Phase II multi-institutional prospective randomised trial comparing S-1+paclitaxel with S-1+cisplatin in patients with unresectable and/or recurrent advanced gastric cancer

BACKGROUND: A combination of S-1 and cisplatin has been shown to be effective with acceptable safety for the first-line treatment of far-advanced gastric cancer in Japan. This is the first randomised phase II trial to compare S-1 + paclitaxel with S-1 + cisplatin in this setting. METHODS: Patients with unresectable and/or recurrent advanced gastric cancer were randomly assigned to receive one of the two regimens: S-1 (40 mg m(-2) twice daily) on days 1-14 plus paclitaxel (60 mg m(-2)) on days 1, 8, and 15 of a 4-week cycle (S-1 + paclitaxel) or S-1 (40 mg m(-2) twice daily) on days 1-21 plus cisplatin (60 mg m(-2)) on day 8 of a 5-week cycle (S-1 + cisplatin). The primary end point was the response rate (RR). Secondary end points included progression-free survival (PFS), overall survival (OS), and safety. RESULTS: A total of 83 patients were eligible for safety and efficacy analyses. In the S-1 + paclitaxel and S-1 + cisplatin groups, RRs (52.3% vs 48.7%; P = 0.74) and median PFS (9 vs 6 months; P = 0.50) were similar. The median OS was similar in the S-1 + paclitaxel and S-1 + cisplatin groups (16 vs 17 months; P = 0.84). The incidence of grade 3 or higher haematological toxicity was 19.0% with S-1 + paclitaxel and 19.5% with S-1 + cisplatin. The incidence of grade 3 or higher non-haematological toxicity was 14.2% with S-1 + paclitaxel and 17.1% with S-1 + cisplatin. CONCLUSION: S-1 + paclitaxel was suggested to be a feasible and effective non-platinum-based regimen for chemotherapy in patients with advanced gastric cancer. Our results should be confirmed in multicenter, phase III-controlled clinical trials. British Journal of Cancer (2012) 107, 31-36. doi:10.1038/bjc.2012.222 www.bjcancer.com Published online 22 May 2012 (C) 2012 Cancer Research UK