Trial reportBreast cancer (Tokyo, Japan)2025
Impact of modified dexamethasone administration sequence on infusion reaction incidence in HER2-positive breast cancer: a randomized multicenter trial.
Trial report in Breast cancer (Tokyo, Japan), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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10 authors.
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Abstract
backgroundInfusion reactions (IRs) are common adverse events associated with HER2-targeted monoclonal antibodies, such as trastuzumab and pertuzumab. Although dexamethasone is routinely administered before docetaxel to prevent hypersensitivity, its optimal timing relative to HER2-targeted agents has not been established. This study assessed whether premedication with dexamethasone reduces the incidence of IRs associated with HER2-targeted therapy.
methodsIn this randomized, multicenter trial, 100 patients with HER2-positive early breast cancer were randomized to receive dexamethasone either before (experimental group) or after (control group) HER2-targeted agents. All patients received trastuzumab, pertuzumab, and docetaxel. The primary endpoint was the incidence of IRs during the first treatment cycle. Secondary endpoints included the incidence of grade ≥ 3 IRs, IRs in cycle 2, and overall adverse events.
resultsIncidence of IRs in cycle 1 was significantly lower in the experimental group (24.0%) than in the control group (60.0%) (P < 0.001), corresponding to an absolute risk reduction of 36.0%. No grade ≥ 3 IRs occurred in either group. The incidence of IRs during cycle 2 was low and similar between groups (8.0% vs. 10.2%; P = 0.703). The incidence of treatment-related adverse events was similar between groups (98.0% vs. 100.0%, P > 0.999). Time-course analysis revealed that most of IRs in the control group occurred before dexamethasone administration.
conclusionsPremedication with dexamethasone before HER2-targeted therapy substantially reduced IRs without additional toxicity. This straightforward, cost-effective modification to the premedication protocol may improve tolerability in HER2-positive breast cancer and other antibody-based therapies.
trial registrationUMIN000045181 (registered on August 18, 2021).
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