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Cancer Chemotherapy and Pharmacology
Published in: Cancer Chemotherapy and Pharmacology 5/2013

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.
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Metadata
Title
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
Publication date
01-05-2013
Publisher
Springer-Verlag
Published in
Cancer Chemotherapy and Pharmacology / Issue 5/2013
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI
https://doi.org/10.1007/s00280-013-2122-0

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