Journal Article

Phase I Study of Docetaxel, Cisplatin and S-1 in Patients with Advanced Gastric Cancer

Shuichi Hironaka, Kentaro Yamazaki, Keisei Taku, Tomoya Yokota, Kohei Shitara, Takashi Kojima, Shinya Ueda, Nozomu Machida, Kei Muro and Narikazu Boku

in Japanese Journal of Clinical Oncology

Volume 40, issue 11, pages 1014-1020
Published in print November 2010 | ISSN: 0368-2811
Published online July 2010 | e-ISSN: 1465-3621 | DOI: https://dx.doi.org/10.1093/jjco/hyq104
Phase I Study of Docetaxel, Cisplatin and S-1 in Patients with Advanced Gastric Cancer

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Objective

S-1 plus cisplatin is standard treatment for advanced gastric cancer in Japan. Triplet therapy with docetaxel, cisplatin and fluoropyrimidine showed a survival benefit over doublet therapy, but was associated with substantial toxicities. We investigated the maximum tolerated dose of combination chemotherapy with divided-dose docetaxel added to standard-dose S-1 plus cisplatin in advanced gastric cancer patients.

Methods

Patients with advanced gastric cancer, naive to chemotherapy or not refractory to fluoropyrimidine, were enrolled. Fixed doses of S-1 (40 mg/m2 twice daily for 3 weeks) and cisplatin (60 mg/m2 on day 1) were administered with increasing docetaxel dose levels of 20 mg/m2 (dose level 1), 25 mg/m2 (dose level 2) and 30 mg/m2 (dose level 3) on days 1, 8 and 15, or 40 mg/m2 (dose level 4) on days 1 and 15 of a 5-week cycle. Treatment cycles were repeated until disease progression, patient's refusal or unacceptable toxicity occurred.

Results

Fifteen patients were enrolled. During the first cycle, no dose-limiting toxicity was observed at dose levels 1 and 2. At dose level 3, grade 3 febrile neutropenia was seen in one patient. At dose level 4, grade 3 infection and grade 3 abdominal pain were observed. Thus, dose level 4 was determined to be the maximum tolerated dose. The response rate was 54% (7/13), and median progression-free survival and overall survival were 243 and 383 days, respectively.

Conclusions

The recommended dose of docetaxel added to standard-dose S-1 (80 mg/m2 days 1–21) plus cisplatin (60 mg/m2 day 1) was 40 mg/m2 on days 1 and 15 of a 5-week cycle.

Keywords: docetaxel; cisplatin; s-1; DCS; gastric cancer

Journal Article.  4472 words. 

Subjects: Medical Oncology

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