不可切除的胸膜间皮瘤 (PM) 的一线护理标准随 3 期 CheckMate 743 研究结果的变化而变化，显示纳武单抗加伊匹单抗 (Nivo Ipi) 与铂类培美曲塞化疗相比，可显着延长 PM 的总生存期 (OS)（中位OS 18.1 个月与 14.1 个月；风险比：0.74；p = 0.002）。需要真实世界 (rw) 环境中的疗效和安全性数据来确认这些结果。这项法国多中心回顾性队列研究旨在评估通过早期访问计划 (EAP) 接受 Nivo Ipi 的初治 PM 患者的结果。主要目标是研究者评估的现实世界无进展生存期（PFS）。次要目标是该组合的总生存期 (OS) 和安全性。从 2021 年 4 月 1 日到 2022 年 2 月 15 日，该分析纳入了 63 个中心接受治疗的 305 名 EAP 患者中的 201 名（79.6% 为男性；中位年龄：75 岁； 91.8% 东部肿瘤合作组表现状态 (ECOG-PS) 0/1；74.5% 上皮样组织学）。所有患者的中位随访时间 (95% CI) 为 18.4 (17.7-19.2) 个月，PFS 和 OS 分别为 6.3 (5.3-7.5) 和 18.9 (17.6-未达到 (NR)) 个月，1 年操作系统为 66.4% (60.1-73.3%)。上皮样和非上皮样的中位 OS 和 1 年生存率为 21.0 (18.7-NR) 和 70.8% (63.9%-780.6%)，14.1 (10.9-21.0) 个月和 54.9% (42.8%-70.4%)分别为 PM 子组。两个亚组之间的 PFS 相等。 23.3% 的患者发生 3-4 级不良事件，三例死亡与治疗相关。对于这个未经选择的 PM 人群，疗效和安全性结果与 CheckMate 743 试验结果相比更为有利。版权所有 © 2024 作者。由 Elsevier B.V. 出版。保留所有权利。

First-line standard-of-care for unresectable, pleural mesothelioma (PM) changed with the phase 3 CheckMate 743 study results, showing that nivolumab plus ipilimumab (Nivo + Ipi) significantly extended overall survival (OS) versus platinum + pemetrexed chemotherapy for PM (median OS 18.1 versus 14.1 months; hazard ratio: 0.74; p = 0.002). Efficacy and safety data in real-world (rw) settings are needed to confirm these results.This French multicenter, retrospective cohort study was undertaken to assess the outcomes of treatment-naïve PM patients given Nivo + Ipi via an early-access program (EAP). The primary objective was investigator-assessed real world -progression-free survival (PFS). The secondary objectives were the combination's -overall survival (OS) and safety.From 1 April 2021 to 15 Feb 2022, the analysis included 201 of the 305 EAP-enrolled patients treated in 63 centers (79.6 % men; median age: 75 years; 91.8 % Eastern Cooperative Oncology Group performance status (ECOG-PS) 0/1; 74.5 % epithelioid histology). With median (95 % CI) follow-up for all patients of 18.4 (17.7-19.2) months, -PFS and OS were 6.3 (5.3-7.5) and 18.9 (17.6-not reached (NR)) months, with 1-year OS at 66.4 % (60.1-73.3 %). Median OS and 1-year survival rates were 21.0 (18.7-NR) and 70.8 % (63.9 %-780.6 %), and 14.1 (10.9-21.0) months and 54.9 % (42.8 %-70.4 %) for epithelioid and non-epithelioid PM subgroups, respectively. PFS was equal between the two subgroups. Grade 3-4 adverse events occurred in 23.3 % of patients and three deaths were treatment-related.For this unselected PM population, efficacy and safety outcomes compared favorably with CheckMate 743 trial results.Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.