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EGFR fluorescence in situ hybridisation assay: guidelines for application to non-small-cell lung cancer

Identifieur interne : 000408 ( Pmc/Checkpoint ); précédent : 000407; suivant : 000409

EGFR fluorescence in situ hybridisation assay: guidelines for application to non-small-cell lung cancer

Auteurs : M. Varella-Garcia [États-Unis] ; J. Diebold [Suisse] ; D A Eberhard [États-Unis] ; K. Geenen [Belgique] ; A. Hirschmann [Suisse] ; M. Kockx [Belgique] ; I. Nagelmeier [Allemagne] ; J. Rüschoff [Allemagne] ; M. Schmitt [Allemagne] ; S. Arbogast [Allemagne] ; F. Cappuzzo [Italie]

Source :

RBID : PMC:2771853

Abstract

There is a need for predictive biomarkers that identify non-small-cell lung cancer (NSCLC) patients most likely to respond to epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) treatment. There are numerous potential candidates, although none has been proven in prospective clinical trials. The EGFR gene copy number evaluated by fluorescence in situ hybridisation (FISH) has been highlighted as one of the most effective markers for sensitivity to EGFR TKIs in large phase III, randomised placebo-controlled trials and has been used in clinical settings to assist physicians in defining the therapeutic regimen. The EGFR FISH assay has technical challenges and it is critical that detailed guidelines are provided to help clinical laboratories in performing and interpreting the test. Excellent assay reproducibility and portability rates among laboratories are crucial to guarantee that accurate clinical decisions can be made for patients with NSCLC. This article discusses the consensus outcomes of a global workshop convened to discuss key technical issues and standardise reading strategies for the EGFR FISH assay of NSCLC tumour tissue.


Url:
DOI: 10.1136/jcp.2009.066548
PubMed: 19861557
PubMed Central: 2771853


Affiliations:


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Le document en format XML

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<p>There is a need for predictive biomarkers that identify non-small-cell lung cancer (NSCLC) patients most likely to respond to epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) treatment. There are numerous potential candidates, although none has been proven in prospective clinical trials. The EGFR gene copy number evaluated by fluorescence in situ hybridisation (FISH) has been highlighted as one of the most effective markers for sensitivity to EGFR TKIs in large phase III, randomised placebo-controlled trials and has been used in clinical settings to assist physicians in defining the therapeutic regimen. The EGFR FISH assay has technical challenges and it is critical that detailed guidelines are provided to help clinical laboratories in performing and interpreting the test. Excellent assay reproducibility and portability rates among laboratories are crucial to guarantee that accurate clinical decisions can be made for patients with NSCLC. This article discusses the consensus outcomes of a global workshop convened to discuss key technical issues and standardise reading strategies for the EGFR FISH assay of NSCLC tumour tissue.</p>
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<name sortKey="Schneider, C P" uniqKey="Schneider C">C-P Schneider</name>
</author>
<author>
<name sortKey="Heigener, D" uniqKey="Heigener D">D Heigener</name>
</author>
<author>
<name sortKey="Schott Von Romer, K" uniqKey="Schott Von Romer K">K Schott-von-Romer</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Crino, L" uniqKey="Crino L">L Crino</name>
</author>
<author>
<name sortKey="Cappuzzo, F" uniqKey="Cappuzzo F">F Cappuzzo</name>
</author>
<author>
<name sortKey="Zatloukal, P" uniqKey="Zatloukal P">P Zatloukal</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Douillard, J" uniqKey="Douillard J">J Douillard</name>
</author>
<author>
<name sortKey="Hirsh, V" uniqKey="Hirsh V">V Hirsh</name>
</author>
<author>
<name sortKey="Mok, T" uniqKey="Mok T">T Mok</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Douillard, J Y" uniqKey="Douillard J">J-Y Douillard</name>
</author>
<author>
<name sortKey="Kim, Es" uniqKey="Kim E">ES Kim</name>
</author>
<author>
<name sortKey="Hirsh, V" uniqKey="Hirsh V">V Hirsh</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Kim, Es" uniqKey="Kim E">ES Kim</name>
</author>
<author>
<name sortKey="Hirsh, V" uniqKey="Hirsh V">V Hirsh</name>
</author>
<author>
<name sortKey="Mok, T" uniqKey="Mok T">T Mok</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Hirsch, Fr" uniqKey="Hirsch F">FR Hirsch</name>
</author>
<author>
<name sortKey="Varella Garcia, M" uniqKey="Varella Garcia M">M Varella-Garcia</name>
</author>
<author>
<name sortKey="Dziadziuszko, R" uniqKey="Dziadziuszko R">R Dziadziuszko</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Eberhard, Da" uniqKey="Eberhard D">DA Eberhard</name>
</author>
<author>
<name sortKey="Giaccone, G" uniqKey="Giaccone G">G Giaccone</name>
</author>
<author>
<name sortKey="Johnson, Be" uniqKey="Johnson B">BE Johnson</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Varella Garcia, M" uniqKey="Varella Garcia M">M Varella-Garcia</name>
</author>
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<name sortKey="Wolff, Ac" uniqKey="Wolff A">AC Wolff</name>
</author>
<author>
<name sortKey="Hammond, Me" uniqKey="Hammond M">ME Hammond</name>
</author>
<author>
<name sortKey="Schwartz, Jn" uniqKey="Schwartz J">JN Schwartz</name>
</author>
</analytic>
</biblStruct>
</listBibl>
</div1>
</back>
</TEI>
<pmc article-type="review-article">
<pmc-dir>properties open_access</pmc-dir>
<front>
<journal-meta>
<journal-id journal-id-type="nlm-ta">J Clin Pathol</journal-id>
<journal-id journal-id-type="publisher-id">jcp</journal-id>
<journal-id journal-id-type="hwp">jclinpath</journal-id>
<journal-title-group>
<journal-title>Journal of Clinical Pathology</journal-title>
</journal-title-group>
<issn pub-type="ppub">0021-9746</issn>
<issn pub-type="epub">1472-4146</issn>
<publisher>
<publisher-name>BMJ Group</publisher-name>
<publisher-loc>BMA House, Tavistock Square, London, WC1H 9JR</publisher-loc>
</publisher>
</journal-meta>
<article-meta>
<article-id pub-id-type="pmid">19861557</article-id>
<article-id pub-id-type="pmc">2771853</article-id>
<article-id pub-id-type="publisher-id">cp66548</article-id>
<article-id pub-id-type="doi">10.1136/jcp.2009.066548</article-id>
<article-categories>
<subj-group subj-group-type="heading">
<subject>Reviews</subject>
</subj-group>
<subj-group subj-group-type="hwp-journal-coll">
<subject>1506</subject>
</subj-group>
<subj-group subj-group-type="hwp-journal-coll">
<subject>1531</subject>
</subj-group>
</article-categories>
<title-group>
<article-title>EGFR fluorescence in situ hybridisation assay: guidelines for application to non-small-cell lung cancer</article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname>Varella-Garcia</surname>
<given-names>M</given-names>
</name>
<xref ref-type="aff" rid="aff1">1</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Diebold</surname>
<given-names>J</given-names>
</name>
<xref ref-type="aff" rid="aff2">2</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Eberhard</surname>
<given-names>D A</given-names>
</name>
<xref ref-type="aff" rid="aff3">3</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Geenen</surname>
<given-names>K</given-names>
</name>
<xref ref-type="aff" rid="aff4">4</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Hirschmann</surname>
<given-names>A</given-names>
</name>
<xref ref-type="aff" rid="aff2">2</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Kockx</surname>
<given-names>M</given-names>
</name>
<xref ref-type="aff" rid="aff4">4</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Nagelmeier</surname>
<given-names>I</given-names>
</name>
<xref ref-type="aff" rid="aff5">5</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Rüschoff</surname>
<given-names>J</given-names>
</name>
<xref ref-type="aff" rid="aff5">5</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Schmitt</surname>
<given-names>M</given-names>
</name>
<xref ref-type="aff" rid="aff5">5</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Arbogast</surname>
<given-names>S</given-names>
</name>
<xref ref-type="aff" rid="aff6">6</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Cappuzzo</surname>
<given-names>F</given-names>
</name>
<xref ref-type="aff" rid="aff7">7</xref>
</contrib>
</contrib-group>
<aff id="aff1">
<label>1</label>
<addr-line>University of Colorado Cancer Center, Aurora, Colorado, USA</addr-line>
</aff>
<aff id="aff2">
<label>2</label>
<addr-line>Luzerner Kantonsspital, Luzern, Switzerland</addr-line>
</aff>
<aff id="aff3">
<label>3</label>
<addr-line>Independent Consultant, San Francisco, USA</addr-line>
</aff>
<aff id="aff4">
<label>4</label>
<addr-line>Histogenex, Antwerp, Belgium</addr-line>
</aff>
<aff id="aff5">
<label>5</label>
<addr-line>Targos GmbH, Kassel, Germany</addr-line>
</aff>
<aff id="aff6">
<label>6</label>
<addr-line>Roche, Penzberg, Germany</addr-line>
</aff>
<aff id="aff7">
<label>7</label>
<addr-line>Istituto Clinico Humanitas, Milano, Italy</addr-line>
</aff>
<author-notes>
<corresp>Correspondence to M Varella-Garcia, University of Colorado Cancer Center, Aurora, CO 80045, USA;
<email>marileila.garcia@ucdenver.edu</email>
</corresp>
</author-notes>
<pub-date pub-type="collection">
<year>2009</year>
</pub-date>
<pub-date pub-type="ppub">
<month>11</month>
<year>2009</year>
</pub-date>
<pub-date pub-type="epub">
<day>20</day>
<month>10</month>
<year>2009</year>
</pub-date>
<pub-date pub-type="pmc-release">
<day>20</day>
<month>10</month>
<year>2009</year>
</pub-date>
<pmc-comment> PMC Release delay is 0 months and 0 days and was based on the . </pmc-comment>
<volume>62</volume>
<issue>11</issue>
<fpage>970</fpage>
<lpage>977</lpage>
<history>
<date date-type="accepted">
<day>18</day>
<month>5</month>
<year>2009</year>
</date>
</history>
<permissions>
<copyright-statement>© Varella-Garcia et al 2009</copyright-statement>
<copyright-year>2009</copyright-year>
<license license-type="openaccess" xlink:href="http://creativecommons.org/licenses/by/2.0/">
<license-p>This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</license-p>
</license>
</permissions>
<self-uri xlink:title="pdf" xlink:type="simple" xlink:href="CPT-62-11-0970.pdf"></self-uri>
<abstract>
<p>There is a need for predictive biomarkers that identify non-small-cell lung cancer (NSCLC) patients most likely to respond to epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) treatment. There are numerous potential candidates, although none has been proven in prospective clinical trials. The EGFR gene copy number evaluated by fluorescence in situ hybridisation (FISH) has been highlighted as one of the most effective markers for sensitivity to EGFR TKIs in large phase III, randomised placebo-controlled trials and has been used in clinical settings to assist physicians in defining the therapeutic regimen. The EGFR FISH assay has technical challenges and it is critical that detailed guidelines are provided to help clinical laboratories in performing and interpreting the test. Excellent assay reproducibility and portability rates among laboratories are crucial to guarantee that accurate clinical decisions can be made for patients with NSCLC. This article discusses the consensus outcomes of a global workshop convened to discuss key technical issues and standardise reading strategies for the EGFR FISH assay of NSCLC tumour tissue.</p>
</abstract>
</article-meta>
</front>
</pmc>
<affiliations>
<list>
<country>
<li>Allemagne</li>
<li>Belgique</li>
<li>Italie</li>
<li>Suisse</li>
<li>États-Unis</li>
</country>
<region>
<li>Californie</li>
<li>Colorado</li>
<li>District de Kassel</li>
<li>Hesse (Land)</li>
</region>
<settlement>
<li>Cassel (Hesse)</li>
<li>San Francisco</li>
</settlement>
</list>
<tree>
<country name="États-Unis">
<region name="Colorado">
<name sortKey="Varella Garcia, M" sort="Varella Garcia, M" uniqKey="Varella Garcia M" first="M" last="Varella-Garcia">M. Varella-Garcia</name>
</region>
<name sortKey="Eberhard, D A" sort="Eberhard, D A" uniqKey="Eberhard D" first="D A" last="Eberhard">D A Eberhard</name>
</country>
<country name="Suisse">
<noRegion>
<name sortKey="Diebold, J" sort="Diebold, J" uniqKey="Diebold J" first="J" last="Diebold">J. Diebold</name>
</noRegion>
<name sortKey="Hirschmann, A" sort="Hirschmann, A" uniqKey="Hirschmann A" first="A" last="Hirschmann">A. Hirschmann</name>
</country>
<country name="Belgique">
<noRegion>
<name sortKey="Geenen, K" sort="Geenen, K" uniqKey="Geenen K" first="K" last="Geenen">K. Geenen</name>
</noRegion>
<name sortKey="Kockx, M" sort="Kockx, M" uniqKey="Kockx M" first="M" last="Kockx">M. Kockx</name>
</country>
<country name="Allemagne">
<region name="Hesse (Land)">
<name sortKey="Nagelmeier, I" sort="Nagelmeier, I" uniqKey="Nagelmeier I" first="I" last="Nagelmeier">I. Nagelmeier</name>
</region>
<name sortKey="Arbogast, S" sort="Arbogast, S" uniqKey="Arbogast S" first="S" last="Arbogast">S. Arbogast</name>
<name sortKey="Ruschoff, J" sort="Ruschoff, J" uniqKey="Ruschoff J" first="J" last="Rüschoff">J. Rüschoff</name>
<name sortKey="Schmitt, M" sort="Schmitt, M" uniqKey="Schmitt M" first="M" last="Schmitt">M. Schmitt</name>
</country>
<country name="Italie">
<noRegion>
<name sortKey="Cappuzzo, F" sort="Cappuzzo, F" uniqKey="Cappuzzo F" first="F" last="Cappuzzo">F. Cappuzzo</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>

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