CLINICAL REPORTSLow-dose capecitabine plus docetaxel as first-line therapy for metastatic breast cancer: phase II resultsMichalaki, Vasiliki; Gennatas, Spyridon; Gennatas, KonstantineAuthor Information Oncology Clinic Department of Surgery, Areteion Hospital, University of Athens, Athens, Greece Correspondence to Professor Konstantine Gennatas, Oncology Clinic Department of Surgery, Areteion Hospital, University of Athens, Arnis 5, Athens 115 28, Greece Tel: +30 210 7244758; fax: +30 210 7246878; e-mail: [email protected] Received 21 September 2008 Revised form accepted 25 December 2008 Anti-Cancer Drugs: March 2009 - Volume 20 - Issue 3 - p 204-207 doi: 10.1097/CAD.0b013e328327d492 Buy Metrics 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.