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Annals of Oncology Advance Access originally published online on February 13, 2008
Annals of Oncology 2008 19(6):1135-1140; doi:10.1093/annonc/mdn013
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© The Author 2008. 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 of combination chemotherapy of 5-fluorouracil, low-dose leucovorin, and oxaliplatin (FLOX regimen) in pretreated advanced gastric cancer

J. Jeong1, H.-C. Jeung1,2, S. Y. Rha1,2, C. K. Im1,2, S. J. Shin1,2, J. B. Ahn1,2, S. H. Noh3, J. K. Roh1,2 and H. C. Chung1,2,*

1 Department of Internal Medicine
2 Cancer Metastasis Research Center, Yonsei Cancer Center
3 Department of Surgery, Yonsei University College of Medicine, Seoul, South Korea

* Correspondence to: Prof. H. C. Chung, Department of Internal Medicine, Cancer Metastasis Research Center, Yonsei Cancer Center, Yonsei University College of Medicine, 250 Seongsanno (134, Shinchon-Dong), Seodaemun-Gu, Seoul 120-752, South Korea. Tel: +82-2-2228-8041; Fax: +82-2-362-5592; E-mail: unchung8{at}yuhs.ac

Background: This phase II study describes the efficacy and safety of combination chemotherapy of 5-fluorouracil (5-FU), low-dose leucovorin, and oxaliplatin (FLOX regimen) for pretreated advanced gastric cancer.

Patients and methods: Patients who had been previously treated with greater than or equal to one regimen were enrolled. Patients received an oxaliplatin 75 mg/m2 on day 1, 5-FU 1000 mg/m2 on days 1–3, and leucovorin 20 mg/m2 on days 1–3, every 3 weeks. The primary end point was overall survival (OS).

Results: Among the 52 patients enrolled, 26 patients were treated as second line, and the remaining 26 patients were enrolled as third- or fourth line. A total of 203 cycles of chemotherapy were administered with the median being three cycles (range 1–15) per patient. The median OS was 6.6 months [95% confidence interval (CI) 4.5–8.8] and the median progression-free survival was 2.5 months (95% CI 1.9–3.0). The response rate was 4% (95% CI 0–9%), and the disease control rate was 48% (95% CI 34–62%). The most common toxic effects of grade 3/4 were neutropenia (16%) and vomiting (6%).

Conclusions: The FLOX regimen showed modest activity as a salvage treatment in pretreated advanced gastric cancer with a favorable compliance.

Key words: advanced gastric cancer, 5-fluorouracil, leucovorin, oxaliplatin, salvage chemotherapy

Received for publication October 9, 2007. Revision received December 28, 2007. Accepted for publication January 4, 2008.


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