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HER2 Status by Standardized Immunohistochemistry and Silver-Enhanced In Situ Hybridization in Korean Breast Cancer

PURPOSE: Amplification of the human epidermal growth factor receptor 2 (HER2) gene occurs in 18% to 20% of breast cancers, and it is recognized as a prognostic and predictive marker. We investigated the HER2 status in Korean breast cancer by immunohistochemistry (IHC) and silver-enhanced in situ hyb...

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Autores principales: Bae, Young Kyung, Gong, Gyungyub, Kang, Jun, Lee, Ahwon, Cho, Eun Yoon, Lee, Ji Shin, Suh, Kwang-Sun, Lee, Dong Wha, Jung, Woo Hee
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Korean Breast Cancer Society 2012
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3542844/
https://www.ncbi.nlm.nih.gov/pubmed/23346165
http://dx.doi.org/10.4048/jbc.2012.15.4.381
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author Bae, Young Kyung
Gong, Gyungyub
Kang, Jun
Lee, Ahwon
Cho, Eun Yoon
Lee, Ji Shin
Suh, Kwang-Sun
Lee, Dong Wha
Jung, Woo Hee
author_facet Bae, Young Kyung
Gong, Gyungyub
Kang, Jun
Lee, Ahwon
Cho, Eun Yoon
Lee, Ji Shin
Suh, Kwang-Sun
Lee, Dong Wha
Jung, Woo Hee
author_sort Bae, Young Kyung
collection PubMed
description PURPOSE: Amplification of the human epidermal growth factor receptor 2 (HER2) gene occurs in 18% to 20% of breast cancers, and it is recognized as a prognostic and predictive marker. We investigated the HER2 status in Korean breast cancer by immunohistochemistry (IHC) and silver-enhanced in situ hybridization (SISH), as the first step toward building a nationwide quality assurance program for HER2 testing. METHODS: A total of 1,198 breast carcinoma samples were collected from six institutions and IHC and SISH were performed using tissue microarrays in central laboratories. The results were compared to those of local laboratories. RESULTS: Available data were obtained from 959 samples. Central IHC results were negative, equivocal, and positive for 756 (78.8%; range among institutions, 76.8-81.8%), 37 (3.9%; 1.9-6.2%), and 166 (17.3%; 13.6-20%), respectively. SISH results were negative, equivocal, and positive for 756 (78.8%; 77.4-79.9%), 2 (0.2%; 0-0.7%), and 201 (21%; 20.1-22.2%), respectively. HER2 gene amplification was observed in 4.4%, 19%, and 73.9% of the negative, equivocal and positive groups stratified by local IHC results, respectively. When central SISH was considered to be the gold standard method for measuring HER2 status, the false-negative and false-positive rates of local IHC were 14.4% (29/201) and 7.1% (54/756). The concordance rate between central IHC and SISH was 98.4%. CONCLUSION: Central IHC and SISH markedly decreased the interlaboratory variability of HER2 status and the results of the two were highly concordant. The quality control program for HER2 testing must be focused on decreasing both the false negativity and positivity of IHC in local laboratories.
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spelling pubmed-35428442013-01-23 HER2 Status by Standardized Immunohistochemistry and Silver-Enhanced In Situ Hybridization in Korean Breast Cancer Bae, Young Kyung Gong, Gyungyub Kang, Jun Lee, Ahwon Cho, Eun Yoon Lee, Ji Shin Suh, Kwang-Sun Lee, Dong Wha Jung, Woo Hee J Breast Cancer Original Article PURPOSE: Amplification of the human epidermal growth factor receptor 2 (HER2) gene occurs in 18% to 20% of breast cancers, and it is recognized as a prognostic and predictive marker. We investigated the HER2 status in Korean breast cancer by immunohistochemistry (IHC) and silver-enhanced in situ hybridization (SISH), as the first step toward building a nationwide quality assurance program for HER2 testing. METHODS: A total of 1,198 breast carcinoma samples were collected from six institutions and IHC and SISH were performed using tissue microarrays in central laboratories. The results were compared to those of local laboratories. RESULTS: Available data were obtained from 959 samples. Central IHC results were negative, equivocal, and positive for 756 (78.8%; range among institutions, 76.8-81.8%), 37 (3.9%; 1.9-6.2%), and 166 (17.3%; 13.6-20%), respectively. SISH results were negative, equivocal, and positive for 756 (78.8%; 77.4-79.9%), 2 (0.2%; 0-0.7%), and 201 (21%; 20.1-22.2%), respectively. HER2 gene amplification was observed in 4.4%, 19%, and 73.9% of the negative, equivocal and positive groups stratified by local IHC results, respectively. When central SISH was considered to be the gold standard method for measuring HER2 status, the false-negative and false-positive rates of local IHC were 14.4% (29/201) and 7.1% (54/756). The concordance rate between central IHC and SISH was 98.4%. CONCLUSION: Central IHC and SISH markedly decreased the interlaboratory variability of HER2 status and the results of the two were highly concordant. The quality control program for HER2 testing must be focused on decreasing both the false negativity and positivity of IHC in local laboratories. Korean Breast Cancer Society 2012-12 2012-12-31 /pmc/articles/PMC3542844/ /pubmed/23346165 http://dx.doi.org/10.4048/jbc.2012.15.4.381 Text en © 2012 Korean Breast Cancer Society. All rights reserved. http://creativecommons.org/licenses/by-nc/3.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Article
Bae, Young Kyung
Gong, Gyungyub
Kang, Jun
Lee, Ahwon
Cho, Eun Yoon
Lee, Ji Shin
Suh, Kwang-Sun
Lee, Dong Wha
Jung, Woo Hee
HER2 Status by Standardized Immunohistochemistry and Silver-Enhanced In Situ Hybridization in Korean Breast Cancer
title HER2 Status by Standardized Immunohistochemistry and Silver-Enhanced In Situ Hybridization in Korean Breast Cancer
title_full HER2 Status by Standardized Immunohistochemistry and Silver-Enhanced In Situ Hybridization in Korean Breast Cancer
title_fullStr HER2 Status by Standardized Immunohistochemistry and Silver-Enhanced In Situ Hybridization in Korean Breast Cancer
title_full_unstemmed HER2 Status by Standardized Immunohistochemistry and Silver-Enhanced In Situ Hybridization in Korean Breast Cancer
title_short HER2 Status by Standardized Immunohistochemistry and Silver-Enhanced In Situ Hybridization in Korean Breast Cancer
title_sort her2 status by standardized immunohistochemistry and silver-enhanced in situ hybridization in korean breast cancer
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3542844/
https://www.ncbi.nlm.nih.gov/pubmed/23346165
http://dx.doi.org/10.4048/jbc.2012.15.4.381
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