Correlation of Immunohistochemistry and Fluorescence in Situ Hybridization for HER-2 Assessment in Breast Cancer Patients: Single Centre Experience


  • Magdalena Bogdanovska-Todorovska Institute of Pathology, Faculty of Medicine, Ss Cyril and Methodius University of Skopje, Skopje, Republic of Macedonia
  • Slavica Kostadinova-Kunovska Institute of Pathology, Faculty of Medicine, Ss Cyril and Methodius University of Skopje, Skopje, Republic of Macedonia
  • Rubens Jovanovik Institute of Pathology, Faculty of Medicine, Ss Cyril and Methodius University of Skopje, Skopje, Republic of Macedonia
  • Blagica Krsteska Institute of Pathology, Faculty of Medicine, Ss Cyril and Methodius University of Skopje, Skopje, Republic of Macedonia
  • Goran Kondov University Clinic for Thoracic and Vascular Surgery, Clinical Centre “Mother Theresa”, Faculty of Medicine, Ss Cyril and Methodius University of Skopje, Skopje
  • Borislav Kondov University Clinic for Thoracic and Vascular Surgery, Clinical Centre “Mother Theresa”, Faculty of Medicine, Ss Cyril and Methodius University of Skopje, Skopje
  • Gordana Petrushevska Institute of Pathology, Faculty of Medicine, Ss Cyril and Methodius University of Skopje, Skopje, Republic of Macedonia



Breast cancer, HER – 2, Fluorescence in situ hybridisation, Immunohistochemistry


BACKGROUND: Accurate assessment of HER-2 is imperative in selecting patients for targeted therapy. Most commonly used test methods for HER-2 are immunohistochemistry (IHC) and fluorescence in situ hybridisation (FISH). We evaluated the concordance between FISH and IHC for HER-2 in breast cancer samples using Food and Drug Administration approved tests.

MATERIAL AND METHODS: Archived paraffin tissue blocks from 73 breast cancer patients were used. HER-2 immunostaining was performed using Ventana anti–HER-2 monoclonal antibody. The FISH assay was performed using PathVysion™ HER-2 DNA Probe Kit.

RESULTS: Of the 73 cases 68.5% were IHC 0/1+, 15.07% were IHC 2+ and 16.44% were IHC 3+. Successful hybridisation was achieved in 72 cases. HER-2 FISH amplification was determined in 16.67% cases. Ten IHC 3+ and two IHC 2+ cases were FISH positive. Two of the IHC 3+ cases were FISH negative. Concordance rate was 100%, 18.18% and 83.33% for IHC 0/1+, 2+ and 3+ group, respectively. Total concordance was 84.72%, kappa 0.598 (p < 0.0001). The sensitivity of IHC in detecting IHC 2+ and IHC 3+ cases was 16.7% and 83.3%, and the specificity was 85% and 96.67%, respectively.

CONCLUSION: The consistency between the methods was highest for IHC negative and lowest for IHC equivocal cases. The immunohistochemistry showed high sensitivity for IHC 2+/3+ cases and high specificity for IHC 3+ cases. Our results support the view that false-positive rather than false-negative IHC results are a problem with HER-2/IHC testing, and that IHC should be used as an initial screening test, but IHC 2+/ 3+ results should be confirmed by FISH.


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How to Cite

Bogdanovska-Todorovska M, Kostadinova-Kunovska S, Jovanovik R, Krsteska B, Kondov G, Kondov B, Petrushevska G. Correlation of Immunohistochemistry and Fluorescence in Situ Hybridization for HER-2 Assessment in Breast Cancer Patients: Single Centre Experience. Open Access Maced J Med Sci [Internet]. 2018 Mar. 22 [cited 2023 Feb. 4];6(4):593-9. Available from:



A - Basic Science

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