• Chikara Kunisaki, Masazumi Takahashi, Yutaka Nagahori, Hirochika Makino, Ryo Takagawa, Tsutomu Sato, Takashi Oshima, Shoichi Fujii, Takashi Kosaka, Hidetaka A Ono, Hirotoshi Akiyama, and Hiroshi Shimada.
• Department of Surgery, Gastroenterological Center, Yokohama City University, 4-57 Urafune-cho, Minami-ku, Yokohama 232-0024, Japan. s0714@med.yokohama-cu.ac.jp
• Anticancer Res. 2008 Jul 1; 28 (4C): 2473-8.

BackgroundDocetaxel 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 MethodsThe 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.ResultsThe 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.ConclusionA phase II clinical trial is required to confirm these results.

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