HER2 testing: how to reach a high concordance rate between immunohistochemistry and fluorescence in situ hybridization

Thaer Khoury; Swati Kulkarni; Carl Morrison; Wiam Bshara; Yousef Zakharia; Stephen Edge

doi:10.1097/PAI.0b013e31820b62be

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HER2 testing: how to reach a high concordance rate between immunohistochemistry and fluorescence in situ hybridization

Journal article

Peer reviewed

HER2 testing: how to reach a high concordance rate between immunohistochemistry and fluorescence in situ hybridization

Thaer Khoury, Swati Kulkarni, Carl Morrison, Wiam Bshara, Yousef Zakharia and Stephen Edge

Applied immunohistochemistry & molecular morphology, Vol.19(5), pp.424-430

10/2011

DOI: 10.1097/PAI.0b013e31820b62be

PMID: 21386703

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Abstract

The concordance rate between immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) for human epidermal growth factor receptor-2 (HER2) is still a major clinical concern. We describe a new criteria evaluating HER2 IHC. We expanded the equivocal category to include the American Society of Clinical Oncology and College of American Pathologists equivocal category and cases with 3+ between 30% to 90% of tumor cells and 2+ in ≥1% of tumor cells. Then, we prospectively evaluated 106 cases with FISH. There were 2 categories that were not required to be tested by FISH based on American Society of Clinical Oncology and College of American Pathologists criteria. The first category, cases with 2+staining between ≥1% and <10%. In this category, there were 15 cases, 2 (13.3%) had HER2 amplification by FISH. The second category, cases with 3+ staining between 30% and 90%. In this category, there were 16 cases, 5 (31.3%) were not amplified and 1 (6.3%) was borderline. Expanding the equivocal category could increase the concordance rate between IHC and FISH with minimal additional cost.

Immunohistochemistry

Diagnostic Techniques and Procedures - standards

United States

Humans

Middle Aged

False Negative Reactions

Female

In Situ Hybridization, Fluorescence

Receptor, ErbB-2 - analysis

False Positive Reactions

Research Design

United States Food and Drug Administration

Details

Title: Subtitle: HER2 testing: how to reach a high concordance rate between immunohistochemistry and fluorescence in situ hybridization
Creators: Thaer Khoury - Department of Pathology, Roswell Park Cancer Institute, Buffalo, NY 14263, USA. thaer.khoury@roswellpark.org
Swati Kulkarni
Carl Morrison
Wiam Bshara
Yousef Zakharia
Stephen Edge
Resource Type: Journal article
Publication Details: Applied immunohistochemistry & molecular morphology, Vol.19(5), pp.424-430
DOI: 10.1097/PAI.0b013e31820b62be
PMID: 21386703
ISSN: 1541-2016
eISSN: 1533-4058
Language: English
Date published: 10/2011
Academic Unit: Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
Record Identifier: 9984094575402771

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