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具有ATM变化的固体瘤患者的Olaparib:来自向剂和分析利用注册表 (TAPUR) 研究的结果
Daniel R Carrizosa1, Michael Rothe2, Pam K Mangat2
1Atrium Health Levine Cancer Institute, Wake Forest University School of Medicine, Charlotte, NC.
JCO precision oncology
|January 15, 2026
概括
奥拉巴里布在患有ATM改变的肺癌和其他固体瘤的患者中显示出抗瘤活性. 然而,它在这个II期试验中没有满足结直肠或胰腺癌患者的疗效标准.
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.
- 这项研究评估了针对癌症晚期和特定基因组变化的患者的向药物的疗效.
研究的目的:
- 评估olaparib在患有ATM改变结直肠癌 (CRC),肺癌 (LC),胰腺癌 (PC) 和其他固体瘤 (组织学聚合,HP) 的患者中的抗瘤活性.
主要方法:
- 纳入了患有晚期固体瘤和ATM变化的患者.
- 主要终点是疾病控制 (DC) 率,定义为客观反应 (OR) 或至少16周的稳定疾病 (SD).
- 统计分析使用西蒙的两阶段设计,用于组织学特定的队列和HP队列的片面90%CI.
主要成果:
- 疾病控制 (DC) 率为CRC的23%,LC的45%,PC的28%,HP的25%.
- 对于LC和HP队列,15%的直流率的零假设被拒绝.
- 17%的患者经历了3级或严重的不良事件.
结论:
- 奥拉巴里布在患有ATM改变的肺癌和其他固体瘤的患者中显示出活性信号.
- 奥拉巴里布在ATM改变的结直肠和胰腺癌队列中不符合预先规定的疗效标准.
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