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在晚期/转移性子宫内膜癌的化疗后维持olaparib:GINECO随机IIb期UTOLA试验

Florence Joly¹, Alexandra Leary², Isabelle Ray-Coquard³

¹Medical Oncology Department, Centre François Baclesse, UniCaen University, Caen, France. f.joly@baclesse.unicancer.fr.

Nature communications

|August 26, 2025

概括

在晚期子宫内膜癌中,使用olaparib的维护性多基酶 (PARP) 抑制并没有改善无进展的存活率. 然而,在特定的患者小组中发现了数值效益,这表明需要进一步研究.

科学领域:

妇科瘤学
医学瘤学
临床药理学

背景情况:

晚期/转移性子宫内膜癌往往没有最佳治疗方案.
基于的化疗是一种标准的第一线治疗.
作为对化疗有反应的患者的策略,正在研究维持性多基酶 (PARP) 抑制.

研究的目的:

评估在先进/ 转移性子宫内膜癌患者中维护olaparib的疗效和安全性,这些患者对前线基于的化疗有反应.
评估无进展生存期 (PFS) 作为主要终点.

主要方法:

随机,双盲,安慰剂控制的IIb期试验 (UTOLA,NCT03745950).
145名女性患者被随机分为2:1接受olaparib (每天两次300毫克) 或安慰剂,直到进展或不耐受.
根据p53状态分层,不匹配修复状态以及对初始化疗的反应.

主要成果:

在olaparib和安慰剂组之间没有显著的PFS差异 (中位数为5. 6个月与4. 0个月;HR为0. 94;p=0. 74).
探索性分析显示在特定亚组 (p53异常,完整反应,染色体不稳定) 中存在潜在的PFS益处.
在olaparib组中,3/4级不良事件的发生率较高 (36%对10%).

结论:

维护olaparib在晚期/转移性子宫内膜癌中没有显著改善PFS.
在某些子群体中,有希望的数值效应需要进一步研究.
奥拉巴里布的安全性与已知的副作用一致.

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