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.

Abstract

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
markers.
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
criteria.
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)

• Journal Article Type: Article
• Publication Date: Jun 1, 2010
• Publicly Available Date: Jun 8, 2019
• 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
• Public URL: https://uwe-repository.worktribe.com/output/978521
• Publisher URL: http://www.archivesofpathology.org/doi/abs/10.1043/1543-2165-134.6.907
• Additional Information: Additional Information : Provided with permission from Archives of Pathology & Laboratory Medicine. Copyright 2010. College of American Pathologists