• E A Perez, D W Hillman, T Dentchev, N A Le-Lindqwister, L H Geeraerts, T R Fitch, H Liu, D L Graham, S P Kahanic, H M Gross, T A Patel, F M Palmieri, and A C Dueck.
• Multidisciplinary Breast Clinic and Breast Cancer Program, Mayo Clinic, Jacksonville, FL. Electronic address: perez.edith@mayo.edu.
• Ann. Oncol. 2010 Feb 1; 21 (2): 269-274.

BackgroundDocetaxel (T; Taxotere) with capecitabine (X) is active against metastatic breast cancer (MBC); bevacizumab (BV) has demonstrated efficacy with taxanes in the first-line setting. This study was conducted to assess the safety and efficacy of TX-BV in patients with MBC.Patients And MethodsIn this single-arm, multicenter phase II study, patients received first-line bevacizumab 15 mg/kg and docetaxel 75 mg/m(2) on day 1 and capecitabine 825 mg/m(2) twice per day on days 1-14 every 21 days. Primary and secondary end points were tumor response rate (RR), overall survival (OS), progression-free survival (PFS), and toxicity.ResultsA total of 45 assessable patients received TX-BV for a median of seven cycles. Two complete and 20 partial responses were observed (overall RR 49%); nine patients had stable disease >6 months, for a clinical benefit rate of 69%. Median response duration was 11.8 months. Median OS and PFS were 28.4 and 11.1 months, respectively. Grade 3/4 adverse events included hand-foot syndrome (29%), fatigue (20%), febrile neutropenia (18%), and diarrhea (18%). In cycles 3-10, median dose levels of docetaxel and capecitabine were 60 mg/m(2) and 660 mg/m(2), respectively.ConclusionTX-BV demonstrated significant activity; dose modifications were required to manage drug-related toxic effects.

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