阿比拉和奥拉巴里布用于转移性割抵抗性前列腺癌
Noel W Clarke1, Andrew J Armstrong2, Antoine Thiery-Vuillemin3
1The Christie and Salford Royal Hospital NHS Foundation Trusts, University of Manchester, Manchester, United Kingdom.
NEJM evidence
|February 6, 2024
概括
结合阿比拉和奥拉巴里布,在患有转移性割抵抗性前列腺癌的男性中显著改善了无进展的生存率. 这一一线治疗证明了显著的好处,无论同源复合修复基因突变状态.
科学领域:
- 在瘤学瘤学.
- 临床药理学 临床药理学
- 生殖尿道癌症 生殖尿道癌症
背景情况:
- 临床前和第二阶段的数据表明,阿比拉 (下一代激素剂) 和奥拉巴里布 (一种多ADP-ribose) 聚合酶抑制剂) 之间具有协同作用的抗瘤作用.
- 这种组合疗法正在研究转移性割抵抗性前列腺癌 (mCRPC).
研究的目的:
- 评估结合abiraterone与olaparib相对abiraterone与安慰剂在mCRPC的第一线治疗中的疗效和安全性.
- 评估基于成像的无进展生存率 (ibPFS) 作为主要终点.
主要方法:
- 一个双盲的第3期试验随机分组1:1的mCRPC患者接受abiraterone加上prednisone/prednisolone与olaparib或安慰剂.
- 患者被录取,不管同源复合修复基因突变 (HRRm) 状态如何,在注册后进行评估.
- 主要终点是研究人员评估的IBPFS;整体存活率是次要终点.
主要成果:
- 与阿比拉加安药 (16.6个月) 相比,阿比拉加安药手臂 (24.8个月) 的ibPFS中位数显著更长 (HR,0.66;P<0.001).
- 研究人员评估和盲目的独立中央审查之间的结果一致.
- 在初级分析时,总生存数据还不成熟 (HR,0.86;P=0.29).
- 安全性概况与已知的个体药物概况一致;常见的不良事件包括贫血,疲劳/喘息和恶心.
结论:
- 与阿比拉加安慰剂相比,mCRPC与阿比拉结合olaparib的第一线治疗显著延长了IBPFS.
- 无论HRRm状态如何,在注册的患者中都观察到这种益处.
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