Department of Pharmacy, University Hospital, Kyoto Prefectural University of Medicine.
Department of Clinical Pharmacy (Currently known as Laboratory of Clinical Pharmacy), Kyoto Pharmaceutical University.
Biol Pharm Bull. 2023;46(7):964-968. doi: 10.1248/bpb.b23-00123.
Trastuzumab is a humanized monoclonal antibody targeting human epidermal growth factor receptor 2 (HER2) that is indicated for the treatment of HER2-positive breast cancer. The administration of biologics, such as trastuzumab, frequently causes infusion reactions (IRs) with fever and chills. This study aimed to clarify the risk factors for IRs in trastuzumab therapy. Between March 2013 and July 2022, 227 patients with breast cancer who started trastuzumab therapy were included in this study. The severity of IRs was graded according to the Common Terminology Criteria for Adverse Events, Version 5.0. The incidence of IRs in trastuzumab therapy was 27.3% (62/227). Dexamethasone administration was significantly different between the IR and non-IR groups in patients receiving trastuzumab therapy (univariate analysis, p < 0.001; multivariate analysis, p = 0.0002). Without dexamethasone, the severity of IRs in the pertuzumab combination group (Grade 1, 8/65; Grade 2, 23/65) was significantly higher than that in the non-pertuzumab group (Grade 1, 9/37; Grade 2, 3/37; p < 0.05). Our findings suggest that the risk of IRs is significantly higher in patients not premedicated with dexamethasone in trastuzumab therapy and that the concomitant use of pertuzumab without dexamethasone increases the severity of IRs caused by trastuzumab.
曲妥珠单抗是一种针对人表皮生长因子受体 2（HER2）的人源化单克隆抗体，用于治疗 HER2 阳性乳腺癌。生物制剂（如曲妥珠单抗）的给药常引起发热和寒战的输注反应（IR）。本研究旨在阐明曲妥珠单抗治疗中 IR 的危险因素。2013 年 3 月至 2022 年 7 月，本研究纳入了 227 例开始曲妥珠单抗治疗的乳腺癌患者。IR 严重程度根据不良事件通用术语标准，版本 5.0 进行分级。曲妥珠单抗治疗中 IR 的发生率为 27.3%（62/227）。在接受曲妥珠单抗治疗的患者中，IR 组和非 IR 组之间地塞米松给药有显著差异（单因素分析，p<0.001；多因素分析，p=0.0002）。未使用地塞米松时，曲妥珠单抗联合 pertuzumab 组（1 级，8/65；2 级，23/65）的 IR 严重程度明显高于非 pertuzumab 组（1 级，9/37；2 级，3/37；p<0.05）。我们的研究结果表明，在未用地塞米松预处理的曲妥珠单抗治疗患者中，IR 的风险显著增加，而在没有地塞米松的情况下联合使用 pertuzumab 会增加曲妥珠单抗引起的 IR 严重程度。
