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布罗利祖马布在患有晚期清细胞妇科癌的患者中:第二期非随机临床试验

Rebecca Kristeleit¹, Michael-John Devlin², Andrew Clamp³

¹Guy's and St Thomas' NHS Foundation Trust and Comprehensive Cancer Centre, King's College London, London, United Kingdom.

|February 6, 2025

概括

晚期透明细胞妇科癌 (CCGC) 的预后不好. 布罗利祖马布在先前接受治疗的患者中显示出临床益处,具有持久的结果和可容忍的安全性,因此需要进一步研究.

科学领域:

妇科瘤学妇科瘤学
医学瘤学医学瘤学
免疫治疗是一种免疫疗法.

背景情况:

先进的清晰细胞妇科癌 (CCGC) 是一个重大的临床挑战,治疗选择有限.
第二线化疗的响应率低于8%,突出显示了对新型治疗策略的需求.

研究的目的:

评估先前用化疗治疗的晚期CCGC患者的pembrolizumab的临床益处和安全性.
在这个患者群体中评估编程细胞死亡1蛋白 (PD-1) 抑制的疗效.

主要方法:

PEACOCC试验是一项单臂,多中心的第二阶段研究,涉及48名晚期CCGC患者.
患者接受了每21天内静脉注射200毫克的班布罗利祖马布,并对无进展生存期 (PFS) 和客观应答率 (ORR) 的评估.

主要成果:

12周的PFS率为42%,客观反应率为25%,观察到持久反应.
平均PFS为2.7个月,平均整体存活时间为14.8个月.
3级与治疗相关的不良事件发生在19%的患者中;没有报告4级或5级事件.

结论:

布罗利祖马布在先前接受过治疗的高级CCGC患者中显示出临床益处,主要是那些具有不匹配修复能力的瘤患者.
观察到的持久的临床结果和可容忍的安全概况支持在随机试验中进一步调查.

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