曲妥珠单抗联合FOLFIRI治疗HER2阳性晚期胃癌的疗效观察  

Efficacy of trsatuzumab(Herceptin) combined with FOLFIRI regimen in the treatment of HER2-positive advanced gastric cancer

作　　者：孙杰[1] 潘赛英[1] 陈倩琪[1] 高小平[1] 李伟[1] 

机构地区：[1]广东医学院附属南山医院肿瘤内科,广东深圳518052

出　　处：《南方医科大学学报》2011年第8期1458-1460,共3页Journal of Southern Medical University

摘　　要：目的评价曲妥珠单抗(herceptin,HCP)联合FOLFIRI方案(伊立替康+5-FU/LV)治疗HER2阳性晚期胃癌的近期临床疗效及不良反应。方法经病理组织学确诊为晚期胃癌患者共34例,其中试验组17例,均为经免疫组化(immunohistochemistry,IHC)和/或荧光原位杂交法(fluorescence in situ hybridization,FISH)检测HER2阳性,对照组(单用FOLFIRI方案)17例。曲妥珠单抗于第1周4 mg/kg IVgtt,此后每周2 mg/kg IVgtt;伊立替康160 mg/m2 IVgtt,第1天,1 h,亚叶酸钙200 mg/m2 IVgtt,第1、2天,2 h,5-氟尿嘧啶先予400 mg/m2 IV、后续600 mg/m2CIV,第1、2天,22 h,每2周重复,共2～4周期,观察其临床疗效与不良反应。结果试验组与对照组总有效率(ORR)与疾病控制率(DCR)分别为58.8%vs 35.3%与88.2%vs vs64.7%,差异均有显著性(P<0.05);主要不良反应为I～II度的腹泻(52.9%vs 47.1%)、恶心呕吐(76.5%vs 64.7%)及骨髓抑制(82.3%vs 82.3%),两组间比较无明显差异(P>0.05)。结论曲妥珠单抗联合FOFIRI方案治疗HER2阳性晚期胃癌安全且疗效明显,毒副反应能耐受,值得临床进一步研究。Objective To evaluate the safety and efficacy of trsatuzumab（Herceptin） combined with FOLFIRI regimen（irinotecan plus 5-FU/LV） in the treatment of HER2-positive advanced gastric cancer.Methods Thirty-four patients with pathologically confirmed advanced gastric cancer,all positive for the human epidermal growth factor receptor 2（HER2） as identified by immunohistochemistry and fluorescence in situ hybridization,were randomized into the test group and control group to for treatment with the combined regimen and the FOLFIRI regimen alone,respectively.FOLFIRI regimen was administered every 2 weeks for 2 to 4 cycles.Trsatuzumab was given intravenously on a weekly basis with an initial dose of 4 mg/kg and a subsequent dose of 2 mg/kg.All the patients were assessed for efficacy and toxicity of the treatments.Results The overall response rate was 58.8% in the test group and 35.3% in the control group,with disease control rates of 88.2% and 64.7%,respectively,showing significant differences between the two groups（P0.05）.The most frequent grade I/II treatment-related adverse events included diarrhea,nausea/vomiting and neutropenia.Conclusion Trsatuzumab combined with FOLFIRI regimen is effective,safe and well tolerated for treatment of HER2-positive advanced gastric cancer.

关 键 词：曲妥珠单抗 伊立替康 氟尿嘧啶 胃癌 HER-2/NEU 

分 类 号：R735.2[医药卫生—肿瘤]