Associations between patient and disease characteristics and severe adverse events during immune checkpoint inhibitor treatment

Autor: Edwin A. Basak, Niels S. Vermeer, Karlijn de Joode, Daan P. Hurkmans, Dorian E.M. Velthuis, Esther Oomen-de Hoop, Marco W.J. Schreurs, Sander Bins, Stijn L.W. Koolen, Reno Debets, Astrid A.M. van der Veldt, Joachim G.J.V. Aerts, Arjen Joosse, Ron H.J. Mathijssen
Přispěvatelé: Medical Oncology, Pharmacy, Immunology, Radiology & Nuclear Medicine, Pulmonary Medicine
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Zdroj: European Journal of Cancer, 174, 113-120. Elsevier Ltd.
ISSN: 0959-8049
DOI: 10.1016/j.ejca.2022.07.015
Popis: AIM: With increasing use of immune checkpoint inhibitors (ICIs) more patients will develop severe and potentially life-threatening immune-related adverse events (irAEs). So far, predictive models for the occurrence of grade ≥3 irAEs are lacking. Therefore, we analysed associations between patient and disease characteristics, and the occurrence of grade ≥3 irAEs.METHODS: Patients with cancer who were treated with anti-PD-1 (+/-anti-CTLA-4) between July 2015 and February 2020, and who were prospectively included in the MULTOMAB-trial, were eligible for this cohort study. Time to and occurrence of grade ≥3 irAEs according to CTCAE v5.0 were retrospectively registered. The associations between patient and disease characteristics and irAE occurrence were analysed using the competing risk cox-regression model of Fine and Gray. Analyses were performed separately in patients treated with monotherapy (anti-PD-1) and combination therapy (anti-PD-1 + anti-CTLA-4). Subgroup analyses were performed in tumour types with the highest number of patients; melanoma and NSCLC.RESULTS: Out of 641 patients, 106 patients (17%) experienced grade ≥3 irAEs. None of the analysed factors were associated with grade ≥3 irAE occurrence in the monotherapy (n = 550) or the combination therapy (n = 91) groups, nor in the subgroup analyses. Of interest, none of the patients with NSCLC with a WHO performance status of 0 (n = 34) experienced grade ≥3 irAEs. Most common NSCLC histology types were adenocarcinoma (n = 99/55%) and squamous cell carcinoma (n = 39/22%).CONCLUDING STATEMENT: This study shows that patient and disease characteristics are not able to predict the occurrence of serious AEs in patients treated with ICIs.
Databáze: OpenAIRE
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