Published 2020 | Version v1
Publication Metadata-only

Immune-related Adverse Events of Pembrolizumab in a Large Real-world Cohort of Patients With NSCLC With a PD-L1 Expression ≥ 50% and Their Relationship With Clinical Outcomes

Cortellini A.
Friedlaender A.
Banna G. L.
Porzio G.
Bersanelli M.
Cappuzzo F.
Aerts J. G. J. V.
Giusti R.
Bria E.
Cortinovis D.
Grossi F.
Migliorino M. R.
Galetta D.
Passiglia F.
Berardi R.
Mazzoni F.
Di Noia V.
Signorelli D.
Tuzi A.
Gelibter A.
Marchetti P.
Macerelli M.
Rastelli F.
Chiari R.
Rocco D.
Inno A.
Di Marino P.
Mansueto G.
Zoratto F.
Santoni M.
Tudini M.
Ghidini M.
Filetti M.
Catino A.
Pizzutilo P.
Sala L.
Occhipinti M. A.
Citarella F.
Marco R.
Torniai M.
Cantini L.
Follador A.
Sforza V.
Nigro O.
Ferrara M. G.
D'Argento E.
Leonetti A.
Pettoruti L.
Antonuzzo L.
Scodes S.
Landi L.
Guaitoli G.
Baldessari C.
Bertolini F.
Della Gravara L.
Dal Bello M. G.
Belderbos R. A.
De Filippis M.
Cecchi C.
Ricciardi S.
Donisi C.
De Toma A.
Proto C.
Addeo A.
Cantale O.
Ricciuti B.
Genova C.
Morabito A.
Santini D.
Ficorella C.
Cannita K.
Others:
Cortellini, A.
Friedlaender, A.
Banna, G. L.
Porzio, G.
Bersanelli, M.
Cappuzzo, F.
Aerts, J. G. J. V.
Giusti, R.
Bria, E.
Cortinovis, D.
Grossi, F.
Migliorino, M. R.
Galetta, D.
Passiglia, F.
Berardi, R.
Mazzoni, F.
Di Noia, V.
Signorelli, D.
Tuzi, A.
Gelibter, A.
Marchetti, P.
Macerelli, M.
Rastelli, F.
Chiari, R.
Rocco, D.
Inno, A.
Di Marino, P.
Mansueto, G.
Zoratto, F.
Santoni, M.
Tudini, M.
Ghidini, M.
Filetti, M.
Catino, A.
Pizzutilo, P.
Sala, L.
Occhipinti, M. A.
Citarella, F.
Marco, R.
Torniai, M.
Cantini, L.
Follador, A.
Sforza, V.
Nigro, O.
Ferrara, M. G.
D'Argento, E.
Leonetti, A.
Pettoruti, L.
Antonuzzo, L.
Scodes, S.
Landi, L.
Guaitoli, G.
Baldessari, C.
Bertolini, F.
Della Gravara, L.
Dal Bello, M. G.
Belderbos, R. A.
De Filippis, M.
Cecchi, C.
Ricciardi, S.
Donisi, C.
De Toma, A.
Proto, C.
Addeo, A.
Cantale, O.
Ricciuti, B.
Genova, C.
Morabito, A.
Santini, D.
Ficorella, C.
Cannita, K.

Description

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%. Patients and Methods: We previously conducted a multicenter retrospective analysis in patients with treatment-naive metastatic NSCLC and a PD-L1 expression of ≥ 50% receiving first-line 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 <.0001), grade 3/4 irAEs (P =.0025), leading to discontinuation irAEs (P =.0144), multiple-site and single-site irAEs (P <.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 <.0001), single-site irAEs (P <.0001), multiple-site irAEs (P =.0005), cutaneous irAEs (P =.0042), endocrine irAEs (P <.0001), gastrointestinal irAEs (P =.0391), and rheumatologic irAEs (P =.0086) were significantly related to progression-free survival. Any grade irAEs (P <.0001), single-site irAEs (P <.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.

Additional details

Identifiers Origin repository
Created:
April 14, 2023
Modified:
November 28, 2023