曲妥珠单抗联合化疗一线治疗人表皮生长因子受体2阳性无法手术的局部进展期或转移性胃或胃食管结合部腺癌的多中心随机对照Ⅲ期临床试验中国亚组报告  

Trastuzumab in combination with chemotherapy versus chemotherapy alone for first-line treatment of HER2-positive advanced gastric or gastroesophageal junction cancer： a Phase HI, multi-center,randomized controlled trial, Chinese subreport

作　　者：沈琳 徐建明 冯奉仪[3] 焦顺昌[4] 王理伟[5] 李进[6] 管忠震[7] 秦叔逵[8] 王杰军[9] 王雅杰[9] 于世英[10] 金冶宁[11] 陶敏[12] 郑磊贞[13] 潘良熹[14] 

机构地区：[1]北京肿瘤医院消化肿瘤内科,100142 [2]解放军第三0七医院消化肿瘤内科 [3]中国医学科学院北京协和医学院肿瘤医院内科 [4]解放军总医院肿瘤内科 [5]上海交通大学附属第一人民医院肿瘤科 [6]复旦大学附属肿瘤医院肿瘤内科 [7]中山大学肿瘤防治中心内科 [8]解放军第八一医院肿瘤内科 [9]上海长征医院肿瘤科 [10]华中科技大学同济医学院附属同济医院肿瘤科 [11]上海交通大学医学院附属瑞金医院肿瘤科 [12]苏州大学附属第一医院肿瘤科 [13]上海交通大学医学院附属新华医院肿瘤科 [14]江苏省肿瘤医院肿瘤内科

出　　处：《中华肿瘤杂志》2013年第4期295-300,共6页Chinese Journal of Oncology

摘　　要：目的比较曲妥珠单抗联合化疗与单纯化疗，一线治疗人表皮生长因子受体2（HER-2）阳性、无法手术的局部进展期、转移性胃或胃食管结合部腺癌的有效性和安全性。方法中国15家研究中心参与B018255（ToGA）试验。患胃或胃食管结合部腺癌且肿瘤HER．2表达阳性的患者入选试验，ToGA试验按照随机区组设计，以1：1的比例随机接受单纯化疗（卡培他滨或氟尿嘧啶＋顺铂，对照组）或化疗联合曲妥珠单抗（试验组），中国地区人组84例患者，试验组患者36例，对照组48例。结果试验组患者的中位生存时问为12．6个月，对照组为9．7个月（HR=0．72，95％CI为0．40～1．29）。试验组患者i〉3级不良反应的发生率（63．9％）高于对照组（47．9％），主要为中性粒细胞减少、呕吐、恶心。只有试验组出现2例轻度心脏不良反应。试验组和对照组中分别有3例患者发生了严重不良反应，其中试验组患者因血小板减少导致死亡1例。结论HER-2阳性、无法手术的局部进展期或转移性中国胃癌患者接受曲妥珠单抗联合化疗治疗后，疗效和安全性与ToGA研究总体人群的分析结果一致，疗效较好，且患者耐受性良好。曲妥珠单抗联合化疗可做为HER-2阳性、无法手术的局部进展期或转移性胃或胃食管结合部腺癌新的治疗选择。Objective To evaluate the efficacy and safety of trastuzumab in combination with chemotherapy versus chemotherapy alone in the first-line treatment of HER-2-positive advanced gastric or gastro-oesophageal junction cancer. Methods Fifteen Chinese research centers are involved in the BO18255 （TOGA） study. Patients with gastric or gastro-oesophageal junction cancer were eligible for inclusion if their tumor showed overexpression of HER-2 protein by immunohistochemistry ＋ ＋ ＋ or FISH- positive. Patients were randomly assigned in a 1 ： 1 ratio to receive a chemotherapy regimen consisting of eapeeitabine or 5-FU plus cisplatin or chemotherapy in combination with intravenous trastuzumab. The primary endpoint was overall survival. Results Eighty-five Chinese patients were enrolled in this study, of whom 84 were included in the primary analysis ： trastuzumab plus chemotherapy （ FP/H ） （ n = 36 ） andchemotherapy alone （FP）（n =48）. The median follow-up was 15.2 months in the FP/H group and 14.2 months in the FP group. The median survival time was 12.6 months in the FP/H group compared with 9.7 months in the FP group [ hazard ratio 0.72, 95% CI （ O. 40 ; 1.29 ） 1. Grade 3/4 adverse events were higher in the FP/H（63.9% ）than FP （47.9%） groups, including neutropenia, vomiting and nausea. Two mild cardiac adverse events occurred in the FP/H group. Severe adverse events occurred in 3 cases of both two groups, respectively. Conduslons Addition of trastuzumab to chemotherapy is well tolerated and shows improved survival in Chinese patients with advanced gastric or gastro-oesophageal junction cancer. These results are consistent with the results of ToGA whole population trial. Trastuzumab in combination with chemotherapy can be considered as a new option for patients with HER-2-positive advanced gastric or gastrooesophageal junction cancer.

关 键 词：胃肿瘤 曲妥珠单抗 人表皮生长因子受体2 胃食管结合部腺癌 治疗结果 

分 类 号：R735[医药卫生—肿瘤]