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Multicenter Study
. 2020 Nov;21(6):498-508.e2.
doi: 10.1016/j.cllc.2020.06.010. Epub 2020 Jun 21.

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

Alessio Cortellini  1 , Alex Friedlaender  2 , Giuseppe L Banna  3 , Giampiero Porzio  4 , Melissa Bersanelli  5 , Federico Cappuzzo  6 , Joachim G J V Aerts  7 , Raffaele Giusti  8 , Emilio Bria  9 , Diego Cortinovis  10 , Francesco Grossi  11 , Maria R Migliorino  12 , Domenico Galetta  13 , Francesco Passiglia  14 , Rossana Berardi  15 , Francesca Mazzoni  16 , Vincenzo Di Noia  17 , Diego Signorelli  18 , Alessandro Tuzi  19 , Alain Gelibter  20 , Paolo Marchetti  21 , Marianna Macerelli  22 , Francesca Rastelli  23 , Rita Chiari  24 , Danilo Rocco  25 , Alessandro Inno  26 , Pietro Di Marino  27 , Giovanni Mansueto  28 , Federica Zoratto  29 , Matteo Santoni  30 , Marianna Tudini  31 , Michele Ghidini  11 , Marco Filetti  8 , Annamaria Catino  13 , Pamela Pizzutilo  13 , Luca Sala  10 , Mario Alberto Occhipinti  20 , Fabrizio Citarella  32 , Marco Russano  32 , Mariangela Torniai  15 , Luca Cantini  33 , Alessandro Follador  22 , Vincenzo Sforza  34 , Olga Nigro  19 , Miriam G Ferrara  9 , Ettore D'Argento  35 , Alessandro Leonetti  5 , Linda Pettoruti  5 , Lorenzo Antonuzzo  16 , Simona Scodes  6 , Lorenza Landi  6 , Giorgia Guaitoli  36 , Cinzia Baldessari  36 , Federica Bertolini  36 , Luigi Della Gravara  25 , Maria Giovanna Dal Bello  37 , Robert A Belderbos  7 , Marco De Filippis  14 , Cristina Cecchi  14 , Serena Ricciardi  12 , Clelia Donisi  38 , Alessandro De Toma  18 , Claudia Proto  18 , Alfredo Addeo  2 , Ornella Cantale  3 , Biagio Ricciuti  39 , Carlo Genova  37 , Alessandro Morabito  34 , Daniele Santini  32 , Corrado Ficorella  4 , Katia Cannita  40
Affiliations
Multicenter Study

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

Alessio Cortellini et al. Clin Lung Cancer. 2020 Nov.

Abstract

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.

Keywords: First line; NSCLC; PD-L1; Pembrolizumab; irAEs.

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