Comparative study between quantitative digital image analysis and fluorescence in situ hybridization of breast cancer equivocal human epidermal growth factor receptors 2 score 2+ cases

Abstract

Background:Optimization of workflow for breast cancer samples with equivocal human epidermal growth factor receptors 2 (HER2)/neu score 2+ results in routine practice, remains to be a central focus of the on-going efforts to assess HER2 status. According to the College of American Pathologists/American Society of Clinical Oncology guidelines equivocal HER2/neu score 2+ cases are subject for further testing, usually by fluorescence in situ hybridization (FISH) investigations. It still remains on open question, whether quantitative digital image analysis of HER2 immunohistochemistry (IHC) stained slides can assist in further refining the HER2 score 2+.Aim of this Work:To assess utility of quantitative digital analysis of IHC stained slides and compare its performance to FISH in cases of breast cancer with equivocal HER2 score 2+.Materials and Methods:Fifteen specimens (previously diagnosed as breast cancer and was evaluated as HER 2- score 2+) represented the study population. Contemporary new cuts were prepared for re-evaluation of HER2 immunohistochemical studies and FISH examination. All the cases were digitally scanned by iScan (Produced by BioImagene [Now Roche-Ventana]). The IHC signals of HER2 were measured using an automated image analyzing system (MECES, www.Diagnomx.eu/meces). Finally, a comparative study was done between the results of the FISH and the quantitative analysis of the virtual slides.Results:Three out of the 15 cases with equivocal HER2 score 2+, turned out to be positive (3+) by quantitative digital analysis, and 12 were found to be negative in FISH too. Two of these three positive cases proved to be positive with FISH, and only one was negative.Conclusions:Quantitative digital analysis is highly sensitive and relatively specific when compared to FISH in detecting HER2/neu overexpression. Therefore, it represents a potential reliable substitute for FISH in breast cancer cases, which desire further refinement of equivocal IHC results.

Quantitative Image Analysis of Human Epidermal Growth Factor Receptor 2 Immunohistochemistry for Breast Cancer: Guideline From the College of American Pathologists

“…The evidence identified by our systematic review included studies with reported practices resulting in high concordance rates of QIA HER2 IHC results with FISH test results. 18,23,33–35 These studies provide indirect evidence that supports the importance of pathologist oversight of automated QIA results. Importantly, cases with QIA HER2 IHC interpretations that were discordant with FISH test results were explored in some of these studies and highlight issues with QIA that require pathologist oversight and awareness.…”

Immunohistochemical Study of Ezrin Expression in Colorectal Carcinoma: A Comparative Study between Objective Method and Digital Quantitative Assessment

“…Similar results were obtained by numerous studies that have demonstrated a high degree of correlation between digital image analysis and pathologist visual scoring. The majority of this research has been performed in breast cancer tissue on estrogen receptor, progesterone receptor (Turbin et al, 2008;Faratian et al, 2009;Bolton et al, 2010;Krecsak et al, 2011), human epidermal growth factor receptor (Atkinson et al, 2011;Ayad et al, 2015), Ki 67 assessment in breast cancer (Ayad et al, 2018).…”

Her2-Positive Cancers and Antibody-Based Treatment: State of the Art and Future Developments

“…For the interpretation of the FISH, the following cut-off points are used according to the updated recommendations of ASCO/CAP of 2013 on the determination of HER-2 [ 11 ]: ( Figure 3 ).…”