Comparison of immunohistochemistry with fluorescence in situ hybridization in determining the human epidermal growth factor receptor 2 status of breast cancer specimens： a multicenter study of 3149 Chinese patients  

作　　者：Han Xiaohong Shi Yuankai Ma Li Lyu Zheng Yang Hongying Yao Jiarui Li Jian Li Bo Qin Yan 

机构地区：[1]Department of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anti-cancer Molecular Targeted Drugs , Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100021. China [2]Department of Pathology , Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100021. China

出　　处：《Chinese Medical Journal》2014年第2期246-253,共8页中华医学杂志（英文版）

摘　　要：Background Accurate detection of human epidermal growth factor receptor 2 （HER2） expression and gene amplification is crucial for the application of HER2-specific therapy and for evaluating the response of patients with breast cancer.A uniform and standard procedure of immunohistochemistry （IHC） and fluorescence in situ hybridization （FISH） needs to be established for evaluating the HER2 status in breast cancer tissues for the treatment of patients with real HER2-positive tumors.The present multicenter study was aimed to examine the HER2 status in breast cancer specimens from Chinese patients using both IHC and FISH methods.Methods A multicenter study was performed on the HER2 status in 3 149 breast cancer specimens from different ethnic populations and areas in China by IHC and FISH assays.The potential association of HER2 status with demographic and clinical characteristics was analyzed.Results The positive rates for HER2 over-expression and HER2 amplification were 23.3％ and 27.5％ in this study,respectively.The concordance between IHC and FISH was 71.2％ （K=0.494,P ＜0.001）.Furthermore,72.9％ of specimens with IHC 2＋ were negative to FISH.The discordance rates among laboratories were from 5％ to 28％ for IHC and 1％ to 16％ for FISH.HER2 amplification was associated significantly with advanced tumor stage （Ⅲ or Ⅳ,P=0.002）,large tumor size （＞5 cm,P=0.002）,moderate and poor histological grades （P ＜0.0001）,post-menopause （P ＜0.0001）,ER-PR-（P=0.002）,and having ＞4 lymph nodes affected （P ＜0.0001） in this population.The positive rates of HER2 amplification in specimens from Man and Hui Chinese were significantly higher than that in other Chinese populations.There are slightly higher positive rates of HER2 expression and amplification in Chinese patients with breast cancer.Conclusion These findings may provide new insights into understanding the epidemiological features of HER2 expression and amplification,and may be valuable for clinical practice.Background Accurate detection of human epidermal growth factor receptor 2 （HER2） expression and gene amplification is crucial for the application of HER2-specific therapy and for evaluating the response of patients with breast cancer.A uniform and standard procedure of immunohistochemistry （IHC） and fluorescence in situ hybridization （FISH） needs to be established for evaluating the HER2 status in breast cancer tissues for the treatment of patients with real HER2-positive tumors.The present multicenter study was aimed to examine the HER2 status in breast cancer specimens from Chinese patients using both IHC and FISH methods.Methods A multicenter study was performed on the HER2 status in 3 149 breast cancer specimens from different ethnic populations and areas in China by IHC and FISH assays.The potential association of HER2 status with demographic and clinical characteristics was analyzed.Results The positive rates for HER2 over-expression and HER2 amplification were 23.3％ and 27.5％ in this study,respectively.The concordance between IHC and FISH was 71.2％ （K=0.494,P ＜0.001）.Furthermore,72.9％ of specimens with IHC 2＋ were negative to FISH.The discordance rates among laboratories were from 5％ to 28％ for IHC and 1％ to 16％ for FISH.HER2 amplification was associated significantly with advanced tumor stage （Ⅲ or Ⅳ,P=0.002）,large tumor size （＞5 cm,P=0.002）,moderate and poor histological grades （P ＜0.0001）,post-menopause （P ＜0.0001）,ER-PR-（P=0.002）,and having ＞4 lymph nodes affected （P ＜0.0001） in this population.The positive rates of HER2 amplification in specimens from Man and Hui Chinese were significantly higher than that in other Chinese populations.There are slightly higher positive rates of HER2 expression and amplification in Chinese patients with breast cancer.Conclusion These findings may provide new insights into understanding the epidemiological features of HER2 expression and amplification,and may be valuable for clinical practice.

关 键 词：human epidermal growth factor receptor 2 fluorescent in situ hybridization IMMUNOHISTOCHEMISTRY breast cancer 

分 类 号：Q55[生物学—生物化学] X703.1[环境科学与工程—环境工程]