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. The aim of this study was to investigate with a large sample size, the predictive and prognostic positive roles of occurrence of immune-related adverse events in patients with non–small-cell lung cancer treated with PD-1 inhibitors. The study confirmed that immune-related adverse events are independent predictors of higher overall response rate, longer progression-free survival and longer overall survival.
Correlations Between the Immune-related Adverse Events Spectrum and Efficacy of Anti-PD1 Immunotherapy in NSCLC Patients / Cortellini, Alessio; Chiari, Rita; Ricciuti, Biagio; Metro, Giulio; Perrone, Fabiana; Tiseo, Marcello; Bersanelli, Melissa; Bordi, Paola; Santini, Daniele; Giusti, Raffaele; Grassadonia, Antonino; Marino, Pietro Di; Tinari, Nicola; De Tursi, Michele; Zoratto, Federica; Veltri, Enzo; Malorgio, Francesco; Garufi, Carlo; Russano, Marco; Anesi, Cecilia; Zeppola, Tea; Filetti, Marco; Marchetti, Paolo; Berardi, Rossana; Rinaldi, Silvia; Tudini, Marianna; Silva, Rosa Rita; Pireddu, Annagrazia; Atzori, Francesco; Iacono, Daniela; Migliorino, Maria Rita; Porzio, Giampiero; Cannita, Katia; Ficorella, Corrado; Buti, Sebastiano. - In: CLINICAL LUNG CANCER. - ISSN 1525-7304. - 20:4(2019), pp. 237-247. [10.1016/j.cllc.2019.02.006]
Correlations Between the Immune-related Adverse Events Spectrum and Efficacy of Anti-PD1 Immunotherapy in NSCLC Patients
Tiseo, Marcello;Bersanelli, Melissa;Bordi, Paola;Rinaldi, Silvia;Buti, Sebastiano
2019-01-01
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. The aim of this study was to investigate with a large sample size, the predictive and prognostic positive roles of occurrence of immune-related adverse events in patients with non–small-cell lung cancer treated with PD-1 inhibitors. The study confirmed that immune-related adverse events are independent predictors of higher overall response rate, longer progression-free survival and longer overall survival.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
