Chromogenic in situ hybridisation for the assessment of HER2 status in breast cancer: an international validation ring study
Identifieur interne : 002B47 ( Pmc/Checkpoint ); précédent : 002B46; suivant : 002B48Chromogenic in situ hybridisation for the assessment of HER2 status in breast cancer: an international validation ring study
Auteurs : Marc Van De Vijver [Pays-Bas] ; Michael Bilous [Australie] ; Wedad Hanna [Canada] ; Manfred Hofmann [Allemagne] ; Petra Kristel [Pays-Bas] ; Frédérique Penault-Llorca [France] ; Josef Rüschoff [Allemagne]Source :
- Breast cancer research : BCR [ 1465-5411 ] ; 2007.
Abstract
Before any new methodology can be introduced into the routine diagnostic setting it must be technically validated against the established standards. To this end, a ring study involving five international pathology laboratories was initiated to validate chromogenic
Each laboratory performed CISH, FISH and IHC on its own samples. Unstained sections from each case were also sent to another participating laboratory for blinded retesting by CISH ('outside CISH').
A total of 211 invasive breast carcinoma cases were tested. In 76 cases with high amplification (HER2/CEP17 ratio >4.0) by FISH, 73 cases (96%) scored positive (scores ≥ 6) by 'outside CISH'. For FISH-negative cases (HER2/CEP17 ratio <2.0), 94 of 100 cases (94%) had CISH scores indicating no amplification (score ≤ 5), and only three cases were positive by CISH; in the three remaining cases, no CISH result could be obtained. For cases with low-level amplification using FISH (HER2/CEP17 ratio 2.0–4.0), 20 of 35 had CISH scores indicating gene amplification. Inter-laboratory concordance was also very high: 95% for normal
These results show that CISH inter- and intra-laboratory concordance to FISH and IHC is very high, even in equivocal IHC 2+ cases. Therefore, we conclude that CISH is a methodology that is a viable alternative to FISH in the HER2 testing algorithm.
Url:
DOI: 10.1186/bcr1776
PubMed: 17922920
PubMed Central: 2242665
Affiliations:
- Allemagne, Australie, Canada, France, Pays-Bas
- Auvergne (région administrative), Auvergne-Rhône-Alpes, District de Kassel, Hesse (Land), Hollande-Septentrionale
- Amsterdam, Cassel (Hesse), Clermont-Ferrand
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PMC:2242665Le document en format XML
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hybridisation for the assessment of HER2 status in breast cancer: an international validation ring study</title>
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<series><title level="j">Breast cancer research : BCR</title>
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<front><div type="abstract" xml:lang="en"><sec><title>Introduction</title>
<p>Before any new methodology can be introduced into the routine diagnostic setting it must be technically validated against the established standards. To this end, a ring study involving five international pathology laboratories was initiated to validate chromogenic <italic>in situ </italic>
hybridisation (CISH) against fluorescence <italic>in situ </italic>
hybridisation (FISH) and immunohistochemistry (IHC) as a test for assessing human epidermal growth factor receptor 2 (HER2) status in breast cancer.</p>
</sec>
<sec sec-type="methods"><title>Methods</title>
<p>Each laboratory performed CISH, FISH and IHC on its own samples. Unstained sections from each case were also sent to another participating laboratory for blinded retesting by CISH ('outside CISH').</p>
</sec>
<sec><title>Results</title>
<p>A total of 211 invasive breast carcinoma cases were tested. In 76 cases with high amplification (HER2/CEP17 ratio >4.0) by FISH, 73 cases (96%) scored positive (scores ≥ 6) by 'outside CISH'. For FISH-negative cases (HER2/CEP17 ratio <2.0), 94 of 100 cases (94%) had CISH scores indicating no amplification (score ≤ 5), and only three cases were positive by CISH; in the three remaining cases, no CISH result could be obtained. For cases with low-level amplification using FISH (HER2/CEP17 ratio 2.0–4.0), 20 of 35 had CISH scores indicating gene amplification. Inter-laboratory concordance was also very high: 95% for normal <italic>HER2 </italic>
copy number (1–5 copies); and 92% for cases with <italic>HER2 </italic>
copy numbers ≥ 6. CISH intra-laboratory concordance with IHC was 92% for IHC-negative cases (IHC 0/1+) and 91% for IHC 3+ cases. Among IHC 2+ cases, CISH was 100% concordant with samples showing high amplification by FISH, and 94% concordant with FISH-negative samples.</p>
</sec>
<sec><title>Conclusion</title>
<p>These results show that CISH inter- and intra-laboratory concordance to FISH and IHC is very high, even in equivocal IHC 2+ cases. Therefore, we conclude that CISH is a methodology that is a viable alternative to FISH in the HER2 testing algorithm.</p>
</sec>
</div>
</front>
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<front><journal-meta><journal-id journal-id-type="nlm-ta">Breast Cancer Res</journal-id>
<journal-title>Breast cancer research : BCR</journal-title>
<issn pub-type="ppub">1465-5411</issn>
<issn pub-type="epub">1465-542X</issn>
<publisher><publisher-name>BioMed Central</publisher-name>
</publisher>
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<article-meta><article-id pub-id-type="pmid">17922920</article-id>
<article-id pub-id-type="pmc">2242665</article-id>
<article-id pub-id-type="publisher-id">bcr1776</article-id>
<article-id pub-id-type="doi">10.1186/bcr1776</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject>
</subj-group>
</article-categories>
<title-group><article-title>Chromogenic <italic>in situ </italic>
hybridisation for the assessment of HER2 status in breast cancer: an international validation ring study</article-title>
</title-group>
<contrib-group><contrib id="A1" corresp="yes" contrib-type="author"><name><surname>van de Vijver</surname>
<given-names>Marc</given-names>
</name>
<xref ref-type="aff" rid="I1">1</xref>
<email>m.vd.vijver@nki.nl</email>
</contrib>
<contrib id="A2" contrib-type="author"><name><surname>Bilous</surname>
<given-names>Michael</given-names>
</name>
<xref ref-type="aff" rid="I2">2</xref>
<email>Michaelb@icpmr.wsahs.nsw.gov.au</email>
</contrib>
<contrib id="A3" contrib-type="author"><name><surname>Hanna</surname>
<given-names>Wedad</given-names>
</name>
<xref ref-type="aff" rid="I3">3</xref>
<email>wedad.Hanna@swchsc.on.ca</email>
</contrib>
<contrib id="A4" contrib-type="author"><name><surname>Hofmann</surname>
<given-names>Manfred</given-names>
</name>
<xref ref-type="aff" rid="I4">4</xref>
<email>hofman1@klinikum-kassel.de</email>
</contrib>
<contrib id="A5" contrib-type="author"><name><surname>Kristel</surname>
<given-names>Petra</given-names>
</name>
<xref ref-type="aff" rid="I1">1</xref>
<email>p.kristel@nki.nl</email>
</contrib>
<contrib id="A6" contrib-type="author"><name><surname>Penault-Llorca</surname>
<given-names>Frédérique</given-names>
</name>
<xref ref-type="aff" rid="I5">5</xref>
<email>Frederique.Penault-Llorca@cjp.u-clermont1.fr</email>
</contrib>
<contrib id="A7" contrib-type="author"><name><surname>Rüschoff</surname>
<given-names>Josef</given-names>
</name>
<xref ref-type="aff" rid="I4">4</xref>
<email>ruesch@klinikum-kassel.de</email>
</contrib>
</contrib-group>
<aff id="I1"><label>1</label>
Netherlands Cancer Institute, Amsterdam, The Netherlands</aff>
<aff id="I2"><label>2</label>
Westmead Hospital, Westmead, New South Wales, Australia</aff>
<aff id="I3"><label>3</label>
Sunnybrook & Women's College, Health Science Center, Toronto, Canada</aff>
<aff id="I4"><label>4</label>
Klinikum Kassel, Kassel, Germany</aff>
<aff id="I5"><label>5</label>
Departement de Pathology, Centre Jean Perrin, Clermont-Ferrand, France</aff>
<pub-date pub-type="ppub"><year>2007</year>
</pub-date>
<pub-date pub-type="epub"><day>8</day>
<month>10</month>
<year>2007</year>
</pub-date>
<volume>9</volume>
<issue>5</issue>
<fpage>R68</fpage>
<lpage>R68</lpage>
<ext-link ext-link-type="uri" xlink:href="http://breast-cancer-research.com/content/9/5/R68"></ext-link>
<history><date date-type="received"><day>26</day>
<month>6</month>
<year>2006</year>
</date>
<date date-type="rev-request"><day>5</day>
<month>9</month>
<year>2006</year>
</date>
<date date-type="rev-recd"><day>12</day>
<month>6</month>
<year>2007</year>
</date>
<date date-type="accepted"><day>8</day>
<month>10</month>
<year>2007</year>
</date>
</history>
<permissions><copyright-statement>Copyright © 2007 van de Vijver et al.; licensee BioMed Central Ltd.</copyright-statement>
<copyright-year>2007</copyright-year>
<copyright-holder>van de Vijver et al.; licensee BioMed Central Ltd.</copyright-holder>
<license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by/2.0"><p>This is an open access article distributed under the terms of the Creative Commons Attribution License (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/2.0"></ext-link>
), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</p>
<pmc-comment>
van de Vijver
Marc
m.vd.vijver@nki.nl
Chromogenic in situ hybridisation for the assessment of HER2 status in breast cancer: an international validation ring study
2007 Breast Cancer Research 9(5): R68-. (2007) 1465-5411(2007)9:5 urn:ISSN:1465-5411 </pmc-comment>
</license>
</permissions>
<abstract><sec><title>Introduction</title>
<p>Before any new methodology can be introduced into the routine diagnostic setting it must be technically validated against the established standards. To this end, a ring study involving five international pathology laboratories was initiated to validate chromogenic <italic>in situ </italic>
hybridisation (CISH) against fluorescence <italic>in situ </italic>
hybridisation (FISH) and immunohistochemistry (IHC) as a test for assessing human epidermal growth factor receptor 2 (HER2) status in breast cancer.</p>
</sec>
<sec sec-type="methods"><title>Methods</title>
<p>Each laboratory performed CISH, FISH and IHC on its own samples. Unstained sections from each case were also sent to another participating laboratory for blinded retesting by CISH ('outside CISH').</p>
</sec>
<sec><title>Results</title>
<p>A total of 211 invasive breast carcinoma cases were tested. In 76 cases with high amplification (HER2/CEP17 ratio >4.0) by FISH, 73 cases (96%) scored positive (scores ≥ 6) by 'outside CISH'. For FISH-negative cases (HER2/CEP17 ratio <2.0), 94 of 100 cases (94%) had CISH scores indicating no amplification (score ≤ 5), and only three cases were positive by CISH; in the three remaining cases, no CISH result could be obtained. For cases with low-level amplification using FISH (HER2/CEP17 ratio 2.0–4.0), 20 of 35 had CISH scores indicating gene amplification. Inter-laboratory concordance was also very high: 95% for normal <italic>HER2 </italic>
copy number (1–5 copies); and 92% for cases with <italic>HER2 </italic>
copy numbers ≥ 6. CISH intra-laboratory concordance with IHC was 92% for IHC-negative cases (IHC 0/1+) and 91% for IHC 3+ cases. Among IHC 2+ cases, CISH was 100% concordant with samples showing high amplification by FISH, and 94% concordant with FISH-negative samples.</p>
</sec>
<sec><title>Conclusion</title>
<p>These results show that CISH inter- and intra-laboratory concordance to FISH and IHC is very high, even in equivocal IHC 2+ cases. Therefore, we conclude that CISH is a methodology that is a viable alternative to FISH in the HER2 testing algorithm.</p>
</sec>
</abstract>
</article-meta>
</front>
</pmc>
<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>Canada</li>
<li>France</li>
<li>Pays-Bas</li>
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