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目的:曲妥珠单抗(新)辅助治疗是人表皮生长因子受体2(human epidermal growth factor receptor 2,HER2)阳性乳腺癌的标准治疗,但存在发生心脏不良反应的风险。本研究拟评价在临床实际中曲妥珠单抗治疗相关心脏不良反应情况及其危险预测因素。方法 :回顾性分析136例曲妥珠单抗(新)辅助治疗的病例。心脏不良反应定义为左室射血分数(left ventricular ejection fraction,LVEF)较治疗前基线下降≥10%,且LVEF<50%,或患者出现心力衰竭相关症状(可无LVEF下降)。结果 :136例患者的中位年龄为49岁(范围:24~75岁)。98.5%(134例)的患者接受过新辅助和(或)辅助化疗。86.0%(117例)的患者接受过以蒽环类药物为基础的化疗。曲妥珠单抗的中位治疗时间为12.0个月(范围:9.0~14.0个月)。3.7%(5例)的患者发生心脏不良反应,其中1.5%(2例)的患者表现为伴有症状的心力衰竭。年龄>60岁的患者的曲妥珠单抗治疗相关心脏不良反应发生率显著增加(21.4%vs 1.6%,P=0.008)。0.7%(1例)的患者因心脏不良反应而永久停止曲妥珠单抗治疗,3.7%(5例)的患者因LVEF值明显下降暂停曲妥珠单抗治疗,LVEF值恢复后继续完成治疗。结论 :本研究中,曲妥珠单抗治疗相关心脏不良反应发生率为3.7%,且大部分是可逆的,其中年龄>60岁患者的风险显著增加。在临床实践中,应该密切监测心脏功能,特别是对于老年患者。
OBJECTIVE: Trastuzumab (neo) adjuvant therapy is the standard treatment for human epidermal growth factor receptor 2 (HER2) positive breast cancer but presents with a risk of adverse cardiac events. This study intended to evaluate the adverse cardiac events associated with trastuzumab in clinical practice and predictors of risk. Methods: A retrospective analysis of 136 cases of trastuzumab (new) adjuvant therapy. Cardiac adverse events were defined as left ventricular ejection fraction (LVEF)> 10% decrease in baseline and <50% LVEF before treatment, or heart failure-related symptoms (with no loss of LVEF) in patients. Results: The median age of 136 patients was 49 years (range: 24-75 years). 98.5% (134 cases) of patients received neoadjuvant and / or adjuvant chemotherapy. Of the 86.0% (117 patients) who received anthracycline-based chemotherapy. The median duration of trastuzumab treatment was 12.0 months (range: 9.0-14.0 months). Cardiac adverse reactions occurred in 3.7% (n = 5) of the patients, and 1.5% (n = 2) presented with symptomatic heart failure. The incidence of adverse cardiac reactions associated with trastuzumab in patients> 60 years of age was significantly increased (21.4% vs 1.6%, P = 0.008). In 0.7% (n = 1) patients, trastuzumab was stopped permanently due to adverse cardiac events, and trastuzumab was stopped in 3.7% (n = 5) due to a significant decrease in LVEF. Treatment was resumed after LVEF was restored . CONCLUSIONS: The incidence of adverse cardiac reactions associated with trastuzumab in this study was 3.7% and mostly reversible, with a significantly increased risk for patients over 60 years of age. In clinical practice, heart function should be closely monitored, especially in the elderly.