Associations between patient and disease characteristics and severe adverse events during immune checkpoint inhibitor treatment: An observational study

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

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

8 Citations (Scopus)
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Abstract

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.

Original languageEnglish
Pages (from-to)113-120
Number of pages8
JournalEuropean Journal of Cancer
Volume174
Early online date18 Aug 2022
DOIs
Publication statusPublished - Oct 2022

Bibliographical note

Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.

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