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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
【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。
【Abstract】 Objective This study was to analyze the safety of trastuzumab combined with chemotherapy in 45 cases of Chinese 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 cardiotoxicity.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 ventricular 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.
- 【文献出处】 临床肿瘤学杂志 ,Chinese Clinical Oncology , 编辑部邮箱 ,2010年11期
- 【分类号】R737.9
- 【被引频次】1
- 【下载频次】156