A real-world retrospective, observational study of first-line pembrolizumab plus chemotherapy for metastatic non-squamous non-small cell lung cancer with PD-L1 tumor proportion score < 50% (PEMBROREAL)
IntroductionThe phase III Keynote-189 trial established a first-line treatment combining pembrolizumab with pemetrexed and platinum as a standard treatment for patients with stage IV non-small cell lung cancer (NSCLC) without known EGFR and ALK driver mutations and independent of programmed cell dea...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2024-03-01
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| Series: | Frontiers in Oncology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fonc.2024.1351995/full |
| _version_ | 1827307860442218496 |
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| author | Alessandro Cafaro Flavia Foca Oriana Nanni Marco Chiumente Marina Coppola Paolo Baldo Sabrina Orzetti Fiorenza Enrico Vito Ladisa Rosa Lerose Patrizia Nardulli Piera Maiolino Federica Gradellini Anna Rita Gasbarro Gisella Carrucciu Riccardo Provasi Paola Cristina Cappelletto Alessandra Pasqualini Stefano Vecchia Marianna Veraldi Adele Emanuela De Francesco Lucio Crinò Angelo Delmonte Carla Masini |
| author_facet | Alessandro Cafaro Flavia Foca Oriana Nanni Marco Chiumente Marina Coppola Paolo Baldo Sabrina Orzetti Fiorenza Enrico Vito Ladisa Rosa Lerose Patrizia Nardulli Piera Maiolino Federica Gradellini Anna Rita Gasbarro Gisella Carrucciu Riccardo Provasi Paola Cristina Cappelletto Alessandra Pasqualini Stefano Vecchia Marianna Veraldi Adele Emanuela De Francesco Lucio Crinò Angelo Delmonte Carla Masini |
| author_sort | Alessandro Cafaro |
| collection | DOAJ |
| description | IntroductionThe phase III Keynote-189 trial established a first-line treatment combining pembrolizumab with pemetrexed and platinum as a standard treatment for patients with stage IV non-small cell lung cancer (NSCLC) without known EGFR and ALK driver mutations and independent of programmed cell death ligand 1 (PD-L1) expression. However, in Italy, eligibility for the National Health Service payment program is limited to patients with PD-L1 <50%. The PEMBROREAL study assesses the real-world effectiveness and safety of pembrolizumab in patients eligible for the National Health Service payment program.MethodsPEMBROREAL is a retrospective, observational study on patients with NSCLC who started pembrolizumab combined with pemetrexed and platinum within the reimbursability time window, considered as December 2019 to December 2020. The primary endpoints were to assess progression-free survival (PFS) and overall survival (OS; using the Kaplan–Meier method), response to therapy, and tolerability.ResultsUntil February 2022, 279 patients (median follow-up: 19.7 months) have been observed. The median PFS was 8.0 months (95% confidence interval: 6.5–9.2). OS was not reached, but we can estimate a 12- to 24-month survival rate for the combined treatment: 66.1% and 52.5%, respectively. PD-L1 expression and Eastern Cooperative Group (ECOG) Performance Status were both associated with PFS and OS. Overall, only 44.4% of patients reported an adverse event, whereas toxicity led to a 5.4% discontinuation rate.ConclusionThe results of the PEMBROREAL study have shown that the combined treatment of pembrolizumab with pemetrexed and platinum is effective for metastatic non-squamous NSCLC, even for patients with PD-L1 levels below 50%, despite the differences in patient demographics and pathological features compared to the Keynote-189 study. The adverse events reported during the study were more typical of chemotherapy treatment rather than immunotherapy, and physicians were able to manage them easily. |
| first_indexed | 2024-04-24T18:46:36Z |
| format | Article |
| id | doaj.art-ac61704f545c4c6cbdb99105082d3c5c |
| institution | Directory Open Access Journal |
| issn | 2234-943X |
| language | English |
| last_indexed | 2024-04-24T18:46:36Z |
| publishDate | 2024-03-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Oncology |
| spelling | doaj.art-ac61704f545c4c6cbdb99105082d3c5c2024-03-27T05:00:55ZengFrontiers Media S.A.Frontiers in Oncology2234-943X2024-03-011410.3389/fonc.2024.13519951351995A real-world retrospective, observational study of first-line pembrolizumab plus chemotherapy for metastatic non-squamous non-small cell lung cancer with PD-L1 tumor proportion score < 50% (PEMBROREAL)Alessandro Cafaro0Flavia Foca1Oriana Nanni2Marco Chiumente3Marina Coppola4Paolo Baldo5Sabrina Orzetti6Fiorenza Enrico7Vito Ladisa8Rosa Lerose9Patrizia Nardulli10Piera Maiolino11Federica Gradellini12Anna Rita Gasbarro13Gisella Carrucciu14Riccardo Provasi15Paola Cristina Cappelletto16Alessandra Pasqualini17Stefano Vecchia18Marianna Veraldi19Adele Emanuela De Francesco20Lucio Crinò21Angelo Delmonte22Carla Masini23Pharmacy Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola, ItalyUnit of Biostatistics and Clinical Trials, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola, ItalyUnit of Biostatistics and Clinical Trials, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola, ItalyScientific Direction, Società Italiana di Farmacia Clinica e Terapia (SIFaCT), Turin, ItalyPharmacy Unit, IRCCS Istituto Oncologico Veneto (IOV), Padova, ItalyPharmacy Unit, CRO Aviano IRCCS, National Cancer Institute, Aviano, ItalyPharmacy Unit, CRO Aviano IRCCS, National Cancer Institute, Aviano, ItalyHospital Pharmacy, Candiolo Cancer Institute, FPO-IRCCS, Candiolo, Turin, ItalyHospital Pharmacy, IRCCS National Cancer Institute Foundation, Milan, ItalyHospital Pharmacy, IRCCS-CROB Referral Cancer Center of Basilicata, Rionero in Vulture, PZ, ItalyPharmacy Unit, National Cancer Research Center Istituto Tumori “Giovanni Paolo II”, Bari, Italy0Pharmacy Unit, Istituto Nazionale Tumori “Fondazione G. Pascale”, IRCCS, Naples, Italy1Pharmacy Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy2Pharmacy Unit, University Hospital Policlinico, Bari, Italy3Pharmacy Unit, Azienda Ospedaliera Brotzu, Cagliari, Italy4Pharmacy Unit, Azienda Sanitaria Universitaria Giuliano Isontina, Trieste, Italy5Hospital Pharmacy, Hospital of Bolzano (SABES-ASDAA), Bolzano, Italy6Pharmacy Unit, S.Chiara Hospital, Trento, Italy7Pharmacy Unit, Hospital Guglielmo da Saliceto, Piacenza, Italy8Protesic and Pharmaceutical Assistance sector n. 3, Department of Health Protection and Health Service Calabria Region, Catanzaro, Italy9Pharmacy Unit, Mater Domini Hospital, Catanzaro, Italy0Thoracic Oncology Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola, Italy0Thoracic Oncology Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola, ItalyPharmacy Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola, ItalyIntroductionThe phase III Keynote-189 trial established a first-line treatment combining pembrolizumab with pemetrexed and platinum as a standard treatment for patients with stage IV non-small cell lung cancer (NSCLC) without known EGFR and ALK driver mutations and independent of programmed cell death ligand 1 (PD-L1) expression. However, in Italy, eligibility for the National Health Service payment program is limited to patients with PD-L1 <50%. The PEMBROREAL study assesses the real-world effectiveness and safety of pembrolizumab in patients eligible for the National Health Service payment program.MethodsPEMBROREAL is a retrospective, observational study on patients with NSCLC who started pembrolizumab combined with pemetrexed and platinum within the reimbursability time window, considered as December 2019 to December 2020. The primary endpoints were to assess progression-free survival (PFS) and overall survival (OS; using the Kaplan–Meier method), response to therapy, and tolerability.ResultsUntil February 2022, 279 patients (median follow-up: 19.7 months) have been observed. The median PFS was 8.0 months (95% confidence interval: 6.5–9.2). OS was not reached, but we can estimate a 12- to 24-month survival rate for the combined treatment: 66.1% and 52.5%, respectively. PD-L1 expression and Eastern Cooperative Group (ECOG) Performance Status were both associated with PFS and OS. Overall, only 44.4% of patients reported an adverse event, whereas toxicity led to a 5.4% discontinuation rate.ConclusionThe results of the PEMBROREAL study have shown that the combined treatment of pembrolizumab with pemetrexed and platinum is effective for metastatic non-squamous NSCLC, even for patients with PD-L1 levels below 50%, despite the differences in patient demographics and pathological features compared to the Keynote-189 study. The adverse events reported during the study were more typical of chemotherapy treatment rather than immunotherapy, and physicians were able to manage them easily.https://www.frontiersin.org/articles/10.3389/fonc.2024.1351995/fullpembrolizumabnon-small cell lung cancerreal-world dataimmunotherapyobservational study |
| spellingShingle | Alessandro Cafaro Flavia Foca Oriana Nanni Marco Chiumente Marina Coppola Paolo Baldo Sabrina Orzetti Fiorenza Enrico Vito Ladisa Rosa Lerose Patrizia Nardulli Piera Maiolino Federica Gradellini Anna Rita Gasbarro Gisella Carrucciu Riccardo Provasi Paola Cristina Cappelletto Alessandra Pasqualini Stefano Vecchia Marianna Veraldi Adele Emanuela De Francesco Lucio Crinò Angelo Delmonte Carla Masini A real-world retrospective, observational study of first-line pembrolizumab plus chemotherapy for metastatic non-squamous non-small cell lung cancer with PD-L1 tumor proportion score < 50% (PEMBROREAL) Frontiers in Oncology pembrolizumab non-small cell lung cancer real-world data immunotherapy observational study |
| title | A real-world retrospective, observational study of first-line pembrolizumab plus chemotherapy for metastatic non-squamous non-small cell lung cancer with PD-L1 tumor proportion score < 50% (PEMBROREAL) |
| title_full | A real-world retrospective, observational study of first-line pembrolizumab plus chemotherapy for metastatic non-squamous non-small cell lung cancer with PD-L1 tumor proportion score < 50% (PEMBROREAL) |
| title_fullStr | A real-world retrospective, observational study of first-line pembrolizumab plus chemotherapy for metastatic non-squamous non-small cell lung cancer with PD-L1 tumor proportion score < 50% (PEMBROREAL) |
| title_full_unstemmed | A real-world retrospective, observational study of first-line pembrolizumab plus chemotherapy for metastatic non-squamous non-small cell lung cancer with PD-L1 tumor proportion score < 50% (PEMBROREAL) |
| title_short | A real-world retrospective, observational study of first-line pembrolizumab plus chemotherapy for metastatic non-squamous non-small cell lung cancer with PD-L1 tumor proportion score < 50% (PEMBROREAL) |
| title_sort | real world retrospective observational study of first line pembrolizumab plus chemotherapy for metastatic non squamous non small cell lung cancer with pd l1 tumor proportion score 50 pembroreal |
| topic | pembrolizumab non-small cell lung cancer real-world data immunotherapy observational study |
| url | https://www.frontiersin.org/articles/10.3389/fonc.2024.1351995/full |
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