帕妥珠单抗、曲妥珠单抗和多西他赛在HER2阳性转移乳腺癌中的疗效研究 - NEJM医学前沿
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帕妥珠单抗、曲妥珠单抗和多西他赛在HER2阳性转移乳腺癌中的疗效研究
Pertuzumab, Trastuzumab, and Docetaxel in HER2-Positive Metastatic Breast Cancer


Sandra M. Swain ... 肿瘤 • 2015.02.19
相关阅读
• 用曲妥珠单抗生物类似药治疗HER2阳性乳腺癌 • ASCO 2017报告——乳腺癌 • 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

在人表皮生长因子受体2(HER2)阳性的转移乳腺癌患者中,一线治疗方案帕妥珠单抗、曲妥珠单抗联合多西他赛,与安慰剂、曲妥珠单抗联合多西他赛治疗相比,无进展生存期显著延长。在中期分析中,帕妥珠单抗治疗的患者总生存期显著延长,但尚未达到中位数。我们报道了中位随访50个月的预期总生存期结果。


方法

我们将以前未接受过针对转移疾病化疗或抗HER2治疗的转移乳腺癌患者随机分组,分别接受帕妥珠单抗联合治疗或安慰剂联合治疗,次要研究终点是总生存期、研究者评估的无进展生存期、独立评估的反应缓解时间和安全性。中期分析后,对那些从安慰剂组交叉到帕妥珠单抗组的患者进行了敏感度分析。


结果

帕妥珠单抗联合治疗的患者中位总生存期为56.5个月(95%可信区间[CI]:49.3~未达到),安慰剂联合治疗的患者中位总生存期为40.8个月(95% CI,35.8~48.3),两者相差15.7个月(帕妥珠单抗组相比较优,风险比,0.68;95% CI,0.56~0.84;P<0.001)。该分析结果相对保守,没有根据交叉到帕妥珠单抗组的患者进行调整。经调整后的敏感度分析与该分析结果一致。在帕妥珠单抗组,研究者评估的无进展生存期延长了6.3个月(风险比,0.68;95% CI,0.58~0.80)。独立评估显示帕妥珠单抗延长了中位缓解时间7.7个月。大多数的不良事件发生在两组的多西他赛治疗期间,但是心脏的安全性一直保持不变。


结论

与安慰剂比较,帕妥珠单抗联合曲妥珠单抗和多西他赛治疗HER2阳性的转移乳腺癌,显著延长患者的中位总生存期至56.5个月,延伸了在以前结果中显示的帕妥珠单抗联合治疗的有效性(由F·霍夫曼-罗氏/基因泰克公司[F. Hoffmann–La Roche/Genentech]资助;CLEOPATRA在ClinicalTrials.gov注册号为NCT00567190)。





作者信息

Sandra M. Swain, M.D., José Baselga, M.D., Sung-Bae Kim, M.D., Jungsil Ro, M.D., Vladimir Semiglazov, M.D., Mario Campone, M.D., Eva Ciruelos, M.D., Jean-Marc Ferrero, M.D., Andreas Schneeweiss, M.D., Sarah Heeson, B.Sc., Emma Clark, M.Sc., Graham Ross, F.F.P.M., Mark C. Benyunes, M.D., and Javier Cortés, M.D., forthe CLEOPATRA Study Group*
The authors' affiliations are listed in the Appendix. Address reprint requests to Dr. Swain at the Washington Cancer Institute, MedStar Washington Hospital Center, 110 Irving St., Washington, DC 20010, or at sandra.m.swain@medstar.net. *A complete list of investigators in the Clinical Evaluation of Pertuzumab and Trastuzumab (CLEOPATRA) study is provided in the Supplementary Appendix, available at NEJM.org.

 

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