Optimal dose-finding study of bi-weekly paclitaxel in unresectable advanced or recurrent gastric cancer.
BACKGROUND
Tri-weekly and weekly regimens of paclitaxel have been reported to be effective in unresectable advanced or recurrent gastric cancer. The present study was conducted to determine the optimal dose of bi-weekly paclitaxel and evaluate safety and antitumor effect.


METHODS
The study included patients with a histologically confirmed diagnosis of advanced or recurrent gastric cancer. Paclitaxel was intravenously infused for 1 h bi-weekly. One cycle consisted of four weeks and at least two cycles were performed. Dose levels 1, 2, 3, 4 and 5 were 100, 120, 140, 160 and 180 mg/m2, respectively.


RESULTS
Of the 21 patients enrolled, 18 patients (85.7%) had received prior treatment. The maximum tolerated dose was 160 mg/m2 (level 4) and dose-limiting toxicities included grade 3 fatigue, anorexia and neuropathy and grade 4 neutropenia and allergic reaction. The recommended dose was designated as to be 140 mg/m2 (level 3). At this dose level, only one patient experienced a dose-limiting toxicity of neutropenia. No patient had grade 3 or higher non-hematological toxicity. The response rate was 12.5% (2/16) and 14 patients (87.5%) had partial response or stable disease. The median number of treatment courses was four (up to 13 courses). The median survival time was 222 days and the time to progression was 76 days.


CONCLUSIONS
In advanced or recurrent gastric cancer, bi-weekly paclitaxel may be safely administered at a recommended dose of 140 mg/m2. A phase II study is now underway.
Koizumi
Wasaburo
W
Department of Gastroenterology, Kitasato University East Hospital, 2-1-1 Asamizodai, Sagamihara, Kanagawa 228-8520, Japan. koizumi@med.kitasato-u.ac.jp
Tanabe
Satoshi
S
Higuchi
Katsuhiko
K
Sasaki
Toru
T
Nakayama
Shosuke
S
Nakatani
Kento
K
Nishimura
Ken
K
Shimoda
Takuya
T
Azuma
Mizutomo
M
Ishido
Kenji
K
Saigenji
Katsunori
K
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012008:Recurrence
D000970:Antineoplastic Agents; D017239:Paclitaxel