在转移性乳腺癌的内分泌治疗后,Trastuzumab Deruxtecan可以治疗转移性乳腺癌
Aditya Bardia1, Xichun Hu1, Rebecca Dent1
1From Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, and Massachusetts General Hospital, Boston, MA (A.B.); the Department of Medical Oncology, Fudan University Shanghai Cancer Center, and the Department of Oncology, Shanghai Medical College, Fudan University, Shanghai (X.H.), and Harbin Medical University Cancer Hospital, Harbin (Q.Z.) - all in China; the Division of Medical Oncology, National Cancer Center Singapore, Singapore (R.D.); National Cancer Center Hospital, Tokyo (K.Y.); the Latin American Cooperative Oncology Group, Porto Alegre, Brazil (C.H.B.); Texas Oncology and US Oncology, Baylor University Medical Center, Dallas (J.A.O.); the Department of General Medical Oncology, University Hospitals Leuven, Leuven, Belgium (H.W.); the Department of Medical Oncology, Institut Curie and Université Paris Cité, Paris (J.-Y.P.), Centre François Baclesse, Caen (C.L.), and the Department of Medical Oncology, Institut du Cancer de Montpellier, Université de Montpellier, INSERM Unité 1194, Montpellier (W.J.) - all in France; Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (C.S.); the Department of Oncology, Santo Stefano Hospital, Azienda Unità Sanitaria Locale Toscana Centro, Prato (L.B.), and the European Institute of Oncology, IRCCS, and the Department of Oncology and Hematology-Oncology, University of Milan, Milan (G.C.) - all in Italy; the Division of Medical Oncology, Yonsei Cancer Center (J.S.), and the Department of Internal Medicine, Seoul National University Hospital (S.-A.I.) - both in Seoul, South Korea; Clinical Development, Late-Stage Development, Oncology Research and Development, AstraZeneca, Cambridge, United Kingdom (N.B., G.P.); and Biometrics Oncology, Late-Stage Development, Oncology Research and Development, AstraZeneca, Waltham, MA (J.K.).
与化疗相比,Trastuzumab deruxtecan显著改善了激素受体阳性,HER2低转移性乳腺癌患者的无进展生存率. 这为之前接受内分泌治疗的患者提供了新的治疗选择.
科学领域:
- 在瘤学瘤学.
- 医学研究 医学研究
背景情况:
- 激素受体阳性转移性乳腺癌的结果在内分泌治疗后下降.
- 特拉斯图祖马布德鲁克斯泰坎在化学治疗后的低HER2转移性乳腺癌中显示出有前途.
研究的目的:
- 为了评估trastuzumab deruxtecan与化疗在激素受体阳性,HER2-低或HER2-超低转移性乳腺癌患者的疗效.
- 评估无进展生存率 (PFS) 和整体生存率 (OS) 作为初级和二级终点.
主要方法:
- 第三阶段,多中心,开放标签试验,比较trastuzumab deruxtecan与医生选择的化疗.
- 随机的1:1分配,用于先前接受内分泌疗法治疗的HER2-低 (IHC 1-2+,ISH-) 或HER2-超低 (IHC 0) 转移性乳腺癌患者.
- 主要终点:HER2-低人群中的PFS;次要终点:所有随机选择的患者中的PFS,生存状况和安全性.
主要成果:
- 在HER2低患者中,PFS的中位数为13.2个月,与Trastuzumab deruxtecan相比,化学疗法为8.1个月 (HR为0.62,P<0.001).
- 在HER2-ultralow亚组中观察到一致的结果.
- 3级以上的不良事件发生在52.8% (特拉斯图祖马布德鲁克斯坦) 和44.4% (化疗) 的患者中;判定间歇性肺病/肺炎发生在11.3%和0.2%的患者中.
结论:
- 在内分泌治疗后,Trastuzumab deruxtecan在激素受体阳性,HER2-低/超低转移性乳腺癌患者中与化疗相比显示出优异的PFS.
- 对于trastuzumab deruxtecan没有发现新的安全问题.
- 这项研究提供了证据,证明特拉斯图祖马布德鲁克斯泰坎在这个患者群体中是有效的治疗选择.
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