Cancer Diagnosis Program | Biorepositories and Biospecimen Research Branch

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Stability of oestrogen and progesterone receptor antigenicity in formalin-fixed paraffin-embedded breast cancer tissue over time.

Author(s): Ehinger A, Bendahl PO, Rydén L, Fernö M, Alkner S

Publication: APMIS, 2018, Vol. 126, Page 746-754

PubMed ID: 30160021 PubMed Review Paper? No

Purpose of Paper

Conclusion of Paper

Studies

1. Study Purpose

   The purpose of this study was to evaluate immunohistochemical staining in archival FFPE breast cancer tumor specimens and compared results of cytsol analysis obtained at the time of diagnosis.  A tissue microarray containing 1328 tumor specimens from 728 patients diagnosed with contralateral breast cancer was used for the analysis.  ER and/or PR cytosol data at the time of diagnosis (1978-2000) was available for 573 tumor specimens on the array.  Immunohistochemical staining for ER, PR, HER2, and KI-67 was conducted on the archival specimens using an autostainer, and staining was evaluated by a pathologist. A positive status was set at ≥10% stained nuclei for ER and PR and a HercepTest score of 3+ for HER2, while Ki-67 staining was considered as high when >20% of cell nuclei stained positive.  Prior cytosol analysis of ER and PR had been performed on freshly frozen specimens within 8 days of surgical removal using the ligand binding assay, the dextran-coated charcoal method and Scatchard analysis, or an enzyme immunoassay. A positive status for cytosol analysis was set at ≥25 fmol/mg protein.

   Summary of Findings:

   Of the breast cancer tumors represented on the tissue microarray, concordant results of cytosol analysis at the time of diagnosis and recent immunohistochemical staining was obtained for 87% of patients for ER and 86% for PR. Notably, concordance for PR was higher among specimens procured more recently (those collected between 1978-1985 versus those collected between 1986-2000; p=0.005), which may be attributable to a change in cytosol analysis method from ligand binding assay to the enzyme immunoassay or more reliable immunohistochemical results with newer specimens.  No such trend with storage duration was observed between immunohistochemical and cytosol analysis for ER. The proportion of HER2 positive and Ki-67-high tumors, which are common among ER-negative breast cancer tumors, remained constant over time among both ER-positive and -negative tumor specimens and among PR-positive and PR-negative tumor specimens.  The authors also noted that since tumor specimens identified as ER or PR positive by immunohistochemistry, but negative by cytosol analysis, were frequently lobular carcinomas, immunohistochemical analysis may be a superior method of detection for this cancer subtype.

   Biospecimens

   • Tissue - Breast

   Preservative Types

   • Frozen
   • Formalin

   Diagnoses:

   • Neoplastic - Carcinoma

   Platform:

   Analyte	Technology Platform
   Protein	Immunohistochemistry
   Protein	Immunoassay
   Protein	Tissue microarray
   Protein	Receptor binding

   Pre-analytical Factors:

   Classification	Pre-analytical Factor	Value(s)
   Storage	Storage duration	Up to 40 y
   Immunoassay Specific	Targeted peptide/protein	ER PR
   Receptor binding Specific	Targeted peptide/protein	ER PR
   Immunohistochemistry Specific	Targeted peptide/protein	ER PR HER2 Ki-67

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