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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.
SUBMITTER: Hammond ME
PROVIDER: S-EPMC2881855 | biostudies-literature | 2010 Jun
REPOSITORIES: biostudies-literature
Hammond M Elizabeth H ME Hayes Daniel F DF Dowsett Mitch M Allred D Craig DC Hagerty Karen L KL Badve Sunil S Fitzgibbons Patrick L PL Francis Glenn G Goldstein Neil S NS Hayes Malcolm M Hicks David G DG Lester Susan S Love Richard R Mangu Pamela B PB McShane Lisa L Miller Keith K Osborne C Kent CK Paik Soonmyung S Perlmutter Jane J Rhodes Anthony A Sasano Hironobu H Schwartz Jared N JN Sweep Fred C G FC Taube Sheila S Torlakovic Emina Emilia EE Valenstein Paul P Viale Giuseppe G Visscher Daniel D Wheeler Thomas T Williams R Bruce RB Wittliff James L JL Wolff Antonio C AC
Journal of clinical oncology : official journal of the American Society of Clinical Oncology 20100419 16
<h4>Purpose</h4>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.<h4>Methods</h4>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 recommendat ...[more]