Benefit-risk assessment of bevacizumab in the treatment of breast cancer.

An evaluation of the benefit-versus-risk of bevacizumab in the treatment of advanced breast cancer is timely and relevant. Recently, the US FDA has withdrawn the approval of bevacizumab as a therapeutic option for the treatment of advanced breast cancer, generating controversy in the scientific community. Although the pivotal study (Eastern Cooperative Oncology Group 2100 trial [E2100]) had shown doubling of the progression-free survival when bevacizumab was added to chemotherapy, this magnitude of benefit could not be replicated in subsequent studies. Furthermore, individual studies and meta-analyses failed to demonstrate an overall survival benefit with the addition of bevacizumab to different chemotherapy regimens. In addition, this agent is associated with an increased incidence of serious adverse events such as hypertension, congestive heart failure and thromboembolism, and its cost is likely to be a consideration in its use for many patients worldwide. Retrospective biomarker-based studies aiming to identify the subpopulation of patients most likely to benefit from the addition of bevacizumab to standard chemotherapy in breast cancer should be a research priority.