scholarly journals HER2 Testing in Invasive Breast Cancer: A Comparison Between Immunohistochemistry and Fluorescence In Situ Hybridization Assays

2020 ◽  
Vol 8 (3) ◽  
pp. 139-146
Author(s):  
Maryam Moradi Chaleshtori ◽  
◽  
Zohreh Hojati ◽  
Ali Jazaeri ◽  
Hossein Teimori ◽  
...  
Keyword(s):  
Breast Cancer ◽  
In Situ Hybridization ◽  
Fluorescence In Situ Hybridization ◽  
Gene Amplification ◽  
Invasive Breast Cancer ◽  
Concordance Rate ◽  
Her2 Status ◽  
Her2 Gene ◽  
Relative Copy Number

Background: HER2 status testing in breast cancer is crucial for the detection of eligible patients for trastuzumab therapy. In this study, the relative copy number of HER2 gene, in patients with breast cancer, was determined by fluorescence in situ hybridization (FISH) and the results were compared with those of immunohistochemistry (IHC) to obtain the concordance rate between these two methods. Material and Methods: HER2 status of 31 invasive breast cancer samples was compared using IHC and FISH techniques. The ratio of HER2/CEP17 was used to determine the amplification of the HER2 gene. If the ratio of HER2/CEP17 is greater than 2.2, HER2 gene amplification has occurred in the cancer cells. Then, a comparative analysis is performed to estimate the concordance rate between FISH and IHC results. Results: The gene amplification of HER2 was observed in 26% of cases by FISH. The IHC and FISH results showed 100%, 36.36%, and 85.71% concordance rates for cases with IHC scores of 3+, 2+, and 0/+1, respectively. The overall concordance between the two methods was 80%. Based on statistical analysis, HER2 status showed a considerable correlation with tumor grade (P= 0.02). No correlation was observed between HER2 gene status and the size and type of tumor, characteristics of lymph node, and patients’ age. Conclusion: The data suggested that IHC results are reliable for HER2 status testing in cases with IHC scores 0/+1 and 3+. However, in patients with an IHC score of +2, it is necessary to perform a complimentary test to evaluate HER2 status to avoid haphazard treatment with trastuzumab in negative cases and identifying positive cases for suitable treatment.

scholarly journals Detection of HER2 Amplification in Breast Carcinomas: Comparison of Multiplex Ligation-Dependent Probe Amplification (MLPA) and Fluorescence In Situ Hybridization (FISH) combined with Automated Spot Counting

2006 ◽  
Vol 28 (4) ◽  
pp. 151-159
Author(s):  
Elna Moerland ◽  
Rens L. H. P. M. van Hezik ◽  
Toine C. J. M. van der Aa ◽  
Mike W. P. M. van Beek ◽  
Adriaan J. C. van den Brule
Keyword(s):  
In Situ Hybridization ◽  
Fluorescence In Situ Hybridization ◽  
Gene Amplification ◽  
Her2 Status ◽  
Her2 Amplification ◽  
Breast Carcinomas ◽  
Her2 Gene ◽  
Her2 Gene Amplification ◽  
Dependent Probe

In this study the detection of HER2 gene amplification was evaluated using Fluorescence In Situ Hybridization (FISH; PathVysion) in comparison with Multiplex Ligation-dependent Probe Amplification (MLPA), a PCR based technique. These two methods were evaluated on a series of 46 formalin fixed paraffin embedded breast carcinomas, previously tested for protein overexpression by HercepTest (grouped into Hercep 1+, 2+ and 3+). HER2 gene amplification (ratio ≥ 2.0) by FISH was found in 9/10, 10/30 and 0/6 in IHC 3+, 2+ and 1+/0 cases, respectively. Digitalized automated spot counting performed with recently developed CW4000 CytoFISH software was 100% concordant with manual FISH scoring. Using MLPA 18/46 samples showed a clear HER2 amplification. Comparing MLPA and IHC showed the same results as for FISH and IHC. All but one FISH positive cases (18/19) were confirmed by MLPA for the presence of the gene amplification. The overall concordance of detection of Her2 gene amplification by FISH and MLPA was 98% (45/46). Furthermore, both the level of amplification and equivocal results correlated well between both methods. In conclusion, MLPA is a reliable and reproducible technique and can be used as an either alternative or additional test to determine HER2 status in breast carcinomas.

Evaluation of HER2/neu Status by Immunohistochemistry Using Computer-Based Image Analysis and Correlation With Gene Amplification by Fluorescence In Situ Hybridization Assay: A 10-Year Experience and Impact of Test Standardization on Concordance Rate

2015 ◽  
Vol 139 (7) ◽  
pp. 922-928 ◽  
Author(s):  
Venetia R. Sarode ◽  
Qun Diane Xiang ◽  
Alana Christie ◽  
Rebecca Collins ◽  
Roshni Rao ◽  
...  
Keyword(s):  
Image Analysis ◽  
In Situ Hybridization ◽  
Fluorescence In Situ Hybridization ◽  
Gene Amplification ◽  
False Negative ◽  
Concordance Rate ◽  
Her2 Status ◽  
Ki 67 ◽  
Test Standardization

Context The American Society of Clinical Oncology/College of American Pathologists proposed several recommendations for human epidermal growth factor receptor 2 (HER2) test standardization. One suggestion was that image analysis (IA) could be useful for scoring of HER2/neu immunohistochemistry. The utilization of IA in a real-world practice in a large cohort of cases has not been previously reported. Objectives To compare HER2/neu quantification by IA with gene amplification by fluorescence in situ hybridization (FISH); to determine sensitivity, specificity, and concordance rates with the FISH assay; and to determine association between HER2 status with estrogen receptor (ER), progesterone receptor (PR), and Ki-67 expression. Design We evaluated HER2 results performed by immunohistochemistry and FISH in conjunction with ER, PR, and Ki-67 in 3093 invasive breast cancer cases from 2002 to 2011. Results The overall concordance between immunohistochemistry and FISH was 87.3% (1768 of 2026). When analyzed by year, there was an improvement in the positive concordance rate from 49.4% (44 of 89) to 95.0% (57 of 60) (P < .001). The negative concordance rate was at least 95% with a median false-negative rate of 1.5%. In the FISH+ group, amplification ratio showed significant correlation with IA scores (P < .001). Positive versus negative HER2 status was associated with lower ER and PR levels (P < .001) and higher Ki-67 expression (P < .001). Conclusion Scoring of HER2/neu by IA was associated with high false-positive rates before 2008. Improvement in concordance rate after 2008 may be due to proper tissue handling, improved HER2/neu scoring by IA, and assay standardization.

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