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
Hauptverfasser: O'Malley, Frances P, Thomson, Tom, Julian, Jim, Have, Cherry, Cosby, Roxanne, Gelmon, Karen, Andrulis, Irene, Whelan, Tim
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container_end_page 65
container_issue 1
container_start_page 61
container_title Archives of pathology & laboratory medicine (1976)
container_volume 132
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. 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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. 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source Allen Press Journals; EZB Electronic Journals Library
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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