Purpose: The aim of this multi-center, retrospective/prospective cohort observational study was to evaluate outcomes in routine clinical practice of first-line chemo-immunotherapy with cis/carboplatin, pemetrexed and pembrolizumab in patients with advanced non-squamous non-small cell lung cancer (NSCLC) in 33 Italian centers. Methods: The outcome measure was to evaluate overall survival (OS) in a real-world patient population. Secondary endpoints were: progression-free survival (PFS), objective response rate (ORR), duration of response (DoR) and incidence of treatment-related adverse events (AEs). Results: 1068 patients were enrolled at the time of data cut-off (January 31st, 2023), and 812 (76.0%) belonged to the retrospective cohort. Median age was 66 years (27-85), ECOG PS was ≥ 2 in 91 (8.6%) patients; 254 (23.8%) patients had brain metastases at baseline; 38 (3.6%) patients had tumor with PD-L1 expression ≥ 50%. After a median follow-up of 17.0 months (95% CI, 16.1-17.9), median OS was 16.1 months (95% CI, 14.4-18.8) and PFS was 9.9 months (95% CI, 8.8-11.2). Median DoR (n = 493) was 14.7 months (95% CI, 13.6-17.1). ORR was 43.4% (95% CI, 40.4-46.4). Any-grade AEs occurred in 636 (59.6%) patients and grade ≥ 3 in 253 (23.7%) patients. Most common grade ≥ 3 AEs were neutropenia (6.3%) and anemia (6.3%). Conclusions: First-line chemo-immunotherapy was effective and tolerable in this large, real-world Italian study of patients with advanced non-squamous NSCLC. Our results were in line with the KEYNOTE-189 registration study, also considering the low number of PD-L1 ≥ 50% patients included in our study.

Real-world outcomes of Italian patients with advanced non-squamous lung cancer treated with first-line pembrolizumab plus platinum-pemetrexed

Bria, Emilio;Vita, Emanuele;Passiglia, Francesco;Delcuratolo, Marco Donatello;Adamo, Vincenzo;Salerno, Flavio;Malorgio, Francesco;
2024-01-01

Abstract

Purpose: The aim of this multi-center, retrospective/prospective cohort observational study was to evaluate outcomes in routine clinical practice of first-line chemo-immunotherapy with cis/carboplatin, pemetrexed and pembrolizumab in patients with advanced non-squamous non-small cell lung cancer (NSCLC) in 33 Italian centers. Methods: The outcome measure was to evaluate overall survival (OS) in a real-world patient population. Secondary endpoints were: progression-free survival (PFS), objective response rate (ORR), duration of response (DoR) and incidence of treatment-related adverse events (AEs). Results: 1068 patients were enrolled at the time of data cut-off (January 31st, 2023), and 812 (76.0%) belonged to the retrospective cohort. Median age was 66 years (27-85), ECOG PS was ≥ 2 in 91 (8.6%) patients; 254 (23.8%) patients had brain metastases at baseline; 38 (3.6%) patients had tumor with PD-L1 expression ≥ 50%. After a median follow-up of 17.0 months (95% CI, 16.1-17.9), median OS was 16.1 months (95% CI, 14.4-18.8) and PFS was 9.9 months (95% CI, 8.8-11.2). Median DoR (n = 493) was 14.7 months (95% CI, 13.6-17.1). ORR was 43.4% (95% CI, 40.4-46.4). Any-grade AEs occurred in 636 (59.6%) patients and grade ≥ 3 in 253 (23.7%) patients. Most common grade ≥ 3 AEs were neutropenia (6.3%) and anemia (6.3%). Conclusions: First-line chemo-immunotherapy was effective and tolerable in this large, real-world Italian study of patients with advanced non-squamous NSCLC. Our results were in line with the KEYNOTE-189 registration study, also considering the low number of PD-L1 ≥ 50% patients included in our study.
2024
202
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https://www.sciencedirect.com/science/article/pii/S095980492400162X?via=ihub
Non-Small-Cell Lung Carcinoma; Pembrolizumab: Platinum chemotherapy; Pemetrexed; Real-world
Leonetti, Alessandro; Perrone, Fabiana; Puntoni, Matteo; Maglietta, Giuseppe; Bordi, Paola; Bria, Emilio; Vita, Emanuele; Gelsomino, Francesco; De Giglio, Andrea; Gelibter, Alain; Siringo, Marco; Mazzoni, Francesca; Caliman, Enrico; Genova, Carlo; Bertolini, Federica; Guaitoli, Giorgia; Passiglia, Francesco; Delcuratolo, Marco Donatello; Montrone, Michele; Cerea, Giulio; Pasello, Giulia; Roca, Elisa; Belluomini, Lorenzo; Cecere, Fabiana Letizia; Guida, Annalisa; Manzo, Anna; Adamo, Vincenzo; Rastelli, Francesca; Bulotta, Alessandra; Citarella, Fabrizio; Toschi, Luca; Zoratto, Federica; Cortinovis, Diego Luigi; Berardi, Rossana; Follador, Alessandro; Carta, Annamaria; Camerini, Andrea; Salerno, Flavio; Silva, Rosa Rita; Baldini, Editta; Cortellini, Alessio; Brighenti, Matteo; Santoni, Matteo; Malorgio, Francesco; Caminiti, Caterina; Tiseo, Marcello
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2318/1962955
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