PMID- 32860265
OWN - NLM
STAT- MEDLINE
DCOM- 20201022
LR  - 20201022
IS  - 1600-0463 (Electronic)
IS  - 0903-4641 (Linking)
VI  - 128
IP  - 11
DP  - 2020 Nov
TI  - Evaluation of analytical accuracy of HER2 status in patients with breast cancer: 
      Comparison of HER2 GPA with HER2 IHC and HER2 FISH.
PG  - 573-582
LID - 10.1111/apm.13076 [doi]
AB  - 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 < 0.0001) for FISH and GPA SISH 
      suggested strong inter-observer association for methods with one observer 
      counting on average 0.23 significant higher for GPA SISH (p = 0.014). 
      Intra-observer IHC method reproducibility was 52.6% (kappa = 0.3122, p = 0.004) and 
      79.7% (kappa = 0.6428, p = 0.9197), suggesting fair significant and substantial 
      non-significant difference between tests for reviewers. Inter-observer 
      reproducibility for IHC methods was 53%. While inter-observer reproducibility for 
      experienced IHC interpretation suggested significant differences (kappa = 0.3636, 
      p = 0.0332), unexperienced interpretation of IHC GPA suggested fair 
      non-significant difference between reviewers (kappa = 0.3101, p = 0.0747). Using FISH 
      as reference, the diagnostic indices for GPA SISH were as follows: sensitivity 
      100%, specificity 95% and accuracy 92%. Inaccuracy between tests was in 80% of 
      cases due to ISH categorization as equivocal by one of the methods. IHC results 
      highlight that it may be beneficial with a method for simultaneously 
      visualization of HER2 gene and protein status.
CI  - (c) 2020 Scandinavian Societies for Medical Microbiology and Pathology.
FAU - Jensen, Steffen Grann
AU  - Jensen SG
AD  - Department of Pathology, Herlev-Gentofte Hospital, Herlev, Denmark.
FAU - Thomas, Peter Engel
AU  - Thomas PE
AD  - Department of Pathology, Herlev-Gentofte Hospital, Herlev, Denmark.
FAU - Christensen, Ib Jarle
AU  - Christensen IJ
AD  - Department of Pathology, Herlev-Gentofte Hospital, Herlev, Denmark.
FAU - Balslev, Eva
AU  - Balslev E
AD  - Department of Pathology, Herlev-Gentofte Hospital, Herlev, Denmark.
FAU - Hansen, Alastair
AU  - Hansen A
AD  - Department of Pathology, Herlev-Gentofte Hospital, Herlev, Denmark.
FAU - Hogdall, Estrid
AU  - Hogdall E
AD  - Department of Pathology, Herlev-Gentofte Hospital, Herlev, Denmark.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
DEP - 20200921
PL  - Denmark
TA  - APMIS
JT  - APMIS : acta pathologica, microbiologica, et immunologica Scandinavica
JID - 8803400
RN  - 0 (Biomarkers, Tumor)
RN  - EC 2.7.10.1 (ERBB2 protein, human)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
SB  - IM
MH  - Biomarkers, Tumor/genetics
MH  - Breast Neoplasms/*diagnosis/genetics/pathology/surgery
MH  - Carcinoma/*diagnosis/genetics/pathology/surgery
MH  - Female
MH  - Gene Expression
MH  - Humans
MH  - Immunohistochemistry
MH  - In Situ Hybridization, Fluorescence
MH  - Lymphatic Metastasis
MH  - Observer Variation
MH  - Protein Array Analysis
MH  - Receptor, ErbB-2/*genetics
MH  - Reproducibility of Results
MH  - Sensitivity and Specificity
OTO - NOTNLM
OT  - Breast cancer
OT  - fluorescence in situ hybridization (FISH)
OT  - gene-protein assay (GPA)
OT  - human epidermal growth factor receptor 2 (HER2)
OT  - immunohistochemistry (IHC)
EDAT- 2020/08/30 06:00
MHDA- 2020/10/23 06:00
CRDT- 2020/08/30 06:00
PHST- 2020/02/27 00:00 [received]
PHST- 2020/08/20 00:00 [accepted]
PHST- 2020/08/30 06:00 [pubmed]
PHST- 2020/10/23 06:00 [medline]
PHST- 2020/08/30 06:00 [entrez]
AID - 10.1111/apm.13076 [doi]
PST - ppublish
SO  - APMIS. 2020 Nov;128(11):573-582. doi: 10.1111/apm.13076. Epub 2020 Sep 21.