SISH/CISH or qPCR as alternative techniques to FISH for determination of HER2 amplification status on breast tumors core needle biopsies: a multicenter experience based on 840 cases
Until now, FISH has been the gold standard technique to identify HER2 amplification status in ambiguous cases of breast cancer. Alternative techniques have been developed to increase the capacities of investigating HER2 amplification status. The aims of this multicenter study in a large series of br...
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| creator | Jacquemier, Jocelyne Spyratos, Frédérique Esterni, Benjamin Mozziconacci, Marie-Joëlle Antoine, Martine Arnould, Laurent Lizard, Sarab Bertheau, Philippe Lehmann-Che, Jacqueline Fournier, Cécile Blanc Krieger, Sophie Bibeau, Frédéric Lamy, Pierre-Jean Chenard, Marie Pierre Legrain, Michèle Guinebretière, Jean-Marc Loussouarn, Delphine Macgrogan, Gaëtan Hostein, Isabelle Mathieu, Marie Christine Lacroix, Ludovic Valent, Alexander Robin, Yves Marie Revillion, Françoise Triki, Magali Lacroix Seaume, Aline Salomon, Anne Vincent de Cremoux, Patricia Portefaix, Geneviève Xerri, Luc Vacher, Sophie Bièche, Ivan Penault-Llorca, Frédérique |
| description | Until now, FISH has been the gold standard technique to identify HER2 amplification status in ambiguous cases of breast cancer. Alternative techniques have been developed to increase the capacities of investigating HER2 amplification status. The aims of this multicenter study in a large series of breast cancer patients were to prospectively compare the level of performance of CISH, SISH, and qPCR alternative techniques on paraffin-embedded core biopsies with "gold standard FISH" for evaluation of HER2 amplification status.
This study was performed on 840 cases scored by immunohistochemistry (IHC): 0=317 (38%), 1+=183 (22%), 2+=109 (13%), 3+=231 (27%). Each of the 15 French centers participating in the study analyzed 56 breast carcinoma cases diagnosed on fixed paraffin-embedded core biopsies. HER2 amplification status was determined by commercially available FISH used as the reference technique with determination of the HER2/CEN17 ratio or HER2 copy number status. The alternative techniques performed on the same cases were commercially available SISH or CISH and a common qPCR method especially designed for the study including a set of 10 primer pairs: 2 for HER2 (exons 8 and 26), 5 to evaluate chromosome 17 polysomy TAOK1, UTP6, MRM1, MKS1, SSTR2 and 3 for diploidy control TSN, LAP3 and ADAMTS16.
The concordance between IHC and FISH was 96% to 95% based on the HER2/CEN17 ratio (n=766) or HER2 copy number (n=840), respectively. The concordance of the alternative techniques with FISH was excellent: 97% and 98% for SISH (498 and 587 cases), 98% and 75% for CISH (108 and 204 cases) and 95% and 93% (699 and 773 cases) for qPCR based on the HER2/CEN17 ratio or HER2 copy number, respectively. Similarly, sensitivity ranged from 99% to 95% for SISH, 100% to 99% for CISH and 89% to 80% for qPCR. The concordance with FISH (ratio) in the 2+ cases was 89% for SISH, 100% for CISH and 93% for qPCR.
These alternative techniques showed an excellent concordance with FISH in core biopsies allowing their use in routine clinical practice. This newly designed qPCR on paraffin-embedded core biopsies deserves special attention, as it is reliable, easy to perform and less expensive than ISH tests. |
| doi_str_mv | 10.1186/1471-2407-13-351 |
| format | Article |
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This study was performed on 840 cases scored by immunohistochemistry (IHC): 0=317 (38%), 1+=183 (22%), 2+=109 (13%), 3+=231 (27%). Each of the 15 French centers participating in the study analyzed 56 breast carcinoma cases diagnosed on fixed paraffin-embedded core biopsies. HER2 amplification status was determined by commercially available FISH used as the reference technique with determination of the HER2/CEN17 ratio or HER2 copy number status. The alternative techniques performed on the same cases were commercially available SISH or CISH and a common qPCR method especially designed for the study including a set of 10 primer pairs: 2 for HER2 (exons 8 and 26), 5 to evaluate chromosome 17 polysomy TAOK1, UTP6, MRM1, MKS1, SSTR2 and 3 for diploidy control TSN, LAP3 and ADAMTS16.
The concordance between IHC and FISH was 96% to 95% based on the HER2/CEN17 ratio (n=766) or HER2 copy number (n=840), respectively. The concordance of the alternative techniques with FISH was excellent: 97% and 98% for SISH (498 and 587 cases), 98% and 75% for CISH (108 and 204 cases) and 95% and 93% (699 and 773 cases) for qPCR based on the HER2/CEN17 ratio or HER2 copy number, respectively. Similarly, sensitivity ranged from 99% to 95% for SISH, 100% to 99% for CISH and 89% to 80% for qPCR. The concordance with FISH (ratio) in the 2+ cases was 89% for SISH, 100% for CISH and 93% for qPCR.
These alternative techniques showed an excellent concordance with FISH in core biopsies allowing their use in routine clinical practice. This newly designed qPCR on paraffin-embedded core biopsies deserves special attention, as it is reliable, easy to perform and less expensive than ISH tests.</description><identifier>ISSN: 1471-2407</identifier><identifier>EISSN: 1471-2407</identifier><identifier>DOI: 10.1186/1471-2407-13-351</identifier><identifier>PMID: 23875536</identifier><language>eng</language><publisher>England: BioMed Central Ltd</publisher><subject>Biopsy ; Biopsy, Large-Core Needle ; Breast cancer ; Breast Neoplasms - genetics ; Cancer ; Clinical trials ; Confidence intervals ; Diagnosis ; Female ; Gene Amplification ; Genes, erbB-2 - genetics ; Humans ; Immunohistochemistry ; In Situ Hybridization - methods ; Methods ; Middle Aged ; Oncology, Experimental ; Polymerase chain reaction ; Predictive Value of Tests ; Real-Time Polymerase Chain Reaction - methods ; Statistical analysis ; Technical Advance</subject><ispartof>BMC cancer, 2013-07, Vol.13 (1), p.351-351, Article 351</ispartof><rights>COPYRIGHT 2013 BioMed Central Ltd.</rights><rights>2013 Jacquemier et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</rights><rights>Copyright © 2013 Jacquemier et al.; licensee BioMed Central Ltd. 2013 Jacquemier et al.; licensee BioMed Central Ltd.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b682t-47355e9f9cc4327c74325fff3ca5841ead4a1b772ea7f568f16fa6aaa28322b93</citedby><cites>FETCH-LOGICAL-b682t-47355e9f9cc4327c74325fff3ca5841ead4a1b772ea7f568f16fa6aaa28322b93</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3729815/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3729815/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,27924,27925,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23875536$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Jacquemier, Jocelyne</creatorcontrib><creatorcontrib>Spyratos, Frédérique</creatorcontrib><creatorcontrib>Esterni, Benjamin</creatorcontrib><creatorcontrib>Mozziconacci, Marie-Joëlle</creatorcontrib><creatorcontrib>Antoine, Martine</creatorcontrib><creatorcontrib>Arnould, Laurent</creatorcontrib><creatorcontrib>Lizard, Sarab</creatorcontrib><creatorcontrib>Bertheau, Philippe</creatorcontrib><creatorcontrib>Lehmann-Che, Jacqueline</creatorcontrib><creatorcontrib>Fournier, Cécile Blanc</creatorcontrib><creatorcontrib>Krieger, Sophie</creatorcontrib><creatorcontrib>Bibeau, Frédéric</creatorcontrib><creatorcontrib>Lamy, Pierre-Jean</creatorcontrib><creatorcontrib>Chenard, Marie Pierre</creatorcontrib><creatorcontrib>Legrain, Michèle</creatorcontrib><creatorcontrib>Guinebretière, Jean-Marc</creatorcontrib><creatorcontrib>Loussouarn, Delphine</creatorcontrib><creatorcontrib>Macgrogan, Gaëtan</creatorcontrib><creatorcontrib>Hostein, Isabelle</creatorcontrib><creatorcontrib>Mathieu, Marie Christine</creatorcontrib><creatorcontrib>Lacroix, Ludovic</creatorcontrib><creatorcontrib>Valent, Alexander</creatorcontrib><creatorcontrib>Robin, Yves Marie</creatorcontrib><creatorcontrib>Revillion, Françoise</creatorcontrib><creatorcontrib>Triki, Magali Lacroix</creatorcontrib><creatorcontrib>Seaume, Aline</creatorcontrib><creatorcontrib>Salomon, Anne Vincent</creatorcontrib><creatorcontrib>de Cremoux, Patricia</creatorcontrib><creatorcontrib>Portefaix, Geneviève</creatorcontrib><creatorcontrib>Xerri, Luc</creatorcontrib><creatorcontrib>Vacher, Sophie</creatorcontrib><creatorcontrib>Bièche, Ivan</creatorcontrib><creatorcontrib>Penault-Llorca, Frédérique</creatorcontrib><title>SISH/CISH or qPCR as alternative techniques to FISH for determination of HER2 amplification status on breast tumors core needle biopsies: a multicenter experience based on 840 cases</title><title>BMC cancer</title><addtitle>BMC Cancer</addtitle><description>Until now, FISH has been the gold standard technique to identify HER2 amplification status in ambiguous cases of breast cancer. Alternative techniques have been developed to increase the capacities of investigating HER2 amplification status. The aims of this multicenter study in a large series of breast cancer patients were to prospectively compare the level of performance of CISH, SISH, and qPCR alternative techniques on paraffin-embedded core biopsies with "gold standard FISH" for evaluation of HER2 amplification status.
This study was performed on 840 cases scored by immunohistochemistry (IHC): 0=317 (38%), 1+=183 (22%), 2+=109 (13%), 3+=231 (27%). Each of the 15 French centers participating in the study analyzed 56 breast carcinoma cases diagnosed on fixed paraffin-embedded core biopsies. HER2 amplification status was determined by commercially available FISH used as the reference technique with determination of the HER2/CEN17 ratio or HER2 copy number status. The alternative techniques performed on the same cases were commercially available SISH or CISH and a common qPCR method especially designed for the study including a set of 10 primer pairs: 2 for HER2 (exons 8 and 26), 5 to evaluate chromosome 17 polysomy TAOK1, UTP6, MRM1, MKS1, SSTR2 and 3 for diploidy control TSN, LAP3 and ADAMTS16.
The concordance between IHC and FISH was 96% to 95% based on the HER2/CEN17 ratio (n=766) or HER2 copy number (n=840), respectively. The concordance of the alternative techniques with FISH was excellent: 97% and 98% for SISH (498 and 587 cases), 98% and 75% for CISH (108 and 204 cases) and 95% and 93% (699 and 773 cases) for qPCR based on the HER2/CEN17 ratio or HER2 copy number, respectively. Similarly, sensitivity ranged from 99% to 95% for SISH, 100% to 99% for CISH and 89% to 80% for qPCR. The concordance with FISH (ratio) in the 2+ cases was 89% for SISH, 100% for CISH and 93% for qPCR.
These alternative techniques showed an excellent concordance with FISH in core biopsies allowing their use in routine clinical practice. This newly designed qPCR on paraffin-embedded core biopsies deserves special attention, as it is reliable, easy to perform and less expensive than ISH tests.</description><subject>Biopsy</subject><subject>Biopsy, Large-Core Needle</subject><subject>Breast cancer</subject><subject>Breast Neoplasms - genetics</subject><subject>Cancer</subject><subject>Clinical trials</subject><subject>Confidence intervals</subject><subject>Diagnosis</subject><subject>Female</subject><subject>Gene Amplification</subject><subject>Genes, erbB-2 - genetics</subject><subject>Humans</subject><subject>Immunohistochemistry</subject><subject>In Situ Hybridization - methods</subject><subject>Methods</subject><subject>Middle Aged</subject><subject>Oncology, Experimental</subject><subject>Polymerase chain reaction</subject><subject>Predictive Value of Tests</subject><subject>Real-Time Polymerase Chain Reaction - methods</subject><subject>Statistical analysis</subject><subject>Technical 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Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>BMC cancer</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Jacquemier, Jocelyne</au><au>Spyratos, Frédérique</au><au>Esterni, Benjamin</au><au>Mozziconacci, Marie-Joëlle</au><au>Antoine, Martine</au><au>Arnould, Laurent</au><au>Lizard, Sarab</au><au>Bertheau, Philippe</au><au>Lehmann-Che, Jacqueline</au><au>Fournier, Cécile Blanc</au><au>Krieger, Sophie</au><au>Bibeau, Frédéric</au><au>Lamy, Pierre-Jean</au><au>Chenard, Marie Pierre</au><au>Legrain, Michèle</au><au>Guinebretière, Jean-Marc</au><au>Loussouarn, Delphine</au><au>Macgrogan, Gaëtan</au><au>Hostein, Isabelle</au><au>Mathieu, Marie Christine</au><au>Lacroix, Ludovic</au><au>Valent, Alexander</au><au>Robin, Yves Marie</au><au>Revillion, Françoise</au><au>Triki, Magali Lacroix</au><au>Seaume, Aline</au><au>Salomon, Anne Vincent</au><au>de Cremoux, Patricia</au><au>Portefaix, Geneviève</au><au>Xerri, Luc</au><au>Vacher, Sophie</au><au>Bièche, Ivan</au><au>Penault-Llorca, Frédérique</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>SISH/CISH or qPCR as alternative techniques to FISH for determination of HER2 amplification status on breast tumors core needle biopsies: a multicenter experience based on 840 cases</atitle><jtitle>BMC cancer</jtitle><addtitle>BMC Cancer</addtitle><date>2013-07-22</date><risdate>2013</risdate><volume>13</volume><issue>1</issue><spage>351</spage><epage>351</epage><pages>351-351</pages><artnum>351</artnum><issn>1471-2407</issn><eissn>1471-2407</eissn><abstract>Until now, FISH has been the gold standard technique to identify HER2 amplification status in ambiguous cases of breast cancer. Alternative techniques have been developed to increase the capacities of investigating HER2 amplification status. The aims of this multicenter study in a large series of breast cancer patients were to prospectively compare the level of performance of CISH, SISH, and qPCR alternative techniques on paraffin-embedded core biopsies with "gold standard FISH" for evaluation of HER2 amplification status.
This study was performed on 840 cases scored by immunohistochemistry (IHC): 0=317 (38%), 1+=183 (22%), 2+=109 (13%), 3+=231 (27%). Each of the 15 French centers participating in the study analyzed 56 breast carcinoma cases diagnosed on fixed paraffin-embedded core biopsies. HER2 amplification status was determined by commercially available FISH used as the reference technique with determination of the HER2/CEN17 ratio or HER2 copy number status. The alternative techniques performed on the same cases were commercially available SISH or CISH and a common qPCR method especially designed for the study including a set of 10 primer pairs: 2 for HER2 (exons 8 and 26), 5 to evaluate chromosome 17 polysomy TAOK1, UTP6, MRM1, MKS1, SSTR2 and 3 for diploidy control TSN, LAP3 and ADAMTS16.
The concordance between IHC and FISH was 96% to 95% based on the HER2/CEN17 ratio (n=766) or HER2 copy number (n=840), respectively. The concordance of the alternative techniques with FISH was excellent: 97% and 98% for SISH (498 and 587 cases), 98% and 75% for CISH (108 and 204 cases) and 95% and 93% (699 and 773 cases) for qPCR based on the HER2/CEN17 ratio or HER2 copy number, respectively. Similarly, sensitivity ranged from 99% to 95% for SISH, 100% to 99% for CISH and 89% to 80% for qPCR. The concordance with FISH (ratio) in the 2+ cases was 89% for SISH, 100% for CISH and 93% for qPCR.
These alternative techniques showed an excellent concordance with FISH in core biopsies allowing their use in routine clinical practice. This newly designed qPCR on paraffin-embedded core biopsies deserves special attention, as it is reliable, easy to perform and less expensive than ISH tests.</abstract><cop>England</cop><pub>BioMed Central Ltd</pub><pmid>23875536</pmid><doi>10.1186/1471-2407-13-351</doi><tpages>1</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1471-2407 |
| ispartof | BMC cancer, 2013-07, Vol.13 (1), p.351-351, Article 351 |
| issn | 1471-2407 1471-2407 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_3729815 |
| source | SpringerOpen; MEDLINE; PubMed Central(OpenAccess); DOAJ Directory of Open Access Journals; SpringerLink (Online service); EZB-FREE-00999 freely available EZB journals; PubMed Central Open Access |
| subjects | Biopsy Biopsy, Large-Core Needle Breast cancer Breast Neoplasms - genetics Cancer Clinical trials Confidence intervals Diagnosis Female Gene Amplification Genes, erbB-2 - genetics Humans Immunohistochemistry In Situ Hybridization - methods Methods Middle Aged Oncology, Experimental Polymerase chain reaction Predictive Value of Tests Real-Time Polymerase Chain Reaction - methods Statistical analysis Technical Advance |
| title | SISH/CISH or qPCR as alternative techniques to FISH for determination of HER2 amplification status on breast tumors core needle biopsies: a multicenter experience based on 840 cases |
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