Evaluation of analytical accuracy of HER2 status in patients with breast cancer: Comparison of HER2 GPA with HER2 IHC and HER2 FISH
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 (G...
Gespeichert in:
| Veröffentlicht in: | APMIS : acta pathologica, microbiologica et immunologica Scandinavica microbiologica et immunologica Scandinavica, 2020-11, Vol.128 (11), p.573-582 |
|---|---|
| Hauptverfasser: | , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 582 |
|---|---|
| container_issue | 11 |
| container_start_page | 573 |
| container_title | APMIS : acta pathologica, microbiologica et immunologica Scandinavica |
| container_volume | 128 |
| creator | Jensen, Steffen Grann Thomas, Peter Engel Christensen, Ib Jarle Balslev, Eva Hansen, Alastair Høgdall, Estrid |
| description | 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 |
| doi_str_mv | 10.1111/apm.13076 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2438680012</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2450195267</sourcerecordid><originalsourceid>FETCH-LOGICAL-c250t-247e08245a5789ca89c849cb2214d7fc0d52cb3b59b9711b18fa0be6c745418f3</originalsourceid><addsrcrecordid>eNpdkE1LxDAQhoMouK4e_AcBL3qoTtJ8tEdZVldYWBA9h2k2xS7dtiapsv_e1PXkwDDM8DDwPoRcM7hnqR5w2N-zHLQ6ITOmADIQKj8lMyghz4QS7JxchLADYLxQekY2yy9sR4xN39G-pthhe4iNxZaitaNHe5jOq-UrpyFiHANtOjok3nUx0O8mftDKOwyRWuys85fkrMY2uKu_OSfvT8u3xSpbb55fFo_rzHIJMeNCOyi4kCh1UVpMXYjSVpwzsdW1ha3ktsorWValZqxiRY1QOWW1kCIt-ZzcHv8Ovv8cXYhm3wTr2hY714_BcJEXqphiJvTmH7rrR5-CTpQEVkqudKLujpT1fQje1WbwzR79wTAwk1qT1JpftfkPZ3FqUA</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2450195267</pqid></control><display><type>article</type><title>Evaluation of analytical accuracy of HER2 status in patients with breast cancer: Comparison of HER2 GPA with HER2 IHC and HER2 FISH</title><source>Wiley Online Library - AutoHoldings Journals</source><creator>Jensen, Steffen Grann ; Thomas, Peter Engel ; Christensen, Ib Jarle ; Balslev, Eva ; Hansen, Alastair ; Høgdall, Estrid</creator><creatorcontrib>Jensen, Steffen Grann ; Thomas, Peter Engel ; Christensen, Ib Jarle ; Balslev, Eva ; Hansen, Alastair ; Høgdall, Estrid</creatorcontrib><description>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% (κ = 0.3122, p = 0.004) and 79.7% (κ = 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 (κ = 0.3636, p = 0.0332), unexperienced interpretation of IHC GPA suggested fair non‐significant difference between reviewers (κ = 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.</description><identifier>ISSN: 0903-4641</identifier><identifier>EISSN: 1600-0463</identifier><identifier>DOI: 10.1111/apm.13076</identifier><language>eng</language><publisher>Copenhagen: Wiley Subscription Services, Inc</publisher><subject>Biological treatment ; Breast cancer ; Chromosomes ; Correlation coefficient ; Correlation coefficients ; Diagnostic systems ; Enumeration ; Epidermal growth factor ; ErbB-2 protein ; Fluorescence ; Fluorescence in situ hybridization ; Growth factors ; Immunohistochemistry ; Paraffin ; Paraffins ; Proteins ; Regression analysis ; Reproducibility</subject><ispartof>APMIS : acta pathologica, microbiologica et immunologica Scandinavica, 2020-11, Vol.128 (11), p.573-582</ispartof><rights>Copyright © 2020 APMIS Published by John Wiley & Sons Ltd</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c250t-247e08245a5789ca89c849cb2214d7fc0d52cb3b59b9711b18fa0be6c745418f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids></links><search><creatorcontrib>Jensen, Steffen Grann</creatorcontrib><creatorcontrib>Thomas, Peter Engel</creatorcontrib><creatorcontrib>Christensen, Ib Jarle</creatorcontrib><creatorcontrib>Balslev, Eva</creatorcontrib><creatorcontrib>Hansen, Alastair</creatorcontrib><creatorcontrib>Høgdall, Estrid</creatorcontrib><title>Evaluation of analytical accuracy of HER2 status in patients with breast cancer: Comparison of HER2 GPA with HER2 IHC and HER2 FISH</title><title>APMIS : acta pathologica, microbiologica et immunologica Scandinavica</title><description>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% (κ = 0.3122, p = 0.004) and 79.7% (κ = 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 (κ = 0.3636, p = 0.0332), unexperienced interpretation of IHC GPA suggested fair non‐significant difference between reviewers (κ = 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.</description><subject>Biological treatment</subject><subject>Breast cancer</subject><subject>Chromosomes</subject><subject>Correlation coefficient</subject><subject>Correlation coefficients</subject><subject>Diagnostic systems</subject><subject>Enumeration</subject><subject>Epidermal growth factor</subject><subject>ErbB-2 protein</subject><subject>Fluorescence</subject><subject>Fluorescence in situ hybridization</subject><subject>Growth factors</subject><subject>Immunohistochemistry</subject><subject>Paraffin</subject><subject>Paraffins</subject><subject>Proteins</subject><subject>Regression analysis</subject><subject>Reproducibility</subject><issn>0903-4641</issn><issn>1600-0463</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><recordid>eNpdkE1LxDAQhoMouK4e_AcBL3qoTtJ8tEdZVldYWBA9h2k2xS7dtiapsv_e1PXkwDDM8DDwPoRcM7hnqR5w2N-zHLQ6ITOmADIQKj8lMyghz4QS7JxchLADYLxQekY2yy9sR4xN39G-pthhe4iNxZaitaNHe5jOq-UrpyFiHANtOjok3nUx0O8mftDKOwyRWuys85fkrMY2uKu_OSfvT8u3xSpbb55fFo_rzHIJMeNCOyi4kCh1UVpMXYjSVpwzsdW1ha3ktsorWValZqxiRY1QOWW1kCIt-ZzcHv8Ovv8cXYhm3wTr2hY714_BcJEXqphiJvTmH7rrR5-CTpQEVkqudKLujpT1fQje1WbwzR79wTAwk1qT1JpftfkPZ3FqUA</recordid><startdate>20201101</startdate><enddate>20201101</enddate><creator>Jensen, Steffen Grann</creator><creator>Thomas, Peter Engel</creator><creator>Christensen, Ib Jarle</creator><creator>Balslev, Eva</creator><creator>Hansen, Alastair</creator><creator>Høgdall, Estrid</creator><general>Wiley Subscription Services, Inc</general><scope>AAYXX</scope><scope>CITATION</scope><scope>7QL</scope><scope>7T5</scope><scope>7T7</scope><scope>7TO</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>M7N</scope><scope>P64</scope><scope>7X8</scope></search><sort><creationdate>20201101</creationdate><title>Evaluation of analytical accuracy of HER2 status in patients with breast cancer</title><author>Jensen, Steffen Grann ; Thomas, Peter Engel ; Christensen, Ib Jarle ; Balslev, Eva ; Hansen, Alastair ; Høgdall, Estrid</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c250t-247e08245a5789ca89c849cb2214d7fc0d52cb3b59b9711b18fa0be6c745418f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Biological treatment</topic><topic>Breast cancer</topic><topic>Chromosomes</topic><topic>Correlation coefficient</topic><topic>Correlation coefficients</topic><topic>Diagnostic systems</topic><topic>Enumeration</topic><topic>Epidermal growth factor</topic><topic>ErbB-2 protein</topic><topic>Fluorescence</topic><topic>Fluorescence in situ hybridization</topic><topic>Growth factors</topic><topic>Immunohistochemistry</topic><topic>Paraffin</topic><topic>Paraffins</topic><topic>Proteins</topic><topic>Regression analysis</topic><topic>Reproducibility</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Jensen, Steffen Grann</creatorcontrib><creatorcontrib>Thomas, Peter Engel</creatorcontrib><creatorcontrib>Christensen, Ib Jarle</creatorcontrib><creatorcontrib>Balslev, Eva</creatorcontrib><creatorcontrib>Hansen, Alastair</creatorcontrib><creatorcontrib>Høgdall, Estrid</creatorcontrib><collection>CrossRef</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Immunology Abstracts</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>APMIS : acta pathologica, microbiologica et immunologica Scandinavica</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Jensen, Steffen Grann</au><au>Thomas, Peter Engel</au><au>Christensen, Ib Jarle</au><au>Balslev, Eva</au><au>Hansen, Alastair</au><au>Høgdall, Estrid</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Evaluation of analytical accuracy of HER2 status in patients with breast cancer: Comparison of HER2 GPA with HER2 IHC and HER2 FISH</atitle><jtitle>APMIS : acta pathologica, microbiologica et immunologica Scandinavica</jtitle><date>2020-11-01</date><risdate>2020</risdate><volume>128</volume><issue>11</issue><spage>573</spage><epage>582</epage><pages>573-582</pages><issn>0903-4641</issn><eissn>1600-0463</eissn><abstract>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% (κ = 0.3122, p = 0.004) and 79.7% (κ = 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 (κ = 0.3636, p = 0.0332), unexperienced interpretation of IHC GPA suggested fair non‐significant difference between reviewers (κ = 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.</abstract><cop>Copenhagen</cop><pub>Wiley Subscription Services, Inc</pub><doi>10.1111/apm.13076</doi><tpages>10</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0903-4641 |
| ispartof | APMIS : acta pathologica, microbiologica et immunologica Scandinavica, 2020-11, Vol.128 (11), p.573-582 |
| issn | 0903-4641 1600-0463 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2438680012 |
| source | Wiley Online Library - AutoHoldings Journals |
| subjects | Biological treatment Breast cancer Chromosomes Correlation coefficient Correlation coefficients Diagnostic systems Enumeration Epidermal growth factor ErbB-2 protein Fluorescence Fluorescence in situ hybridization Growth factors Immunohistochemistry Paraffin Paraffins Proteins Regression analysis Reproducibility |
| title | Evaluation of analytical accuracy of HER2 status in patients with breast cancer: Comparison of HER2 GPA with HER2 IHC and HER2 FISH |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-04T05%3A52%3A02IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Evaluation%20of%20analytical%20accuracy%20of%20HER2%20status%20in%20patients%20with%20breast%20cancer:%20Comparison%20of%20HER2%20GPA%20with%20HER2%20IHC%20and%20HER2%20FISH&rft.jtitle=APMIS%20:%20acta%20pathologica,%20microbiologica%20et%20immunologica%20Scandinavica&rft.au=Jensen,%20Steffen%20Grann&rft.date=2020-11-01&rft.volume=128&rft.issue=11&rft.spage=573&rft.epage=582&rft.pages=573-582&rft.issn=0903-4641&rft.eissn=1600-0463&rft_id=info:doi/10.1111/apm.13076&rft_dat=%3Cproquest_cross%3E2450195267%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2450195267&rft_id=info:pmid/&rfr_iscdi=true |