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American Society of Clinical Oncology/College of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer

Hammond, M. Elizabeth H.; Hayes, Daniel F.; Dowsett, Mitch; Allred, D. Craig; Hagerty, Karen L.; Badve, Sunil; Fitzgibbons, Patrick L.; Francis, Glenn; Goldstein, Neil S.; Hayes, Malcolm; Hicks, David G.; Lester, Susan; Love, Richard; Mangu, Pamela B; McShane, Lisa; Miller, Keith; Osbourne, C. Kent; Paik, Soonmyung; Permutter, Jane; Rhodes, Anthony; Sasano, Hironobu; Schwartz, Jared N; Sweep, Fred CG; Taube, Sheila; Torlakovic, Emina Emilia; Valenstein, Paul; Viale, Guiseppe; Visscher, Daniel; Wheeler, Thomas; Williams, R. Bruce; Wittcliff, James L.; Wolff, Antonio C.


M. Elizabeth H. Hammond

Daniel F. Hayes

Mitch Dowsett

D. Craig Allred

Karen L. Hagerty

Sunil Badve

Patrick L. Fitzgibbons

Glenn Francis

Neil S. Goldstein

Malcolm Hayes

David G. Hicks

Susan Lester

Richard Love

Pamela B Mangu

Lisa McShane

Keith Miller

C. Kent Osbourne

Soonmyung Paik

Jane Permutter

Anthony Rhodes

Hironobu Sasano

Jared N Schwartz

Fred CG Sweep

Sheila Taube

Emina Emilia Torlakovic

Paul Valenstein

Guiseppe Viale

Daniel Visscher

Thomas Wheeler

R. Bruce Williams

James L. Wittcliff

Antonio C. Wolff


Purpose: To develop a guideline to improve the
accuracy of immunohistochemical (IHC) estrogen receptor
(ER) and progesterone receptor (PgR) testing in breast
cancer and the utility of these receptors as predictive
Methods: The American Society of Clinical Oncology
and the College of American Pathologists convened an
international Expert Panel that conducted a systematic
review and evaluation of the literature in partnership with
Cancer Care Ontario and developed recommendations for
optimal IHC ER/PgR testing performance.
Results: Up to 20% of current IHC determinations of
ER and PgR testing worldwide may be inaccurate (false
negative or false positive). Most of the issues with testing
have occurred because of variation in preanalytic
variables, thresholds for positivity, and interpretation
Recommendations: The Panel recommends that ER and
PgR status be determined on all invasive breast cancers and
breast cancer recurrences. A testing algorithm that relies
on accurate, reproducible assay performance is proposed.
Elements to reliably reduce assay variation are specified. It is recommended that ER and PgR assays be considered
positive if there are at least 1% positive tumor nuclei in the sample on testing in the presence of expected reactivity of internal (normal epithelial elements) and external controls. The absence of benefit from endocrine therapy for women with ER-negative invasive breast cancers has been confirmed in large overviews of randomized clinical trials.(Arch Pathol Lab Med. 2010;134:907–922)


progesterone receptors in breast cancer. Archives of Pathology and Laboratory Medicine, 134(6), 907-922

Journal Article Type Article
Publication Date Jun 1, 2010
Journal Archives of Pathology and Laboratory Medicine
Print ISSN 0003-9985
Publisher College of American Pathologists
Peer Reviewed Peer Reviewed
Volume 134
Issue 6
Pages 907-922
Keywords breast cancer, immunohistochemical testing
Publisher URL
Additional Information Additional Information : Provided with permission from Archives of Pathology & Laboratory Medicine. Copyright 2010. College of American Pathologists


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