Real-World efficacy and safety of combination nivolumab plus ipilimumab for Untreated, Unresectable, pleural Mesothelioma: The Meso-Immune (GFPC 04–2021) trial

IF 4.5 2区医学 Q1 ONCOLOGY

Lung Cancer Pub Date : 2024-06-29 DOI:10.1016/j.lungcan.2024.107866

Olivier Bylicki , Florian Guisier , Arnaud Scherpereel , Catherine Daniel , Aurélie Swalduz , Emmanuel Grolleau , Marie Bernardi , Stephane Hominal , Jean.Briac Prevost , Guillaume Pamart , Marie.Héléne Marques , Nicolas Cloarec , Simon Deshayes , Judith Raimbourg , Rémi Veillon , Youssef Oulkhouir , Clarisse Audigier Valette , Fabien Subtil , Christos Chouaïd , Laurent Greillier

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引用次数: 0

Abstract

Background

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.

Methods

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.

Results

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.

Conclusions

For this unselected PM population, efficacy and safety outcomes compared favorably with CheckMate 743 trial results.

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nivolumab 加 ipilimumab 联合治疗未经治疗、无法切除的胸膜间皮瘤的真实世界疗效和安全性：Meso-Immune（GFPC 04-2021）试验。

背景：3 期 CheckMate 743 研究结果显示，nivolumab 加 ipilimumab（Nivo + Ipi）与铂 + 培美曲塞化疗相比，可显著延长胸膜间皮瘤患者的总生存期（OS）（中位 OS 18.1 个月对 14.1 个月；危险比：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证实这些结果：这项法国多中心回顾性队列研究旨在评估通过早期治疗计划（EAP）给予 Nivo + Ipi 治疗的 PM 患者的疗效。首要目标是研究者评估的实际无进展生存期（PFS）。次要目标是组合疗法的总生存期（OS）和安全性：从 2021 年 4 月 1 日至 2022 年 2 月 15 日，在 63 个中心接受治疗的 305 例 EAP 登记患者中，有 201 例接受了分析（79.6% 为男性；中位年龄：75 岁；91.8% 为东部合作肿瘤学组表现状态（ECOG-PS）0/1；74.5% 为上皮样组织学）。所有患者的中位（95 % CI）随访时间为 18.4（17.7-19.2）个月，PFS 和 OS 分别为 6.3（5.3-7.5）个月和 18.9（17.6-未达标（NR））个月，1 年 OS 为 66.4 %（60.1-73.3 %）。上皮样和非上皮样 PM 亚组的中位 OS 和 1 年生存率分别为 21.0 个月（18.7-NR）和 70.8%（63.9%-780.6%），以及 14.1 个月（10.9-21.0）和 54.9%（42.8%-70.4%）。两个亚组的 PFS 相同。23.3%的患者出现了3-4级不良反应，3例死亡与治疗相关：结论：在这一未经选择的 PM 群体中，疗效和安全性结果均优于 CheckMate 743 试验结果。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Lung Cancer 医学-呼吸系统

CiteScore

9.40

自引率

3.80%

发文量

407

审稿时长

25 days

期刊介绍： Lung Cancer is an international publication covering the clinical, translational and basic science of malignancies of the lung and chest region.Original research articles, early reports, review articles, editorials and correspondence covering the prevention, epidemiology and etiology, basic biology, pathology, clinical assessment, surgery, chemotherapy, radiotherapy, combined treatment modalities, other treatment modalities and outcomes of lung cancer are welcome.