A phase II multicentric trial of S-1 combined with24 h-infusion of cisplatin in patients with advanced gastric cancer

Abstract

4055 Background: In Japan, S-1-based chemotherapy is used for the treatment of advanced gastric cancer. The aim of this multicentric trial was to determine the clinical toxicities, antitumor effects of a chemotherapy regimen of S-1 combined with 24-h infusion of cisplatin in patients with high grade advanced gastric cancer. Methods: 42 patients with unresectable locally advanced or metastatic gastric cancer were entered into the multicentric study. S-1 (80 mg/m2) was administered orally a day for 14 consecutive days and 24-h infusion of cisplatin (70 mg/m2) was administered on day 8 without 14 days drug of every 28-day cycle. Results: CR was observed in 2 and PR was observed in 19 patients (CR rate: 4.8% (95% CI: 0.6%–16.2%), PR rate: 45%(95%CI: 29.8%–61.3%)). The overall response rate was 50% (21/42) (95%CI: 32.4%–65.8%). The most common adverse event was leucopenia, which occurred with grade 3 in 7 patients (16.6%) and grade 4 in 2 patients (4.8%). Nonhematologic adverse events were generally mild. Grade 3 nausea and vomiting were observed in 4 patients (9.5%). Grade 3 mucositis, and hand and-foot syndrome were not observed. One patient suffered perforation of the stomach during second chemotherapy. The median survival time was 342 days. The 1-year survival rate was 44.4% (95% CI: 29.2%–59.6%). The 2-year survival rate was 22.9% (95%CI: 9.4%–36.4%). Conclusions: This combination chemotherapy with S-1 and cisplatin is active, convenient, well tolerated and may have the possibility to improve survival in patients with high grade advanced gastric cancer. No significant financial relationships to disclose.