在先前接受过治疗的晚期细胞癌患者中,使用abemaciclib抑制CDK4/6
Bradley A McGregor1, Wanling Xie1, Stephanie A Berg1
1Dana Farber Cancer Institute, Boston MA.
Clinical genitourinary cancer
|March 13, 2025
概括
在晚期细胞癌 (RCC) 患者中,abemaciclib单一治疗没有显著的益处. 这项研究为正在进行的试验提供了关键数据,将CDK4/6抑制剂与其他治疗方法结合用于RCC治疗.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 临床前数据表明CDK4/6抑制剂与HIF-2α抑制剂相结合可以治疗清细胞细胞癌 (ccRCC).
- 随机试验正在研究治疗耐药ccRCC中的palbociclib和belzutifan组合.
- 在ccRCC中CDK4/6抑制剂的单剂活性以前没有报告.
研究的目的:
- 调查abemaciclib,一个口服CDK4/6抑制剂的安全性和疗效,作为一个单一药物,在先进的,预先治疗的细胞癌 (RCC) 患者中.
- 评估该患者群体中abemaciclib单一治疗的客观响应率 (ORR) 和安全概况.
主要方法:
- 一项多中心1b期临床试验招募了在免疫疗法和VEGFR TKI后进展的晚期RCC (清洁细胞组成部分) 的成年患者.
- 患者每天两次接受abemaciclib200毫克,直到疾病进展或毒性.
- 客观反应率 (ORR) 是主要终点,根据RECIST 1.1进行评估;安全性根据CTCAE v5.0.0进行评估.
主要成果:
- 纳入了11名重度预治疗的患者;中位数年龄为62岁,大多数患有中等风险疾病.
- 客观应答率 (ORR) 为0% (0/11),其中8名患者患有进展性疾病.
- 在27%的患者中,发生了3级或更高的与治疗相关的不良事件 (腹,恶心,中性质减退).
结论:
- 在重度预先治疗的转移性RCC患者中,abemaciclib单一治疗没有显示出具有临床意义的活性.
- 没有发现新的安全信号,但该药物作为单一药物的有效性有限.
- 这些发现为解释正在进行的RCC组合疗法中CDK4/6抑制剂试验提供了有价值的见解.
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