Risk factors for cetuximab-related infusion reaction in Japanese patients: a retrospective multicentre clinical study

Abstract Background Chemotherapy with cetuximab is effective for colorectal and head and neck cancers. However, it may lose effectiveness if interrupted or postponed due to an infusion reaction (IR). We aimed to identify factors linked to IRs during cetuximab treatment in Japanese patients. Methods This retrospective cohort study included Japanese individuals aged ≥ 20 years who received their first dose of cetuximab at collaborating institutions between April 2018 and September 2021. Patient information, including demographics and symptoms of and interventions for IRs, was collected from medical records. Patients were divided into two groups based on the presence or absence of IRs. The least absolute shrinkage and selection operator regression analysis was used to identify the risk factors for IRs. Results Of the 244 patients enrolled at 10 centres, 19 (7.8%) developed an IR. The univariate analysis revealed that head and neck cancer ( p = 0.023), previous radiotherapy ( p = 0.008), lung metastasis ( p = 0.031), and concurrent taxane chemotherapy ( p = 0.009) were significantly more common in the IR group than in the non-IR group. We identified head and neck cancer (β = 0.321), histamine type-2 receptor antagonists (β = 0.212), and prior radiation therapy (β = 0.110) as variables selected as potential predictors of IRs. Conclusions The incidence of cetuximab-related IRs in Japanese patients was comparable to or lower than the previously reported rates in Western populations. Therefore, patients treated with cetuximab-containing regimens should be carefully evaluated for the possibility of IRs. Caution is advised when administering cetuximab to patients with head and neck cancer. Factors like histamine type-2 receptor antagonists and a history of radiation therapy are still exploratory; thus, they need to be confirmed in larger prospective studies that include standardized premedication protocols and IR checks. Trial registration This study was retrospectively registered with the Japan Registry of Clinical Trials (jRCT1040210116 registration date 25 December 2021).