患有BRCA1/2变异的固体瘤患者的Olaparib:来自向剂和分析利用注册表 (TAPUR) 研究的结果
Tareq Al Baghdadi1, Michael Rothe2, Pam K Mangat2
1Michigan Cancer Research Consortium, IHA Hematology Oncology, Ypsilanti, MI.
JCO precision oncology
|October 16, 2025
概括
奥拉巴里布在患有 BRCA1/2 突变的高级固体瘤的患者中表现出显著的抗瘤活性. 这种向疗法在多种癌症类型中显示出有希望的疾病控制率,需要进一步调查.
科学领域:
- 在瘤学瘤学.
- 基因组学就是基因组学.
- 临床试验 临床试验
背景情况:
- 针对性代理和分析利用注册表研究 (TAPUR) 是一个第二阶段的篮子试验.
- 在具有基因组改变的晚期癌症中研究向剂.
研究的目的:
- 评估olaparib在患有晚期固体瘤和BRCA1/2突变的患者中的抗瘤活性.
- 评估olaparib在五种不同的癌症队伍中的疗效:乳腺,胆道,肺,子宫和其他固体瘤.
主要方法:
- 第二阶段的篮子试验设计与五个患者队列.
- 主要终点:疾病控制 (DC) 率定义为完全响应,部分响应或至少16周的稳定疾病 (SD).
- 利用西蒙的两阶段设计,用于组织学特定的队列和一个单面的精确二项式测试,用于较小的队列.
主要成果:
- 招募了119名患有BRCA1/2-改变的高级固体瘤的患者.
- 在所有队列中实现了显著的疾病控制率,超过了15%的DC的零假设.
- 报告的DC率在41%至69%之间,在乳腺癌和胆道癌症中显著有效.
结论:
- 奥拉巴里布在患有各种高级BRCA1/2-改变的固体瘤的患者中显示出临床活性信号.
- 该研究符合其宣布有效性的预规定的标准.
- 结果支持olaparib作为BRCA1/2-突变固体恶性瘤的潜在向治疗.
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