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

Abstract

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.

Incidence proportions and prognosis of breast cancer patients with bone metastases at initial diagnosis

“…All patients included in the analysis were histopathologically reconfirmed independently by two experienced pathologists according to the ASCO/CAP 2010 criteria. The cutoff for estrogen receptor or progesterone receptor positivity was ≥1% of tumor cells with nuclear staining 26. Cytoplasmic staining was ignored 27.…”

Dual-Time 18F-FDG PET/CT Imaging in Initial Locoregional Staging of Breast Carcinoma: Comparison with Conventional Imaging and Pathological Prognostic Factors

“…For immunohistochemical analysis, estrogen (ER) and progesterone (PR) receptor expression statuses were scored as high (≥10 %), low (1-9 %), and negative (0 %) [7]. Her-2/ neu was categorized with scores of 0, 1+, 2+, and 3+.…”

Estrogen receptor (ER) mRNA expression and molecular subtype distribution in ER-negative/progesterone receptor-positive breast cancers

“…(1,483 words) Introduction Estrogen (ER) and progesterone receptor (PR) are routinely assessed in all primary breast cancers by immunohistochemistry (IHC) [1] and adjuvant endocrine therapy is recommended if either of these receptors is positive (i.e. > 1% by IHC) [2][3][4].…”

“…[12] Some data suggests that cancers may not significantly benefit from adjuvant endocrine therapy. [1]. Historically, many investigators and clinicians considered 10% or greater IHC staining as the threshold for defining HR positive status and therefore eligibility for endocrine therapy.…”