Phase I Study of Biweekly Docetaxel and S-1 Combination Chemotherapy for Advanced Gastric Cancer

Abstract

Background: Docetaxel and S-1 are novel anti-tumour chemotherapeutic agents with distinct toxicities. Here a phase I study of combined docetaxel and S-1 therapy for advanced gastric cancer is reported. Patients and Methods: The study group comprised 21 patients who received at least two courses of treatment. Intravenous docetaxel was administered with dose escalation from 20-45 mg/m² depending on the dose-limiting toxicity (DLT) on days 1 and 15, and oral S-1 (BSA <1.25 m², 80 mg/day; 1.25≤ BSA <1.50 m², 100 mg/day; 1.50 m² ≤BSA, 120 mg/day) was administered on days 1-7 and 15-21 . Results: The maximum tolerated dose of docetaxel was 45 mg/m² and the DLT was defined as neutropenia. The recommended docetaxel dose was identified as 40 mg/m². The response rate (including partial responses) was 57.1% . Five cases showed no change and four showed progressive disease after two courses of treatment. The mean survival rate was 15 months. Conclusion: A phase II clinical trial is required to confirm these results.