| Sumario: | Purpose: This research aimed to investigate the incidence, severity, timing, and associated factors of cetuximab-induced infusion-related reactions (IRRs) in metastatic colorectal cancer and to inform post-infusion observation strategy. Methods: This retrospective cohort study analyzed medical records of 821 patients treated with cetuximab at a tertiary hospital between 2006 and 2019. IRRs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. χ² tests, Fisher's exact tests, and logistic regression were used. Results: IRRs occurred in 99 of 821 patients (12.1%), totaling 107 events; 87.9% were grade 1-2 and 12.1% were grade 3-4 (no grade 5 events were observed). Most initial IRRs occurred during the test dose (44.4%) or first full dose (45.5%), and only 10.1% occurred from cycle 2 onward. Median time to onset was 15.5 minutes for the test dose and 60 minutes for the first full dose, and 12 of 13 grade≥3 reactions (92.3%) and all 7 grade 4 reactions occurred within 30 minutes. All 17 IRRs from cycle 2 onward occurred during infusion, with none during the 1-hour post-infusion monitoring. Combined antihistamine--corticosteroid premedication significantly reduced IRR risk versus antihistamine alone (OR=0.60, 95% CI=0.38--0.93, p=.020). Conclusion: Cetuximab-induced IRRs predominantly occur during the first cycle, suggesting the potential for risk-adapted, cycle-differentiated monitoring. These findings provide evidence-based data to support oncology nurses in risk assessment and resource allocation in outpatient chemotherapy, pending multicenter validation.
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