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Annals of Oncology Advance Access originally published online on May 27, 2009
Annals of Oncology 2009 20(9):1529-1534; doi:10.1093/annonc/mdp047
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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

Meta-analysis of the REAL-2 and ML17032 trials: evaluating capecitabine-based combination chemotherapy and infused 5-fluorouracil-based combination chemotherapy for the treatment of advanced oesophago-gastric cancer

A. F. C. Okines1, A. R. Norman1, P. McCloud2, Y.-K. Kang3 and D. Cunningham1,*

1 The Royal Marsden Hospital NHS Foundation Trust, Sutton, Surrey, UK
2 Roche Products Pty Ltd, Dee Why, Australia
3 Division of Oncology, Department of Internal Medicine, Asan Medical Centre, University of Ulsan College of Medicine, Songpa Gu, Seoul, South Korea

* Correspondence to: Prof. D. Cunningham, Department of Medicine, Royal Marsden Hospital, Downs Road, Sutton, Surrey SM2 5PT, UK. Tel: +44-208-661-3156; Fax: +44-208-661-3890; E-mail: david.cunningham{at}rmh.nhs.uk

Background: The REAL-2 and ML17032 trials demonstrated that the oral fluoropyrimidine, capecitabine, is noninferior to 5-fluorouracil (5-FU) for overall survival (OS) and progression-free survival (PFS), respectively, in advanced oesophago-gastric cancer.

Methods: Individual patient data were collected on all patients randomised within the trials (n = 1318). Kaplan–Meier survival curves were generated and the log-rank test was used to compare OS and PFS between patients receiving 5-FU combinations and capecitabine combinations. Stepwise multivariate Cox regression analysis was used to calculate corrected hazard ratios (HRs) and 95% confidence intervals (CIs) for OS and PFS. Logistic regression was used for objective response rate. Forest plots with tests of heterogeneity were generated.

Results: OS was superior in the 654 patients treated with capecitabine combinations compared with the 664 patients treated with 5-FU combinations; HR 0.87 (95% CI 0.77–0.98, P = 0.02). Poor performance status, age <60 and metastatic disease were independent predictors of poor survival. There was no significant difference in PFS between treatment groups on multivariate analysis. Assessable patients treated with capecitabine combinations were significantly more likely to have an objective response to treatment than those treated with 5-FU combinations; odds ratio 1.38 (95% CI 1.10–1.73, P = 0.006).

Conclusion: OS is superior in patients treated with capecitabine combinations compared with 5-FU combinations in advanced oesophago-gastric cancer.

Key words: capecitabine, fluoropyrimidine, 5-fluorouracil, oesophago-gastric cancer, overall survival

Received for publication January 2, 2009. Accepted for publication February 3, 2009.


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