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Annals of Oncology Advance Access published online on October 29, 2009

Annals of Oncology, doi:10.1093/annonc/mdp464
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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 oxaliplatin plus S-1 as first-line treatment for advanced gastric cancer (G-SOX study)

W. Koizumi1,*, H. Takiuchi2, Y. Yamada3, N. Boku4, N. Fuse5, K. Muro6, Y. Komatsu7 and A. Tsuburaya8

1 Department of Gastroenterology/Gastrointestinal Oncology, Kitasato University School of Medicine, Sagamihara
2 Department of Gastroenterology, Osaka Medical College, Takatsuki
3 Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo
4 Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Sunto-gun
5 Division of Gastrointestinal Oncology and Digestive Endoscopy, National Cancer Center Hospital East, Kashiwa
6 Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya
7 Department of Cancer Chemotherapy, Hokkaido University Hospital Cancer Center, Sapporo
8 Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan

* Correspondence to: Dr W. Koizumi, Department of Gastroenterology/Gastrointestinal Oncology, Kitasato University School of Medicine, 2-1-1 Asamizodai, Sagamihara, Kanagawa 228-8520, Japan. Tel: +81-42-748-9111; Fax: +81-42-748-5120; E-mail: koizumi{at}med.kitasato-u.ac.jp

Background: The efficacy and safety of oxaliplatin combined with S-1 (SOX regimen) for unresectable advanced or recurrent gastric cancer were investigated.

Patients and methods: Oxaliplatin was administered i.v. (100 mg/m2) on day 1, while S-1 was administered orally (80 mg/m2/day, b.i.d.) for 14 days followed by a 7-day rest. This schedule was repeated every 3 weeks.

Results: Among 55 patients enrolled, one patient received oxaliplatin for the other study, and three patients were considered unsuitable against the inclusion criteria. Accordingly, 51 patients were assessable for efficacy. The response rate was 59%, and the disease control rate was 84%. The median progression-free survival time was 6.5 months, the 1-year survival rate was 71%, and the median survival time was 16.5 months. In 54 patients assessed for safety, the major grade 3/4 toxic effects were neutropenia (22%), thrombocytopenia (13%), anemia (9%), anorexia (6%), fatigue (6%), and sensory neuropathy (4%).

Conclusion: These findings indicate that SOX regimen with oxaliplatin at a dose of 100 mg/m2 is feasible and shows promising efficacy against advanced gastric cancer.

advanced gastric cancer, oxaliplatin, phase II, S-1, SOX

Received for publication August 8, 2009. Accepted for publication August 17, 2009.


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