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, 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 & 12 others 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

Research output: Contribution to journalArticle

344 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)907-922
Number of pages16
JournalArchives of Pathology and Laboratory Medicine
Volume134
Issue number6
Publication statusPublished - Jun 2010

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Medical Oncology
Progesterone Receptors
Estrogen Receptors
Guidelines
Breast Neoplasms
Ontario
Pathologists
Neoplasms
Randomized Controlled Trials
Recurrence

ASJC Scopus subject areas

  • Pathology and Forensic Medicine
  • Medical Laboratory Technology

Cite this

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; Osborne, C. Kent; Paik, Soonmyung; Perlmutter, Jane; Rhodes, Anthony; Sasano, Hironobu; Schwartz, Jared N.; Sweep, Fred C G; Taube, Sheila; Torlakovic, Emina Emilia; Valenstein, Paul; Viale, Giuseppe; Visscher, Daniel; Wheeler, Thomas; Williams, R. Bruce; Wittliff, James L.; Wolff, Antonio C.

In: Archives of Pathology and Laboratory Medicine, Vol. 134, No. 6, 06.2010, p. 907-922.

Research output: Contribution to journalArticle

Hammond, MEH, Hayes, DF, Dowsett, M, Allred, DC, Hagerty, KL, Badve, S, Fitzgibbons, PL, Francis, G, Goldstein, NS, Hayes, M, Hicks, DG, Lester, S, Love, R, Mangu, PB, McShane, L, Miller, K, Osborne, CK, Paik, S, Perlmutter, J, Rhodes, A, Sasano, H, Schwartz, JN, Sweep, FCG, Taube, S, Torlakovic, EE, Valenstein, P, Viale, G, Visscher, D, Wheeler, T, Williams, RB, Wittliff, JL & Wolff, AC 2010, 'American Society of Clinical oncology/college of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer', Archives of Pathology and Laboratory Medicine, vol. 134, no. 6, pp. 907-922.
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 ; Osborne, C. Kent ; Paik, Soonmyung ; Perlmutter, Jane ; Rhodes, Anthony ; Sasano, Hironobu ; Schwartz, Jared N. ; Sweep, Fred C G ; Taube, Sheila ; Torlakovic, Emina Emilia ; Valenstein, Paul ; Viale, Giuseppe ; Visscher, Daniel ; Wheeler, Thomas ; Williams, R. Bruce ; Wittliff, James L. ; Wolff, Antonio C. / American Society of Clinical oncology/college of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer. In: Archives of Pathology and Laboratory Medicine. 2010 ; Vol. 134, No. 6. pp. 907-922.
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AU - Hammond, M. Elizabeth H

AU - Hayes, Daniel F.

AU - Dowsett, Mitch

AU - Allred, D. Craig

AU - Hagerty, Karen L.

AU - Badve, Sunil

AU - Fitzgibbons, Patrick L.

AU - Francis, Glenn

AU - Goldstein, Neil S.

AU - Hayes, Malcolm

AU - Hicks, David G.

AU - Lester, Susan

AU - Love, Richard

AU - Mangu, Pamela B.

AU - McShane, Lisa

AU - Miller, Keith

AU - Osborne, C. Kent

AU - Paik, Soonmyung

AU - Perlmutter, Jane

AU - Rhodes, Anthony

AU - Sasano, Hironobu

AU - Schwartz, Jared N.

AU - Sweep, Fred C G

AU - Taube, Sheila

AU - Torlakovic, Emina Emilia

AU - Valenstein, Paul

AU - Viale, Giuseppe

AU - Visscher, Daniel

AU - Wheeler, Thomas

AU - Williams, R. Bruce

AU - Wittliff, James L.

AU - Wolff, Antonio C.

PY - 2010/6

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N2 - 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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