Trastuzumab Deruxtecan versus Trastuzumab Emtansine for Breast Cancer
Trastuzumab Deruxtecan versus Trastuzumab Emtansine for Breast Cancer
复制标题
DOI：
10.1056/nejmoa2115022
复制
发表时间：
2022-03-24
影响因子：
158.5
通讯作者：
Hurvitz, S. A.
中科院分区：
文献类型：
--
作者：
Cortes, J.;Kim, S. -B;Hurvitz, S. A.
研究背景曲妥珠单抗-美坦新偶联物是目前用于人表皮生长因子受体2（HER 2）阳性转移性乳腺癌患者的标准治疗方法，该患者的疾病在用抗HER 2抗体和紫杉烷的组合治疗后进展。比较曲妥珠单抗deruxtecan的疗效和安全性的随机试验在先前用曲妥珠单抗和紫杉烷治疗的患有HER 2阳性转移性乳腺癌的患者中，曲妥珠单抗-美坦新偶联物（HER 2抗体-药物缀合物）与曲妥珠单抗-美坦新偶联物的那些的差异。主要终点是无进展生存期（由设盲独立中心审查确定）;在524例随机分配的患者中，12个月时无疾病进展的存活率为75.8%，（95%置信区间[CI]，69.8 - 80.7），曲妥珠单抗和34.1%曲妥珠单抗-美坦新偶联物（95% CI，27.7 - 40.5）（进展或全因死亡的风险比，0.28; 95% CI，0.22 - 0.37; P
BACKGROUNDTrastuzumab emtansine is the current standard treatment for patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer whose disease progresses after treatment with a combination of anti-HER2 antibodies and a taxane.METHODSWe conducted a phase 3, multicenter, open-label, randomized trial to compare the efficacy and safety of trastuzumab deruxtecan (a HER2 antibody-drug conjugate) with those of trastuzumab emtansine in patients with HER2-positive metastatic breast cancer previously treated with trastuzumab and a taxane. The primary end point was progression-free survival (as determined by blinded independent central review); secondary end points included overall survival, objective response, and safety.RESULTSAmong 524 randomly assigned patients, the percentage of those who were alive without disease progression at 12 months was 75.8% (95% confidence interval [CI], 69.8 to 80.7) with trastuzumab deruxtecan and 34.1% (95% CI, 27.7 to 40.5) with trastuzumab emtansine (hazard ratio for progression or death from any cause, 0.28; 95% CI, 0.22 to 0.37; P