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Superior Survival With Capecitabine Plus Docetaxel Combination Therapy In Anthracycline-Pretreated Patients With Advanced Breast Cancer: Phase III Trial Results

Joyce O’Shaughnessy, David Miles, Svetislava Vukelja, Vladimir Moiseyenko, Jean-Pierre Ayoub, Guadalupe Cervantes, Pierre Fumoleau, Stephen Jones, Wing-Yiu Lui, Louis Mauriac, Chris Twelves, Guy Van Hazel, Shailendra Verma, Robert Leonard

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PURPOSE: Docetaxel and capecitabine, a tumor-activated oral fluoropyrimidine, show high single-agent efficacy in metastatic breast cancer (MBC) and synergy in preclinical studies. This international phase III trial compared efficacy and tolerability of capecitabine/docetaxel therapy with single-agent docetaxel in anthracycline-pretreated patients with MBC. PATIENTS AND METHODS: Patients were randomized to 21-day cycles of oral capecitabine 1,250 mg/m2 twice daily on days 1 to 14 plus docetaxel 75 mg/m2 on day 1 (n = 255) or to docetaxel 100 mg/m2 on day 1 (n = 256). RESULTS: Capecitabine/docetaxel resulted in significantly superior efficacy in time to disease progression (TTP) (hazard ratio, 0.652; 95% confidence interval [CI], 0.545 to 0.780; P = .0001; median, 6.1 v 4.2 months), overall survival (hazard ratio, 0.775; 95% CI, 0.634 to 0.947; P = .0126; median, 14.5 v 11.5 months), and objective tumor response rate (42% v 30%, P = .006) compared with docetaxel. Gastrointestinal side effects and hand-foot syndrome were more common with combination therapy, whereas myalgia, arthralgia, and neutropenic fever/sepsis were more common with single-agent docetaxel. More grade 3 adverse events occurred with combination therapy (71% v 49%, respectively), whereas grade 4 events were slightly more common with docetaxel (31% v 25% with combination). CONCLUSION: The significantly superior TTP and survival achieved with the addition of capecitabine to docetaxel 75 mg/m2, with the manageable toxicity profile, indicate that this combination provides clear benefits over single-agent docetaxel 100 mg/m2. Docetaxel/capecitabine therapy is an important treatment option for women with anthracycline-pretreated MBC.