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. (November 2020)

• Record Type: Journal Article
• Authors: Schweizer, Claudia; Schubert, Philipp; Rutzner, Sandra; Eckstein, Markus; Haderlein, Marlen; Lettmaier, Sebastian; Semrau, Sabine; Gostian, Antoniu-Oreste; Frey, Benjamin; Gaipl, Udo S.; Zhou, Jian-Guo; Fietkau, Rainer; Hecht, Markus
• Is Part Of: European journal of cancer. Volume 140(2020)
• Page Start: 55
• Page End: 62
• Publication Date: 2020-11
• Subjects: Non-melanoma solid tumours -- Immune checkpoint inhibitors -- Radiotherapy -- Immune-related adverse events -- Prognostic parameters; Cancer -- Periodicals; Neoplasms -- Periodicals; Cancer -- Périodiques; Cancer; Tumors; Electronic journals; Periodicals; Electronic journals; 616.994
• DOI: 10.1016/j.ejca.2020.09.001
• Languages: English
• ISSNs: 0959-8049

Abstract

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. Highlights: ST-ICI prospectively enrolled patients with non-melanoma tumour treated with anti-programmed cell death-ligand 1 (PD-L1). Immune-related adverse events (irAEs) correlated with improved overall survival and progression-free survival. Combination of radiotherapy with PD-L1 inhibitors did not increase irAEs. In the subgroup with radiotherapy irAEs also had a positive prognostic value.