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曲妥珠单抗辅助治疗在HER2阳性乳腺癌中的应用
Adjuvant Trastuzumab in HER2-Positive Breast Cancer


Dennis Slamon ... 肿瘤 • 2011.10.06
相关阅读
• 用曲妥珠单抗生物类似药治疗HER2阳性乳腺癌 • 来那替尼治疗HER2阳性乳腺癌:5年结局 • 帕妥珠单抗和曲妥珠单抗辅助治疗早期HER2阳性乳腺癌 • 双重靶向HER2阳性乳腺癌

摘要


背景

曲妥珠单抗改善了HER阳性乳腺癌患者的生存,虽然与蒽环类为基础的化疗方案的联合使用增加了心脏毒性。我们的目的是评价一种新的不含蒽环类药物的曲妥珠单抗方案的有效性及安全性。


方法

我们随机选取3,222名HER2阳性早期乳腺癌女性患者,让她们接受多柔比星+环磷酰胺序贯多西他赛 (AC-T)每3周1次的化疗,相同疗法加上52周的曲妥珠单抗治疗(AC-T加曲妥珠单抗),或者多西他赛+卡铂加52周曲妥珠单抗治疗(TCH)。主要研究终点为无病生存。次要终点为总生存率和安全性。


结果

在65个月中位随访期中,656次事件触发了方案特定的分析。接受AC-T方案的患者5年无病生存率估计为75%,AC-T加曲妥珠单抗的人群为84%,接受TCH的人群则为81%。估计总生存率分别为87%、92%和91%。包含曲妥珠单抗的两种方案之间无病生存率和总生存率并无显著差异,但是两者都比AC-T的结果好。充血性心力衰竭和心脏功能不全的发生率在AC-T加曲妥珠单抗组显著高于TCH组(P<0.001)。本研究报告了8例急性白血病:其中7例出现在使用蒽环类方案的患者中,另外1例则是在TCH组中,该病例之前在本研究之外接受过蒽环类药物治疗。


结论

增加1年的曲妥珠单抗辅助治疗明显改善了HER2阳性乳腺癌患者的无病生存率和总生存率。从风险效益比来看,不含蒽环类的TCH方案优于AC-T加曲妥珠单抗方案。该结论基于TCH具有相似的疗效、较少的急性毒作用、较低的心脏毒性和白血病风险(由赛诺菲-安万特[Sanofi-Aventis]和基因泰克[Genentech]公司提供资助,BCIRG-006研究在ClinicalTrials.gov注册号为NCT00021255)。





作者信息

Dennis Slamon, M.D., Ph.D., Wolfgang Eiermann, M.D., Nicholas Robert, M.D., Tadeusz Pienkowski, M.D., Miguel Martin, M.D., Michael Press, M.D., Ph.D., John Mackey, M.D., John Glaspy, M.D., Arlene Chan, M.D., Marek Pawlicki, M.D., Tamas Pinter, M.D., Vicente Valero, M.D., Mei-Ching Liu, M.D., Guido Sauter, M.D., Gunter von Minckwitz, M.D., Frances Visco, J.D., Valerie Bee, M.Sc., Marc Buyse, Sc.D., Belguendouz Bendahmane, M.D., Isabelle Tabah-Fisch, M.D., Mary-Ann Lindsay, Pharm.D., Alessandro Riva, M.D., and John Crown, M.D., for the Breast Cancer International Research Group*
The authors' affiliations are listed in the Appendix. Address reprint requests to Dr. Slamon at the University of California–Los Angeles, 10945 Le Conte Ave., Suite 3360, Los Angeles, CA 90095-1678, or at dslamon@mednet.ucla.edu. *Additional investigators in the Breast Cancer International Research Group (BCIRG) 006 study are listed in the Supplementary Appendix, available at NEJM.org.

 

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