Originally published as JCO Early Release 10.1200/JCO.2006.09.2775 on December 11 2006
Journal of Clinical Oncology, Vol 25, No 1 (January 1), 2007: pp. 118-145
Copyright © 2007 American Society of Clinical Oncology and College of American Pathologists. All rights reserved.
American Society of Clinical Oncology/College of American Pathologists Guideline Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer
Antonio C. Wolff,
M. Elizabeth H. Hammond,
Jared N. Schwartz,
Karen L. Hagerty,
D. Craig Allred,
Richard J. Cote,
Mitchell Dowsett,
Patrick L. Fitzgibbons,
Wedad M. Hanna,
Amy Langer,
Lisa M. McShane,
Soonmyung Paik,
Mark D. Pegram,
Edith A. Perez,
Michael F. Press,
Anthony Rhodes,
Catharine Sturgeon,
Sheila E. Taube,
Raymond Tubbs,
Gail H. Vance,
Marc van de Vijver,
Thomas M. Wheeler,
Daniel F. Hayes
From the American Society of Clinical Oncology, Alexandria, VA; and the College of American Pathologists, Northfield, IL
Address reprint requests to American Society of Clinical Oncology, Cancer Policy and Clinical Affairs, 1900 Duke Street, Suite 200, Alexandria, VA 22314; e-mail: guidelines{at}asco.org
Purpose To develop a guideline to improve the accuracy of human epidermal growth factor receptor 2 (HER2) testing in invasive breast cancer and its utility as a predictive marker.
Methods The American Society of Clinical Oncology and the College of American Pathologists convened an expert panel, which conducted a systematic review of the literature and developed recommendations for optimal HER2 testing performance. The guideline was reviewed by selected experts and approved by the board of directors for both organizations.
Results Approximately 20% of current HER2 testing may be inaccurate. When carefully validated testing is performed, available data do not clearly demonstrate the superiority of either immunohistochemistry (IHC) or in situ hybridization (ISH) as a predictor of benefit from anti-HER2 therapy.
Recommendations The panel recommends that HER2 status should be determined for all invasive breast cancer. A testing algorithm that relies on accurate, reproducible assay performance, including newly available types of brightfield ISH, is proposed. Elements to reliably reduce assay variation (for example, specimen handling, assay exclusion, and reporting criteria) are specified. An algorithm defining positive, equivocal, and negative values for both HER2 protein expression and gene amplification is recommended: a positive HER2 result is IHC staining of 3+ (uniform, intense membrane staining of > 30% of invasive tumor cells), a fluorescent in situ hybridization (FISH) result of more than six HER2 gene copies per nucleus or a FISH ratio (HER2 gene signals to chromosome 17 signals) of more than 2.2; a negative result is an IHC staining of 0 or 1+, a FISH result of less than 4.0 HER2 gene copies per nucleus, or FISH ratio of less than 1.8. Equivocal results require additional action for final determination. It is recommended that to perform HER2 testing, laboratories show 95% concordance with another validated test for positive and negative assay values. The panel strongly recommends validation of laboratory assay or modifications, use of standardized operating procedures, and compliance with new testing criteria to be monitored with the use of stringent laboratory accreditation standards, proficiency testing, and competency assessment. The panel recommends that HER2 testing be done in a CAP-accredited laboratory or in a laboratory that meets the accreditation and proficiency testing requirements set out by this document.
published online ahead of print at www.jco.org on December 11, 2006.
Antonio C. Wolff, M. Elizabeth H. Hammond, Jared N. Schwartz, and Daniel F. Hayes are American Society of Clinical Oncology/College of American Pathologists Expert Panel co-chairs.
Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.
This guideline was developed through a collaboration between American Society of Clinical Oncology and College of American Pathologists and has been published jointly by invitation and consent in both the Journal of Clinical Oncology and the Archives of Pathology & Laboratory Medicine. Copyright © 2007 American Society of Clinical Oncology and College of American Pathologists. All rights reserved. No part of this document may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopy, recording, or any information storage and retrieval system, without written permission by American Society of Clinical Oncology or College of American Pathologists.
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