曲妥珠单抗治疗45例HER-2阳性乳腺癌安全性的初步观察  

Primary safety analysis of trastuzumab in 45 cases of HER-2 positive breast cancer patients

作　　者：林琳[1] 刘健[1] 李娜妮[1] 陈心华[1] 陈丽敏[1] 吴凡[1] 李重颖[1] 黄伟炜[1] 洪熠[1] 郑弘宇[1] 施纯玫[1] 

机构地区：[1]福建省肿瘤医院乳腺内科,福州350014

出　　处：《临床肿瘤学杂志》2010年第11期996-998,共3页Chinese Clinical Oncology

摘　　要：目的 探讨HER-2阳性乳腺癌患者应用曲妥珠单抗治疗的安全性.方法 45例HER-2阳性乳腺癌患者接受3周1次的曲妥珠单抗治疗,首次以负荷剂量8 mg/kg给药,然后每3周给予6mg/kg静脉滴注,观察其毒副反应,特别是对心脏功能的影响.结果 45例中接受治疗＞1年为4例（8.9%）,6～12个月为17例（37.8%）,＜6个月为24例（53.3%）.有2例在第1次用药时出现寒战和发热;6例患者治疗后左心射血分数下降,其中2例下降超过10%;19例治疗过程中出现轻度ST-T波改变,但未出现心力衰竭.结论 曲妥珠单抗对HER-2阳性国人乳腺癌患者心脏功能有一定影响,应在治疗中注意监测观察,但总体安全性良好.Objective This study was to analyze the safety of trastuzumab combined with chemotherapy in 45 cases of Chi- nese HER-2 positive breast cancer patients. Methods Forth-five patients with HER-2 positive breast cancer were enrolled in the study. Trastuzumab combined with chemotherapy was administered every 21 days. The initial dose was 8 mg/kg, and the subsequent dose was 6mg/kg. The side effects of these patients were analyzed, especially cardiotoxieity. Results There were 4 patients （ 8.9% ） achieved 〉 12 months, 17 patients（37. 8% ） achieved 6-12 months, 24 patients（53.3% ） achieved 〈6 months. Two patients had shivering and fever during the first infusion with trastuzumab. Left ventrieular ejection fraction（LVEF） level dropped in 19 cases after the treatment with trastuzumab, and 2 of them decreased more than 10%, however, no cardiac failure was observed. Conclusion Trastuzumab shows a satisfactory safety profile in Chinese patients with HER-2 positive breast cancer. However, the potentialcardiotoxicity of trastuzumab should be carefully monitored during therapy.

关 键 词：乳腺癌 HER-2阳性 曲妥珠单抗 安全性 

分 类 号：R737.9[医药卫生—肿瘤]