UM/Sylvester Comprehensive Cancer Center, University of Miami, Miller School of Medicine, Miami, FL, USA.
Curr Oncol Rep. 2012 Feb;14(1):1-11. doi: 10.1007/s11912-011-0202-z.
Metastatic breast cancer (MBC) is a major cause of death among women worldwide. Progress has been made in treating MBC with the advent of anti-estrogen therapies, potent cytotoxic agents, and monoclonal antibodies. Bevacizumab is a monoclonal antibody against circulating vascular endothelial growth factor (VEGF), which was approved in 2008 by the US Food and Drug Administration (FDA), for first-line treatment of HER-2 negative MBC in combination with paclitaxel. The FDA then reversed this decision in December 2010 by recommending removal of the MBC indication from bevacizumab, citing primarily safety concerns, and that these risks did not outweigh the ability of bevacizumab to significantly prolong progression-free survival. This decision was unexpected in the oncology community and remains controversial. This review looks at all available phase 3 data with bevacizumab in the MBC setting to determine whether the data support this decision by the FDA, and discusses the future of bevacizumab in breast cancer.
转移性乳腺癌(MBC)是全球女性死亡的主要原因。随着抗雌激素治疗、有效细胞毒性药物和单克隆抗体的出现,MBC 的治疗取得了进展。贝伐珠单抗是一种针对循环血管内皮生长因子(VEGF)的单克隆抗体,于 2008 年被美国食品和药物管理局(FDA)批准与紫杉醇联合用于 HER-2 阴性 MBC 的一线治疗。随后,FDA 在 2010 年 12 月推翻了这一决定,建议将贝伐珠单抗的 MBC 适应证从其说明书中删除,主要是出于安全性方面的考虑,并且认为这些风险大于贝伐珠单抗显著延长无进展生存期的能力。这一决定在肿瘤学界出人意料,仍然存在争议。本文回顾了贝伐珠单抗在 MBC 治疗中的所有可用的 3 期数据,以确定这些数据是否支持 FDA 的这一决定,并讨论了贝伐珠单抗在乳腺癌中的未来。