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Phase II study of S-1, an oral fluoropyrimidine, in patients with advanced or recurrent cervical cancer.

Katsumata N, Hirai Y, Kamiura S, Sugiyama T, Kokawa K, Hatae M, Nishimura R, Ochiai K - Ann. Oncol. (2011)

Bottom Line: This phase II study was designed to evaluate the efficacy and safety of S-1 in patients with advanced or recurrent uterine cervical cancer.The most frequent grade 3 or 4 adverse events were anemia (16%), anorexia (16%), and diarrhea (22%).Phase III studies of S-1 in patients with advanced or recurrent cervical cancer are thus warranted.

View Article: PubMed Central - PubMed

Affiliation: Department of Medical Oncology, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan. nkatsuma@ncc.go.jp

ABSTRACT

Background: 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.

Patients and methods: 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.

Results: 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%).

Conclusions: 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.

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Related in: MedlinePlus

Kaplan–Meier plot for overall survival (n = 36). CI, confidence interval.
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fig2: Kaplan–Meier plot for overall survival (n = 36). CI, confidence interval.

Mentions: After a median follow-up duration of 25 months, the median TTP was 5.2 months (95% CI 4.5–6.6 months; Figure 1) and the MST was 15.4 months (95% CI 11.5–17.8 months; Figure 2). One-year survival was 58.3%.


Phase II study of S-1, an oral fluoropyrimidine, in patients with advanced or recurrent cervical cancer.

Katsumata N, Hirai Y, Kamiura S, Sugiyama T, Kokawa K, Hatae M, Nishimura R, Ochiai K - Ann. Oncol. (2011)

Kaplan–Meier plot for overall survival (n = 36). CI, confidence interval.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3101364&req=5

fig2: Kaplan–Meier plot for overall survival (n = 36). CI, confidence interval.
Mentions: After a median follow-up duration of 25 months, the median TTP was 5.2 months (95% CI 4.5–6.6 months; Figure 1) and the MST was 15.4 months (95% CI 11.5–17.8 months; Figure 2). One-year survival was 58.3%.

Bottom Line: This phase II study was designed to evaluate the efficacy and safety of S-1 in patients with advanced or recurrent uterine cervical cancer.The most frequent grade 3 or 4 adverse events were anemia (16%), anorexia (16%), and diarrhea (22%).Phase III studies of S-1 in patients with advanced or recurrent cervical cancer are thus warranted.

View Article: PubMed Central - PubMed

Affiliation: Department of Medical Oncology, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan. nkatsuma@ncc.go.jp

ABSTRACT

Background: 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.

Patients and methods: 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.

Results: 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%).

Conclusions: 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.

Show MeSH
Related in: MedlinePlus