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Cancer Chemotherapy and Pharmacology
Published in: Cancer Chemotherapy and Pharmacology 6/2006

01-06-2006 | Original Article

A phase I combination chemotherapy study of biweekly paclitaxel and S-1 administration in patients with advanced gastric cancer

Authors: 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

Published in: Cancer Chemotherapy and Pharmacology | Issue 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.
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Metadata
Title
A phase I combination chemotherapy study of biweekly paclitaxel and S-1 administration in patients with advanced gastric cancer
Authors
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
Publication date
01-06-2006
Publisher
Springer-Verlag
Published in
Cancer Chemotherapy and Pharmacology / Issue 6/2006
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI
https://doi.org/10.1007/s00280-005-0122-4

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