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Observational Study
. 2019 Jul;20(4):237-247.e1.
doi: 10.1016/j.cllc.2019.02.006. Epub 2019 Feb 21.

Correlations Between the Immune-related Adverse Events Spectrum and Efficacy of Anti-PD1 Immunotherapy in NSCLC Patients

Alessio Cortellini  1 , Rita Chiari  2 , Biagio Ricciuti  2 , Giulio Metro  2 , Fabiana Perrone  3 , Marcello Tiseo  3 , Melissa Bersanelli  3 , Paola Bordi  3 , Daniele Santini  4 , Raffaele Giusti  5 , Antonino Grassadonia  6 , Pietro Di Marino  7 , Nicola Tinari  5 , Michele De Tursi  5 , Federica Zoratto  8 , Enzo Veltri  8 , Francesco Malorgio  9 , Carlo Garufi  9 , Marco Russano  4 , Cecilia Anesi  4 , Tea Zeppola  4 , Marco Filetti  5 , Paolo Marchetti  5 , Rossana Berardi  10 , Silvia Rinaldi  10 , Marianna Tudini  11 , Rosa Rita Silva  11 , Annagrazia Pireddu  12 , Francesco Atzori  12 , Daniela Iacono  13 , Maria Rita Migliorino  13 , Giampiero Porzio  14 , Katia Cannita  15 , Corrado Ficorella  14 , Sebastiano Buti  3
Affiliations
Observational Study

Correlations Between the Immune-related Adverse Events Spectrum and Efficacy of Anti-PD1 Immunotherapy in NSCLC Patients

Alessio Cortellini et al. Clin Lung Cancer. 2019 Jul.

Abstract

Background: Immune-related adverse events (irAEs) developed during immunotherapy with anti-PD-1 agents, could be a predictive surrogate marker of clinical benefit in patients with advanced non-small-cell lung cancer (NSCLC).

Methods: Patients with NSCLC, treated with anti-PD-1 agents, were retrospectively evaluated. Univariate and multivariate analyses were performed to evaluate the relationships between types of irAEs (differentiated according to system/organ involved and to single-site/multiple-site), overall response rate (ORR), progression-free survival (PFS) and overall survival (OS). We further performed a 6-week landmark analysis.

Results: A total of 559 patients were enrolled; 231 patients (41.3%) developed irAEs of any grade and 50 patients (8.9%) G3/G4 events; 191 of them (82.6%) developed "single-site" irAEs and 40 (17.4%) "multiple-site" irAEs. At multivariate analysis, higher ORR was related to irAEs of any grade (P < .0001), "single-site" irAEs (P < .0001), endocrine (P = .0043) and skin irAEs (P = .0005). Longer PFS was related to irAEs of any grade (P < .0001), "single-site" irAEs (P < .0001), "multiple-site" irAEs (P = .0374), endocrine irAEs (P = .0084) and skin irAEs (P = .0001). Longer OS was related to irAEs of any grade (P < .0001), "single-site" irAEs (P < .0001), endocrine irAEs (P = .0044), gastrointestinal irAEs (P = .0437), skin irAEs (P = .0006), and others irAEs (P = .0378). At the 6-week landmark analysis, irAEs of any grade was confirmed an independent predictor of higher ORR, longer PFS, and longer OS.

Conclusion: Our study confirmed that irAEs are concordantly related to higher ORR, longer PFS, and longer OS with anti-PD-1 immunotherapy in patients with NSCLC.

Keywords: Immune-related adverse events; Immunotherapy; NSCLC; Nivolumab; Pembrolizumab.

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