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



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.



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 criteria.



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.
Intermountain Healthcare, University of Utah School of Medicine, Salt Lake City, UT, USA.
M Elizabeth H
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Hammond
Daniel F
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Hayes
Mitch
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Dowsett
D Craig
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Allred
Karen L
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Hagerty
Sunil
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Badve
Patrick L
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Fitzgibbons
Glenn
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Francis
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Goldstein
Malcolm
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David G
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Hicks
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Lester
Richard
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Love
Pamela B
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Mangu
Lisa
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McShane
Keith
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Miller
C Kent
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Osborne
Soonmyung
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Paik
Jane
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Perlmutter
Anthony
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Rhodes
Hironobu
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Sasano
Jared N
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Schwartz
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Sweep
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Taube
Emina Emilia
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Torlakovic
Paul
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Valenstein
Giuseppe
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Viale
Daniel
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Visscher
Thomas
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Wheeler
R Bruce
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Williams
James L
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Wittliff
Antonio C
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Wolff
D005260:Female; D006801:Humans; D000465:Algorithms; D014408:Biomarkers, Tumor / Q000378:metabolism; D001943:Breast Neoplasms / Q000175:diagnosis / Q000378:metabolism; D017408:Guidelines as Topic; D006287:Health Planning Guidelines; D007150:Immunohistochemistry / Q000379:methods; D011237:Predictive Value of Tests; D011960:Receptors, Estrogen / Q000378:metabolism; D011980:Receptors, Progesterone / Q000378:metabolism; D012955:Societies, Medical; D014481:United States; D000078202:Systematic Reviews as Topic
D014408:Biomarkers, Tumor; D011960:Receptors, Estrogen; D011980:Receptors, Progesterone