High concordance between HercepTest immunohistochemistry and ERBB2 fluorescence in situ hybridization before and after implementation of American Society of Clinical Oncology/College of American Pathology 2007 guidelines
Human epidermal growth factor receptor 2 ( HER2, ERBB2 ) is an important critical predictive marker in patients with invasive breast cancer. It is thus imperative to ensure accuracy and precision in HER2 and ERBB2 testing. In 2007, the American Society of Clinical Oncology and College of American Pa...
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| Veröffentlicht in: | Modern pathology 2012-10, Vol.25 (10), p.1326-1332 |
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| creator | Vergara-Lluri, Maria E Moatamed, Neda A Hong, Elizabeth Apple, Sophia K |
| description | Human epidermal growth factor receptor 2 (
HER2, ERBB2
) is an important critical predictive marker in patients with invasive breast cancer. It is thus imperative to ensure accuracy and precision in HER2 and
ERBB2
testing. In 2007, the American Society of Clinical Oncology and College of American Pathologists (ASCO/CAP) proposed new guidelines for immunohistochemistry and fluorescence
in-situ
hybridization scoring in an effort to improve accuracy and utility of these companion diagnostic tests. The goal of the 2007 guidelines was to improve concordance rates between the diagnostic tests and decrease the number of inconclusive cases. This study examines the impact in concordance rates and number of inconclusive cases based on the recent change in guidelines in a large study cohort. HER2 immunohistochemistry and
ERBB2
fluorescence
in-situ
hybridization were performed on all specimens from our facility from years 2003 through 2010 (
n
=1437). Cases from 2003–2007 (
n
=1016) were scored using Food and Drug Administration guidelines, with immunohistochemical 3+ cases staining >10% of tumor cells and fluorescence
in-situ
hybridization amplification cutoff value of 2.0. The 2007 guidelines were implemented and scored accordingly for cases from 2008–2010 (
n
=421), with immunohistochemical 3+ cases staining >30% of tumor cells and fluorescence
in-situ
hybridization amplification cutoff value of 2.2. We compared concordance rates before and after 2007 guidelines. For the 2003–2007 study population, the concordance rate between the assays was 97.6% with a corresponding kappa coefficient (
k
) of 0.90. For the 2008–2010 study population, concordance rate was 97.6% with a corresponding
k
of 0.89. There was no significant difference in number of inconclusive rates before and after 2007 guidelines. In our study, implementation of the new ASCO/CAP 2007 HER2 guidelines did not show a significant difference in concordance rates and did not decrease the number of inconclusive cases. |
| doi_str_mv | 10.1038/modpathol.2012.93 |
| format | Article |
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HER2, ERBB2
) is an important critical predictive marker in patients with invasive breast cancer. It is thus imperative to ensure accuracy and precision in HER2 and
ERBB2
testing. In 2007, the American Society of Clinical Oncology and College of American Pathologists (ASCO/CAP) proposed new guidelines for immunohistochemistry and fluorescence
in-situ
hybridization scoring in an effort to improve accuracy and utility of these companion diagnostic tests. The goal of the 2007 guidelines was to improve concordance rates between the diagnostic tests and decrease the number of inconclusive cases. This study examines the impact in concordance rates and number of inconclusive cases based on the recent change in guidelines in a large study cohort. HER2 immunohistochemistry and
ERBB2
fluorescence
in-situ
hybridization were performed on all specimens from our facility from years 2003 through 2010 (
n
=1437). Cases from 2003–2007 (
n
=1016) were scored using Food and Drug Administration guidelines, with immunohistochemical 3+ cases staining >10% of tumor cells and fluorescence
in-situ
hybridization amplification cutoff value of 2.0. The 2007 guidelines were implemented and scored accordingly for cases from 2008–2010 (
n
=421), with immunohistochemical 3+ cases staining >30% of tumor cells and fluorescence
in-situ
hybridization amplification cutoff value of 2.2. We compared concordance rates before and after 2007 guidelines. For the 2003–2007 study population, the concordance rate between the assays was 97.6% with a corresponding kappa coefficient (
k
) of 0.90. For the 2008–2010 study population, concordance rate was 97.6% with a corresponding
k
of 0.89. There was no significant difference in number of inconclusive rates before and after 2007 guidelines. In our study, implementation of the new ASCO/CAP 2007 HER2 guidelines did not show a significant difference in concordance rates and did not decrease the number of inconclusive cases.</description><identifier>ISSN: 0893-3952</identifier><identifier>EISSN: 1530-0285</identifier><identifier>DOI: 10.1038/modpathol.2012.93</identifier><identifier>PMID: 22699517</identifier><identifier>CODEN: MODPEO</identifier><language>eng</language><publisher>New York: Nature Publishing Group US</publisher><subject>631/1647/2017/1947 ; 631/1647/664/1257 ; 692/699/67/1347 ; 692/700/1538 ; Accuracy ; Biomarkers, Tumor - metabolism ; Breast cancer ; Breast Neoplasms - diagnosis ; Breast Neoplasms - genetics ; Breast Neoplasms - metabolism ; Carcinoma, Ductal, Breast - diagnosis ; Carcinoma, Ductal, Breast - metabolism ; Diagnostic tests ; Epidermal growth factor ; False Negative Reactions ; False Positive Reactions ; FDA approval ; Female ; Genes, erbB-2 ; Glycoproteins ; Humans ; Hybridization ; Immunohistochemistry - methods ; In Situ Hybridization, Fluorescence ; Laboratory Medicine ; Medicine ; Medicine & Public Health ; Oncology ; original-article ; Pathology ; Practice Guidelines as Topic ; Proteins ; Receptor, ErbB-2 - genetics ; Receptor, ErbB-2 - metabolism</subject><ispartof>Modern pathology, 2012-10, Vol.25 (10), p.1326-1332</ispartof><rights>United States and Canadian Academy of Pathology, Inc. 2012</rights><rights>Copyright Nature Publishing Group Oct 2012</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c411t-77cca54ff0ef80d6d14a046264fcb6a43dfb7965d99fedf7441b49c1bc659cb23</citedby><cites>FETCH-LOGICAL-c411t-77cca54ff0ef80d6d14a046264fcb6a43dfb7965d99fedf7441b49c1bc659cb23</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22699517$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Vergara-Lluri, Maria E</creatorcontrib><creatorcontrib>Moatamed, Neda A</creatorcontrib><creatorcontrib>Hong, Elizabeth</creatorcontrib><creatorcontrib>Apple, Sophia K</creatorcontrib><title>High concordance between HercepTest immunohistochemistry and ERBB2 fluorescence in situ hybridization before and after implementation of American Society of Clinical Oncology/College of American Pathology 2007 guidelines</title><title>Modern pathology</title><addtitle>Mod Pathol</addtitle><addtitle>Mod Pathol</addtitle><description>Human epidermal growth factor receptor 2 (
HER2, ERBB2
) is an important critical predictive marker in patients with invasive breast cancer. It is thus imperative to ensure accuracy and precision in HER2 and
ERBB2
testing. In 2007, the American Society of Clinical Oncology and College of American Pathologists (ASCO/CAP) proposed new guidelines for immunohistochemistry and fluorescence
in-situ
hybridization scoring in an effort to improve accuracy and utility of these companion diagnostic tests. The goal of the 2007 guidelines was to improve concordance rates between the diagnostic tests and decrease the number of inconclusive cases. This study examines the impact in concordance rates and number of inconclusive cases based on the recent change in guidelines in a large study cohort. HER2 immunohistochemistry and
ERBB2
fluorescence
in-situ
hybridization were performed on all specimens from our facility from years 2003 through 2010 (
n
=1437). Cases from 2003–2007 (
n
=1016) were scored using Food and Drug Administration guidelines, with immunohistochemical 3+ cases staining >10% of tumor cells and fluorescence
in-situ
hybridization amplification cutoff value of 2.0. The 2007 guidelines were implemented and scored accordingly for cases from 2008–2010 (
n
=421), with immunohistochemical 3+ cases staining >30% of tumor cells and fluorescence
in-situ
hybridization amplification cutoff value of 2.2. We compared concordance rates before and after 2007 guidelines. For the 2003–2007 study population, the concordance rate between the assays was 97.6% with a corresponding kappa coefficient (
k
) of 0.90. For the 2008–2010 study population, concordance rate was 97.6% with a corresponding
k
of 0.89. There was no significant difference in number of inconclusive rates before and after 2007 guidelines. In our study, implementation of the new ASCO/CAP 2007 HER2 guidelines did not show a significant difference in concordance rates and did not decrease the number of inconclusive cases.</description><subject>631/1647/2017/1947</subject><subject>631/1647/664/1257</subject><subject>692/699/67/1347</subject><subject>692/700/1538</subject><subject>Accuracy</subject><subject>Biomarkers, Tumor - metabolism</subject><subject>Breast cancer</subject><subject>Breast Neoplasms - diagnosis</subject><subject>Breast Neoplasms - genetics</subject><subject>Breast Neoplasms - metabolism</subject><subject>Carcinoma, Ductal, Breast - diagnosis</subject><subject>Carcinoma, Ductal, Breast - metabolism</subject><subject>Diagnostic tests</subject><subject>Epidermal growth factor</subject><subject>False Negative Reactions</subject><subject>False Positive Reactions</subject><subject>FDA approval</subject><subject>Female</subject><subject>Genes, erbB-2</subject><subject>Glycoproteins</subject><subject>Humans</subject><subject>Hybridization</subject><subject>Immunohistochemistry - methods</subject><subject>In Situ Hybridization, Fluorescence</subject><subject>Laboratory Medicine</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Oncology</subject><subject>original-article</subject><subject>Pathology</subject><subject>Practice Guidelines as Topic</subject><subject>Proteins</subject><subject>Receptor, ErbB-2 - genetics</subject><subject>Receptor, ErbB-2 - metabolism</subject><issn>0893-3952</issn><issn>1530-0285</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp1kc9u1DAQxiMEokvhAbggS1y4ZGs7zh8f21VhkSoVQTlHjj1OXDn2YidC4Vl5GJzdUgESp5Fmft83o_my7DXBW4KL5mL06iCmwdstxYRuefEk25CywDmmTfk02-CGF3nBS3qWvYjxHmPCyoY-z84orTgvSb3Jfu5NPyDpnfRBCScBdTB9B3BoD0HC4Q7ihMw4zs4PJk5eDjCmGhYknELXn6-uKNJ29gGihFVuHIpmmtGwdMEo80NMxrtkqhNy1Ag9QUiWBwsjuOk09xpdjhCMFA598dLAtKy9nTUu9Sy6TfdZ3y8XO28t9PCX4NPxB2mKKMY16mejIAkhvsyeaWEjvHqo59nX99d3u31-c_vh4-7yJpeMkCmvaylFybTGoBusKkWYwKyiFdOyqwQrlO5qXpWKcw1K14yRjnFJOlmVXHa0OM_enXwPwX-b08fa9CMJ1goHfo4twQ1p6gpTktC3_6D3fg4uXXekWFE0zUqREyWDjzGAbg_BjCIsCWrX6NvH6Ns1-pYXSfPmwXnuRlCPit9ZJ4CegJhGrofw5-r_uf4Cq0vDOQ</recordid><startdate>20121001</startdate><enddate>20121001</enddate><creator>Vergara-Lluri, Maria E</creator><creator>Moatamed, Neda A</creator><creator>Hong, Elizabeth</creator><creator>Apple, Sophia K</creator><general>Nature Publishing Group US</general><general>Elsevier Limited</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7QP</scope><scope>7RV</scope><scope>7TK</scope><scope>7X7</scope><scope>7XB</scope><scope>88A</scope><scope>88E</scope><scope>8AO</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>KB0</scope><scope>LK8</scope><scope>M0S</scope><scope>M1P</scope><scope>M7P</scope><scope>NAPCQ</scope><scope>PHGZM</scope><scope>PHGZT</scope><scope>PJZUB</scope><scope>PKEHL</scope><scope>PPXIY</scope><scope>PQEST</scope><scope>PQGLB</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>7X8</scope></search><sort><creationdate>20121001</creationdate><title>High concordance between HercepTest immunohistochemistry and ERBB2 fluorescence in situ hybridization before and after implementation of American Society of Clinical Oncology/College of American Pathology 2007 guidelines</title><author>Vergara-Lluri, Maria E ; Moatamed, Neda A ; Hong, Elizabeth ; Apple, Sophia K</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c411t-77cca54ff0ef80d6d14a046264fcb6a43dfb7965d99fedf7441b49c1bc659cb23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>631/1647/2017/1947</topic><topic>631/1647/664/1257</topic><topic>692/699/67/1347</topic><topic>692/700/1538</topic><topic>Accuracy</topic><topic>Biomarkers, Tumor - 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Academic</collection><jtitle>Modern pathology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Vergara-Lluri, Maria E</au><au>Moatamed, Neda A</au><au>Hong, Elizabeth</au><au>Apple, Sophia K</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>High concordance between HercepTest immunohistochemistry and ERBB2 fluorescence in situ hybridization before and after implementation of American Society of Clinical Oncology/College of American Pathology 2007 guidelines</atitle><jtitle>Modern pathology</jtitle><stitle>Mod Pathol</stitle><addtitle>Mod Pathol</addtitle><date>2012-10-01</date><risdate>2012</risdate><volume>25</volume><issue>10</issue><spage>1326</spage><epage>1332</epage><pages>1326-1332</pages><issn>0893-3952</issn><eissn>1530-0285</eissn><coden>MODPEO</coden><abstract>Human epidermal growth factor receptor 2 (
HER2, ERBB2
) is an important critical predictive marker in patients with invasive breast cancer. It is thus imperative to ensure accuracy and precision in HER2 and
ERBB2
testing. In 2007, the American Society of Clinical Oncology and College of American Pathologists (ASCO/CAP) proposed new guidelines for immunohistochemistry and fluorescence
in-situ
hybridization scoring in an effort to improve accuracy and utility of these companion diagnostic tests. The goal of the 2007 guidelines was to improve concordance rates between the diagnostic tests and decrease the number of inconclusive cases. This study examines the impact in concordance rates and number of inconclusive cases based on the recent change in guidelines in a large study cohort. HER2 immunohistochemistry and
ERBB2
fluorescence
in-situ
hybridization were performed on all specimens from our facility from years 2003 through 2010 (
n
=1437). Cases from 2003–2007 (
n
=1016) were scored using Food and Drug Administration guidelines, with immunohistochemical 3+ cases staining >10% of tumor cells and fluorescence
in-situ
hybridization amplification cutoff value of 2.0. The 2007 guidelines were implemented and scored accordingly for cases from 2008–2010 (
n
=421), with immunohistochemical 3+ cases staining >30% of tumor cells and fluorescence
in-situ
hybridization amplification cutoff value of 2.2. We compared concordance rates before and after 2007 guidelines. For the 2003–2007 study population, the concordance rate between the assays was 97.6% with a corresponding kappa coefficient (
k
) of 0.90. For the 2008–2010 study population, concordance rate was 97.6% with a corresponding
k
of 0.89. There was no significant difference in number of inconclusive rates before and after 2007 guidelines. In our study, implementation of the new ASCO/CAP 2007 HER2 guidelines did not show a significant difference in concordance rates and did not decrease the number of inconclusive cases.</abstract><cop>New York</cop><pub>Nature Publishing Group US</pub><pmid>22699517</pmid><doi>10.1038/modpathol.2012.93</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
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| issn | 0893-3952 1530-0285 |
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| subjects | 631/1647/2017/1947 631/1647/664/1257 692/699/67/1347 692/700/1538 Accuracy Biomarkers, Tumor - metabolism Breast cancer Breast Neoplasms - diagnosis Breast Neoplasms - genetics Breast Neoplasms - metabolism Carcinoma, Ductal, Breast - diagnosis Carcinoma, Ductal, Breast - metabolism Diagnostic tests Epidermal growth factor False Negative Reactions False Positive Reactions FDA approval Female Genes, erbB-2 Glycoproteins Humans Hybridization Immunohistochemistry - methods In Situ Hybridization, Fluorescence Laboratory Medicine Medicine Medicine & Public Health Oncology original-article Pathology Practice Guidelines as Topic Proteins Receptor, ErbB-2 - genetics Receptor, ErbB-2 - metabolism |
| title | High concordance between HercepTest immunohistochemistry and ERBB2 fluorescence in situ hybridization before and after implementation of American Society of Clinical Oncology/College of American Pathology 2007 guidelines |
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