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A decision tree-based prediction model for fluorescence in situ hybridization HER2 gene status in HER2 immunohistochemistry-2+breast cancers: a 2538-case multicenter study on consecutive surgical specimens

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机构: [1]Department of Pathology, West China Hospital, Sichuan University, Chengdu, Sichuan Province, China. [2]Laboratory of Pathology, West China Hospital, Sichuan University, Chengdu, Sichuan Province, China. [3]Department of Epidemiology and Biostatistics, West China School of Public Health, Sichuan University, Chengdu, Sichuan Province, China. [4]Department of Pathology, Sichuan Academy of Medical Sciences & Sichuan Provincial People’ s Hospital, Chengdu, Sichuan Province, China. [5]Department of Pathology, Shanghai Cancer Center, Fudan University, Shanghai, China. [6]Department of Pathology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei Province, China. [7]Department of Pathology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China. [8]Department of Pathology, Harbin Medical University Cancer Hospital, Harbin, Heilongjiang Province, China. [9]Department of Pathology and Laboratory Medicine, Guangdong General Hospital, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong Province, China. [10]Department of Pathology, First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China. [11]Department of Pathology, Fujian Medical University Union Hospital, Fuzhou, Fujian Province, China. [12]Department of Pathology, Affiliated Tumor Hospital, Guangxi Medical University, Nanning, Guangxi Province, China. [13]Department of Pathology, Xijing Hospital, the Air Force Military Medical University, Xi'an, Shanxi Province, China. [14]Department of Pathology, Shanxi Cancer Hospital, Taiyuan, Shanxi Province, China. [15]Institute of Pathology and Southwest Cancer Center, Southwest Hospital, Third Military Medical University, Chongqing, China.
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关键词: Breast Cancer HER2 Immunohistochemistry Fluorescence in situ hybridization

摘要:
Objective: To investigate the proportion of HER2 gene amplifications and the association between the HER2-IHC-staining pattern and gene status in IHC-2+ breast cancers according to 2013 American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines. Methods: We retrospectively analyzed and re-evaluated the IHC-staining pattern of 2538 IHC-2+ surgical specimens of breast cancer from November 2014 to October 2015 in 12 institutions. All cases used for building a prediction model of HER2 gene amplification according to the IHC-staining pattern and were randomly divided into a training set (n = 1914) or validation set (n = 624). Results: The overall HER2 fluorescence in situ hybridization (FISH) amplification, non-amplification and equivocation rates in HER2 IHC-2+ cases were 17.8%, 76.2% and 6.0%, respectively. In the training set, cases that had <= 10% of cells with intense, complete and circumferential membrane staining or had > 85% of cells with complete membrane staining of any staining intensity tended to be HER2 gene amplified (77.0% and 60.5%, respectively). And cases with weak and incomplete membrane staining had the lowest amplification rate of 6.1%. The prediction model was constructed based on IHC-staining pattern in the training set and validated using a validation set. The positive and negative prediction values were 51.6% and 79.2%, respectively, in the validation set. Moreover, the HER2 copy number per cell was much higher in cases with amplification-associated staining patterns (7.84 and 8.75) than in cases with non-amplification-associated staining patterns (2.97 to 4.41, P < 0.05). Conclusions: In HER2 IHC-2+ breast cancers, the staining pattern is associated with the HER2 gene status. This finding is compatible with recommendations of 2013 ASCO/CAP guidelines.

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基金编号: 81702599

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出版当年[2018]版:
大类 | 3 区 医学
小类 | 3 区 肿瘤学
最新[2023]版:
大类 | 3 区 医学
小类 | 4 区 肿瘤学
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出版当年[2018]版:
Q2 ONCOLOGY
最新[2023]版:
Q2 ONCOLOGY

影响因子: 最新[2023版] 最新五年平均 出版当年[2018版] 出版当年五年平均 出版前一年[2017版] 出版后一年[2019版]

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第一作者机构: [1]Department of Pathology, West China Hospital, Sichuan University, Chengdu, Sichuan Province, China. [2]Laboratory of Pathology, West China Hospital, Sichuan University, Chengdu, Sichuan Province, China.
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通讯机构: [1]Department of Pathology, West China Hospital, Sichuan University, Chengdu, Sichuan Province, China. [2]Laboratory of Pathology, West China Hospital, Sichuan University, Chengdu, Sichuan Province, China. [*1]Department of Pathology, West China Hospital, Sichuan University, Chengdu, Sichuan Province, China [*2]Department of Pathology and Laboratory of Pathology, West China Hospital, Sichuan University, Chengdu, Sichuan Province, China
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