• I Lang, M J Inbar, Z Kahán, R Greil, S Beslija, S M Stemmer, B Kaufman, Z Zvirbule, G G Steger, D Messinger, T Brodowicz, and C Zielinski.
• National Institute of Oncology, Oncology Department, Budapest, Hungary. lang@oncol.hu
• Eur. J. Cancer. 2012 Nov 1; 48 (17): 3140-9.

BackgroundWe report safety data from a randomised, phase III study (CECOG/BC.1.3.005) evaluating first-line bevacizumab plus paclitaxel or capecitabine for locally recurrent or metastatic breast cancer.Patients And MethodsPatients aged ≥18 years with human epidermal growth factor receptor-2-negative breast adenocarcinoma were randomised to Arm A: bevacizumab 10 mg/kg days 1 and 15; paclitaxel 90 mg/m(2) days 1, 8, and 15, every 4 weeks; or Arm B: bevacizumab 15 mg/kg day 1; capecitabine 1000 mg/m(2) b.i.d., days 1-14, every 3 weeks, until disease progression, unacceptable toxicity or consent withdrawal.ResultsA post hoc interim safety analysis included 561 patients (Arm A: 284, Arm B: 277). The regimens demonstrated similar frequencies of all-grade and serious adverse events (SAEs), but different safety profiles. Treatment-related events occurred in 85.2% (Arm A) and 78.0% (Arm B) of patients. Fatigue was most common in Arm A (30.6% versus 23.5% Arm B), and hand-foot syndrome (HFS) most common in Arm B (49.5% versus 2.5% Arm A). Diarrhoea (Arm A: 0.4%, Arm B: 1.4%) and pulmonary embolism (Arm A: 0.7%, Arm B: 1.1%) were the most frequently reported SAEs.ConclusionThese findings are in-line with safety data for bevacizumab plus paclitaxel or capecitabine, reported in previous phase III trials.Copyright © 2012 Elsevier Ltd. All rights reserved.

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