Prospective evaluation of the prognostic value of immune-related adverse events in patients with non-melanoma solid tumour treated with PD-1/PD-L1 inhibitors alone and in combination with radiotherapy.

BACKGROUND

Prospective data about the prognostic value of immune-related adverse events (irAEs) in non-melanoma solid tumours are rare. The prognostic value of irAEs in patients treated with combined radiotherapy and immunotherapy is currently unknown.

PATIENTS AND METHODS

The prospective non-interventional ST-ICI trial investigates treatment response of tumour patients to anti-programmed cell death-ligand 1 (PD-L1) immune checkpoint inhibitors alone and in combination with radiotherapy and possible predictive markers. Patients undergoing immunotherapy or immunoradiotherapy were surveyed for irAEs.

RESULTS

A total of 104 patients were included of whom 29 patients (28%) developed irAEs. Additional radiotherapy was performed in 50 patients (48%). Main tumour entities within the entire cohort were non-small cell lung cancer (NSCLC) (44%) and head and neck squamous cell carcinoma (42%). The rate of irAEs did not differ in patients with and without radiotherapy (p = 0.668). Patients who developed irAEs had longer overall survival (OS) (median: 22.8 months versus 9.0 months without irAEs, p = 0.001) and progression-free survival (PFS) (median: 7.8 months versus 3.2 months without irAEs, p = 0.002). In the subgroup with combined radiotherapy, patients with irAEs also had longer OS (median: 22.8 months versus 7.1 months without irAEs, p = 0.005) and PFS (median: 8.8 months versus 3.0 months without irAEs, p = 0.005). On multivariate analysis only PD-L1 on tumour cells (p = 0.049) and irAEs (p = 0.001) remained independent predictors of OS.

CONCLUSION

The development of irAEs represents a favourable prognostic parameter in patients undergoing immunotherapy and immunoradiotherapy for solid tumours.

Informations de copyright

Copyright © 2020 Elsevier Ltd. All rights reserved.

Déclaration de conflit d'intérêts

Conflict of interest statement S.R. reports research funding from AstraZeneca and MSD. M.E. reports employment, advisory role, speakers' bureau membership, honoraria and travel expenses from Diaceutics; AstraZeneca advisory role, speakers' bureau membership, honoraria and travel expenses from AstraZeneca; Roche; honoraria and speakers' bureau membership from MSD; honoraria, advisory role, speakers bureau membership and travel expenses from GenomicHealth; honoraria and speakers' bureau membership from Astellas; Janssen-Cilag; and research funding and patents from Stratifyer. S.S. reports stocks in Strycker, Varian, Abbot; Crispr Techn, Pfitzer, Merck Serono, Symrise; honoraria, advisory role, speakers' bureau membership, research funding and travel expenses from Ortho; PharmaMar; and speakers' bureau membership from Haema. U.S.G. reports advisory role and research funding from AstraZeneca; advisory role from BMS; research funding from MSD; and travel expenses from Sennewald Medizintechnik. R.F. reports honoraria, advisory role, research funding and travel expenses from MSD; honoraria from Fresenius; honoraria from BrainLab; AstraZeneca; Merck Serono; Novocure; and speakers' bureau membership and travel expenses Sennewald. M.H. reports advisory role, speakers' bureau membership, honoraria, travel expenses and research funding from Merck Serono; advisory role, speakers' bureau membership, travel expenses and research funding MSD; AstraZeneca; Novartis; advisory role, honoraria and speakers’ bureau membership from BMS'; and travel expenses from Teva. The other authors declare no conflicts of interest.