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Annals of Oncology Advance Access published online on July 15, 2009
Annals of Oncology, doi:10.1093/annonc/mdp260
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© The Author 2009. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

Phase II study of weekly intravenous and intraperitoneal paclitaxel combined with S-1 for advanced gastric cancer with peritoneal metastasis

H. Ishigami*, J. Kitayama, S. Kaisaki, A. Hidemura, M. Kato, K. Otani, T. Kamei, D. Soma, H. Miyato, H. Yamashita and H. Nagawa

Department of Surgical Oncology, The University of Tokyo, Tokyo, Japan

* Correspondence to: Dr H. Ishigami, Department of Surgical Oncology, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan. Tel: +81-3-3815-5411; Fax: +81-3-3811-6822; E-mail: ishigami-tky{at}umin.net

Background: A phase II study to evaluate the efficacy and tolerability of weekly i.v. and i.p. paclitaxel (PTX) combined with S-1 was carried out in gastric cancer patients with peritoneal metastasis.

Patients and methods: Gastric cancer patients with peritoneal dissemination and/or cancer cells on peritoneal cytology were enrolled. PTX was administered i.v. at 50 mg/m2 and i.p. at 20 mg/m2 on days 1 and 8. S-1 was administered at 80 mg/m2/day for 14 consecutive days, followed by 7 days rest. The primary end point was the 1-year overall survival (OS) rate. Secondary end points were the response rate, efficacy against malignant ascites and safety.

Results: Forty patients were enrolled, including 21 with primary tumors with peritoneal dissemination, 13 with peritoneal recurrence and six with positive peritoneal cytology only. The median number of courses was 7 (range 1–23). The 1-year OS rate was 78% (95% confidence interval 65% to 90%). The overall response rate was 56% in 18 patients with target lesions. Malignant ascites disappeared or decreased in 13 of 21 (62%) patients. The frequent grade 3/4 toxic effects included neutropenia (38%), leukopenia (18%) and anemia (10%).

Conclusion: Combination chemotherapy of i.v. and i.p. PTX with S-1 is well tolerated and active in gastric cancer patients with peritoneal metastasis.

gastric cancer, i.p. chemotherapy, paclitaxel, phase II study, S-1

Received for publication January 24, 2009. Revision received March 31, 2009. Accepted for publication April 1, 2009.


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