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

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 pre-analytic 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.

• 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, American Society of Clinical Oncology, College of American Pathologists
• Journal: Archives of pathology & laboratory medicine (Arch Pathol Lab Med) Vol. 134 Issue 7 Pg. e48-72 (Jul 2010) ISSN: 1543-2165 [Electronic] United States
• PMID: 20586616 (Publication Type: Journal Article, Practice Guideline, Review, Systematic Review)

Chemical References

• Biomarkers, Tumor
• Receptors, Estrogen
• Receptors, Progesterone

Topics

• Algorithms
• Biomarkers, Tumor (analysis)
• Breast Neoplasms (chemistry, drug therapy, pathology)
• False Negative Reactions
• False Positive Reactions
• Female
• Humans
• Immunohistochemistry (standards)
• Neoplasm Invasiveness
• Neoplasm Recurrence, Local
• Receptors, Estrogen (analysis)
• Receptors, Progesterone (analysis)
• Reproducibility of Results
• Treatment Failure