{"title":"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。","authors":"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","doi":"10.1016/j.lungcan.2024.107866","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>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; <em>p</em> = 0.002). Efficacy and safety data in real-world (rw) settings are needed to confirm these results.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Results</h3><p>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.</p></div><div><h3>Conclusions</h3><p>For this unselected PM population, efficacy and safety outcomes compared favorably with CheckMate 743 trial results.</p></div>","PeriodicalId":18129,"journal":{"name":"Lung Cancer","volume":"194 ","pages":"Article 107866"},"PeriodicalIF":4.5000,"publicationDate":"2024-06-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0169500224004008/pdfft?md5=f5e526d17567761e429dcf6f0e020f85&pid=1-s2.0-S0169500224004008-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Real-World efficacy and safety of combination nivolumab plus ipilimumab for Untreated, Unresectable, pleural Mesothelioma: The Meso-Immune (GFPC 04–2021) trial\",\"authors\":\"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\",\"doi\":\"10.1016/j.lungcan.2024.107866\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>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; <em>p</em> = 0.002). Efficacy and safety data in real-world (rw) settings are needed to confirm these results.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Results</h3><p>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.</p></div><div><h3>Conclusions</h3><p>For this unselected PM population, efficacy and safety outcomes compared favorably with CheckMate 743 trial results.</p></div>\",\"PeriodicalId\":18129,\"journal\":{\"name\":\"Lung Cancer\",\"volume\":\"194 \",\"pages\":\"Article 107866\"},\"PeriodicalIF\":4.5000,\"publicationDate\":\"2024-06-29\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S0169500224004008/pdfft?md5=f5e526d17567761e429dcf6f0e020f85&pid=1-s2.0-S0169500224004008-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Lung Cancer\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0169500224004008\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Lung Cancer","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0169500224004008","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}
Real-World efficacy and safety of combination nivolumab plus ipilimumab for Untreated, Unresectable, pleural Mesothelioma: The Meso-Immune (GFPC 04–2021) trial
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.
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.
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