Phase I study of biweekly docetaxel and S-1 combination chemotherapy for advanced gastric cancer.
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.
Kunisaki
Chikara
C
Department of Surgery, Gastroenterological Center, Yokohama City University, 4-57 Urafune-cho, Minami-ku, Yokohama 232-0024, Japan. s0714@med.yokohama-cu.ac.jp
Takahashi
Masazumi
M
Nagahori
Yutaka
Y
Makino
Hirochika
H
Takagawa
Ryo
R
Sato
Tsutomu
T
Oshima
Takashi
T
Fujii
Shoichi
S
Kosaka
Takashi
T
Ono
Hidetaka A
HA
Akiyama
Hirotoshi
H
Shimada
Hiroshi
H