrile neutropenia in patients treated with docetaxel, cisplatin, and 5-fluorouracil chemotherapy. ( Fukutomi, A; Hamauchi, S; Kawahira, M; Kawai, S; Machida, N; Onozawa, Y; Todaka, A; Tsushima, T; Yamazaki, K; Yasui, H; Yokota, T; Yoshida, Y, 2018)
"Febrile neutropenia was observed in 20 (21."6.90Risk factors for febrile neutropenia and effectiveness of primary prophylaxis with pegfilgrastim in patients with esophageal cancer treated with docetaxel, cisplatin, and 5-fluorouracil. ( Ohkura, Y; Udagawa, H; Ueno, M, 2019)
"Patients with previously untreated thoracic AEC who had T4 tumors or M1 lymph node metastasis (M1 LYM), or both, received intravenous infusions of docetaxel (35 mg/m(2)) and cisplatin (40 mg/m(2)) on day 1 and a continuous intravenous infusion of 5-fluorouracil (400 mg/m(2)/day) on days 1 to 5, every 2 weeks, plus concurrent radiation."5.19Definitive chemoradiation therapy with docetaxel, cisplatin, and 5-fluorouracil (DCF-R) in advanced esophageal cancer: a phase 2 trial (KDOG 0501-P2). ( Azuma, M; Hayakawa, K; Higuchi, K; Ishido, K; Ishiyama, H; Katada, C; Katada, N; Koizumi, W; Komori, S; Sasaki, T; Tanabe, S, 2014)
"TRIBE and TRIBE-2 studies demonstrated higher benefit from FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan)/bevacizumab compared with FOLFIRI (fluorouracil, leucovorin, and irinotecan) or FOLFOX/bevacizumab as an upfront option for metastatic colorectal cancer patients, with more toxicities."5.12Clinical impact of neutropenia and febrile neutropenia in metastatic colorectal cancer patients treated with FOLFOXIRI/bevacizumab: a pooled analysis of TRIBE and TRIBE2 studies by GONO. ( Antonuzzo, A; Boccaccino, A; Borelli, B; Buonadonna, A; Caponnetto, S; Conca, V; Cremolini, C; Daniel, F; Falcone, A; Lonardi, S; Marmorino, F; Masi, G; Pietrantonio, F; Raimondi, A; Rossini, D; Santini, D; Sbrana, A; Tomasello, G; Zaniboni, A, 2021)
"Despite widespread use of fluorouracil, epirubicin, cyclophosphamide, docetaxel (FEC-D) chemotherapy in breast cancer, the optimal strategy for primary febrile neutropenia (FN) prophylaxis remains unknown."4.98Primary Febrile Neutropenia Prophylaxis for Patients Who Receive FEC-D Chemotherapy for Breast Cancer: A Systematic Review. ( Clemons, M; Dudani, S; Fergusson, D; Fernandes, R; Gyawali, B; Hutton, B; Ibrahim, MFK; Majeed, H; Mazzarello, S; Perdrizet, K; Shorr, R; Stober, C; Vandermeer, L, 2018)
"There is limited real-world data on the efficacy of 2-weekly cycles of docetaxel, oxaliplatin, leucovorin, and fluorouracil (FLOT) compared to epirubicin, oxaliplatin, and capecitabine (EOX) as perioperative therapy in esophagogastric adenocarcinomas (EGAC)."4.31Perioperative Modified FLOT Versus EOX in Locally Advanced Resectable Gastric and Gastro-Oesophageal Junction Adenocarcinoma: Results of a Matched-Pair Analysis. ( Bhandare, M; Bhargava, P; Booma, N; Chaudhari, V; Chaugule, D; Das, S; Kannan, S; Kapoor, A; Mantri, A; Ostwal, V; Ramaswamy, A; Shrikhande, SV; Srinivas, S, 2023)
"Docetaxel + cisplatin + 5-fluorouracil (DCF) therapy, a frequently prescribed regimen for esophageal cancer, is associated with a high risk of febrile neutropenia (FN)."4.31Low pretherapy skeletal muscle mass index is associated with an increased risk of febrile neutropenia in patients with esophageal cancer receiving docetaxel + cisplatin + 5-fluorouracil (DCF) therapy. ( Kawasaki, K; Nara, K; Sato, Y; Seto, Y; Suzuki, H; Takada, T; Toriumi, T; Yagi, K; Yamamoto, T, 2023)
"Nedaplatin (NDP)/5-fluorouracil (5-FU) combination therapy frequently causes severe neutropenia and febrile neutropenia (FN)."4.31Poor Renal Function and a High Modified Glasgow Prognostic Score Are Predictive Factors for Nedaplatin/5-Fluorouracil Combination Therapy-induced Febrile Neutropenia. ( Harasawa, H; Hashizume, J; Kodama, Y; Nakagawa, H; Nambu, M, 2023)
"The efficacy of primary prophylactic granulocyte colony-stimulating factor (G-CSF) in preventing febrile neutropenia (FN) in patients treated with docetaxel, cisplatin, and 5-fluorouracil (TPF) chemotherapy remains controversial."3.88Primary prophylactic granulocyte colony-stimulating factor according to ASCO guidelines has no preventive effect on febrile neutropenia in patients treated with docetaxel, cisplatin, and 5-fluorouracil chemotherapy. ( Fukutomi, A; Hamauchi, S; Kawahira, M; Kawai, S; Machida, N; Onozawa, Y; Todaka, A; Tsushima, T; Yamazaki, K; Yasui, H; Yokota, T; Yoshida, Y, 2018)
"This study retrospectively explored pharmacogenetic associations of single nucleotide polymorphisms (SNPs) of the uridine glucuronosyltransferase 2B7 (UGT2B7, rs7668258), glutathione-S-transferase pi 1 (GSTP1, rs1695), and microcephalin 1 (MCPH1, rs2916733) genes with chemotherapy-related adverse events in 102 Japanese women who received epirubicin and cyclophosphamide as perioperative chemotherapy for early breast cancer."3.83Pharmacogenetic association between GSTP1 genetic polymorphism and febrile neutropenia in Japanese patients with early breast cancer. ( Ando, Y; Hasegawa, Y; Imai, T; Inada-Inoue, M; Kikumori, T; Mitsuma, A; Morita, S; Sawaki, M; Shibata, T; Shimokata, T; Sugishita, M, 2016)
" We retrospectively ana- lyzed the incidence and risk factors of febrile neutropenia(FN)among women receiving FEC(5-fluorouracil 500mg/m2, epirubicin 100mg/m2, and cyclophosphamide 500 mg/m2)chemotherapy."3.83[Analysis of the Risk Factors of Febrile Neutropenia Among 72 Women Receiving FEC in Early Breast Cancer Chemotherapy]. ( Fujimori, T; Ishii, N; Kasagawa, T; Udagawa, I, 2016)
"5-fluorouracil, epirubicin, cyclophosphamide → docetaxel (FEC-D) has been associated with higher-than-expected rates of febrile neutropenia (FN) that meet the current guideline threshold of 20 % for primary prophylaxis (PP) with granulocyte colony-stimulating factor (G-CSF)."3.81Cost-effectiveness of prophylactic granulocyte colony-stimulating factor for febrile neutropenia in breast cancer patients receiving FEC-D. ( Chan, KK; Lee, EK; Trudeau, ME; Wong, WW, 2015)
"Retrospective analysis of 189 patients with non-metastatic breast cancer consecutively treated with FEC-D (3 cycles of 5-FU, Epirubicin and Cyclophosphamide followed by 3 cycles of Docetaxel) at our Center during 33 months."3.81Febrile neutropenia in FEC-D regimen for early stage breast cancer: is there a place for G-CSF primary prophylaxis? ( Brito, M; Cardoso, C; Miguel, I; Moreira, A; Sousa, M; Winckler, P, 2015)
"Febrile neutropenia was observed in 20 (21."2.90Risk factors for febrile neutropenia and effectiveness of primary prophylaxis with pegfilgrastim in patients with esophageal cancer treated with docetaxel, cisplatin, and 5-fluorouracil. ( Ohkura, Y; Udagawa, H; Ueno, M, 2019)
" The aim of this study was to investigate the effects of synbiotics in esophageal cancer patients receiving neoadjuvant chemotherapy on the intestinal microbiota and the adverse events of chemotherapy."2.84Randomized study of the effect of synbiotics during neoadjuvant chemotherapy on adverse events in esophageal cancer patients. ( Akita, H; Asahara, T; Fujiwara, Y; Gotoh, K; Ishikawa, O; Kobayashi, S; Miyata, H; Miyoshi, N; Motoori, M; Nomoto, K; Noura, S; Ohue, M; Omori, T; Saito, T; Sakon, M; Sugimura, K; Takahashi, H; Yano, M, 2017)
" 2006-001177-25) investigated aflibercept, a vascular endothelial growth factor decoy receptor protein (VEGF Trap), in combination with docetaxel, cisplatin, and 5-fluorouracil in patients with advanced solid tumors."2.82Phase I Dose-Escalation and Pharmacokinetic Study of Intravenous Aflibercept in Combination with Docetaxel, Cisplatin, and 5-Fluorouracil in Patients with Advanced Solid Malignancies. ( Ajani, JA; Assadourian, S; Bahleda, R; Baker, J; Boelle, E; Deutsch, E; Gadgeel, SM; Garris, JL; Izzedine, H; Khan, A; Massard, C; Rogers, JE; Soria, JC, 2016)
"Three patients (25%) developed anastomotic leakage."1.56Induction chemoradiotherapy including docetaxel, cisplatin, and 5-fluorouracil for locally advanced esophageal cancer. ( Fujiwara, T; Hashimoto, M; Katsui, K; Maeda, N; Nishizaki, M; Noma, K; Sakurama, K; Shirakawa, Y; Tanabe, S, 2020)
"By using the Korean Pancreatic Cancer (K-PaC) registry, we compared the clinical outcomes of FOLFIRINOX (FFX) and gemcitabine plus nab-paclitaxel (GNP) in patients with metastatic pancreatic cancer (MPC)."1.56Comparison of FOLFIRINOX and Gemcitabine Plus Nab-paclitaxel for Treatment of Metastatic Pancreatic Cancer: Using Korean Pancreatic Cancer (K-PaC) Registry. ( Cha, HS; Hwang, JH; Kim, J; Kim, JW; Kim, MJ; Lee, JC; Lee, WJ; Park, P; Shin, DW; Woo, SM; Yang, SY, 2020)
"5% objective response) but an important morbidity with 10% toxic deaths in our very symptomatic population with a very important tumor burden."1.51[Toxicity of docetaxel, platine, 5-fluorouracil-based induction chemotherapy for locally advanced head and neck cancer: The importance of nutritional status]. ( Bernadach, M; Biau, J; Dillies, AF; Durando, X; Kwiatkowski, F; Lapeyre, M; Miroir, J; Moreau, J; Pham-Dang, N; Saroul, N, 2019)
"Metastatic gastric cancer patients who progressed on modified DCF regimens were included."1.40Comparison the efficacy of second-line modified EOX (epirubicin, oxaliplatin, and capecitabine) and irinotecan, 5-fluorouracil, and leucovorin (FOLFIRI) regimens in metastatic gastric cancer patients that progressed on first-line modified docetaxel and ci ( Aksoy, S; Benekli, M; Ekinci, AS; Günaydın, Y; Oksuzoglu, B; Özatlı, T; Ozdemir, N; Sendur, MA; Yazıcı, O; Yazılıtaş, D; Zengin, N, 2014)

Research

Studies (24)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's0 (0.00)29.6817
2010's16 (66.67)24.3611
2020's8 (33.33)2.80

Authors

AuthorsStudies
Rossini, D1
Boccaccino, A1
Sbrana, A1
Daniel, F1
Borelli, B1
Raimondi, A1
Santini, D1
Conca, V1
Tomasello, G1
Caponnetto, S1
Marmorino, F1
Zaniboni, A1
Buonadonna, A1
Masi, G1
Lonardi, S1
Pietrantonio, F1
Falcone, A1
Antonuzzo, A1
Cremolini, C1
Ramaswamy, A1
Bhargava, P1
Srinivas, S1
Kannan, S1
Bhandare, M1
Chaudhari, V1
Mantri, A1
Kapoor, A1
Das, S1
Booma, N1
Chaugule, D1
Shrikhande, SV1
Ostwal, V1
Nara, K1
Yamamoto, T1
Sato, Y1
Yagi, K1
Kawasaki, K1
Toriumi, T1
Takada, T1
Seto, Y1
Suzuki, H1
Kurogochi, T1
Matsumoto, A1
Nyumura, Y1
Tanishima, Y1
Nakayoshi, T1
Okamoto, T1
Yano, F1
Eto, K1
Hashizume, J1
Nambu, M1
Nakagawa, H1
Harasawa, H1
Kodama, Y1
Hashimoto, M1
Shirakawa, Y1
Maeda, N1
Tanabe, S2
Noma, K1
Sakurama, K1
Katsui, K1
Nishizaki, M1
Fujiwara, T1
Keum, J1
Lee, HS1
Kang, H1
Jo, JH1
Chung, MJ1
Park, JY1
Park, SW1
Song, SY1
Bang, S1
Lee, JC1
Woo, SM1
Shin, DW1
Kim, J2
Yang, SY1
Kim, MJ1
Kim, JW2
Lee, WJ1
Cha, HS1
Park, P1
Hwang, JH1
Kawahira, M1
Yokota, T1
Hamauchi, S1
Kawai, S1
Yoshida, Y1
Onozawa, Y1
Tsushima, T1
Todaka, A1
Machida, N1
Yamazaki, K1
Fukutomi, A1
Yasui, H1
Eckstrom, J1
Bartels, T1
Abraham, I1
Patel, H1
Elquza, E1
Scott, AJ1
Malangone, S1
Hollings, J1
McBride, A1
Fernandes, R1
Mazzarello, S1
Stober, C1
Ibrahim, MFK1
Dudani, S1
Perdrizet, K1
Majeed, H1
Vandermeer, L1
Shorr, R1
Hutton, B1
Fergusson, D1
Gyawali, B1
Clemons, M1
Bernadach, M1
Lapeyre, M1
Dillies, AF1
Miroir, J1
Moreau, J1
Kwiatkowski, F1
Pham-Dang, N1
Saroul, N1
Durando, X1
Biau, J1
Ohkura, Y1
Ueno, M1
Udagawa, H1
Higuchi, K1
Komori, S1
Katada, C1
Azuma, M1
Ishiyama, H1
Sasaki, T1
Ishido, K1
Katada, N1
Hayakawa, K1
Koizumi, W1
Sugishita, M1
Imai, T1
Kikumori, T1
Mitsuma, A1
Shimokata, T1
Shibata, T1
Morita, S1
Inada-Inoue, M1
Sawaki, M1
Hasegawa, Y1
Ando, Y1
Sendur, MA1
Ozdemir, N1
Özatlı, T1
Yazıcı, O1
Aksoy, S1
Ekinci, AS1
Yazılıtaş, D1
Günaydın, Y1
Oksuzoglu, B1
Benekli, M1
Zengin, N1
Lee, EK1
Wong, WW1
Trudeau, ME1
Chan, KK1
Nakahara, S1
Kitamura, K1
Honma, K1
Yamamoto, Y1
Takenaka, Y1
Yasui, T1
Hanamoto, A1
Morii, E1
Inohara, H1
Miguel, I1
Winckler, P1
Sousa, M1
Cardoso, C1
Moreira, A1
Brito, M1
Bahleda, R1
Baker, J1
Massard, C1
Gadgeel, SM1
Rogers, JE1
Izzedine, H1
Deutsch, E1
Garris, JL1
Khan, A1
Boelle, E1
Assadourian, S1
Soria, JC1
Ajani, JA1
Motoori, M1
Yano, M1
Miyata, H1
Sugimura, K1
Saito, T1
Omori, T1
Fujiwara, Y1
Miyoshi, N1
Akita, H1
Gotoh, K1
Takahashi, H1
Kobayashi, S1
Noura, S1
Ohue, M1
Asahara, T1
Nomoto, K1
Ishikawa, O1
Sakon, M1
Huang, X1
Knoble, JL1
Zeng, M1
Aguila, FN1
Patel, T1
Chambers, LW1
Hu, H1
Liu, H1
Pinter, T1
Klippel, Z1
Cesas, A1
Croitoru, A1
Decaestecker, J1
Gibbs, P1
Hotko, Y1
Jassem, J1
Kurteva, G1
Novotny, J1
O'Reilly, S1
Salek, T1
Reiner, M1
Morrow, PK1
Choi, MR1
Whittaker, S1
Blanke, C1
Ishii, N1
Fujimori, T1
Kasagawa, T1
Udagawa, I1

Clinical Trials (3)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Survival Rate and Treatment Cost in Patients With Pancreatic Cancer With the Advent of New Chemotherapeutic Agents in Korea: An Analysis Using NHIS Database and K-PaC Registry Focusing on the Newest One, Liposomal Irinotecan[NCT04984174]54,000 participants (Anticipated)Observational2021-08-04Recruiting
Concurrent Docetaxel Plus Cisplatin or Cisplatin Alone With Intensity-modulated Radiotherapy in High Risk Locregionally Advanced Nasopharyngeal Carcinoma: a Phase 2 Randomized Controlled Trial[NCT02610556]Phase 2130 participants (Anticipated)Interventional2016-01-31Recruiting
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Pegfilgrastim Admininstered to Subjects With Newly Diagnosed, Locally-advanced or Metastatic Colorectal Cancer Treated With Bevacizumab & Either 5-fluorouracil, Oxaliplatin, Leucovorin (FOLF[NCT00911170]Phase 3847 participants (Actual)Interventional2009-11-03Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Overall Survival

Median time from randomization to date of death caclulated using the Kaplan-Meier method. Participants were censored on the date of last contact (i.e., the date the participant was last known to be alive) if they were not known to have died. (NCT00911170)
Timeframe: From randomization to the data cut-off date of 8 June 2012. Median time on study was 11.6 months and the maximum was 27.6 months.

Interventionmonths (Median)
Placebo24.6
Pegfilgrastim21.8

Percentage of Participants With an Objective Response

The percentage of participants with a complete response (CR) or partial response (PR) defined by the RECIST v1.1 criteria at any time during the study. Response was be determined by the investigator's assessment of radiographic scans. CR: Disappearance of all non-nodal target lesions and the disappearance of all non-nodal non-target lesions, and no new lesions. All nodal lesions must have reduction of short axis to < 10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters and no new lesions and/or unequivocal progression of existing non-target lesions, or, the disappearance of all non-nodal target lesions with persistence of one or more non-target lesion(s). (NCT00911170)
Timeframe: From randomization to the data cut-off date of 8 June 2012. Median time on study was 11.6 months and the maximum was 27.6 months.

Interventionpercentage of participants (Number)
Placebo56.7
Pegfilgrastim58.1

Percentage of Participants With Grade 3/4 Febrile Neutropenia Across the First 4 Cycles of Chemotherapy

Grade 3/4 febrile neutropenia (FN) is defined as: • A temperature ≥ 38.0°C (≥ 100.4°F) and absolute neutrophil count (ANC) < 1.0 × 10^9/L, where ANC was measured the same day or within ± 1 calendar day of a temperature ≥ 38.0°C (≥ 100.4°F), or • An ANC < 1.0 × 10^9/L in combination with: - documented sepsis or infection, OR - neutropenia-related hospitalization where ANC was measured the same day or within ± 1 calendar day. Participants monitored their oral temperatures and maintained diaries to record their temperature twice per day: once in the morning and once in the evening, as well as whenever they suspect they had fever throughout the first 4 cycles of chemotherapy treatment. (NCT00911170)
Timeframe: Approximately 2 months duration (Daily for 4 cycles of treatment; 2 weeks per cycle)

Interventionpercentage of participants (Number)
Placebo5.7
Pegfilgrastim2.4

Percentage of Participants With Grade 3/4 Neutropenia Across the First 4 Cycles of Chemotherapy

Grade 3/4 severe neutropenia is defined as neutropenia with absolute neutrophil count (ANC) <1.0 x 10^9/L. (NCT00911170)
Timeframe: Approximately 2 months duration (Daily for 4 cycles of treatment; 2 weeks per cycle)

Interventionpercentage of participants (Number)
Placebo17.0
Pegfilgrastim3.6

Percentage of Participants With Grade 4 Febrile Neutropenia Across the First 4 Cycles of Chemotherapy

"Grade 4 febrile neutropenia (FN) is defined as:~A temperature ≥ 38.0ºC (≥ 100.4ºF) and absolute neutrophil count (ANC) < 0.5 × 10^9/L, where ANC is measured the same day or within +/- 1 calendar day of a temperature ≥ 38.0ºC (≥ 100.4ºF), or~An ANC <0.5 × 10^9/L in combination with:~Documented sepsis or infection, OR~Neutropenia-related hospitalization where ANC is measured the same day or within +/- 1 calendar day." (NCT00911170)
Timeframe: Approximately 2 months duration (Daily for 4 cycles of treatment; 2 weeks per cycle)

Interventionpercentage of participants (Number)
Placebo3.5
Pegfilgrastim2.4

Percentage of Participants With Grade 4 Neutropenia Across the First 4 Cycles of Chemotherapy

Grade 4 severe neutropenia is defined as neutropenia with absolute neutrophil count (ANC) <0.5 x 10^9/L. (NCT00911170)
Timeframe: Approximately 2 months duration (Daily for 4 cycles of treatment; 2 weeks per cycle)

Interventionpercentage of participants (Number)
Placebo8.3
Pegfilgrastim2.4

Progression Free Survival

Time from randomization to date of radiological disease progression or death from any cause, whichever event occurs first, calculated using the Kaplan-Meier method. Participants without either event by the analysis data cutoff date were censored on the date of their last evaluable disease assessment. Disease progression based on the investigator's assessment of radiographic scans using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Clinical progression without radiological assessment was not be considered a disease progression in this analysis. Progression defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. (NCT00911170)
Timeframe: From randomization to the data cut-off date of 8 June 2012. Median time on study was 11.6 months and the maximum was 27.6 months.

Interventionmonths (Median)
Placebo10.1
Pegfilgrastim9.7

Time to Progression

Time from randomization to date of radiological disease progression calculated using the Kaplan-Meier method. Participants without progression were censored on the date of their last radiographic tumor assessment. Disease progression based on the investigator's assessment of scans using the RECIST v1.1. Clinical progression without radiological assessment was not considered a disease progression. Progression defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. (NCT00911170)
Timeframe: From randomization to the data cut-off date of 8 June 2012. Median time on study was 11.6 months and the maximum was 27.6 months.

Interventionmonths (Median)
Placebo11.1
Pegfilgrastim10.8

Number of Participants With Adverse Events (AEs)

A serious adverse event (SAE) is defined as an adverse event that - is fatal; - is life threatening (places the participant at immediate risk of death); - requires inpatient hospitalization or prolongation of existing hospitalization; - results in persistent or significant disability/incapacity; - is a congenital anomaly/birth defect; - other significant medical hazard. AEs were assessed for severity according to National Cancer Institute, Common Terminology Criteria for Adverse Events, Version 3.0, based on this general guideline: Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE. (NCT00911170)
Timeframe: Approximately 8 weeks (4 treatment cycles)

,
Interventionparticipants (Number)
Any adverse eventWorst Grade of > 2Worst Grade of > 3Worst Grade of > 4Serious adverse eventsSevere adverse eventsLife-threatening adverse eventsFatal adverse eventsLeading to discontinuation of IPLeading to discontinuation from study treatment
Pegfilgrastim3442401153168106271038
Placebo3552541194555103431119

Reviews

3 reviews available for fluorouracil and Febrile Neutropenia

ArticleYear
Clinical impact of neutropenia and febrile neutropenia in metastatic colorectal cancer patients treated with FOLFOXIRI/bevacizumab: a pooled analysis of TRIBE and TRIBE2 studies by GONO.
    ESMO open, 2021, Volume: 6, Issue:6

    Topics: Antineoplastic Combined Chemotherapy Protocols; Bevacizumab; Camptothecin; Colorectal Neoplasms; Feb

2021
Primary Febrile Neutropenia Prophylaxis for Patients Who Receive FEC-D Chemotherapy for Breast Cancer: A Systematic Review.
    Journal of global oncology, 2018, Volume: 4

    Topics: Antineoplastic Combined Chemotherapy Protocols; Breast Neoplasms; Chemoprevention; Cyclophosphamide;

2018
[A Case of Nasopharyngeal Cancer with Febrile Neutropenia Followed by Death during Adjuvant Chemotherapy].
    Nihon Jibiinkoka Gakkai kaiho, 2015, Volume: 118, Issue:6

    Topics: Antineoplastic Combined Chemotherapy Protocols; Autopsy; Carcinoma, Squamous Cell; Chemoradiotherapy

2015

Trials

5 trials available for fluorouracil and Febrile Neutropenia

ArticleYear
Risk factors for febrile neutropenia and effectiveness of primary prophylaxis with pegfilgrastim in patients with esophageal cancer treated with docetaxel, cisplatin, and 5-fluorouracil.
    World journal of surgical oncology, 2019, Jul-17, Volume: 17, Issue:1

    Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Cisplatin; Docetaxel; Esophageal Neoplasms; Fe

2019
Definitive chemoradiation therapy with docetaxel, cisplatin, and 5-fluorouracil (DCF-R) in advanced esophageal cancer: a phase 2 trial (KDOG 0501-P2).
    International journal of radiation oncology, biology, physics, 2014, Jul-15, Volume: 89, Issue:4

    Topics: Aged; Anemia; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Chemoradioth

2014
Phase I Dose-Escalation and Pharmacokinetic Study of Intravenous Aflibercept in Combination with Docetaxel, Cisplatin, and 5-Fluorouracil in Patients with Advanced Solid Malignancies.
    Oncology, 2016, Volume: 90, Issue:1

    Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Cisplatin; Docetaxel; Drug Administrati

2016
Randomized study of the effect of synbiotics during neoadjuvant chemotherapy on adverse events in esophageal cancer patients.
    Clinical nutrition (Edinburgh, Scotland), 2017, Volume: 36, Issue:1

    Topics: Acetic Acid; Adult; Aged; Aged, 80 and over; Cisplatin; Docetaxel; Endpoint Determination; Esophagea

2017
A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Pegfilgrastim in Patients Receiving First-Line FOLFOX/Bevacizumab or FOLFIRI/Bevacizumab for Locally Advanced or Metastatic Colorectal Cancer: Final Results of the Pegfilgrastim and Anti-V
    Clinical colorectal cancer, 2017, Volume: 16, Issue:2

    Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Bevacizumab; Camptot

2017

Other Studies

16 other studies available for fluorouracil and Febrile Neutropenia

ArticleYear
Perioperative Modified FLOT Versus EOX in Locally Advanced Resectable Gastric and Gastro-Oesophageal Junction Adenocarcinoma: Results of a Matched-Pair Analysis.
    Journal of gastrointestinal cancer, 2023, Volume: 54, Issue:3

    Topics: Adenocarcinoma; Antineoplastic Combined Chemotherapy Protocols; Esophageal Neoplasms; Esophagogastri

2023
Low pretherapy skeletal muscle mass index is associated with an increased risk of febrile neutropenia in patients with esophageal cancer receiving docetaxel + cisplatin + 5-fluorouracil (DCF) therapy.
    Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2023, Feb-04, Volume: 31, Issue:2

    Topics: Antineoplastic Combined Chemotherapy Protocols; Cisplatin; Docetaxel; Esophageal Neoplasms; Febrile

2023
Efficacy and Cost-effectiveness of Pegfilgrastim for Preventing Febrile Neutropenia During Docetaxel, Cisplatin, and 5-Fluorouracil Therapy for Esophageal Cancer.
    Anticancer research, 2023, Volume: 43, Issue:5

    Topics: Antineoplastic Combined Chemotherapy Protocols; Cisplatin; Cost-Benefit Analysis; Docetaxel; Esophag

2023
Poor Renal Function and a High Modified Glasgow Prognostic Score Are Predictive Factors for Nedaplatin/5-Fluorouracil Combination Therapy-induced Febrile Neutropenia.
    Anticancer research, 2023, Volume: 43, Issue:5

    Topics: Animals; Antineoplastic Combined Chemotherapy Protocols; Cachexia; Febrile Neutropenia; Fluorouracil

2023
Induction chemoradiotherapy including docetaxel, cisplatin, and 5-fluorouracil for locally advanced esophageal cancer.
    Esophagus : official journal of the Japan Esophageal Society, 2020, Volume: 17, Issue:2

    Topics: Aged; Anastomotic Leak; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Chemo

2020
Single-center risk factor analysis for FOLFIRINOX associated febrile neutropenia in patients with pancreatic cancer.
    Cancer chemotherapy and pharmacology, 2020, Volume: 85, Issue:4

    Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Factor Analysis, Statistical; Febrile N

2020
Comparison of FOLFIRINOX and Gemcitabine Plus Nab-paclitaxel for Treatment of Metastatic Pancreatic Cancer: Using Korean Pancreatic Cancer (K-PaC) Registry.
    American journal of clinical oncology, 2020, Volume: 43, Issue:9

    Topics: Aged; Albumins; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Pancreatic Ductal; Cross-

2020
Primary prophylactic granulocyte colony-stimulating factor according to ASCO guidelines has no preventive effect on febrile neutropenia in patients treated with docetaxel, cisplatin, and 5-fluorouracil chemotherapy.
    International journal of clinical oncology, 2018, Volume: 23, Issue:6

    Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Cisplatin; Docetaxel; Febrile Neutropen

2018
A single-arm, retrospective analysis of the incidence of febrile neutropenia using same-day versus next-day pegfilgrastim in patients with gastrointestinal cancers treated with FOLFOX or FOLFIRI.
    Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2019, Volume: 27, Issue:3

    Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Camptothecin; Colorectal Neoplasms; Dru

2019
[Toxicity of docetaxel, platine, 5-fluorouracil-based induction chemotherapy for locally advanced head and neck cancer: The importance of nutritional status].
    Cancer radiotherapie : journal de la Societe francaise de radiotherapie oncologique, 2019, Volume: 23, Issue:4

    Topics: Adult; Age Factors; Aged; Anemia; Antineoplastic Combined Chemotherapy Protocols; Cisplatin; Docetax

2019
Pharmacogenetic association between GSTP1 genetic polymorphism and febrile neutropenia in Japanese patients with early breast cancer.
    Breast cancer (Tokyo, Japan), 2016, Volume: 23, Issue:2

    Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Biomarkers, Tumor; Breast Neoplasms; Cy

2016
Comparison the efficacy of second-line modified EOX (epirubicin, oxaliplatin, and capecitabine) and irinotecan, 5-fluorouracil, and leucovorin (FOLFIRI) regimens in metastatic gastric cancer patients that progressed on first-line modified docetaxel and ci
    Medical oncology (Northwood, London, England), 2014, Volume: 31, Issue:9

    Topics: Adult; Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Camptothecin; Fe

2014
Cost-effectiveness of prophylactic granulocyte colony-stimulating factor for febrile neutropenia in breast cancer patients receiving FEC-D.
    Breast cancer research and treatment, 2015, Volume: 150, Issue:1

    Topics: Antineoplastic Combined Chemotherapy Protocols; Breast Neoplasms; Canada; Chemotherapy, Adjuvant; Co

2015
Febrile neutropenia in FEC-D regimen for early stage breast cancer: is there a place for G-CSF primary prophylaxis?
    Breast disease, 2015, Volume: 35, Issue:3

    Topics: Adult; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Breast Neoplasms; Chem

2015
Neoadjuvant Gemcitabine Chemotherapy followed by Concurrent IMRT Simultaneous Boost Achieves High R0 Resection in Borderline Resectable Pancreatic Cancer Patients.
    PloS one, 2016, Volume: 11, Issue:12

    Topics: Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Chemoradiotherapy; Colitis;

2016
[Analysis of the Risk Factors of Febrile Neutropenia Among 72 Women Receiving FEC in Early Breast Cancer Chemotherapy].
    Gan to kagaku ryoho. Cancer & chemotherapy, 2016, Volume: 43, Issue:12

    Topics: Antineoplastic Combined Chemotherapy Protocols; Breast Neoplasms; Chemotherapy, Adjuvant; Cyclophosp

2016