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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D. F. Hayes, V. Stearns, J. Rae, D. Flockhart, and on behalf of the Consortium on Breast Cancer Pharm
A Model Citizen? Is Tamoxifen More Effective Than Aromatase Inhibitors if We Pick the Right Patients?
J Natl Cancer Inst,
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M. V. Karamouzis, P. A. Konstantinopoulos, and A. G. Papavassiliou
ErbB/HER receptor family in breast cancer--the more we search the more we learn
Ann. Onc.,
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A. Jimeno, A. C. Tan, J. Coffa, N.V. Rajeshkumar, P. Kulesza, B. Rubio-Viqueira, J. Wheelhouse, B. Diosdado, W. A. Messersmith, C. Iacobuzio-Donahue, et al.
Coordinated Epidermal Growth Factor Receptor Pathway Gene Overexpression Predicts Epidermal Growth Factor Receptor Inhibitor Sensitivity in Pancreatic Cancer
Cancer Res.,
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[Abstract]
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H. Sugimura
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Carcinogenesis,
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29(4):
681 - 687.
[Abstract]
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F. J. Esteva
Commentary: Can Circulating HER-2 Extracellular Domain Predict Response to Trastuzumab in HER-2-Negative Breast Cancer?
Oncologist,
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S. Paik, C. Kim, and N. Wolmark
HER2 Status and Benefit from Adjuvant Trastuzumab in Breast Cancer
N. Engl. J. Med.,
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M. Kyndi, F. B. Sorensen, H. Knudsen, M. Overgaard, H. M. Nielsen, and J. Overgaard
Estrogen Receptor, Progesterone Receptor, HER-2, and Response to Postmastectomy Radiotherapy in High-Risk Breast Cancer: The Danish Breast Cancer Cooperative Group
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F. Pinter, J. Papay, A. Almasi, Z. Sapi, E. Szabo, M. Kanya, A. Tamasi, B. Jori, E. Varkondi, J. Moldvay, et al.
Epidermal Growth Factor Receptor (EGFR) High Gene Copy Number and Activating Mutations in Lung Adenocarcinomas Are Not Consistently Accompanied by Positivity for EGFR Protein by Standard Immunohistochemistry
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B. K.T. Tan, L. K. Tan, K. Yu, P. H. Tan, M. Lee, L. H. Sii, C. Y. Wong, G. H. Ho, A. W.Y. Yeo, P. K.H. Chow, et al.
Clinical Validation of a Customized Multiple Signature Microarray for Breast Cancer
Clin. Cancer Res.,
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E. Rakha, I. Ellis, and J. Reis-Filho
Are Triple-Negative and Basal-Like Breast Cancer Synonymous?
Clin. Cancer Res.,
January 15, 2008;
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A. C. Wolff, S. Paik, and M. F. Press
HER2 as a Predictive Marker: Why Bother Testing?
ASCO Educational Book,
January 1, 2008;
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25 - 28.
[Abstract]
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D. F. Hayes
Markers for Predicting and Evaluating Response to Therapy for Breast Cancer
ASCO Educational Book,
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30 - 34.
[Abstract]
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M Hofmann, O Stoss, T Gaiser, H Kneitz, P Heinmoller, T Gutjahr, M Kaufmann, T Henkel, and J Ruschoff
Central HER2 IHC and FISH analysis in a trastuzumab (Herceptin) phase II monotherapy study: assessment of test sensitivity and impact of chromosome 17 polysomy
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C. B. Moeder, J. M. Giltnane, M. Harigopal, A. Molinaro, A. Robinson, K. Gelmon, D. Huntsman, R. L. Camp, and D. L. Rimm
Quantitative Justification of the Change From 10% to 30% for Human Epidermal Growth Factor Receptor 2 Scoring in the American Society of Clinical Oncology/College of American Pathologists Guidelines: Tumor Heterogeneity in Breast Cancer and Its Implications for Tissue Microarray Based Assessment of Outcome
J. Clin. Oncol.,
December 1, 2007;
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A. Sapino, F. Montemurro, C. Marchio, G. Viale, J. Kulka, M. Donadio, A. Bottini, G. Botti, A. P. dei Tos, A. Bersiga, et al.
Patients with advanced stage breast carcinoma immunoreactive to biotinylated Herceptin(R) are most likely to benefit from trastuzumab-based therapy: an hypothesis-generating study
Ann. Onc.,
December 1, 2007;
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L. Harris, H. Fritsche, R. Mennel, L. Norton, P. Ravdin, S. Taube, M. R. Somerfield, D. F. Hayes, and R. C. Bast Jr
American Society of Clinical Oncology 2007 Update of Recommendations for the Use of Tumor Markers in Breast Cancer
J. Clin. Oncol.,
November 20, 2007;
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American Society of Clinical Oncology 2007 Update of Recommendations for the Use of Tumor Markers in Breast Cancer
J. Oncol. Pract,
November 1, 2007;
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L. Arnould, P. Arveux, J. Couturier, M. Gelly-Marty, C. Loustalot, F. Ettore, C. Sagan, M. Antoine, F. Penault-Llorca, B. Vasseur, et al.
Pathologic Complete Response to Trastuzumab-Based Neoadjuvant Therapy Is Related to the Level of HER-2 Amplification
Clin. Cancer Res.,
November 1, 2007;
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G. D Francis, M. Dimech, L. Giles, and A. Hopkins
Frequency and reliability of oestrogen receptor, progesterone receptor and HER2 in breast carcinoma determined by immunohistochemistry in Australasia: results of the RCPA Quality Assurance Program
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E. P. Winer, J. R. Harris, B. L. Smith, H. A. D'Alessandro, and E. F. Brachtel
Case 32-2007 -- A 62-Year-Old Woman with a Second Breast Cancer
N. Engl. J. Med.,
October 18, 2007;
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D. F. Hayes, A. D. Thor, L. G. Dressler, D. Weaver, S. Edgerton, D. Cowan, G. Broadwater, L. J. Goldstein, S. Martino, J. N. Ingle, et al.
HER2 and Response to Paclitaxel in Node-Positive Breast Cancer
N. Engl. J. Med.,
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K. Vang Nielsen, J. T. Jorgensen, A. Schonau, and A. Oster
Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer
J. Clin. Oncol.,
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A. C. Wolff, M. E. H. Hammond, J. N. Schwartz, D. F. Hayes, and On behalf of the ASCO/CAP Panel on HER-2 Testing i
In Reply
J. Clin. Oncol.,
September 1, 2007;
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D. J. Hsiang, M. Yamamoto, R. S. Mehta, M.-Y. Su, C. H. Baick, K. T. Lane, and J. A. Butler
Predicting Nodal Status Using Dynamic Contrast-Enhanced Magnetic Resonance Imaging in Patients With Locally Advanced Breast Cancer Undergoing Neoadjuvant Chemotherapy With and Without Sequential Trastuzumab
Arch Surg,
September 1, 2007;
142(9):
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S. Rauser, R. Weis, H. Braselmann, M. Feith, H. J. Stein, R. Langer, P. Hutzler, M. Hausmann, S. Lassmann, J. R. Siewert, et al.
Significance of HER2 Low-Level Copy Gain in Barrett's Cancer: Implications for Fluorescence In situ Hybridization Testing in Tissues
Clin. Cancer Res.,
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S. Pruthi, J. C. Boughey, K. R. Brandt, A. C. Degnim, G. K. Dy, M. P. Goetz, E. A. Perez, C. A. Reynolds, P. J. Schomberg, and J. N. Ingle
A Multidisciplinary Approach to the Management of Breast Cancer, Part 2: Therapeutic Considerations
Mayo Clin. Proc.,
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C. A. Hudis
Trastuzumab -- Mechanism of Action and Use in Clinical Practice
N. Engl. J. Med.,
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B. P. Coudert, R. Largillier, L. Arnould, P. Chollet, M. Campone, D. Coeffic, F. Priou, J. Gligorov, X. Martin, V. Trillet-Lenoir, et al.
Multicenter Phase II Trial of Neoadjuvant Therapy With Trastuzumab, Docetaxel, and Carboplatin for Human Epidermal Growth Factor Receptor-2 Overexpressing Stage II or III Breast Cancer: Results of the GETN(A)-1 Trial
J. Clin. Oncol.,
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A Di Leo
The state of HER-2 status
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J. T. Jorgensen, K. V. Nielsen, and B. Ejlertsen
Pharmacodiagnostics and Targeted Therapies--A Rational Approach for Individualizing Medical Anticancer Therapy in Breast Cancer
Oncologist,
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