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

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Hammond, M. E. H. ; Hayes, D. F. ; Dowsett, M. ; Allred, D. C. ; Hagerty, K. L. ; Badve, S. ; Fitzgibbons, P. L. ; Francis, G. ; Goldstein, N. S. ; Hayes, M. ; Hicks, D. G. ; Lester, S. ; Love, R. ; Mangu, P. B. ; McShane, L. ; Miller, K. ; Osbourne, C. K. ; Paik, S. ; Permutter, J. ; Rhodes, A. ; Sasano, H. ; Schwartz, J. N. ; Sweep, F. C. ; Taube, S. ; Torlakovic, E. E. ; Valenstein, P. ; Viale, G. ; Visscher, D. ; Wheeler, T. ; Williams, R. B. ... view all 32 authors (2010)
  • Publisher: College of American Pathologists
  • Subject:
    mesheuropmc: skin and connective tissue diseases

Purpose: To develop a guideline to improve the\ud accuracy of immunohistochemical (IHC) estrogen receptor\ud (ER) and progesterone receptor (PgR) testing in breast\ud cancer and the utility of these receptors as predictive\ud markers.\ud Methods: The American Society of Clinical Oncology\ud and the College of American Pathologists convened an\ud international Expert Panel that conducted a systematic\ud review and evaluation of the literature in partnership with\ud Cancer Care Ontario and developed recommendations for\ud optimal IHC ER/PgR testing performance.\ud Results: Up to 20% of current IHC determinations of\ud ER and PgR testing worldwide may be inaccurate (false\ud negative or false positive). Most of the issues with testing\ud have occurred because of variation in preanalytic\ud variables, thresholds for positivity, and interpretation\ud criteria.\ud Recommendations: The Panel recommends that ER and\ud PgR status be determined on all invasive breast cancers and\ud breast cancer recurrences. A testing algorithm that relies\ud on accurate, reproducible assay performance is proposed.\ud Elements to reliably reduce assay variation are specified. It is recommended that ER and PgR assays be considered\ud 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.(Arch Pathol Lab Med. 2010;134:907–922)
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