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Anti-Cancer Drugs:
doi: 10.1097/CAD.0b013e328327d492
Clinical Reports

Low-dose capecitabine plus docetaxel as first-line therapy for metastatic breast cancer: phase II results

Michalaki, Vasiliki; Gennatas, Spyridon; Gennatas, Konstantine

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Abstract

The addition of capecitabine to docetaxel significantly improves overall survival in anthracycline-pretreated metastatic breast cancer. We evaluated a low-dose capecitabine–docetaxel regimen as first-line therapy. Patients who had received adjuvant anthracyclines received docetaxel 75 mg/m2 on day 1 and capecitabine 950 mg/m2 twice daily, days 1–14, every 3 weeks until disease progression or unacceptable toxicity. The primary endpoint was time to progression. Forty-five patients were evaluable (median age 56 years, range 35–75). The response rate was 42%, including two complete responses. Nine patients (20%) attained stable disease. Median time to progression was 8 months and median overall survival was 23 months. Five patients (11%) experienced grade 3 neutropenia but febrile neutropenia was absent. Three patients (7%) experienced grade 3 hand–foot syndrome; there was no significant gastrointestinal toxicity. This capecitabine–docetaxel regimen is an active first-line therapy and appears better tolerated than regimens using a higher capecitabine dose. Data from the randomized trial comparing the registered versus a lower capecitabine dose, both in combination with docetaxel, should definitively answer whether a lower dose provides a better safety profile while maintaining the considerable efficacy of this combination.

© 2009 Lippincott Williams & Wilkins, Inc.

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