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Annals of Oncology Advance Access originally published online on January 19, 2009
Annals of Oncology 2009 20(5):892-896; doi:10.1093/annonc/mdn721
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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

gastrointestinal tumors

Phase II study with oxaliplatin and S-1 for patients with metastatic colorectal cancer

D. Y. Zang1,*, B. H. Lee2, H.-C. Park2, H. H. Song1, H. J. Kim1, J. Y. Jung1, J. H. Kim1, H. Y. Kim1, J. H. Kwon1, S. W. Hwang1, S. R. Park1, C. H. Park1, K. O. Kim1, M.-J. Kim3 and K. M. Jang3

1 Department of Internal Medicine
2 Department of Surgery
3 Department of Radiology, Hallym University Medical Center and Hallym University College of Medicine, Anyang, South Korea

* Correspondence to: Dr D. Y. Zang, Division of Hematology–Oncology, Department of Internal Medicine, Hallym University Sacred Heart Hospital, 896 Pyeongchon-dong, Dongan-gu, Anyang 431-070, South Korea. Tel: +82-31-380-3871; Fax: +82-31-386-2269; E-mail: fhdzang{at}hallym.or.kr

Background: To evaluate the efficacy and safety of the combination of oxaliplatin and S-1 (OS) in treating metastatic colorectal cancer.

Patients and methods: Eligible patients were those with measurable lesions, no previous history of chemotherapy (except adjuvant chemotherapy), an age of 18–70 years, and an Eastern Cooperative Oncology Group performance status of zero to two. Oxaliplatin 130 mg/m2 was administered i.v. on day 1, and S-1 40 mg/m2 b.i.d. was administered orally on days 1–14, every 3 weeks.

Results: Forty-eight patients (median age, 56 years) were enrolled: 23 had colon cancer, seven rectosigmoid colon cancer; and 18 rectal cancer. Of the 48 patients, 31 were diagnosed with metastatic cancer and 17 had relapsed cancer after surgery, with adjuvant chemotherapy or chemoradiotherapy. In total, 413 cycles were administered (median 6 per patient; range 2–24). Toxicity was evaluated in 48 patient and response in 46. Major toxic effects were grade 3/4 thrombocytopenia (13%) and neutropenia (10%). The overall response rate was 54% [95% confidence interval (CI) 40% to 68%]. The median time to progression and median survival time were 8.5 (95% CI 6.2–10.9) months and 27.2 (95% CI 20.3–34.0) months, respectively.

Conclusions: These data indicate that the OS regimen is effective and well tolerated in patients with advanced colorectal cancer.

Key words: colorectal neoplasm, oxaliplatin, S1

Received for publication September 1, 2008. Revision received October 26, 2008. Accepted for publication October 27, 2008.


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