American Society of Clinical Oncology/College Of American Pathologists Guideline Recommendations for Immunohistochemical Testing of Estrogen and Progesterone Receptors in Breast Cancer

Overview

Journal J Clin Oncol

Specialty Oncology

Date 2010 Apr 21

PMID 20404251

Citations 1402

Authors

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 Osborne

Soonmyung Paik

Jane Perlmutter

Anthony Rhodes

Hironobu Sasano

Jared N Schwartz

Fred C G Sweep

Sheila Taube

Emina Emilia Torlakovic

Paul Valenstein

Giuseppe Viale

Daniel Visscher

Thomas Wheeler

R Bruce Williams

James L Wittliff

Antonio C Wolff

Affiliations

Soon will be listed here.

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.

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