Article

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: 2.84). 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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    • "Tumour grade was assigned according to Nottingham Grading System. ER and PR status were assessed on tissue microarrays (TMAs) using immunohistochemestry (IHC) with Dako (Glostrup, Denmark) ER antibody and Leica (Wetzlar, Germany) PR antibody and scored according to the American Society of Clinical Oncology and College of American Pathologists guidelines with a cutoff value of 1% positive tumour nuclei (Hammond et al, 2010). Her2 status were assessed visually using TMAs as previously described, that is, a score 3 þ is regarded as positive; 2 þ is regarded as equivocal, leading to referral for Her-2 FISH; and 0 and 1 þ are regarded as negative (Mohammed et al, 2012b). "
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