A Phase II Multicentric Trial of S-1 Combined with 24 h-infusion of Cisplatin in Patients with Advanced Gastric Cancer

Abstract

Background: The aim of this multicentric trial was to determine the clinical toxicities and antitumor effects of a chemotherapy regimen of S-1 combined with cisplatin in patients with inoperable locally or metastatic advanced gastric cancer. Patients and Methods: Forty-two patients were entered into the study. S-1 (80 mg/m²) was administered orally daily for 14 consecutive days and 24-h infusion of cisplatin (70 mg/m²) was administered on day 8 of every 28-day cycle. Results: The overall response rate was 50% and complete response rate was 5%. 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%). Non-hematological adverse events were generally mild. The median survival time was 342 days. The 2-year survival rate was 22.9%. Conclusion: This combination chemotherapy is active, convenient and well tolerated in patients with high-grade advanced gastric cancer.