软组织肉瘤患者的Palbociclib与CDK4放大:来自向剂和分析利用注册表研究的结果
Scott Schuetze1, Michael Rothe2, Pam K Mangat2
1Department of Internal Medicine, University of Michigan, Ann Arbor, MI.
JCO precision oncology
|July 16, 2024
概括
帕尔博西克利布在软组织肉瘤患者中表现出抗瘤活性,具有CDK4放大. 该药物表现出46%的疾病控制率,满足了针对性治疗试验中有效性的试验标准.
科学领域:
- 在瘤学瘤学.
- 基因组学就是基因组学.
- 药理学 药理学是指药理学的学科.
背景情况:
- 针对性代理和分析利用注册表 (TAPUR) 试验研究了针对性治疗在具有特定基因组改变的晚期癌症中.
- 软组织肉瘤 (STS) 是一组异质的癌症,识别可操作的基因组变化对于治疗选择至关重要.
研究的目的:
- 为了评估palbociclib的抗瘤活性,一个向药物,在患有晚期软组织肉瘤的患者中,藏着循环素依赖激酶4 (CDK4) 放大.
- 评估这种特定患者队列中的疾病控制,反应率,生存结果和palbociclib的安全性.
主要方法:
- 采用了II期篮子试验设计,招募了具有可测量疾病和充足绩效状态的患者.
- 主要终点是疾病控制 (DC),定义为客观反应 (OR) 或至少16周 (SD16+) 的稳定疾病 (SD),通过RECIST v1.1.1.评估.
- 二级终点包括OR,无进展生存率 (PFS),总生存率 (OS) 和安全性评估.
主要成果:
- 招募了42名患有CDK4放大STS的患者;其中一个不能评估疗效.
- 疾病控制率为46% (90% CI,36-100),其中有一个部分反应,18名患者实现SD16+.
- 中位数的PFS为16周 (95% CI, 9-28) 和中位数的OS为69周 (95% CI, 31-111). 可能与palbociclib相关的3-4级不良事件发生在20名患者身上,没有报告严重事件.
结论:
- 在软组织肉瘤和CDK4放大患者中,Palbociclib显示出抗瘤活性信号.
- 该药物满足了TAPUR试验中对于这个特定的分子定义子组的预规定的疗效标准.
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