Molecular Therapeutic Research Unit, Medical Oncology Department, Vall dHebron Institute of Oncology, Barcelona, Spain.
Drug Saf. 2012 Jan 1;35(1):15-25. doi: 10.2165/11595910-000000000-00000.
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 Recently, the US FDA has withdrawn the approval of bevacizumab as a therapeutic option for the treatment of advanced breast cancer, generating controversy in the scientific community.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.
评估贝伐珠单抗治疗晚期乳腺癌的获益与风险是及时且相关的。最近，美国食品药品监督管理局（FDA）撤回了贝伐珠单抗作为晚期乳腺癌治疗选择的批准，这在科学界引起了争议。尽管关键性研究（东部肿瘤协作组 2100 试验[E2100]）表明，贝伐珠单抗联合化疗可使无进展生存期延长一倍，但随后的研究未能复制这种获益程度。此外，个别研究和荟萃分析未能证明在不同的化疗方案中加入贝伐珠单抗可带来总体生存获益。此外，该药物与严重不良事件的发生率增加有关，如高血压、充血性心力衰竭和血栓栓塞，其成本可能是全球许多患者使用该药物的一个考虑因素。基于生物标志物的回顾性研究旨在确定最有可能从贝伐珠单抗联合标准化疗中获益的乳腺癌患者亚群，这应该是一个研究重点。
