贝伐单抗在乳腺癌治疗中的疗效和风险评估

Benefit-risk Evaluation of Bevacizumab in the treatment of Breast Cancer

近年来贝伐单抗在乳腺癌治疗中备受争议。尽管E2100研究结果提示贝伐单抗联合化疗能使无进展生存期(PFS)提高一倍,但是之后的其他研究并没有重复该试验结果,各个独立研究和荟萃分析提示贝伐单抗联合化疗方案不能提高总生存期(OS)。美国FDA于2011年11月以贝伐单抗未能延长转移性乳腺癌患者的总生存期为理由撤销了其乳腺癌适应症的许可。另外,使用贝伐单抗可能发生严重的不良反应,如高血压、充血性心力衰竭和血栓等。因此,在全球范围内使用该药物需考虑其效价比,并对疗效和风险进行重新评估。未来的研究方向是以生物标记为基础,以筛选出能从贝伐单抗治疗中获益的乳腺癌人群。

Recently, bevacizumab in the treatment of advanced breast cancer is controver- sial. Although the E2100 had doubled the pro- gression-free survival when bevacizumab was added to chemotherapy, this magnitude of bene- fit could not be replicated in subsequent studies. Furthermore, individual studies and meta-analy- ses failed to demonstrate an overall survival ben- efit with the addition of bevacizumab to different chemotherapy regimens. The US FDA has with- drawn the approval of bevacizumab as a thera- peutic option for the treatment of metastatic breast cancer in November, 2011; because that it cannot prolong the overall survival time. 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 worldwide. Reevaluation of the benefit-versus-risk is indispensable. Bio- marker-based studies aiming to identify the sub- population of patients most likely to benefit from the addition of bevacizumab to standard chemo- therapy in breast cancer should be a research pri- ority in future.