对于具有BRAF变异的固体瘤患者的Regorafenib:来自向剂和分析利用注册表 (TAPUR) 研究的结果
Vaibhav Sahai1, Michael Rothe2, Pam K Mangat2
1University of Michigan Rogel Cancer Center, Ann Arbor, MI.
JCO precision oncology
|April 11, 2024
概括
在BRAF变异的晚期固体瘤中,雷戈拉费尼不表现出显著的抗瘤活性. 这种药物未能在这个向治疗试验中满足疾病控制的预规定的标准.
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:
- 具有特定基因组变化的晚期癌症会带来治疗挑战.
- 向疗法提供了基于分子分析的个性化癌症治疗的潜力.
- 在各种固体瘤中,BRAF基因是已知的标.
研究的目的:
- 为了评估regorafenib在患有BRAF变异的先进实体瘤的患者中的抗瘤活性.
- 评估疾病控制率作为该II期篮子试验的主要终点.
- 调查二次终点,包括客观反应和生存结果.
主要方法:
- 一项II期篮子试验招募了28名患有12种瘤类型和BRAF变化的患者.
- 患者接受了regorafenib;疗效通过研究人员对疾病控制 (DC) 的评估来评估.
- 主要终点 (DC率) 与15%的零率进行了比较,使用单面精确二项式测试.
主要成果:
- 总体疾病控制率为21% (2个部分反应,4个稳定疾病≥16周).
- 客观的响应率为7%.
- 在这个队列中,雷戈拉费尼布的3级不良事件发生率为29%.
结论:
- 雷戈拉芬尼不符合预先规定的标准,以证明BRAF改变的固体瘤患者的活性信号.
- 这些发现不支持在这种特定患者群体中对regorafenib的进一步研究.
- 该研究强调了在向治疗试验中严格的终点评估的重要性.
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