Published in:
Open Access
01-05-2013 | Original Article
Phase I/II study of intraperitoneal docetaxel plus S-1 for the gastric cancer patients with peritoneal carcinomatosis
Authors:
S. Fushida, J. Kinoshita, M. Kaji, Y. Hirono, F. Goda, Y. Yagi, K. Oyama, Y. Sudo, Y. Watanabe, T. Fujimura, Society for the Study of Peritoneal Carcinomatosis in Gastric Cancer
Published in:
Cancer Chemotherapy and Pharmacology
|
Issue 5/2013
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Abstract
Purpose
We designed a phase I/II trial of intraperitoneal (IP) docetaxel plus S-1 to determine the maximum tolerated dose (MTD) and recommended dose (RD) and to evaluate its efficacy and safety in gastric cancer patients with peritoneal carcinomatosis (PC).
Methods
Patients with PC confirmed by laparoscopy or laparotomy received IP docetaxel on days 1 and 15 and S-1 (80 mg/m2) on days 1–14 every 4 weeks.
Results
In the phase I part (n = 12), each cohort received escalating doses of docetaxel (35–50 mg/m2); the MTD was determined to be 50 mg/m2 and the RD was determined to be 45 mg/m2. Dose-limiting toxicities included grade 3 febrile neutropenia and grade 3 diarrhea. In the phase II part (n = 27), the median number of courses was 4 (range 2–11). The 1-year overall survival (OS) rate was 70 % (95 % confidence interval 53–87 %). The overall response rate was 22 % and peritoneal cytology turned negative in 18 of 22 (81 %) patients. The most frequent grade 3/4 toxicities included anorexia (19 %), neutropenia (7 %), and leukopenia (7 %).
Conclusion
IP docetaxel plus S-1 is active and safety in gastric cancer patients with PC.