E A Perez1, D W Hillman2, T Dentchev3, N A Le-Lindqwister4, L H Geeraerts5, T R Fitch6, H Liu2, D L Graham7, S P Kahanic8, H M Gross9, T A Patel10, F M Palmieri10, A C Dueck6. 1. Multidisciplinary Breast Clinic and Breast Cancer Program, Mayo Clinic, Jacksonville, FL. Electronic address: perez.edith@mayo.edu. 2. Mayo Clinic, Rochester, MN. 3. Altru Health Systems, Grand Forks, ND. 4. Illinois Oncology Research Association Community Clinical Oncology Program, Peoria, IL. 5. Community Clinical Oncology Program, MeritCare Hospital, Fargo, ND. 6. Mayo Clinic, Scottsdale, AZ. 7. Carle Cancer Center, Urbana, IL. 8. Siouxland Hematology-Oncology Associates, Sioux City, IA. 9. Hematology and Oncology of Dayton, Inc., Dayton, OH, USA. 10. Multidisciplinary Breast Clinic and Breast Cancer Program, Mayo Clinic, Jacksonville, FL.
Abstract
BACKGROUND: Docetaxel (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 METHODS: In 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. RESULTS: A 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. CONCLUSION: TX-BV demonstrated significant activity; dose modifications were required to manage drug-related toxic effects.
BACKGROUND:Docetaxel (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 METHODS: In 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. RESULTS: A 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. CONCLUSION: TX-BV demonstrated significant activity; dose modifications were required to manage drug-related toxic effects.
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