紫杉醇联合曲妥珠单抗辅助治疗淋巴结阴性HER2阳性乳腺癌 - NEJM医学前沿
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紫杉醇联合曲妥珠单抗辅助治疗淋巴结阴性HER2阳性乳腺癌
Adjuvant Paclitaxel and Trastuzumab for Node-Negative, HER2-Positive Breast Cancer


Sara M. Tolaney ... 肿瘤 • 2015.01.08
相关阅读
• 用曲妥珠单抗生物类似药治疗HER2阳性乳腺癌 • 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

迄今为止,对于肿瘤体积小、淋巴结阴性、人类表皮生长因子受体2型(human epidermal growth factor receptor type 2,HER2)表达阳性乳腺癌尚无一种标准治疗方案,其原因在于绝大多数这样的患者不符合曲妥珠单抗辅助治疗的关键性临床试验的纳入标准。


方法

我们完成了一项非对照、单组、多中心、由研究者发起的紫杉醇联合曲妥珠单抗辅助治疗研究,共计纳入406名肿瘤最大直径不超过3 cm的乳腺癌患者。入组患者前12周每周接受紫杉醇联合曲妥珠单抗治疗,随后的9个月接受曲妥珠单抗单药治疗。试验的主要终点是无侵袭性疾病生存。


结果

中位随访期4年。3年无侵袭性疾病生存率是98.7%(95%可信区间,97.6~99.8)。在12个复发病例中,2例是由于出现乳腺癌远处转移。除了对侧HER2阴性乳腺癌和其他组织癌之外,还发现7种特异性疾病事件。总共有13例患者(3.2%;95%可信区间,1.7~5.4)出现至少发作1次的3级神经病变。2例患者(0.5%;95%可信区间,0.1~1.8)出现有症状的充血性心力衰竭,并且这2例在停用曲妥珠单抗后左心室射血分数恢复正常。总共有13例患者出现有意义的无症状的射血分数下降(3.2%;95%可信区间,1.7~5.4),但是根据本研究的规定,上述13例患者中有11例在短暂停药之后恢复曲妥珠单抗治疗。

 

结论

在Ⅰ期HER2阳性乳腺癌女性患者中,紫杉醇联合曲妥珠单抗辅助治疗的早期复发风险率大约是2%;由于出现规定方案中的不良事件,有6%的患者退出本研究(由Genentech资助;ClinicalTrials.gov注册号为NCT00542451)。





作者信息

Sara M. Tolaney, M.D., M.P.H., William T. Barry, Ph.D., Chau T. Dang, M.D., Denise A. Yardley, M.D., Beverly Moy, M.D., M.P.H., P. Kelly Marcom, M.D., Kathy S. Albain, M.D., Hope S. Rugo, M.D., Matthew Ellis, M.B., B.Chir., Ph.D., Iuliana Shapira, M.D., Antonio C. Wolff, M.D., Lisa A. Carey, M.D., Beth A. Overmoyer, M.D., Ann H. Partridge, M.D., M.P.H., Hao Guo, M.S., Clifford A. Hudis, M.D., Ian E. Krop, M.D., Ph.D., Harold J. Burstein, M.D., Ph.D., and Eric P. Winer, M.D.
The authors’ affiliations are listed in the Appendix. Address reprint requests to Dr. Winer at the Department of Medical Oncology, Dana–Farber Cancer Institute, 450 Brookline Ave., Boston, MA 02215, or at ewiner@partners.org.

 

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