HER2 Testing in a Population-Based Study of Patients With Metastatic Breast Cancer Treated With Trastuzumab
Context.--The development of trastuzumab has led to new therapeutic strategies for patients with breast cancer. Trastuzumab has been shown to only be effective in those patients whose cancers are HER2 positive by either immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH). Objecti...
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Veröffentlicht in: | Archives of pathology & laboratory medicine (1976) 2008-01, Vol.132 (1), p.61-65 |
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container_title | Archives of pathology & laboratory medicine (1976) |
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creator | O'Malley, Frances P Thomson, Tom Julian, Jim Have, Cherry Cosby, Roxanne Gelmon, Karen Andrulis, Irene Whelan, Tim |
description | Context.--The development of trastuzumab has led to new therapeutic strategies for patients with breast cancer. Trastuzumab has been shown to only be effective in those patients whose cancers are HER2 positive by either immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH). Objective.--To determine the accuracy of HER2 testing in 2 provinces in Canada. Design.--Patients with metastatic breast cancer diagnosed between 1999 and 2002 who were HER2 positive in the local laboratories were included in this study. All cases were retested centrally, by IHC (using 4 methods) and FISH. In addition, 205 locally reported HER2-negative metastatic breast cancer cases were retested centrally. Results.--Concordance between the 505 local IHC-positive cases with central IHC testing varied between 79.3% and 89.6% depending on the IHC method and scoring method used. HER2 gene amplification by FISH was present in 86.1% of local IHC-positive cases. Concordance between the 205 local IHC-negative tumors with central testing ranged between 94.8% and 100% for IHC and was 98.5% for FISH. Conclusions.--This study demonstrated that locally reported HER2-negative results were highly accurate, but less accuracy was demonstrated with local HER2-positive results. These results emphasize the need for participation in a quality assurance program. |
doi_str_mv | 10.5858/2008-132-61-HTIAPS |
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Trastuzumab has been shown to only be effective in those patients whose cancers are HER2 positive by either immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH). Objective.--To determine the accuracy of HER2 testing in 2 provinces in Canada. Design.--Patients with metastatic breast cancer diagnosed between 1999 and 2002 who were HER2 positive in the local laboratories were included in this study. All cases were retested centrally, by IHC (using 4 methods) and FISH. In addition, 205 locally reported HER2-negative metastatic breast cancer cases were retested centrally. Results.--Concordance between the 505 local IHC-positive cases with central IHC testing varied between 79.3% and 89.6% depending on the IHC method and scoring method used. HER2 gene amplification by FISH was present in 86.1% of local IHC-positive cases. Concordance between the 205 local IHC-negative tumors with central testing ranged between 94.8% and 100% for IHC and was 98.5% for FISH. Conclusions.--This study demonstrated that locally reported HER2-negative results were highly accurate, but less accuracy was demonstrated with local HER2-positive results. These results emphasize the need for participation in a quality assurance program.</description><identifier>ISSN: 0003-9985</identifier><identifier>ISSN: 1543-2165</identifier><identifier>EISSN: 1543-2165</identifier><identifier>DOI: 10.5858/2008-132-61-HTIAPS</identifier><identifier>CODEN: APLMAS</identifier><language>eng</language><publisher>Northfield: College of American Pathologists</publisher><subject>Accuracy ; Antigens ; Breast cancer ; Chemotherapy ; Clinical medicine ; Diagnosis ; Drug therapy ; Gene amplification ; Genetic aspects ; Genetic screening ; Kinases ; Laboratories ; Metastasis ; Methods ; Patient outcomes ; Patients ; Proteins ; Quality control ; Tumors</subject><ispartof>Archives of pathology & laboratory medicine (1976), 2008-01, Vol.132 (1), p.61-65</ispartof><rights>COPYRIGHT 2008 College of American Pathologists</rights><rights>Copyright College of American Pathologists Jan 2008</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c382t-5c32f2c71a7abb90f9c8ebea5e78658510e2283830296ed808712f8f401eefb43</citedby><cites>FETCH-LOGICAL-c382t-5c32f2c71a7abb90f9c8ebea5e78658510e2283830296ed808712f8f401eefb43</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27903,27904</link.rule.ids></links><search><creatorcontrib>O'Malley, Frances P</creatorcontrib><creatorcontrib>Thomson, Tom</creatorcontrib><creatorcontrib>Julian, Jim</creatorcontrib><creatorcontrib>Have, Cherry</creatorcontrib><creatorcontrib>Cosby, Roxanne</creatorcontrib><creatorcontrib>Gelmon, Karen</creatorcontrib><creatorcontrib>Andrulis, Irene</creatorcontrib><creatorcontrib>Whelan, Tim</creatorcontrib><title>HER2 Testing in a Population-Based Study of Patients With Metastatic Breast Cancer Treated With Trastuzumab</title><title>Archives of pathology & laboratory medicine (1976)</title><description>Context.--The development of trastuzumab has led to new therapeutic strategies for patients with breast cancer. Trastuzumab has been shown to only be effective in those patients whose cancers are HER2 positive by either immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH). Objective.--To determine the accuracy of HER2 testing in 2 provinces in Canada. Design.--Patients with metastatic breast cancer diagnosed between 1999 and 2002 who were HER2 positive in the local laboratories were included in this study. All cases were retested centrally, by IHC (using 4 methods) and FISH. In addition, 205 locally reported HER2-negative metastatic breast cancer cases were retested centrally. Results.--Concordance between the 505 local IHC-positive cases with central IHC testing varied between 79.3% and 89.6% depending on the IHC method and scoring method used. HER2 gene amplification by FISH was present in 86.1% of local IHC-positive cases. Concordance between the 205 local IHC-negative tumors with central testing ranged between 94.8% and 100% for IHC and was 98.5% for FISH. Conclusions.--This study demonstrated that locally reported HER2-negative results were highly accurate, but less accuracy was demonstrated with local HER2-positive results. 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Trastuzumab has been shown to only be effective in those patients whose cancers are HER2 positive by either immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH). Objective.--To determine the accuracy of HER2 testing in 2 provinces in Canada. Design.--Patients with metastatic breast cancer diagnosed between 1999 and 2002 who were HER2 positive in the local laboratories were included in this study. All cases were retested centrally, by IHC (using 4 methods) and FISH. In addition, 205 locally reported HER2-negative metastatic breast cancer cases were retested centrally. Results.--Concordance between the 505 local IHC-positive cases with central IHC testing varied between 79.3% and 89.6% depending on the IHC method and scoring method used. HER2 gene amplification by FISH was present in 86.1% of local IHC-positive cases. Concordance between the 205 local IHC-negative tumors with central testing ranged between 94.8% and 100% for IHC and was 98.5% for FISH. Conclusions.--This study demonstrated that locally reported HER2-negative results were highly accurate, but less accuracy was demonstrated with local HER2-positive results. These results emphasize the need for participation in a quality assurance program.</abstract><cop>Northfield</cop><pub>College of American Pathologists</pub><doi>10.5858/2008-132-61-HTIAPS</doi><tpages>5</tpages></addata></record> |
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subjects | Accuracy Antigens Breast cancer Chemotherapy Clinical medicine Diagnosis Drug therapy Gene amplification Genetic aspects Genetic screening Kinases Laboratories Metastasis Methods Patient outcomes Patients Proteins Quality control Tumors |
title | HER2 Testing in a Population-Based Study of Patients With Metastatic Breast Cancer Treated With Trastuzumab |
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