Phase I/II study of intraperitoneal docetaxel plus S-1 for the gastric cancer patients with peritoneal carcinomatosis.

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/m(2)) 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/m(2)); the MTD was determined to be 50 mg/m(2) and the RD was determined to be 45 mg/m(2). 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.

authors

Fushida S,Kinoshita J,Kaji M,Hirono Y,Goda F,Yagi Y,Oyama K,Sudo Y,Watanabe Y,Fujimura T,Society for Study of Peritoneal Carcinomatosis in Gastric Cancer.

doi

10.1007/s00280-013-2122-0

subject

Has Abstract

pub_date

2013-05-01 00:00:00

pages

1265-72

issue

5

eissn

0344-5704

issn

1432-0843

journal_volume

71

pub_type

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