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

University of Milan, Milano, Lombardy, Italy
Archives of pathology & laboratory medicine (Impact Factor: 2.88). 06/2010; 134(6):907-22. DOI: 10.1043/1543-2165-134.6.907
Source: PubMed

ABSTRACT 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.
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.
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.
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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Available from: David G Hicks, Aug 18, 2015
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    • "HER2 overexpression was analyzed using the HercepTest assay (Dako). Tumors were classified as ER or PR positive when at least 1% of the tumor cells showed staining in the nuclei cells [29]. HER2 was considered overexpressed when a uniform intense (3 +) membrane staining was present in N 30% of invasive tumor cells [30]. "
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    • "Cases were subclassified by the following intrinsic subtypes based on local pathology reports (Goldhirsch et al, 2011): (1) luminal human epidermal growth factor receptor 2 (HER2)- negative tumours (oestrogen receptor (ER) þ or progesterone receptor (PR) þ with HER2 À ), (2) HER2 þ tumours (HER2 þ irrespective of ER or PR results); and (3) triple-negative tumours (ER À , PR À and HER2 À ). The ER, PR and HER2 positivity were defined according to ASCO/CAP guidelines (Hammond et al, 2010; Wolff et al, 2013). The EpiGEICAM study was approved by the Ethics Committees of all 23 participating hospitals. "
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    • "American Society of Clinical Oncology (ASCO)/ College of American Pathologists (CAP) guidelines [46] "
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