Association of age and overall survival in capecitabine-treated patients with metastatic breast cancer in clinical trials
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We sought to determine if an association exists between age and capecitabine efficacy among patients with metastatic breast cancer (MBC). Pooled analysis of five phase II or III registration trials of capecitabine 2,500–2,510 mg/m2/day for 2 weeks and 1 week off, or combination therapy was performed. Four trials enrolled patients previously exposed to other chemotherapy, generally a taxane. Of 570 patients, 193 (34%) were 18–49 years old, 246 (43%) were 50–64, and 131 (23%) were ≥65. Median average daily dose was 2,067 mg/m2 in the 18- to 49-year-old group and 2,105 mg/m2 in the 50–64 and ≥65 year groups. Overall survival (OS) in all groups was similar by log-rank test for the individual trials (P = 0.71–0.95) and Cox regression of the pooled trials. Univariate analysis demonstrated no difference in clinical benefit or objective response between groups. Treatment failure analysis showed 283 (50%) patients experienced progressive disease, while 114 (20%) withdrew for safety. Serious adverse events (AEs) occurred in 71 (36.8%), 85 (34.6%), and 59 (45.0%) patients in the 18–49, 50–64, and ≥65 years groups, respectively. There was no statistically significant association between age and OS, clinical benefit, or objective response in patients with MBC treated with capecitabine. Frequency of AEs and serious AEs was not related to age at treatment, although women ≥65 years were more likely to withdraw from treatment because of an AE than younger women.
KeywordsMetastatic breast cancer Capecitabine Chemotherapy Clinical trial Age Tolerability
The five studies, individually and pooled, were sponsored by Roche, manufacturer of Xeloda® (capecitabine). Editorial support was provided by Insight Medical Communications, NY, funded by Roche.
Conflict of interest
Dr. Joanne Blum serves as a consultant or advisor to Roche, manufacturer of capecitabine [Xeloda®]. Dr. Joseph Kohles was an employee of Roche Laboratories, Inc. at the time this study and manuscript were developed. Dr. Edward McKenna is an employee of Roche Laboratories, Inc. Dr. Nana Scotto is an employee of F. Hoffmann-La Roche. Dr. Sylvia Hu is an employee of Genentech-Roche and has stock ownership in F. Hoffman-La Roche. Roche sponsored the research summarized in this manuscript through funding to RTI Health Solutions, which employs Dawn Odom and Dr. James Kaye. Dr. Stefan Glück serves as a consultant or advisor for and has received honoraria and research support from Roche.
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