Abstract：
To clarify the incidence and risk factors of infusion-related reactions (IRRs) caused by trastuzumab in breast cancer patients and verify the preventive effects of dexamethasone.
All breast cancer patients newly treated with trastuzumab at the Osaka Medical and Pharmaceutical University Hospital from 1 January 2017 to 31 December 2020 were included. The electronic medical records were retrospectively reviewed. The outcome measure was the occurrence of IRRs of grade 1 or higher during trastuzumab infusion. Only dexamethasone and anticancer drugs administered concomitantly before trastuzumab were used as explanatory variables.
The 176 patients included in the study received 2320 infusions. Fifty-eight patients (33.0%) experienced IRRs, and IRRs occurred in 80 (3.4%) of the total 2320 infusions. Owing to the hierarchical structure of the data, the independence of the observed values was evaluated using the intraclass correlation coefficient. Multivariate multilevel logistic regression analysis showed that premedication with dexamethasone lowered the risk of trastuzumab-induced IRRs (mg, per 1 unit, odds ratio [OR] = 0.61, 95% confidence interval [95% CI] 0.43-0.85, P = .003). In addition, preoperative status (OR = 38.9, 95% CI 5.4-278.7, P < .001) and high-dose trastuzumab (mg/kg, per 1 unit, OR = 60.6, 95% CI 20.1-182.9, P < .001) were independent risk factors for IRRs.
The results of this study suggest that premedication with dexamethasone exhibits preventive effects on trastuzumab-induced IRRs in breast cancer patients. Future studies are needed to determine the optimal dose of dexamethasone to prevent IRRs and the impact of dexamethasone on the efficacy of trastuzumab in breast cancer.
All breast cancer patients newly treated with trastuzumab at the Osaka Medical and Pharmaceutical University Hospital from 1 January 2017 to 31 December 2020 were included. The electronic medical records were retrospectively reviewed. The outcome measure was the occurrence of IRRs of grade 1 or higher during trastuzumab infusion. Only dexamethasone and anticancer drugs administered concomitantly before trastuzumab were used as explanatory variables.
The 176 patients included in the study received 2320 infusions. Fifty-eight patients (33.0%) experienced IRRs, and IRRs occurred in 80 (3.4%) of the total 2320 infusions. Owing to the hierarchical structure of the data, the independence of the observed values was evaluated using the intraclass correlation coefficient. Multivariate multilevel logistic regression analysis showed that premedication with dexamethasone lowered the risk of trastuzumab-induced IRRs (mg, per 1 unit, odds ratio [OR] = 0.61, 95% confidence interval [95% CI] 0.43-0.85, P = .003). In addition, preoperative status (OR = 38.9, 95% CI 5.4-278.7, P < .001) and high-dose trastuzumab (mg/kg, per 1 unit, OR = 60.6, 95% CI 20.1-182.9, P < .001) were independent risk factors for IRRs.
The results of this study suggest that premedication with dexamethasone exhibits preventive effects on trastuzumab-induced IRRs in breast cancer patients. Future studies are needed to determine the optimal dose of dexamethasone to prevent IRRs and the impact of dexamethasone on the efficacy of trastuzumab in breast cancer.
摘要：
目的：明确曲妥珠单抗在乳腺癌患者中引起的输液相关反应（IRRs）的发生率和危险因素，验证地塞米松的预防作用。
方法：纳入2017年1月1日至2020年12月31日在大阪医学药科大学医院接受曲妥珠单抗治疗的所有乳腺癌患者。对电子病历进行回顾性审查。结果测量是在曲妥珠单抗输注期间发生1级或更高的IRR。仅在曲妥珠单抗之前同时施用的地塞米松和抗癌药物被用作解释变量。
结果：纳入研究的176名患者接受了2,320次输注。58名患者(33.0%)经历了IRR，IRR发生在总共2,320次输液中的80次(3.4%)。由于数据的层次结构，使用组内相关系数评估观察值的独立性.多变量多水平logistic回归分析显示，使用地塞米松的术前用药降低了曲妥珠单抗诱导的IRRs的风险（mg；每1单位；比值比，OR=0.61；95%置信区间，95%CI，0.43-0.85；p=0.003）。此外,术前状态(OR=38.9;95%CI,5.4~278.7;p<0.001)和大剂量曲妥珠单抗(mg/kg;每1单位;OR=60.6;95%CI,20.1~182.9;p<0.001)是IRRs的独立危险因素.
结论：这项研究的结果表明，在乳腺癌患者中，地塞米松的术前用药对曲妥珠单抗诱导的IRR具有预防作用。未来的研究需要确定地塞米松预防IRRs的最佳剂量以及地塞米松对曲妥珠单抗治疗乳腺癌疗效的影响。
方法：纳入2017年1月1日至2020年12月31日在大阪医学药科大学医院接受曲妥珠单抗治疗的所有乳腺癌患者。对电子病历进行回顾性审查。结果测量是在曲妥珠单抗输注期间发生1级或更高的IRR。仅在曲妥珠单抗之前同时施用的地塞米松和抗癌药物被用作解释变量。
结果：纳入研究的176名患者接受了2,320次输注。58名患者(33.0%)经历了IRR，IRR发生在总共2,320次输液中的80次(3.4%)。由于数据的层次结构，使用组内相关系数评估观察值的独立性.多变量多水平logistic回归分析显示，使用地塞米松的术前用药降低了曲妥珠单抗诱导的IRRs的风险（mg；每1单位；比值比，OR=0.61；95%置信区间，95%CI，0.43-0.85；p=0.003）。此外,术前状态(OR=38.9;95%CI,5.4~278.7;p<0.001)和大剂量曲妥珠单抗(mg/kg;每1单位;OR=60.6;95%CI,20.1~182.9;p<0.001)是IRRs的独立危险因素.
结论：这项研究的结果表明，在乳腺癌患者中，地塞米松的术前用药对曲妥珠单抗诱导的IRR具有预防作用。未来的研究需要确定地塞米松预防IRRs的最佳剂量以及地塞米松对曲妥珠单抗治疗乳腺癌疗效的影响。
