曲妥珠单抗单药或联合诺维本治疗转移性乳腺癌  

Trastuzumab single or combined with vinorelbine in the treatment of metastatic breast cancer

作　　者：申戈[1] 江泽飞[1] 宋三泰[1] 吴世凯[1] 王涛[1] 张少华[1] 卢新友[1] 路春蕾[1] 曾敏[1] 

机构地区：[1]军事医学科学院附属医院乳癌科,北京100039

出　　处：《中国癌症杂志》2008年第3期212-214,共3页China Oncology

摘　　要：背景与目的:曲妥珠单抗作用靶点是人表皮生长因子受体-2(Her-2)的细胞外部位,对Her-2过表达的乳腺癌患者疗效肯定,与化疗药物联合应用疗效更好。本研究观察了国产曲妥珠单抗单药或联合诺维本(NVB)治疗转移性乳腺癌的疗效及不良反应。方法:共24例转移性乳癌患者入组,单药组:曲妥珠单抗首次4 mg/kg,以后每周1次,2 mg/kg;联合组:NVB 25 mg/m2d 1、8、15,同时应用曲妥珠单抗,用法同单药组,4周为1个周期。8周、12周、20周和24周时进行疗效评价。结果:可评价疗效的有23例。单药组有效率20.0%(2/10),1例CR、1例PR,SD 30.0%(3/10),PD 50.0%(5/10);联合组有效率为84.6%(11/13),均为PR,SD 7.7%(1/13),PD 7.7%(1/13)。不良反应与曲妥珠单抗有关的:寒战8例、发热11例,皮疹3例,心悸2例,与诺维本有关的主要有乏力7例、手麻7例,麻痹性肠梗阻2例。诺维本引起的Ⅲ、Ⅳ度粒细胞减少为80.0%(12/15)。结论:单药曲妥珠单抗治疗转移性乳腺癌有一定疗效,联合诺维本后有非常好的疗效,不良反应可耐受。Background and purpose：Trastuzumab is a monoclonal antibody directed against the Her-2 extracellular domain.The effect of single-agent trastuzumab is analyzed in the treatment of HER-2 positive metastatic breast cancer.The response rate is higher when combined with chemotherapy.This study was to observe the efficacy and adverse reactions of trastuzumab made in China as single-agent or combined with vinorelbin in the treatment of metastatic breast cancer.Methods：Single-agent group：trastuzumab was given 4mg/kg on day1,then 2 mg/kg,every 7 days.Combined group：vinorel-bine（25mg/m^2）was given on days 1,8,15 every 28 and trastuzumab was given as that of the single-group.The effect was assessed on 8 weeks,12 weeks,20 weeks and 24 weeks.Results：24 patients were enrolled.The effect could be observed in 23 patients. Objective response in single-agent group was observed in 2 of 10 patients（20.0%）,one with complete response and the others with partial responses;stable and progressive disease（PD）were observed in 30.0%（3/10）and 50.0%（5/10）patients,respectively.Partial response of the combined group was observed in 11 of 13 patients（84.6%）,and stable disease（SD）was 7.7%（1/13）,progressive disease（PD）was 7.7%（1/13）.The side effect related to trastuzumab was shiver 8/24,fever 11/24,rash 3/24 and palpitation 2/24.The side effect related to vinorelbine was fatigue 7/15,hand numbness 7/15,paralytic ileus 2/15,vomiting 2/15,diarrhea 1/15 and vein inflammation 1/15.Ⅲ or Ⅳ degree neutropenia occurred in 80.0%（12/15）patients.Conclusions：Trastuzumab made in China was efficient,and could achieve good response when combined with vinorelbine.The adverse reaction could be well tolerated.

关 键 词：曲委珠单抗 诺维本 转移性 乳腺癌 

分 类 号：R730.53[医药卫生—肿瘤]