曲妥珠单抗Deruxtecan在以前治疗her2阳性乳腺癌。

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莫迪年代,01 C,山下式T,公园YH, Kim某人田村K,安德烈F,岩田聪H, Ito Y, Tsurutani J,孙J, Denduluri N,佩兰C, Aogi K, Tokunaga E, Im SA,李KS, Hurvitz SA议会J,李C,陈年代,张L, Shahidi J,青年志愿,Krop我

曲妥珠单抗Deruxtecan在以前治疗her2阳性乳腺癌。

郑传经地中海J。2019年12月11日。doi: 10.1056 / NEJMoa1914510。

PubMed ID
31825192 (在PubMed
]
文摘

背景:曲妥珠单抗deruxtecan (ds - 8201)是一种抗体药物共轭组成一个anti-HER2(人类表皮生长因子受体2)抗体,一个劈得开的tetrapeptide-based链接器,和细胞毒性拓扑异构酶抑制剂。在第一阶段研究的一项研究中,多数晚期her2阳性乳腺癌患者有响应曲妥珠单抗deruxtecan(平均响应时间,20.7个月)。曲妥珠单抗的功效deruxtecan her2阳性转移性乳腺癌患者以前用曲妥珠单抗治疗emtansine需要确认。方法:在这个由两部分组成,非盲、单一群体,多中心,第二阶段的研究中,我们评估曲妥珠单抗deruxtecan成人与her2阳性转移性乳腺癌病理记录收到前一曲妥珠单抗治疗emtansine。在第一部分的研究中,我们评估了三种不同剂量曲妥珠单抗deruxtecan建立推荐剂量;在第二部分中,我们评估推荐剂量的疗效和安全性。主要终点是客观缓解,根据独立的中央审查。关键的次级终点是疾病控制利率,临床效益率、响应时间和无进展生存,安全。结果:总体而言,184名患者此前曾接受过中等6治疗收到的推荐剂量曲妥珠单抗deruxtecan(5.4毫克/公斤体重)。在意向处理分析,对治疗的反应是在112年报道的患者(60.9%; 95% confidence interval [CI], 53.4 to 68.0). The median duration of follow-up was 11.1 months (range, 0.7 to 19.9). The median response duration was 14.8 months (95% CI, 13.8 to 16.9), and the median duration of progression-free survival was 16.4 months (95% CI, 12.7 to not reached). During the study, the most common adverse events of grade 3 or higher were a decreased neutrophil count (in 20.7% of the patients), anemia (in 8.7%), and nausea (in 7.6%). On independent adjudication, the trial drug was associated with interstitial lung disease in 13.6% of the patients (grade 1 or 2, 10.9%; grade 3 or 4, 0.5%; and grade 5, 2.2%). CONCLUSIONS: Trastuzumab deruxtecan showed durable antitumor activity in a pretreated patient population with HER2-positive metastatic breast cancer. In addition to nausea and myelosuppression, interstitial lung disease was observed in a subgroup of patients and requires attention to pulmonary symptoms and careful monitoring. (Funded by Daiichi Sankyo and AstraZeneca; DESTINY-Breast01 ClinicalTrials.gov number, NCT03248492.).

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药物
药物靶点
药物 目标 类 生物 药理作用 行动
gs - 441524 L RNA-directed RNA聚合酶 蛋白质 扎伊尔ebolavirus(应变mayinga - 76)
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