Evaluation of analytical accuracy of HER2 status in patients with breast cancer: Comparison of HER2 GPA with HER2 IHC and HER2 FISH

Human epidermal growth factor receptor 2 (HER2) gene status and overexpression, occurring in ~ 13.6% of primary breast cancers, is essential for identifying patients likely to benefit from biological treatment. In this method of evaluation study, we tested and compared the HER2 gene–protein assay (G...

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Bibliographic Details
Published in:APMIS : acta pathologica, microbiologica et immunologica Scandinavica microbiologica et immunologica Scandinavica, 2020-11, Vol.128 (11), p.573-582
Main Authors: Jensen, Steffen Grann, Thomas, Peter Engel, Christensen, Ib Jarle, Balslev, Eva, Hansen, Alastair, Høgdall, Estrid
Format: Article
Language:English
Subjects:
Biological treatment
Breast cancer
Chromosomes
Correlation coefficient
Correlation coefficients
Diagnostic systems
Enumeration
Epidermal growth factor
ErbB-2 protein
Fluorescence
Fluorescence in situ hybridization
Growth factors
Immunohistochemistry
Paraffin
Paraffins
Proteins
Regression analysis
Reproducibility
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Summary:Human epidermal growth factor receptor 2 (HER2) gene status and overexpression, occurring in ~ 13.6% of primary breast cancers, is essential for identifying patients likely to benefit from biological treatment. In this method of evaluation study, we tested and compared the HER2 gene–protein assay (GPA) with routine HER2 immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH). The GPA was evaluated using 67 formalin‐fixed paraffin‐embedded (FFPE) HER2 equivoval IHC (2+) breast cancer tissue samples. Overall, agreement between GPA silver in situ hybridization (SISH) and FISH was 91.9% (57/62). Regression analysis revealed slightly higher, but non‐significant difference in HER2/chromosome enumeration probe 17 ( CEP17 ) ratio for GPA as compared to FISH (p = 0.074). Intraclass correlation coefficients (ICCs) of 0.94 and Spearman´s rank correlation coefficients of 0.93 (p 
ISSN:0903-4641
1600-0463
DOI:10.1111/apm.13076