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在患有转移性割抵抗性前列腺癌 (CYCLONE 2) 的患者中,Abemaciclib加上abiraterone:一个随机,双盲,安慰剂控制的第三阶段试验
Matthew Smith1, Josep Piulats2, Tilman Todenhöfer3
1Massachusetts General Hospital Cancer Center, Boston, MA, USA.
The Lancet. Oncology
|October 30, 2025
概括
阿贝马西克利布与阿比拉结合并没有改善转移性割抵抗性前列腺癌 (mCRPC) 患者的无进展生存率. 该组合的安全性与单独的阿比拉相似,但需要进一步研究才能获得有效的mCRPC疗法.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
背景情况:
- 作为CDK4/6抑制剂的Abemaciclib在前列腺癌中表现出抗瘤活性.
- 转移性割抵抗性前列腺癌 (mCRPC) 是一个具有挑战性的疾病,治疗选择有限.
研究的目的:
- 为了评估abemaciclib与abiraterone联合用于mCRPC患者的安全性和有效性.
- 为了确定CDK4/6和雄激素受体通路的双重抑制是否能改善结果.
主要方法:
- CYCLONE 2是一个随机的,双盲的,安慰剂控制的,第三阶段试验.
- 患有mCRPC的成年人接受了abiraterone加上abemaciclib或安慰剂.
- 主要结局是研究人员评估的无进展的X光生存期.
主要成果:
- 阿贝马西克利布和阿比拉的联合治疗没有达到无放射性进展生存的主要终点 (HR 0.83; p=0.21).
- 放射性无进展生存时间的中位数为abemaciclib加abiraterone的22.0个月,与安慰剂加abiraterone的20.3个月相比.
- 3级或更高的不良事件包括贫血,中性质减退和ALT升高;三例与治疗相关的死亡发生在间歇性肺部疾病中.
结论:
- 用abemaciclib和abiraterone进行双重抑制并没有改善mCRPC患者的无放射性进展生存率.
- 组合的安全性概况与单个药物概况一致.
- 需要进一步的研究来确定mCRPC的有效组合疗法,特别是在高风险患者中.
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