American Society of Clinical Oncology/College of American Pathologists Guideline Recommendations for Immunohistochemical Testing of Estrogen and Progesterone Receptors in Breast Cancer

By M. Hammond, Daniel F. Hayes, Mitchell Dowsett, D. Allred, K. Hagerty, S. Badve, P. Fitzgibbons, G. Francis, Neil S. Goldstein, M. Hayes and 22 more. Archives of Pathology & Laboratory Medicine, 2010

3,652 citations recorded by the source corpus.

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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Citations in the corpus

• Subclonal diversification of primary breast cancer revealed by multiregion sequencing (2015, unknown): “Therapies targeted against the estrogen and HER2 receptors improve survival and benefit may extend to cases where the targetable alteration is subclonal 8,9 .”
• Awareness and current knowledge of breast cancer (2017, background): “management of breast cancer The estrogen receptor assay has developed into a typical practice in the treatment of complex breast cancer [177].”
• Breast Cancer Histopathology Image Analysis: A Review (2014, unknown): “consistency of the interpretation [8], [9].”
• Phase II Trial of Bicalutamide in Patients with Androgen Receptor–Positive, Estrogen Receptor–Negative Metastatic Breast Cancer (2013, background): “At the time of study accrual, ASCO/CAP guidelines had not yet lowered the threshold defining ER positivity to its current level of 1% or greater (22).”
• Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline. (2016, background): “Subsequently, ASCO collaborated with the College of American Pathologists (CAP) to publish and update guidelines on testing for HER22,3 and ER/PgR.4 Thus, to facilitate future updates in a rapidly developing field, the ASCO Breast Cancer © 2016 by American Society of Clinical Oncology 1 http://jco.a”
• Prognostic value of tumor-infiltrating lymphocytes in triple-negative breast cancers from two phase III randomized adjuvant breast cancer trials: ECOG 2197 and ECOG 1199. (2014, methodology): “ER and PR were considered negative using the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines ( 1%).(9) In E1199, 5,052 women with T1-3N1-2 or T2-3N0 breast cancer were enrolled between October 1999 and January 2002 and randomly assigned to”
• The Genomic Landscape of Endocrine-Resistant Advanced Breast Cancers (2018, methodology): “…cancer subtypes based on ER and PR IHC results and the HER2 IHC and/or FISH results rendered at the time of diagnosis in accordance with the American Society of Clinical Oncology (ASCO) and College of American Pathology (CAP) guideline recommendations (Hammond et al., 2010; Wolff et al., 2014).”
• Primary breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. (2015, background): “Tumors with no detectable expression of ER and PgR are considered hormone receptor negative or endocrine non-responsive [44].”
• Strategies for subtypes—dealing with the diversity of breast cancer: highlights of the St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2011 (2011, background): “Guidelines have been published for estrogen and progesterone receptor determination [76] and for the detection of HER2 positivity [77].”
• Breast Cancer—Epidemiology, Risk Factors, Classification, Prognostic Markers, and Current Treatment Strategies—An Updated Review (2021, background): “These factors—ER, PR, HER2, grade, and multigene assays—are recommended in practice to define prognosis [183,184].”