TY - JOUR
T1 - Immune-related Adverse Events of Pembrolizumab in a Large Real-world Cohort of Patients With NSCLC With a PD-L1 Expression ≥ 50Their Relationship With Clinical Outcomes.
AU - Cortellini, Alessio
AU - Friedlaender, Alex
AU - Banna, Giuseppe L.
AU - Porzio, Giampiero
AU - Bersanelli, Melissa
AU - Cappuzzo, Federico
AU - Aerts, Joachim G. J. V.
AU - Giusti, Raffaele
AU - Bria, Emilio
AU - Cortinovis, Diego
AU - Grossi, Francesco
AU - Migliorino, Maria R.
AU - Galetta, Domenico
AU - Passiglia, Francesco
AU - Berardi, Rossana
AU - Mazzoni, Francesca
AU - Di Noia, Vincenzo
AU - Signorelli, Diego
AU - Tuzi, Alessandro
AU - Gelibter, Alain
AU - Marchetti, Paolo
AU - Macerelli, Marianna
AU - Rastelli, Francesca
AU - Chiari, Rita
AU - Rocco, Danilo
AU - Inno, Alessandro
AU - Di Marino, Pietro
AU - Mansueto, Giovanni
AU - Zoratto, Federica
AU - Santoni, Matteo
AU - Tudini, Marianna
AU - Ghidini, Michele
AU - Filetti, Marco
AU - Catino, Annamaria
AU - Pizzutilo, Pamela
AU - Sala, Luca
AU - Occhipinti, Mario Alberto
AU - Citarella, Fabrizio
AU - Marco, Russano
AU - Torniai, Mariangela
AU - Cantini, Luca
AU - Follador, Alessandro
AU - Sforza, Vincenzo
AU - Nigro, Olga
AU - Ferrara, Miriam G.
AU - D'Argento, Ettore
AU - Leonetti, Alessandro
AU - Pettoruti, Linda
AU - Antonuzzo, Lorenzo
AU - Scodes, Simona
AU - Landi, Lorenza
AU - Guaitoli, Giorgia
AU - Baldessari, Cinzia
AU - Bertolini, Federica
AU - Della Gravara, Luigi
AU - Dal Bello, Maria Giovanna
AU - Belderbos, Robert A.
AU - De Filippis, Marco
AU - Cecchi, Cristina
AU - Ricciardi, Serena
AU - Donisi, Clelia
AU - De Toma, Alessandro
AU - Proto, Claudia
AU - Addeo, Alfredo
AU - Cantale, Ornella
AU - Ricciuti, Biagio
AU - Genova, Carlo
AU - Morabito, Alessandro
AU - Santini, Daniele
AU - Ficorella, Corrado
AU - Cannita, Katia
N1 - Place: United States
PY - 2020/11/1
Y1 - 2020/11/1
N2 - BACKGROUND: The role of immune-related adverse events (irAEs), as a surrogate predictor of the efficacy of checkpoint inhibitors, has not yet been described in the setting of first-line, single-agent pembrolizumab for patients with metastatic non-small-cell lung-cancer (NSCLC) with a programmed death-ligand 1 (PD-L1) expression of ≥ 50 We previously conducted a multicenter retrospective analysis in patients with treatment-naive metastatic NSCLC and a PD-L1 expression of ≥ 50line pembrolizumab. Here, we report the results of the irAE analysis and the potential correlation between irAEs and clinical outcomes. RESULTS: A total of 1010 patients were included in this analysis; after a 6-week landmark selection, 877 (86.8 patients were included in the efficacy analysis. Any grade irAEs (P textless .0001), grade 3/4 irAEs (P = .0025), leading to discontinuation irAEs (P = .0144), multiple-site and single-site irAEs (P textless .0001), cutaneous irAEs (P = .0001), endocrine irAEs (P = .0227), pulmonary irAEs (P = .0479), and rheumatologic irAEs (P = .0018) were significantly related to a higher objective response rate. Any grade irAEs (P textless .0001), single-site irAEs (P textless .0001), multiple-site irAEs (P = .0005), cutaneous irAEs (P = .0042), endocrine irAEs (P textless .0001), gastrointestinal irAEs (P = .0391), and rheumatologic irAEs (P = .0086) were significantly related to progression-free survival. Any grade irAEs (P textless .0001), single-site irAEs (P textless .0001), multiple-site irAEs (P = .0003), cutaneous irAEs (P = .0002), endocrine irAEs (P = .0001), and rheumatologic irAEs (P = .0214) were significantly related to overall survival. CONCLUSIONS: This study confirms the feasibility and the safety of first-line, single-agent pembrolizumab, in a large, real-world cohort of patients with NSCLC with PD-L1 expression ≥ 50%. The occurrence of irAEs may be a surrogate of clinical activity and improved outcomes in this setting.
AB - BACKGROUND: The role of immune-related adverse events (irAEs), as a surrogate predictor of the efficacy of checkpoint inhibitors, has not yet been described in the setting of first-line, single-agent pembrolizumab for patients with metastatic non-small-cell lung-cancer (NSCLC) with a programmed death-ligand 1 (PD-L1) expression of ≥ 50 We previously conducted a multicenter retrospective analysis in patients with treatment-naive metastatic NSCLC and a PD-L1 expression of ≥ 50line pembrolizumab. Here, we report the results of the irAE analysis and the potential correlation between irAEs and clinical outcomes. RESULTS: A total of 1010 patients were included in this analysis; after a 6-week landmark selection, 877 (86.8 patients were included in the efficacy analysis. Any grade irAEs (P textless .0001), grade 3/4 irAEs (P = .0025), leading to discontinuation irAEs (P = .0144), multiple-site and single-site irAEs (P textless .0001), cutaneous irAEs (P = .0001), endocrine irAEs (P = .0227), pulmonary irAEs (P = .0479), and rheumatologic irAEs (P = .0018) were significantly related to a higher objective response rate. Any grade irAEs (P textless .0001), single-site irAEs (P textless .0001), multiple-site irAEs (P = .0005), cutaneous irAEs (P = .0042), endocrine irAEs (P textless .0001), gastrointestinal irAEs (P = .0391), and rheumatologic irAEs (P = .0086) were significantly related to progression-free survival. Any grade irAEs (P textless .0001), single-site irAEs (P textless .0001), multiple-site irAEs (P = .0003), cutaneous irAEs (P = .0002), endocrine irAEs (P = .0001), and rheumatologic irAEs (P = .0214) were significantly related to overall survival. CONCLUSIONS: This study confirms the feasibility and the safety of first-line, single-agent pembrolizumab, in a large, real-world cohort of patients with NSCLC with PD-L1 expression ≥ 50%. The occurrence of irAEs may be a surrogate of clinical activity and improved outcomes in this setting.
M3 - Article
JO - Clinical Lung Cancer
JF - Clinical Lung Cancer
SN - 1525-7304
IS - 6
ER -