title: Phase I study of biweekly docetaxel and S-1 combination chemotherapy for advanced gastric cancer.
abstract: 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.
  
  
  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.
  
  
  CONCLUSIONS
  A phase II clinical trial is required to confirm these results.
authors.affiliation: Department of Surgery, Gastroenterological Center, Yokohama City University, 4-57 Urafune-cho, Minami-ku, Yokohama 232-0024, Japan. s0714@med.yokohama-cu.ac.jp
authors.forename: Chikara
authors.initials: C
authors.lastname: Kunisaki
authors.forename: Masazumi
authors.initials: M
authors.lastname: Takahashi
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Nagahori
authors.forename: Hirochika
authors.initials: H
authors.lastname: Makino
authors.forename: Ryo
authors.initials: R
authors.lastname: Takagawa
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Sato
authors.forename: Takashi
authors.initials: T
authors.lastname: Oshima
authors.forename: Shoichi
authors.initials: S
authors.lastname: Fujii
authors.forename: Takashi
authors.initials: T
authors.lastname: Kosaka
authors.forename: Hidetaka A
authors.initials: HA
authors.lastname: Ono
authors.forename: Hirotoshi
authors.initials: H
authors.lastname: Akiyama
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Shimada