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Clinical Trial
. 2020 Nov:140:55-62.
doi: 10.1016/j.ejca.2020.09.001. Epub 2020 Oct 9.

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

Claudia Schweizer  1 , Philipp Schubert  2 , Sandra Rutzner  2 , Markus Eckstein  3 , Marlen Haderlein  2 , Sebastian Lettmaier  2 , Sabine Semrau  2 , Antoniu-Oreste Gostian  4 , Benjamin Frey  2 , Udo S Gaipl  2 , Jian-Guo Zhou  5 , Rainer Fietkau  2 , Markus Hecht  2
Affiliations
Clinical Trial

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

Claudia Schweizer et al. Eur J Cancer. 2020 Nov.

Abstract

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.

Keywords: Immune checkpoint inhibitors; Immune-related adverse events; Non-melanoma solid tumours; Prognostic parameters; Radiotherapy.

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Conflict of interest statement

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.

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