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Fluorouracil versus combination of irinotecan plus cisplatin versus S-1 in metastatic gastric cancer: a randomised phase 3 study : The Lancet Oncology
The Lancet Oncology - Online First, 10/09/09

Boku N et al. – S-1 is non-inferior to fluorouracil and, in view of the convenience of an oral administration, could replace intravenous fluorouracil for treatment of unresectable or recurrent gastric cancer, at least in Asia. Irinotecan plus cisplatin is not superior to fluorouracil in this setting.

Methods

Phase 3 open label randomised trial
Enrolled patients aged 20—75 years or younger, who had histologically proven gastric adenocarcinoma, and randomly assigned them by minimisation to receive either: a continuous infusion of fluorouracil (800 mg/m2 per day, on days 1—5) every 4 weeks (n=234); intravenous irinotecan (70 mg/m2, on days 1 and 15) and cisplatin (80 mg/m2, on day 1) every 4 weeks (n=236); or oral S-1 (40 mg/m2, twice a day, on days 1—28) every 6 weeks (n=234)
Primary endpoint was overall survival
Analyses done by intention to treat

Results

All randomised patients were included in the primary analysis
Median overall survival was 10·8 months for individuals assigned fluorouracil
12·3 months (8·1—19·5) for those allocated irinotecan plus cisplatin
11·4 months (6·4—21·3) for those assigned S-1
3 treatment-related deaths occurred in irinotecan plus cisplatin group and one recorded in S-1 group

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