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多塔利单抗与单纯化疗用于一线错配修复缺陷的晚期子宫内膜癌患者的比较

DOMENICA: dostarlimab versus chemotherapy alone in first-line MMR-deficient advanced endometrial cancer patients.

作者信息

Cherifi François, Ray-Coquard Isabelle, Rubio Maria Jesus, Paoletti Xavier, Lorusso Domenica, Choi Chel Hun, Hasegawa Kosei, Tan David Shao Peng, Hudson Emma, Davis Alison, Tognon Germana, Lheureux Stéphanie, Vardar Key Mehmet Ali, Kurtz Jean Emmanuel, Alexandre Jerome, Joly Florence

机构信息

Clinical Research Department, Centre François Baclesse, Caen, France.

Léon Bérard Center, University of Claude Bernard Lyon Est, Lyon, France.

出版信息

Future Oncol. 2025 Jun;21(13):1613-1623. doi: 10.1080/14796694.2025.2496133. Epub 2025 May 5.

Abstract

Immunotherapy (IO) in endometrial cancer (EC) is the standard of care in the second line setting in combination with an anti-angiogenic agent. Randomized clinical trials have reported results supporting the addition of IO to chemotherapy (paclitaxel plus carboplatin) in the first-line setting in advanced EC patients in the global population, with high efficacy in mismatch repair deficient (MMRd) patients. These trials were not designed to answer this de-escalation question in the MMRd population, who benefit greatly from IO.The international, randomized phase III, DOMENICA trial compares first-line dostarlimab versus chemotherapy alone (with planned cross-over) for advanced MMRd EC. Our primary endpoint will be progression-free survival. The key secondary endpoints will be overall survival, safety and quality of life [NCT05201547].

摘要

子宫内膜癌(EC)的免疫疗法(IO)在二线治疗中是标准治疗方案,需与抗血管生成药物联合使用。随机临床试验报告的结果支持在全球晚期EC患者的一线治疗中,将IO添加到化疗(紫杉醇加卡铂)中,错配修复缺陷(MMRd)患者疗效显著。这些试验并非旨在回答MMRd人群中的降阶梯问题,而MMRd人群从IO中获益匪浅。国际随机III期DOMENICA试验比较了晚期MMRd EC患者一线使用多斯塔利单抗与单纯化疗(计划交叉治疗)的效果。我们的主要终点将是无进展生存期。关键次要终点将是总生存期、安全性和生活质量 [NCT05201547]。

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