Erschienen in:
01.06.2006 | Original Article
A phase I combination chemotherapy study of biweekly paclitaxel and S-1 administration in patients with advanced gastric cancer
verfasst von:
Shuichi Hokita, Takashi Aikou, Futoshi Miyazono, Sumiya Ishigami, Kuniaki Aridome, Shigeho Maenohara, Tetsushi Saihara, Kuniaki Suenaga, Hidehiro Nomura, Satoshi Maeda, Hiroyuki Takatori, Hideo Arima, Yasuto Uchikado, Shoji Natsugoe, Sonshin Takao
Erschienen in:
Cancer Chemotherapy and Pharmacology
|
Ausgabe 6/2006
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Abstract
The aim of the current study was to determine the maximum tolerated dose (MTD) and the dose limiting toxicity (DLT) of a combination of paclitaxel and S-1 in patients with advanced gastric cancer. Fifteen patients were enrolled. The dose for S-1 was set at 80 mg/m2/day (days 1–14), while the dose for paclitaxel increased by 10 mg/m2 for every three patients, with a starting dose of 100 mg/m2 and was given biweekly on day 1 and 15. There was no severe toxicity (grade 4) recorded in patients receiving up to 120 mg/m2 of paclitaxel. Leukopenia/neutrophilia with grade 1 to 3 occurred in six patients up to level 3. At 130 mg/m2 of paclitaxel, grade 4 leukocytopenia and neutropenia events and grade 3 diarrhea developed in one out of three patients. One patient in another group of three patients that were enrolled at level 3, developed grade 4 granulocytopenia with fever (a body temperature higher than 38°C) and grade 3 leukocytopenia. Eight patients, out of a total of 15, showed a partial response, resulting in an objective response rate of 53%. Five patients received gastrectomy. Median survival time was 428 days and the 1 year survival rate was 53%. Biweekly paclitaxel/S-1 combination chemotherapy could be safely used for the treatment of advanced gastric cancer. The recommended doses for a phase II study with paclitaxel and S-1 are 120 mg/m2 and 80 mg/m2, respectively.