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Immune-related adverse events associated with immune checkpoint inhibitors: a call to action for collecting and sharing clinical trial and real-world data

Authors :
Kerry L. Reynolds
Elad Sharon
Meghan E. Sise
Douglas B. Johnson
Laura A. Petrillo
William C Louv
Mace L. Rothenberg
Michael Dougan
Sean Khozin
Aakanksha Khandelwal
Teilo H Schaller
Amanda C. Guidon
Shaily Arora
Ravikumar Komandur Elayavilli
Osama E. Rahma
Alexandra-Chloé Villani
Leyre Zubiri
Source :
Journal for Immunotherapy of Cancer, Journal for ImmunoTherapy of Cancer, Vol 9, Iss 7 (2021)
Publication Year :
2021
Publisher :
BMJ Publishing Group, 2021.

Abstract

Immune checkpoint inhibitors (ICIs) have revolutionized the treatment of cancer, improving outcomes in patients with advanced malignancies. The use of ICIs in clinical practice, and the number of ICI clinical trials, are rapidly increasing. The use of ICIs in combination with other forms of cancer therapy, such as chemotherapy, radiotherapy, or targeted therapy, is also expanding. However, immune-related adverse events (irAEs) can be serious in up to a third of patients. Critical questions remain surrounding the characteristics and outcomes of irAEs, and how they may affect the overall risk–benefit relationship for combination therapies. This article proposes a framework for irAE classification and reporting, and identifies limitations in the capture and sharing of data on irAEs from current clinical trial and real-world data. We outline key gaps and suggestions for clinicians, clinical investigators, drug sponsors, patients, and other stakeholders to make these critical data more available to researchers for pooled analysis, to advance contemporary understanding of irAEs, and ultimately improve the efficacy of ICIs.

Details

Language :
English
ISSN :
20511426
Volume :
9
Issue :
7
Database :
OpenAIRE
Journal :
Journal for Immunotherapy of Cancer
Accession number :
edsair.doi.dedup.....548612cdcb271f069d4e64f2c99e383d