Background: Adding bevacizumab to chemotherapy improves response rates and progression-free survival (PFS) in\nmetastatic breast cancer (mBC). We aimed to demonstrate decreased toxicity with metronomic chemotherapy/\nbevacizumab compared with paclitaxel/bevacizumab.\nMethods: This multicenter, randomized phase III trial compared bevacizumab with either paclitaxel (arm A) or daily\noral capecitabine-cyclophosphamide (arm B) as first-line treatment in patients with HER2-negative advanced breast\ncancer. The primary endpoint was the incidence of selected grade 3ââ?¬â??5 adverse events (AE) including: febrile\nneutropenia, infection, sensory/motor neuropathy, and mucositis. Secondary endpoints included objective response\nrate, disease control rate, PFS, overall survival (OS), quality of life (QoL), and pharmacoeconomics. The study was\nregistered prospectively with ClinicalTrials.gov, number NCT01131195 on May 25, 2010.\nResults: Between September 2010 and December 2012, 147 patients were included at 22 centers. The incidence of\nprimary endpoint-defining AEs was similar in arm A (25 % [18/71]; 95 % CI 15ââ?¬â??35 %) and arm B (24 % [16/68]; 95 %\nCI 13ââ?¬â??34 %; P = 0.96). Objective response rates were 58 % (42/73; 95 % CI 0.46ââ?¬â??0.69) and 50 % (37/74; 95 % CI 0.39ââ?¬â??\n0.61) in arms A and B, respectively (P = 0.45). Median PFS was 10.3 months (95 % CI 8.7ââ?¬â??11.3) in arm A and 8.\n5 months (95 % CI 6.5ââ?¬â??11.9) in arm B (P = 0.90). Other secondary efficacy endpoints were not significantly different\nbetween study arms. The only statistically significant differences in QoL were less hair loss and less numbness in\narm B. Treatment costs between the two arms were equivalent.Conclusion: This trial failed to meet its primary endpoint of a reduced rate of prespecified grade 3ââ?¬â??5 AEs with\nmetronomic bevacizumab, cyclophosphamide and capecitabine.
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