中国尿路上皮癌患者HER2表达及其与临床病理学特征的关联分析  

Correlation of HER2 expression and clinicopathological characteristics in patients with urothelial carcinoma in China

作　　者：王珊珊 叶定伟 杨立[2] 程帆 杨铁军[4] 章小平[5] 余志贤[6] 张庆云[7] 杨勇[8] WANG Shanshan;YE Dingwei;YANG Li;CHENG Fan;YANG Tiejun;ZHANG Xiaoping;YU Zhixian;ZHANG Qingyun;YANG Yong(Department of Urology,Fudan University Shanghai Cancer Center,Department of Oncology,Shanghai Medical College,Fudan University,Shanghai 200032,China;Department of Urology,The Second Hospital of Lanzhou University,Lanzhou 730030,Gansu Province,China;Department of Urology,Renmin Hospital of Wuhan University(Hubei General Hospital),Wuhan 430060,Hubei Province,China;Department of Urology,Henan Cancer Hospital,Zhengzhou 450003,Henan Province,China;Department of Urology,Union Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430090,Hubei Province,China;Department of Urology,The First Affiliated Hospital of Wenzhou Medical University,Wenzhou 325000,Zhejiang Province,China;Department of Urology,Affiliated Tumor Hospital of Guangxi Medical University,Nanning 530000,Jiangsu Province,China;Department of Urology,Peking University Cancer Hospital,Beijing 100142)

机构地区：[1]复旦大学附属肿瘤医院泌尿外科,复旦大学上海医学院肿瘤学系,上海200032 [2]兰州大学第二医院泌尿外科,甘肃兰州730030 [3]武汉大学人民医院(湖北省人民医院)泌尿外科,湖北武汉430060 [4]河南省肿瘤医院泌尿外科,河南郑州450003 [5]华中科技大学同济医学院附属协和医院泌尿外科,湖北武汉430090 [6]温州医科大学附属第一医院泌尿外科,浙江温州325000 [7]广西医科大学附属肿瘤医院泌尿外科,广西南宁530000 [8]北京大学肿瘤医院泌尿外科,北京100142

出　　处：《中国癌症杂志》2024年第11期1011-1019,共9页China Oncology

摘　　要：背景:人表皮生长因子受体2(human epidermal growth factor receptor 2,HER2)与尿路上皮癌(urothelial carcinoma,UC)的疗效及患者预后密切相关。HER2是多种肿瘤的重要生物标志物和治疗靶点,抗HER2抗体药物偶联物对HER2高表达的UC患者具有显著的临床疗效,因此深入了解中国UC患者HER2表达及其特点,对于指导治疗决策、优化治疗方案和实现个体化治疗具有重要意义。本研究旨在充分探究中国UC患者的HER2表达情况及其与临床病理学特征的相关性。方法:本研究是一项多中心研究,回顾性纳入了中国5个地理区域(华北、华东、华南、华中和西北)共8个三甲医院的泌尿外科2023年1月—2024年3月采集组织样本的UC患者。纳入标准:①年龄18岁以上;②经组织病理学或细胞学检查确诊的UC;③需有肿瘤原发灶免疫组织化学(immunohistochemistry,IHC)检测HER2表达的完整资料。排除标准:①已确诊合并其他部位肿瘤者;②医师评估其他不适合纳入本研究的情况。收集患者的HER2 IHC检测结果及疾病信息,根据《中国尿路上皮癌人表皮生长因子受体2检测临床病理专家共识》的标准对HER2表达进行判读,将HER22+及3+定义为HER2高表达。分析HER2的表达情况及其与临床病理学特征的关联。本研究已获得复旦大学附属肿瘤医院医学伦理委员会批准(伦理编号:2301268-12),并于中国临床试验注册中心注册(注册编号:ChiCTR2300069746)。结果:共纳入1054例UC患者,其中以膀胱UC为主(n=807,76.6%),平均年龄为(66.8±10.5)岁,多数(78.5%)患者为男性。HER2高表达率为58.4%(n=616),此外还有23%的患者为HER21+表达(n=242),少数(n=196,18.6%)患者为HER2零表达。HER2表达与多种临床病理学特征存在显著关联,包括美国东部肿瘤协作组(Eastern Cooperative Oncology Group,ECOG)评分、心脑血管疾病病史、脂代谢病病史、吸烟史、UC疾病部位、分化程度、病理学类型和肿瘤分期�Background and purpose:Human epidermal growth factor receptor 2(HER2)is closely associated with drug effi cacy and prognosis in urothelial carcinoma(UC).HER2 is a significant biomarker and therapeutic target in various tumors.In recent years,anti-HER2 antibody-drug conjugates have shown significant clinical effi cacy in UC patients with HER2 overexpression.Therefore,an in-depth understanding of HER2 expression and its characteristics in Chinese UC patients is crucial to guide treatment decision-making,optimize treatment strategies and achieve personalized therapy.This study aimed to thoroughly investigate correlation of HER2 expression and clinicopathological characteristics in Chinese patients with UC.Methods:This study was a multicenter study that retrospectively included UC patients from urology departments of 8 tertiary hospitals in 5 geographical regions of China(North China,East China,South China,Central China and Northwest)whose tissue samples were collected from January 2023 to March 2024.Inclusion criteria:①age above 18 years;②UC diagnosed by histopathological or cytological examination;③complete results of HER2 expression detection using immunohistochemistry(IHC)in the primary tumor site were required.Exclusion criteria:①diagnosed patients with tumors in other parts of the body;②physicians evaluated other situations that were not suitable for inclusion in this study.IHC results for HER2 expression and clinicopathological data were collected.HER2 expression was determined according to the criteria outlined in“Clinical pathological expert consensus on HER2 testing in urothelial carcinoma in China”,with HER22+and 3+defined as HER2 overexpression.The HER2 expression and clinicopathological features were analyzed.This study was approved by the medical ethics committee of Fudan University Shanghai Cancer Center(ethical number:2301268-12)and was registered at China Clinical Trial Registry(registration number:ChiCTR2300069746).Results:A total of 1054 patients with UC were included.Most of the tumo

关 键 词：尿路上皮癌 人表皮生长因子受体2 临床病理学特征 中国 

分 类 号：R737.1[医药卫生—肿瘤]