曲妥珠单抗治疗185例HER2阳性乳腺癌患者的心脏安全性评价

Cardiac Safety of Trastuzumab on 185 Patients with HER2 Positive Breast Cancer

目的探讨HER2阳性乳腺癌患者应用曲妥珠单抗治疗的心脏安全性。方法 185例HER2阳性乳腺癌患者接受每3周一次的曲妥珠单抗治疗,首次以负荷剂量8 mg/kg给药,此后每3周给予6 mg/kg静脉滴注,接受治疗4~36周期,观察其心脏安全性。结果接受曲妥珠单抗治疗的HER2阳性乳腺癌患者中位治疗周期数为17个(4~36个),88例(47.6%)出现LVEF下降、74例(40.0%)出现瓣膜反流(新增+加重)、16例(8.0%)出现左室舒张功能下降。发生心脏毒性88例(47.6%),其中Ⅰ级心脏毒性83例、Ⅱ级心脏毒性5例,未见Ⅲ级心脏毒性发生。结论曲妥珠单抗对HER2阳性乳腺癌患者心脏功能有一定影响,总体安全性良好。但是,在治疗中仍需注意评估与监测。

Objective To analyze the cardiac safety of trastuzumab on HER2 positive breast cancer patients. Methods Trastuzumab was administrated every three weeks in 185 patients with HER2 positive breast cancer. The initial dose was 8 mg/kg, and the subsequent dose was 6 mg/kg, for 4-36 cycles. The cardiotoxicity of these patients was analyzed. Results The median treatment was 17 cycles in Her-2 positive breast cancer patients who received trastuzumab. Left ventricular ejection fraction （LVEF） level dropped in 88 cases （47.6%） after trastuzumab treatment; 74 patients （40.0%） occurred valvular regurgitation （new＋ aggravation）; 16 patients （8.0%） occurred the reduction of diastolic function of left ventricle; 88 patients （47.6%） experienced cardiotoxicity, among which 83 patients experienced gradeⅠcardiotoxicity and five patients experienced grade Ⅱ cardiotoxicity, no patient experienced grade Ⅲ cardiotoxicity. Conclusion The treatment of trastuzumab on Chinese patients with HER2 positive breast cancer shows a satisfactory cardiac safety. However, the potential cardiotoxicity of trastuzumab should be carefully monitored during therapy.