Incidence of Hypersensitivity Reactions from Monoclonal Antibody Use in Cancer Patients at Srinagarind Hospital

Abstract

Background and Objective: Monoclonal antibodies (mAbs) are therapeutic agents widely used in the treatment of various malignancies. Despite their efficacy, these agents are associated with hypersensitivity reactions (HSRs), which may lead to temporary suspension or discontinuation of treatment. HSRs are considered preventable adverse drug reactions. This study aimed to investigate the prevalence, clinical manifestations, severity, and management strategies of HSRs among cancer patients receiving mAbs therapy at Srinagarind Hospital.

Methods: A retrospective descriptive study was conducted by reviewing electronic medical records from the Health Object (HO) system at Srinagarind Hospital. Data were collected from cancer patients who developed HSRs during treatment with monoclonal antibodies between January 1, 2020, and December 31, 2024. The data were obtained from both inpatient and outpatient departments.

Results: Of 1,838 patients who received mAbs, 47 patients (2.56%; 95% CI: 1.89–3.39) experienced a total of 59 HSR events. Most patients were female (68.09%) with a mean age of 59.70 ± 11.21 years. The most common malignancy was lymphoma (40.43%). A majority of patients (89.36%) had no prior history of drug allergy. The highest incidence of HSRs was associated with daratumumab (13.51%, 95% CI: 5.91-27.97), followed by rituximab (4.09%, 95% CI: 2.69–6.17) and cetuximab (3.85%, 95% CI: 0.68-18.90). Most reactions occurred during the first cycle of administration (59.32%), followed by the second cycle (10.17%). Based on CTCAE v5.0, grade 1 and 2 reactions were most commonly observed (37.29% and 28.81%, respectively), while grade 4 reactions accounted for 18.64%. The most frequently reported symptoms included chills (25.26%), followed by fever, chest tightness, and tachycardia (8.42%). Anaphylaxis occurred in 10.53% of the events. The most commonly used management strategy was temporary cessation of the infusion combined with symptom assessment, prolonged infusion time, and administration of premedications (45.76%), which enabled continuation of treatment in 71.19% of patients.

Conclusion: Monoclonal antibodies may induce HSRs as early as the first dose, with severity ranging from mild to life-threatening. Daratumumab and rituximab, in particular, require careful monitoring during initial administration. Preparedness of healthcare personnel and the implementation of appropriate treatment protocols are essential to reduce the risk and ensure safe monoclonal antibodies administration.