Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer
Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer
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DOI：
10.1056/nejmoa2028485
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发表时间：
2021-04-22
影响因子：
158.5
通讯作者：
Rugo, H. S.
中科院分区：
文献类型：
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作者：
Bardia, A.;Hurvitz, S. A.;Rugo, H. S.
背景
转移性三阴性乳腺癌患者预后较差。戈沙妥珠单抗是一种抗体偶联药物，由靶向人滋养层细胞表面抗原2（Trop - 2，大多数乳腺癌中均有表达）的抗体通过专有的可水解连接子与SN - 38（拓扑异构酶I抑制剂）偶联而成。
方法
在这项随机3期试验中，我们对复发或难治性转移性三阴性乳腺癌患者，比较了戈沙妥珠单抗与医生选择的单药化疗（艾立布林、长春瑞滨、卡培他滨或吉西他滨）的疗效。主要终点是无脑转移患者的无进展生存期（由盲态独立中心审查确定）。
结果
共有468例无脑转移患者被随机分配接受戈沙妥珠单抗（235例患者）或化疗（233例患者）。中位年龄为54岁；所有患者既往均使用过紫杉类药物。戈沙妥珠单抗组的中位无进展生存期为5.6个月（95%置信区间[CI]，4.3～6.3；166个事件），化疗组为1.7个月（95%CI，1.5～2.6；150个事件）（疾病进展或死亡风险比为0.41；95%CI，0.32～0.52；P 此处P值未给出完整 ）
BackgroundPatients with metastatic triple-negative breast cancer have a poor prognosis. Sacituzumab govitecan is an antibody-drug conjugate composed of an antibody targeting the human trophoblast cell-surface antigen 2 (Trop-2), which is expressed in the majority of breast cancers, coupled to SN-38 (topoisomerase I inhibitor) through a proprietary hydrolyzable linker.MethodsIn this randomized, phase 3 trial, we evaluated sacituzumab govitecan as compared with single-agent chemotherapy of the physician's choice (eribulin, vinorelbine, capecitabine, or gemcitabine) in patients with relapsed or refractory metastatic triple-negative breast cancer. The primary end point was progression-free survival (as determined by blinded independent central review) among patients without brain metastases.ResultsA total of 468 patients without brain metastases were randomly assigned to receive sacituzumab govitecan (235 patients) or chemotherapy (233 patients). The median age was 54 years; all the patients had previous use of taxanes. The median progression-free survival was 5.6 months (95% confidence interval [CI], 4.3 to 6.3; 166 events) with sacituzumab govitecan and 1.7 months (95% CI, 1.5 to 2.6; 150 events) with chemotherapy (hazard ratio for disease progression or death, 0.41; 95% CI, 0.32 to 0.52; P