OBJECTIVE

Increasing reports of immune-related severe adverse events (ir-SAEs) among patients with cancer treated with immune checkpoint inhibitors (ICIs) have raised significant concerns regarding patient safety. Although considerable research has addressed immune-related adverse events (irAEs), the risk factors specifically associated with ir-SAEs remain less well defined. This study aims to identify and synthesize the risk factors contributing to ir-SAEs in patients with cancer.

METHODS

Adhering to the Joanna Briggs Institute scoping review guidelines, we conducted a comprehensive literature search across multiple databases including PubMed, Embase, Web of Science, ProQuest Dissertations and Theses, Clinical Trials, China Biomedical Literature Database, CNKI, Wanfang Database, and VIP Database. Studies published from the inception of each database up to 28 January 2024 were considered. Two independent reviewers screened the literature and extracted the relevant data.

RESULTS

A total of 41 studies were included, comprising 20 retrospective case-control studies, 9 retrospective cohort studies, 8 prospective cohort studies, and 4 meta-analyses. The analysis identified three primary categories of risk factors: demographic factors, disease-related factors, and laboratory examination-related factors.

CONCLUSIONS

A diverse range of risk factors is associated with ir-SAEs in patients with cancer. Enhancing the education of clinical oncology nurses regarding these risk factors may facilitate early identification and management of high-risk groups, thereby improving patient safety. Given the observed inconsistencies among studies, further research is warranted to elucidate risk factors with high predictive value for ir-SAEs.