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曲妥珠单抗对30例Her2阳性中国乳腺癌患者术后辅助治疗安全性的初步观察 被引量:1

Primary Safety Analysis of Trastuzumab after Adjuvant Chemotherapy in 30 Chinese Her2-positive Early Breast Cancer Patients
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摘要 背景与目的:国际多中心研究已经证实,曲妥珠单抗对Her2阳性的晚期乳腺癌和早期乳腺癌术后辅助治疗均有良好的疗效。本文中我们主要探讨Her2阳性中国乳腺癌患者术后完成辅助治疗后应用曲妥珠单抗的安全性。方法:早期乳腺癌患者术后完成辅助化疗和/或放疗后接受3周一次的曲妥珠单抗治疗,首次以负荷剂量8mg/kg给药,然后每3周给予6mg/kg静脉滴注,至少接受治疗4疗程,最长35疗程,观察其不良反应,特别是对心脏功能的影响。结果:共30例Her2阳性的乳腺癌患者术后接受曲妥珠单抗治疗,中位治疗疗程数是18个(4~35个),有2例在第一次用药时出现寒战和发热。18例患者治疗后LVEF下降,其中9例下降超过10%。24例治疗过程中曾出现轻度ST-T波改变,但未出现心力衰竭。结论:曲妥珠单抗对Her2阳性中国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。 BACKGROUND & OBJECTIVE: It has been proved that trastuzumab has clinical activity in early and advanced breast cancer with Her2-overexpression. This study was to analyze the safety of trastuzumab after adjuvant chemotherapy in 30 Chinese Her2-positive early breast cancer patients. METHODS. Trastuzumab was administrated after adjuvant chemotherapy every 21 days. The initial dose was 8 mg/kg, and the subsequent dose was 6 mg/kg, for four to 35 cycles (medium 18 cycles). The side effects of these patients, especially cardiotoxicity, were analyzed. RESULTS: Thirty patients with Her2-positive early breast cancer were entered into the study. The average treatment period was one year (range nine weeks to two years). Two patients had shivering and fever during the first infusion with trastuzumab. Left ventricular ejection fraction (LVEF) level dropped in 18 cases after treatment with trastuzumab, half of which decreased more then 10%; however, no cardiac failure was observed. CONCLUSIONS, The postsurgical treatment of trastuzumab in Chinese patients with Her2-positive early breast cancer shows a satisfactory safety profile. However, the potential cardiotoxicity of trastuzumab should be carefully monitored during therapy.
出处 《癌症》 SCIE CAS CSCD 北大核心 2008年第12期1307-1309,共3页 Chinese Journal of Cancer
关键词 乳腺肿瘤/联合治疗 HER-2阳性 曲妥珠单抗/治疗应用 安全性 Breast neoplasm/combined therapy Her2 positive Trastuzumab Safety
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