ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2011
Standardization of estrogen receptor measurement in breast cancer suggests false-negative results are a function of threshold intensity rather than percentage of positive cells.
Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers, 2 of them syntheses that pooled it.
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Who cites it
42 citing papers in PubMed, 2 syntheses or guidelines pooled it, 76 citations in OpenAlex.
- Discordance in hormone receptor status among primary, metastatic, and second primary breast cancers: biological difference or misclassification?The oncologist · 2014Pooled it
- Construction and analysis of multiparameter prognostic models for melanoma outcome.Methods in molecular biology (Clifton, N.J.) · 2014Pooled it
- Effect of continuous statistically standardized measures of estrogen and progesterone receptors on disease-free survival in NCIC CTG MA.12 Trial and BC Cohort.Breast cancer research : BCR · 2013Trial
- Diet quality indices are associated with breast cancer by molecular subtypes in Mexican women.European journal of nutrition · 2024Article
- Rare Germline Variants in DNA Repair Genes Detected inCancers · 2024Article
- Clinical Proteomics for Solid Organ Tissues.Molecular & cellular proteomics : MCP · 2023Article
- Multiomics technologies for comprehensive tumor microenvironment analysis in triple-negative breast cancer under neoadjuvant chemotherapy.Frontiers in oncology · 2023Review
- Intrinsic and Extrinsic Factors Governing the Transcriptional Regulation of ESR1.Hormones & cancer · 2020Review
- Association between low estrogen receptor positive breast cancer and staining performance.NPJ breast cancer · 2020Article
- Correlating nuclear morphometric patterns with estrogen receptor status in breast cancer pathologic specimens.NPJ breast cancer · 2018Article
- Analytic Response Curves of Clinical Breast Cancer IHC Tests.The journal of histochemistry and cytochemistry : official journal of the Histochemistry Society · 2017Article
- Proof of the quantitative potential of immunofluorescence by mass spectrometry.Laboratory investigation; a journal of technical methods and pathology · 2017Article
- Spheroid arrays for high-throughput single-cell analysis of spatial patterns and biomarker expression in 3D.Scientific reports · 2017Article
- The ABCs of finding a good antibody: How to find a good antibody, validate it, and publish meaningful data.F1000Research · 2017Article
- A prospective comparison of ER, PR, Ki67 and gene expression in paired sequential core biopsies of primary, untreated breast cancer.BMC cancer · 2016Article
- Automated measurement of estrogen receptor in breast cancer: a comparison of fluorescent and chromogenic methods of measurement.Laboratory investigation; a journal of technical methods and pathology · 2016Article
- ESR1 and PGR polymorphisms are associated with estrogen and progesterone receptor expression in breast tumors.Physiological genomics · 2016Article
- Translating pharmacodynamic biomarkers from bench to bedside: analytical validation and fit-for-purpose studies to qualify multiplex immunofluorescent assays for use on clinical core biopsy specimens.Seminars in oncology · 2016Review
- Osteopontin splice variants are differential predictors of breast cancer treatment responses.BMC cancer · 2016Article
- Menacalc, a quantitative method of metastasis assessment, as a prognostic marker for axillary node-negative breast cancer.BMC cancer · 2015Article
Corrections and comments
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Authors and funding
8 authors at 1 institution in 1 country.
Funding
Abstract
purposeRecent misclassification (false negative) incidents have raised awareness concerning limitations of immunohistochemistry (IHC) in assessment of estrogen receptor (ER) in breast cancer. Here we define a new method for standardization of ER measurement and then examine both change in percentage and threshold of intensity (immunoreactivity) to assess sources for test discordance.
methodsAn assay was developed to quantify ER by using a control tissue microarray (TMA) and a series of cell lines in which ER immunoreactivity was analyzed by quantitative immunoblotting in parallel with the automated quantitative analysis (AQUA) method of quantitative immunofluorescence (QIF). The assay was used to assess the ER protein expression threshold in two independent retrospective cohorts from Yale and was compared with traditional methods.
resultsTwo methods of analysis showed that change in percentage of positive cells from 10% to 1% did not significantly affect the overall number of ER-positive patients. The standardized assay for ER on two Yale TMA cohorts showed that 67.9% and 82.5% of the patients were above the 2-pg/μg immunoreactivity threshold. We found 9.1% and 19.7% of the patients to be QIF-positive/IHC-negative, and 4.0% and 0.4% to be QIF-negative/IHC-positive for a total of 13.1% and 20.1% discrepant cases when compared with pathologists' judgment of threshold. Assessment of survival for both cohorts showed that patients who were QIF-positive/pathologist-negative had outcomes similar to those of patients who had positive results for both assays.
conclusionAssessment of intensity threshold by using a quantitative, standardized assay on two independent cohorts suggests discordance in the 10% to 20% range with current IHC methods, in which patients with discrepant results have prognostic outcomes similar to ER-positive patients with concordant results.
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