[Clinical pathological expert consensus on HER-2 testing in urothelial carcinoma in China].

Human epidermal growth factor receptor 2 (HER-2) plays an important role in carcinogenesis and development of urothelial carcinoma. Overexpression of HER-2 is associated with poor prognosis of urothelial carcinoma. Although there is no significant benefit from anti-HER-2 targeted therapies of monoclonal antibody and tyrosine kinase inhibitor, Anti-HER-2 antibody-drug conjugate (HER-2-ADC) has shown a promising efficacy in urothelial carcinoma patients with HER-2 overexpression. Therefore, effectively screening the potential beneficiaries of HER-2-ADC drugs has become a new challenge. However, standardized HER-2 scoring system for urothelial carcinoma has yet to be developed. Thus, the Committees organized experts to reach this expert consensus based on the clinical practice of HER-2 expression, gene amplification and mutation testing in urothelial carcinoma, combined with the current research progress and internal discussion of committee members, in order to construct HER-2 testing standard of urothelial carcinoma and improve the accuracy of interpretation, to guide the clinical application.人表皮生长因子受体2(HER-2)基因在尿路上皮癌的发生发展中起重要作用，HER-2高表达与尿路上皮癌预后差有关。尽管尿路上皮癌患者不能从单抗类及小分子抗HER-2靶向治疗中获益，但抗HER-2抗体-偶联(ADC)类药物在HER-2过表达尿路上皮癌治疗中显示出了显著的临床疗效，因此，筛选出抗HER-2-ADC类药物治疗潜在获益人群成为诊疗的关键。目前，国际上尚无针对尿路上皮癌HER-2表达状态的标准化检测流程和判读标准。中国抗癌协会肿瘤病理专业委员会和中国临床肿瘤学会尿路上皮癌专家委员会组织相关专家以尿路上皮癌中HER-2表达、基因扩增和突变检测的临床实践为基础，结合目前研究进展，委员会成员内部讨论，最终达成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，旨在规范尿路上皮癌HER-2检测标准和提高判读的准确性，以指导临床应用。.