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Practice Guideline
. 2010 Jun;134(6):907-22.
doi: 10.5858/134.6.907.

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

M Elizabeth H Hammond  1 , 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
Practice Guideline

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

M Elizabeth H Hammond et al. Arch Pathol Lab Med. 2010 Jun.

Erratum in

  • Arch Pathol Lab Med. 2010 Aug;134(8):1101

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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Conflict of interest statement

AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

Employment or Leadership Position: Jared N. Schwartz, Aperio (C). Consultant or Advisory Role: Mitch Dowsett, Dako (C); D. Craig Allred, Genomic Health (C), Clarient (C), Dako (C); Sunil Badve, Dako (C); Neal S. Goldstein, Clarient (C); Giuseppe Viale, Dako (C). Stock Ownership: D. Craig Allred, Clarient. Honoraria: Glenn Francis, Roche Ventana Medical Systems; Giuseppe Viale, Dako. Research Funding: Hironobu Sasano, Ventana Japan. Expert Testimony: None. Other Remuneration: Glenn Francis, Roche Ventana Medical Systems.

After the guideline manuscript was completed, Jared N. Schwartz assumed an Employment or Leadership Position with Aperio and resigned as co-chair of the Expert Panel.

References

    1. Wolff AC, Hammond ME, Schwartz JN, et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. J Clin Oncol. 2007;25:118–145. - PubMed
    1. Wolff AC, Hammond ME, Schwartz JN, et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. Arch Pathol Lab Med. 2007;131:18–43. - PubMed
    1. Fitzgibbons PL, Murphy DA, Hammond MEH, et al. Recommendations for validating estrogen and progesterone receptor immunohistochemistry assays. Arch Pathol Lab Med. (in press) - PubMed
    1. McCarty KS, Jr, Miller LS, Cox EB, et al. Estrogen receptor analyses: Correlation of biochemical and immunohistochemical methods using monoclonal antireceptor antibodies. Arch Pathol Lab Med. 1985;109:716–721. - PubMed
    1. Barnes DM, Harris WH, Smith P, et al. Immunohistochemical determination of oestrogen receptor: Comparison of different methods of assessment of staining and correlation with clinical outcome of breast cancer patients. Br J Cancer. 1996;74:1445–1451. - PMC - PubMed

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