American Society of Clinical Oncology/College of American Pathologists Guideline Recommendations for Immunohistochemical Testing of Estrogen and Progesterone Receptors in Breast Cancer -- Hammond et al., 10.1200/JCO.2009.25.6529 -- Journal of Clinical Oncology

JCO Early Release, published online ahead of print Apr 19 2010
Journal of Clinical Oncology, 10.1200/JCO.2009.25.6529

Received August 14, 2009
Accepted February 23, 2010


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, 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, and Antonio C. Wolff

From Intermountain Healthcare, University of Utah School of Medicine, Salt Lake City, UT; Washington University School of Medicine, St Louis, MO; American Society of Clinical Oncology, Alexandria, VA; University of Michigan Comprehensive Cancer Center, University of Michigan Health System; St Joseph Mercy Hospital; Gemini Group, Ann Arbor; Advanced Diagnostics Laboratory, Redford, MI; Presbyterian Hospital, Charlotte, NC; Indiana University, Bloomington, IN; St Jude Medical Center, Fullerton, CA; University of Rochester, Rochester, NY; Brigham and Women's Hospital, Boston, MA; National Cancer Institute, Bethesda; ST Consulting, Glen Echo; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Ohio State University, Columbus, OH; Baylor College of Medicine, Houston, TX; National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA; The Delta Pathology Group, Shreveport, LA; University of Louisville, Louisville, KY; Royal Marsden Hospital, London; United Kingdom National External Quality Assessment Service, Sheffield; University of West of England, Bristol, United Kingdom; Princess Alexandra Hospital, Brisbane, Queensland, Australia; University of British Columbia, Vancouver, British Columbia; Royal University Hospital, Saskatoon, Saskatchewan, Canada; Tohoku University School of Medicine, Sendai, Japan; Radboud University, Nijmegen, the Netherlands; and European Institute of Oncology and University of Milan, Milan, Italy.

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.



open here to see the Guideline from ASCO and CAP:
American Society of Clinical Oncology/College of American Pathologists Guideline Recommendations for Immunohistochemical Testing of Estrogen and Progesterone Receptors in Breast Cancer -- Hammond et al., 10.1200/JCO.2009.25.6529 -- Journal of Clinical Oncology