曲妥珠单抗治疗晚期乳腺癌患者的心脏毒性研究  

Clinical trial of the cardiotoxicity of trastuzumab in the treatment of patients with metastatic breast cancer

作　　者：黄平[1] 刘雅娟[2] 陈占红[1] 郑亚兵[1] 孙燕[1] 黄健[1] 曹文明[1] 邵喜英[1] 王晓稼[1] 

机构地区：[1]浙江省肿瘤医院肿瘤内科,杭州310022 [2]杭州市肿瘤医院肿瘤综合治疗科,杭州310022

出　　处：《中国临床药理学杂志》2017年第9期778-781,共4页The Chinese Journal of Clinical Pharmacology

基　　金：浙江省医药卫生科技计划基金资助项目(2015RCB005;2016KYA046)

摘　　要：目的观察曲妥珠单抗治疗人表皮生长因子受体2(HER2)阳性晚期转移性乳腺癌的心脏毒性。方法回顾性收集102例用曲妥珠单抗治疗HER2阳性晚期转移性乳腺癌住院患者的临床资料,包括一般情况、临床疗效、左心室射血分数(LVEF)。分析影响LVEF变化的临床因素,以及心脏毒性药物不良反应的发生情况。结果 102例患者首次曲妥珠单抗治疗完全缓解7例(6.86%),部分缓解73例(71.57%)。LVEF基线值为(72.85±4.64)%,持续使用曲妥珠单抗的患者LVEF值第21个月及第39个月到达谷点,分别为(66.05±5.96)%和(65.15±3.38)%。首次使用含曲妥珠单抗无进展生存期(PFS)和使用曲妥珠单抗时间是影响LVEF下降的临床因素(均P<0.05),整个LVEF监测过程中曲妥珠单抗相关的心脏毒性药物不良反应累积发生率为14.71%(15例),未发生曲妥珠单抗治疗导致的心力衰竭,无曲妥珠单抗治疗相关的死亡。结论使用曲妥珠单抗治疗晚期乳腺癌,心脏功能呈现周期性下降及恢复趋势,心脏毒性药物不良反应发生率平稳,长期使用耐受性及安全性良好。Abstract： Objective To study the cardiotoxicity of trastuzumab in hu- man epidermal growth factor receptor 2 （HER2） positive metastatic breast cancer patients. MethOds We retrospectively collected the clinical data of general characteristic, left ventricular ejection fraction （LVEF） and clinical efficacy in 102 HER2 positive metastatic breast cancer patients treated with trastuzumab and analyzed the factors which influence the changes of LVEF and the incidence of cardiotoxicity induced by trastuzumab. Results In all of the 102 patients, the complete remission and partial remission were 7 cases （6.86%） and 73 cases （71.57%） in patients firstly treated with trastuzumab -based regimens respectively. The LVEF value was （ 72. 85 ± 4. 64 ） % at baseline and decreased to （ 66. 05 ± 3, 96 ） % and （65.15±3.38） % as the valley points at 21 and 39 months in patients who continually used trastuzumab. The progression free （PFS） of the first use of trastuzumab containing regimen and trastuzumab usage time were the clinical factors influencing the LVEF decreased value （P 〈 0. 05）. The cumulative incidence of trastuzumab associated cardiotoxicity （TACT） was 14. 71% （15 cases） in the whole course of LVEF monitoring. All patients had no occurrence of heart failure and trastuzumab treatment related death caused by trastuzumab.Conclusion The heart function deceased and recovered periodically under treatment with trastuzumab in metastatic breast cancer. The incidence of cardiotoxicity was stable. Long term use of trastuzumab was well tolerated and safe.

关 键 词：曲妥珠单抗 乳腺肿瘤 心脏功能 左心室射血分数 心脏毒性 

分 类 号：R979.1[医药卫生—药品]