Phase I study of biweekly docetaxel and S-1 combination chemotherapy for advanced gastric cancer
Chikara Kunisaki1, Masazumi Takahashi, Yutaka Nagahori
1Department of Surgery, Gastroenterological Center, Yokohama City University, 4-57 Urafune-cho, Minami-ku, Yokohama 232-0024, Japan. s0714@med.yokohama-cu.ac.jp
Background:
Docetaxel and S-1 are novel antitumour 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 < or = BSA < 1.50 m2, 100 mg/day; 1.50 m2 < or = 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.
