Medical Oncology and Hematology Unit, Humanitas Clinical and Research Center - IRCCS, Via Manzoni 56, 20089, Rozzano, MI, Italy; Humanitas University, Department of Biomedical Sciences, Via Rita Levi Montalcini 4, 20090, Pieve Emanuele, Milan, Italy.
Medical Oncology and Hematology Unit, Humanitas Clinical and Research Center - IRCCS, Via Manzoni 56, 20089, Rozzano, MI, Italy.
Breast. 2021 Jun;57:80-85. doi: 10.1016/j.breast.2021.03.004. Epub 2021 Mar 17.
Few data are available about real-life cardiotoxicity associated with s.c. versus i.v. trastuzumab treatment of early-stage, HER2-positive breast cancer, and little is known about its predisposing factors.
We retrospectively reviewed data of 363 adult patients treated with adjuvant trastuzumab for HER2-positive breast cancer. Univariate statistical analysis was performed, and a multivariable logistic model was developed to identify independent risk factors of cardiac toxicity.
Within 5 years, the overall incidence of events meeting our criteria was 11.8%, and an early discontinuation of trastuzumab was recorded in 20 patients (5.5%). No cases of congestive heart failure occurred, neither multiple events per patient were observed. A total of 184 patients received i.v. and 179 received s.c. trastuzumab. Compared with the s.c. formulation, a higher cardiotoxicity rate for the i.v. administration (15.2% vs 8.4%) was found, and particularly in those patients with cardiovascular risk factors (19.3% vs 8.7%), at the univariate and multivariate analyses. Although more patients with prior anthracycline-based chemotherapy experienced cardiac events, the association of this therapy with cardiac events was not significant. The incidence of cardiac events was not influenced by anthropometric data (e.g. body mass index) or a diagnosis of diabetes mellitus. 5-year event-free survival was 91.7% in the overall population; event-free survival rates were similar between the s.c. and the i.v. groups.
Our study shows a more favorable safety profile of s.c. versus i.v trastuzumab administration. The use of s.c. trastuzumab could be advisable in at-risk patients.
关于早期 HER2 阳性乳腺癌患者皮下注射与静脉注射曲妥珠单抗相关的实际心脏毒性的数据很少，其易患因素也知之甚少。
我们回顾性分析了 363 例接受曲妥珠单抗辅助治疗的 HER2 阳性乳腺癌成人患者的数据。进行了单变量统计分析，并建立了多变量逻辑模型，以确定心脏毒性的独立危险因素。
在 5 年内，符合我们标准的事件总发生率为 11.8%，有 20 例（5.5%）患者提前停止使用曲妥珠单抗。没有发生充血性心力衰竭，也没有观察到每位患者的多个事件。共有 184 例患者接受静脉注射曲妥珠单抗，179 例患者接受皮下注射曲妥珠单抗。与皮下制剂相比，静脉制剂的心脏毒性发生率更高（15.2%比 8.4%），在有心血管危险因素的患者中（19.3%比 8.7%），单变量和多变量分析均如此。尽管更多接受过蒽环类药物化疗的患者发生了心脏事件，但这种治疗与心脏事件之间的关联并不显著。心脏事件的发生率不受人体测量数据（如体重指数）或糖尿病诊断的影响。总体人群的 5 年无事件生存率为 91.7%；皮下组和静脉组的无事件生存率相似。
我们的研究表明，与静脉注射曲妥珠单抗相比，皮下注射曲妥珠单抗具有更好的安全性。在有风险的患者中，使用皮下曲妥珠单抗可能是明智的。
