(158) Incidence of Infusion Related Reactions from Cetuximab During the Observation Period

Poster Abstract:

Background: The cetuximab package insert states that infusion related reactions (IRR) of any grade occurred in 8.4% of patients and grade 3/4 IRR occurred in 2.2% of patients. It is recommended to monitor patients in clinic for 1 hour following cetuximab infusions. Some studies suggest 90% of severe IRR occur with the first dose of cetuximab and there is literature to support that a majority of cetuximab IRR occur during the first dose. Literature and anecdotal reports by M Health Fairview employees suggest that cetuximab IRR are more likely to occur during the infusion compared to following the infusion. M Health Fairview required a 1-hour observation period following the first cetuximab dose and 30-minute observation periods following each subsequent dose.

Objectives: The objective of this study is to determine the rate of cetuximab IRR during the mandated observation period following cetuximab infusions. The overall goal is to improve clinic efficiency, ensure patient safety, and minimize patient time spent in clinic.

Methods: Retrospective, multi-site, chart review study of adult patients treated with cetuximab between 11/1/2011 and 11/1/2021. No patients were excluded from this study regardless of the number of cetuximab infusions that they received. There were 129 patients and 1862 cetuximab administrations included in this study. Nursing notes were used to grade IRR and determine if the IRR occurred during the cetuximab infusion or during the observation period.

Results: Overall, 1.6% (95% CI: 0.2-5.6%) of patients had a cetuximab IRR during the observation time and 10.9% (95% CI: 5.9-18.2%) of patients reacted during the infusion. Two patients reacted during the observation time; one patient experienced a grade 2 reaction, and the other reaction was grade 3. Both reactions occurred with the first dose of cetuximab. Out of all IRR, one patient reacted during the third cetuximab dose; the reaction occurred during infusion. IRR during the observation period occurred in 0.1% (95% CI: 0.01-0.4%) of cetuximab administrations.
Discussion/

Conclusion: The majority of cetuximab IRR occurred during infusion with the first dose of cetuximab. Considering cetuximab IRR were more likely to occur with the first dose, and there was one patient that reacted on their third dose, M Health Fairview decided to continue monitoring for 1-hour following the first dose and for 30 minutes following doses 2 and 3. The observation period was discontinued for all subsequent doses . By implementing this change, M Health Fairview is expected to save 75 chair hours annually.

References (must also be included in final poster): Cetuximab (ERBITUX) [Package Insert]. Eli Lilly. Indianapolis, Indiana. Updated: June 22, 2023.

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Rombouts MD, Swart EL, VAN DEN Eertwegh AJM, Crul M. Systematic Review on Infusion Reactions to and Infusion Rate of Monoclonal Antibodies Used in Cancer Treatment. Anticancer Res. 2020;40(3):1201-1218. doi:10.21873/anticanres.14062.

O'Neil BH, Allen R, Spigel DR, et al. High incidence of cetuximab-related infusion reactions in Tennessee and North Carolina and the association with atopic history. J Clin Oncol. 2007;25(24):3644-3648. doi:10.1200/JCO.2007.11.7812.