s-1-(combination) and Uterine-Cervical-Neoplasms

This pilot study retrospectively aimed to assess the feasibility effectiveness and safety of oral S-1 in heavily pretreated patients with advanced or recurrent cervical cancer (ARCC) among Chinese population.Thirty patients with ARCC who had undergone one or more lines of chemotherapy received oral S-1 (40-60 mg/m) twice daily for 6 weeks. Outcome measurements included tumor response, time to progression (TTP), overall survival (OS) time, and occurrence of adverse events (AEs).The overall response rate was 43.3%. After a median follow-up of 6 months, the median TTP was 4.4 months and the median OS time was 10.2 months. The most frequent grade 3 or 4 AEs were neutropenia (13.3%) and nausea (16.7%).The results of this study show that oral S-1 is effective and well-tolerated in patients with ARCC who were heavily pretreated among Chinese population.

Topics: Adult; Aged; Antimetabolites, Antineoplastic; China; Disease-Free Survival; Drug Combinations; Feasibility Studies; Female; Humans; Middle Aged; Oxonic Acid; Pilot Projects; Retrospective Studies; Survival Rate; Tegafur; Treatment Outcome; Uterine Cervical Neoplasms; Young Adult

This open-label phase III trial evaluated efficacy and safety of S-1 plus cisplatin vs. cisplatin alone as first-line chemotherapy in patients with stage IVB, recurrent, or persistent cervical cancer.. Patients were randomised (1:1) to S-1 plus cisplatin (study group) or cisplatin alone (control group). In each cycle, cisplatin 50 mg/m. A total of 375 patients were enrolled, of whom 364 (188, study group; 176, control group) received treatment. Median OS was 21.9 and 19.5 months in the study and control groups, respectively (log-rank P = 0.125; hazard ratio [HR] 0.84, 95% confidence interval [CI] 0.67-1.05). Median progression-free survival (PFS) was 7.3 and 4.9 months in the study and control groups, respectively (HR 0.62, 95% CI 0.48-0.80, P < 0.001). The adverse event (AE) rate increased in the study group despite the absence of any unexpected AEs.. S-1 plus cisplatin did not show superiority over cisplatin alone in OS but significantly increased PFS in patients with stage IVB, recurrent, or persistent cervical cancer. Since the standard therapy has changed in the course of this study, further studies are warranted to confirm the clinical positioning of S-1 combined with cisplatin for this population.

Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Cisplatin; Drug Administration Schedule; Drug Combinations; Female; Humans; Middle Aged; Neoplasm Recurrence, Local; Neoplasm Staging; Oxonic Acid; Survival Analysis; Tegafur; Treatment Outcome; Uterine Cervical Neoplasms

In the present study, we compared the efficacy and safety of concurrent radiotherapy with S-1 plus cisplatin (CRSC) versus concurrent radiotherapy with cisplatin alone (CRC) for the treatment of advanced cervical carcinoma (ACC).. Between February 2006 and January 2009, 72 eligible patients with ACC were included and randomly divided into two groups. Thirty-six patients received CRSC with radiotherapy (60 Gy/30 fractions over 6 weeks) beginning on day 1, S-1 (according to body surface area) for 28 days repeated every 6 weeks, and cisplatin (50 mg/m(2), intravenously on day 1) every 4 weeks for two cycles. The other 36 received CRC at the same cisplatin and radiotherapy dosage as for CRSC. The primary outcome was overall survival, whereas the secondary outcomes included progression-free survival and toxicity.. The median overall survival was 75 months (range 4-86 months) for the CRSC group and 66 months (range 3-87 months) for the CRC group (P = 0.039). The median corresponding progression-free survival was 66 months (range 3-75 months) and 58 months (range 3-71 months), respectively (P = 0.042). The toxicity profile was similar in both the groups.. Our results suggested that CRSC might be more effective than CRC in patients with ACC with acceptable toxicity.

Topics: Antineoplastic Combined Chemotherapy Protocols; Chemoradiotherapy; Cisplatin; Drug Combinations; Female; Follow-Up Studies; Humans; Middle Aged; Neoplasm Invasiveness; Neoplasm Staging; Oxonic Acid; Pilot Projects; Prognosis; Radiotherapy Dosage; Survival Rate; Tegafur; Uterine Cervical Neoplasms

Our aim was to evaluate the efficacy and safety of S-1 in heavily pre-treated patients with advanced (FIGO stage IVB) or recurrent cervical cancer.. The Institutional Review Board of our hospital approved the protocol for this retrospective phase II study. Patients with measurable disease received two oral doses of S-1 (35 mg/m(2)) daily for 4 weeks of a 6-week cycle or 2 weeks of a 3-week cycle. The antitumor effect, time to progression, overall survival, and adverse events were investigated.. We retrospectively analyzed relevant data of 28 patients with advanced or recurrent cervical cancer. Twenty-two patients had prior chemotherapy (not including chemoradiotherapy) and 27 had prior radiotherapy. The median number of prior chemotherapy regimens and cycles was 2 (range 0-4) and 7 (range 0-35), respectively. Two patients (7.1%) had partial response, and 10 patients (35.7%) had stable disease. Ten patients (35.7%) discontinued the therapy because of progressive disease. The response in 5 patients could not be evaluated because of termination of treatment in the middle of the first cycle. The disease control rate was 42.8%. After a median follow-up duration of 7.5 months, the median time to progression was 4.2 months (95% CI 2.7-5.4) and the median overall survival was 9.92 months (95% CI 9.20-NA). The two patients with partial response had received less prior chemotherapy.. Oral S-1 in palliative chemotherapy is a useful and well-tolerated treatment in heavily pre-treated patients with advanced or recurrent uterine cervical cancer.

Topics: Adult; Aged; Antimetabolites, Antineoplastic; Chemoradiotherapy; Drug Combinations; Female; Humans; Kaplan-Meier Estimate; Middle Aged; Neoplasm Metastasis; Neoplasm Recurrence, Local; Oxonic Acid; Retrospective Studies; Salvage Therapy; Survival Rate; Tegafur; Treatment Outcome; Uterine Cervical Neoplasms

This study aimed to determine the maximum tolerated dose and acute dose-limiting toxicities (DLTs) of intravenous irinotecan plus oral S-1 in patients with advanced or recurrent uterine cervical cancer.. Irinotecan was administered intravenously over the course of 90 minutes on day 1, and S-1 was given orally in 2 divided doses from days 1 to 14 of a 21-day cycle. The dose of S-1 was escalated in a stepwise fashion from 40 (level 1) to 60 mg/m (level 2) and then 80 mg/m (level 3), whereas the dosage of irinotecan remained the same (150 mg/m). The primary end point for the escalation study was acute DLT that occurred within 2 cycles of chemotherapy.. Twelve patients were enrolled and treated over 3 dose levels. Their median age was 47 years (range, 28-48 years). At level 1, one episode of grade 3 anemia and a grade 3 fatigue were observed, but no DLT developed. At level 2, the first patient experienced febrile neutropenia, which was considered to be a DLT. To evaluate the toxicity of this dose level, 5 more patients were evaluated. However, no DLT developed in these patients. At level 3, although grade 1 to 2 hematological and nonhematological toxicities developed, no DLT occurred.. In women with advanced or recurrent cervical cancer previously treated with platinum-based chemotherapy, S-1 plus irinotecan in a triweekly setting is a reasonable treatment regimen with an acceptable toxicity profile. The recommended doses of S-1 and irinotecan for this regimen are 80 and 150 mg/m, respectively.

Topics: Adult; Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Camptothecin; Carcinoma; Drug Combinations; Female; Humans; Irinotecan; Middle Aged; Neoplasm Recurrence, Local; Oxonic Acid; Tegafur; Uterine Cervical Neoplasms

To evaluate the feasibility of a cisplatin and S-1 combination regimen for the treatment for metastatic and recurrent cervical cancers, we performed this study prior to a randomized phase III trial to evaluate the clinical benefits of a cisplatin and S-1 combination regimen compared with cisplatin alone.. Cisplatin (50 mg/m(2), intravenously on day 1) and S-1 (80-120 mg/m(2), orally twice a day between days 1 and 14) were administered every 21 days for 6 cycles in patients with advanced or recurrent uterine cervical cancer.. A total of 10 patients were enrolled in this trial. A total of 46 treatment cycles (median 6; range 1-6) were administered. All grade 3 or 4 hematologic toxicities were recorded in the 6 patients: 2 patients experienced anemia, 5 experienced neutropenia, 1 experienced thrombocytopenia, and 2 experienced febrile neutropenia. All grade 3 non-hematologic toxicities were recorded in the 6 patients, and no grade 4 non-hematologic toxicities occurred; the most frequent toxicities were hyponatremia in 3 patients, diarrhea in 2 patients, and infection in 2 patients. The patients with grade 3 diarrhea had received prior radiotherapy. All the patients recovered from the toxicities after receiving appropriate supportive care, and no treatment-related deaths occurred. Five patients (50 %) achieved a partial response, and 1 patient (10 %) had a stable disease.. A cisplatin and S-1 combination regimen was feasible for patients with recurrent cervical cancer. Since patients who receive prior radiotherapy may experience severe diarrhea, these patients may require an S-1 dose reduction.

Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Cisplatin; Combined Modality Therapy; Dose-Response Relationship, Drug; Drug Combinations; Feasibility Studies; Female; Humans; Middle Aged; Neoplasm Metastasis; Neoplasm Recurrence, Local; Oxonic Acid; Pilot Projects; Tegafur; Treatment Outcome; Uterine Cervical Neoplasms

S-1 is an oral fluoropyrimidine. This phase II study was designed to evaluate the efficacy and safety of S-1 in patients with advanced or recurrent uterine cervical cancer.. S-1 35 mg/m(2) was given twice daily for 28 days repeated every 6 weeks. Eligible patients were women aged 20-74 years, who had Eastern Cooperative Oncology Group performance status of zero or one, who had stage IVB or recurrent uterine cervical cancer, and who had received no more than one platinum-containing chemotherapy regimen for stage IVB or recurrent disease. The primary end point was overall response rate (ORR) determined by RECIST.. A total of 37 patients were enrolled in the trial and 36 were eligible. The median number of cycles administered was 4. The confirmed ORR was 30.6% (95% confidence interval 15.5% to 45.6%). The response rate for patients who had received platinum-based treatment including chemoradiotherapy was 31.8% (7 of 22). After a median follow-up duration of 25 months, the median time to progression and the median survival time were 5.2 and 15.4 months, respectively. The most frequent grade 3 or 4 adverse events were anemia (16%), anorexia (16%), and diarrhea (22%).. This phase II study of S-1 in cervical cancer suggests a promising response rate and a contribution toward prolonging survival, with modest toxic effects. Phase III studies of S-1 in patients with advanced or recurrent cervical cancer are thus warranted.

Topics: Administration, Oral; Adult; Aged; Antimetabolites, Antineoplastic; Drug Combinations; Female; Humans; Middle Aged; Neoplasm Grading; Neoplasm Staging; Oxonic Acid; Recurrence; Tegafur; Uterine Cervical Neoplasms

The efficacy and safety of S-1/oxaliplatin (SOX) therapy in patients with recurrent adenocarcinoma of the uterine cervix were examined in a pilot study.. S-1 was orally administered for 14 days at a dose of 80-120 mg/body/day to 7 patients with recurrent adenocarcinoma of the uterine cervix, with oxaliplatin being administered intravenously at a dose of 100 mg/m(2) on day 1. Each therapy cycle was 21 days, and the patients received 6 cycles at most. The antitumor effect, adverse events, progression-free survival (PFS), and overall survival (OS) were investigated.. The median age of the patients was 49 years. The antitumor effect was rated as a complete response in 2 patients, partial response in 2, and stable disease in 3. The overall response rate was 57.1 %, and the disease control rate was 100 %. Regarding hematological toxicities of grade 3 or more, leukopenia, neutropenia and thrombocytopenia occurred in 42.9, 28.6 and 14.3 %, respectively; regarding non-hematological toxicities, grade 3 rectovaginal fistula occurred in 14.3 %, as well as grade 2 fatigue in 14.3 % of the patients. The median PFS and OS were 5 months (range 3-9 months) and 7 months (range 4-43 months), respectively.. These results suggest that SOX therapy is useful for the treatment of recurrent adenocarcinoma of the uterine cervix, having a promising antitumor effect and minimal adverse effects. It was also suggested that SOX therapy may contribute to improving the prognosis for patients with adenocarcinoma of the uterine cervix.

Topics: Adenocarcinoma; Administration, Oral; Adult; Antineoplastic Combined Chemotherapy Protocols; Drug Combinations; Female; Humans; Middle Aged; Neoplasm Recurrence, Local; Organoplatinum Compounds; Oxaliplatin; Oxonic Acid; Pilot Projects; Quality of Life; Tegafur; Uterine Cervical Neoplasms

We investigated the antitumor activity of TS-1 in comparison with that of UFT and cisplatin (CDDP) against cervical cancer using xenografts of a human uterine cervical squamous cell cancer cell line, CaSki, transplanted into female Balb/cA JcL-nu mice. CaSki cell xenografts were prepared by subcutaneous (s.c.) implantation of 3x10(6) cells/animal into the right dorsal region of the mice. The tumor volume was measured twice a week and the relative tumor volume (RTV) was calculated. We divided the animals into four groups according to the treatment administered; TS-1 (10 mg/kg orally, once daily for 14 consecutive days), UFT (24 mg/kg orally, once daily for 14 consecutive days), CDDP (7.6 mg/kg injected intravenously once on the 1st day) and control (no treatment) groups. The antitumor effects of the drugs were measured. On the 35th day after the completion of treatment, the mean tumor volume in the mice treated with TS-1 or CDDP changed from 132.873+/-11.783 mm(3) to 706.401+/-613.122 mm(3) and 133.809+/-19.366 mm(3) to 722.630+/-855.509 mm(3), respectively. The mean tumor volume in the groups treated with TS-1 or CDDP was significantly lower compared to that in the control group (p<0.001; one-tailed Student's t-test). The relative inhibition of the tumor growth was 65.31 in the TS-1 group, 48.31 in the UFT group and 64.51 in the CDDP group. We conclude that TS-1 administered orally for 14 consecutive days showed the highest antitumor activity.

Topics: Animals; Antimetabolites, Antineoplastic; Drug Combinations; Female; Humans; Mice; Oxonic Acid; Tegafur; Uterine Cervical Neoplasms; Xenograft Model Antitumor Assays

Case 1: A-35-year-old woman was diagnosed as cervical cancer Stage IIIb. When admitted to the hospital, her tumor marker SCC level was 50 ng/mL. Concurrent chemoradiation therapy was started on November, 2005. The SCC level was reduced by 0.9 ng/mL in February, 2006. In April, tumor recurrence was found by PET, and chemotherapy was restarted, but the SCC level was increased. In September, paclitaxel/S-1 therapy was performed, and the tumor markers were again reduced remarkably (SCC 9.8--> 1.3 ng/mL). Case 2: A-78-year-old woman was diagnosed as cervical cancer Stage IIIb. In August, 2004, concurrent chemoradiation therapy was started, and tumor markers were reduced (SCC 25.4--> 1.8 ng/mL). However, tumor markers were increased soon after the therapy. Chemotherapy was started, but it could not be maintained because of the side effects. In April, 2006, paclitaxel/S-1 therapy was performed, and the tumor markers were reduced remarkably (SCC 120--> 10 ng/mL). However, that therapy could also not be maintained because of the side effect. In July, she died of the cancer.

Topics: Adult; Aged; Antigens, Neoplasm; Antineoplastic Combined Chemotherapy Protocols; Biomarkers, Tumor; Drug Combinations; Female; Humans; Magnetic Resonance Imaging; Neoplasm Staging; Oxonic Acid; Paclitaxel; Serpins; Tegafur; Treatment Failure; Uterine Cervical Neoplasms