Infusion-Related Reactions Among Cancer Patients Receiving Immune Checkpoint Inhibitors: The ARON-MOUSEION-013 Systematic Review and Meta-Analysis

Drug Des Devel Ther. 2025 Dec 13:19:11107-11118. doi: 10.2147/DDDT.S560518. eCollection 2025.

Abstract

Purpose: To investigate the incidence of Infusion-Related Reactions (IRRs) among cancer patients receiving Immune Checkpoint Inhibitors (ICIs) and immune-based combinations.

Patients and methods: The ARON-MOUSEION-013 was registered in PROSPERO (CRD420251018433). Observational, randomized and quasi-experimental studies were included in the present review, and rates in IRR among cancer adults (≥18 years) receiving ICIs were recorded and then analyzed.

Results: A total of 4 records were considered for analyses, with a total of 55 observations and 35 events. The overall prevalence of IRR, considering Any Grade, was 67.4% [95% CI: 3.9%; 99.1%]. Considering Grade ≥ 3, a total of 55 observations and 8 events were registered. The overall prevalence of irAEs in IRRs was 6% [95% CI: 0.2%; 74.7%].

Conclusion: Mild-to-moderate IRRs are not rare events in patients receiving ICIs. IRRs may be avoided to manage these infusions slowly; however, severe reactions require emergency handling.

Keywords: cancer; immunotherapy; infusion-related reactions; injection site reaction; neoplasms.

Publication types

  • Meta-Analysis
  • Systematic Review

MeSH terms

  • Humans
  • Immune Checkpoint Inhibitors* / administration & dosage
  • Immune Checkpoint Inhibitors* / adverse effects
  • Immune Checkpoint Inhibitors* / therapeutic use
  • Infusions, Intravenous
  • Neoplasms* / drug therapy

Substances

  • Immune Checkpoint Inhibitors