RT Journal Article
SR Electronic
T1 Immune-related adverse events associated with immune checkpoint inhibitors: a call to action for collecting and sharing clinical trial and real-world data
JF Journal for ImmunoTherapy of Cancer
JO J Immunother Cancer
FD BMJ Publishing Group Ltd
SP e002896
DO 10.1136/jitc-2021-002896
VO 9
IS 7
A1 Reynolds, Kerry L
A1 Arora, Shaily
A1 Elayavilli, Ravikumar Komandur
A1 Louv, William C
A1 Schaller, Teilo H
A1 Khandelwal, Aakanksha
A1 Rothenberg, Mace
A1 Khozin, Sean
A1 Guidon, Amanda C
A1 Dougan, Michael
A1 Zubiri, Leyre
A1 Petrillo, Laura
A1 Sise, Meghan E
A1 Villani, Alexandra-Chloe
A1 Johnson, Douglas B
A1 Rahma, Osama
A1 Sharon, Elad
YR 2021
UL http://jitc.bmj.com/content/9/7/e002896.abstract
AB 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.