Monoclonal antibodies (mAb) are an important part of modern cancer treatment due to their target specificity and more favorable safety profile compared with conventional anticancer therapies. Nevertheless, infusion-related reactions (IRs) may occur during or shortly after administration and are among the more common adverse effects of these medicines.
In this retrospective study we investigated the incidence and characteristics of IRs in patients treated with mAb or antibody-drug conjugates at the Institute of Oncology Ljubljana between 2020 and 2024. We assessed which drugs were most frequently associated with IRs, the treatment cycle in which these reactions most commonly occurred, their severity, and the proportion of patients who continued treatment on the same day or in subsequent treatment cycles following an IR.
During the study period, a total of 7.784 patients received treatment with mAb, with 258 IRs recorded in 238 patients following the administration of 18 different drugs. The highest number of IRs was reported for rituximab (107), followed by trastuzumab (65), cetuximab (39), and obinutuzumab (14). The highest incidence of IRs was observed in patients treated with tafasitamab (37.5%), although the sample size was very small, followed by obinutuzumab (21.5%), mogamulizumab (16.7%), and cetuximab (15.2%). For most other drugs, the incidence was below 1%. Most patients experienced grade 2 IRs (84.0%) according to the Common Terminology Criteria for Adverse Events, while grade 3 and 4 reactions were uncommon. IRs most frequently occurred during the first administration or early treatment cycles, except for bevacizumab, pembrolizumab, and ipilimumab, for which they occurred during later administrations. In most patients with grade 2 IRs, treatment was successfully resumed on the same day after symptom resolution without further complications. Obinutuzumab and cetuximab were particularly notable: infusion was resumed on the same day in all patients receiving obinutuzumab, compared with only 13% of patients treated with cetuximab. A similar trend was observed in subsequent treatment cycles, with nearly all patients continuing treatment after experiencing a grade 2 IR for most drugs, with cetuximab being the only exception (6% continuing treatment). Recurrence of IRs following re-exposure to the same drug was uncommon (11% of cases), and recurrent IR were generally the same or a lower severity grade than the inicial IR.
The findings of this study contribute to a better understanding of IRs associated with the parenteral administration of mAb for cancer treatment, which is particularly important given the increasing incidence of cancer and the consequent growing use of mAb.
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