Comparison of estrogen and progesterone receptor antibody reagents using proficiency testing data

Megan Troxell, Thomas Long, Jason L. Hornick, Abiy B. Ambaye, Kristin C. Jensen

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Context. - Immunohistochemical analysis of estrogen receptor (ER) and progesterone receptor (PgR) expression in breast cancer is the current standard of care and directly determines therapy. In 2010 the American Society of Clinical Oncology and the College of American Pathologists (ASCO/CAP) published guidelines for ER and PgR predictive testing, encompassing preanalytic, analytic, postanalytic factors; antibody validation; and proficiency testing. Objective. - To compare the performance of different antibody reagents for ER and PgR immunohistochemical analysis by using CAP proficiency testing data. Design. - The CAP PM2 survey uses tissue microarrays of ten 2-mm cores per slide. We analyzed survey data from 80 ER and 80 PgR cores by antibody clone from more than 1200 laboratories. Results. - Laboratories used the ER antibodies SP1 (72%), 6F11 (17%), 1D5 (3%), and the PgR antibodies 1E2 (61%), 16 (12%), PgR-636 (13%), PgR-1294 (8%) in 2015. While 63 of 80 ER cores (79%) were scored similarly using each of the 3 antibodies, there were significant differences for others, with SP1 yielding more positive interpretations. Four cores were scored as ER negative by more than half of the laboratories using 1D5 or 6F11, while SP1 produced positive results in more than 70% of laboratories using that antibody. Despite the greater variety of PgR antibody reagents and greater PgR tumor heterogeneity, 61 of 80 cores (76%) were scored similarly across the 4 PgR antibodies. Conclusions. - Accurate ER and PgR testing in breast cancer is crucial for appropriate treatment. The CAP proficiency testing data demonstrate differences in staining results by ER clone, with SP1 yielding more positive results.

Original languageEnglish (US)
Pages (from-to)1402-1412
Number of pages11
JournalArchives of Pathology and Laboratory Medicine
Volume141
Issue number10
DOIs
StatePublished - Oct 1 2017
Externally publishedYes

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Progesterone Receptors
Estrogen Receptors
Antibodies
Clone Cells
Breast Neoplasms
Standard of Care
Guidelines
Staining and Labeling

ASJC Scopus subject areas

  • Pathology and Forensic Medicine
  • Medical Laboratory Technology

Cite this

Comparison of estrogen and progesterone receptor antibody reagents using proficiency testing data. / Troxell, Megan; Long, Thomas; Hornick, Jason L.; Ambaye, Abiy B.; Jensen, Kristin C.

In: Archives of Pathology and Laboratory Medicine, Vol. 141, No. 10, 01.10.2017, p. 1402-1412.

Research output: Contribution to journalArticle

Troxell, Megan ; Long, Thomas ; Hornick, Jason L. ; Ambaye, Abiy B. ; Jensen, Kristin C. / Comparison of estrogen and progesterone receptor antibody reagents using proficiency testing data. In: Archives of Pathology and Laboratory Medicine. 2017 ; Vol. 141, No. 10. pp. 1402-1412.
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abstract = "Context. - Immunohistochemical analysis of estrogen receptor (ER) and progesterone receptor (PgR) expression in breast cancer is the current standard of care and directly determines therapy. In 2010 the American Society of Clinical Oncology and the College of American Pathologists (ASCO/CAP) published guidelines for ER and PgR predictive testing, encompassing preanalytic, analytic, postanalytic factors; antibody validation; and proficiency testing. Objective. - To compare the performance of different antibody reagents for ER and PgR immunohistochemical analysis by using CAP proficiency testing data. Design. - The CAP PM2 survey uses tissue microarrays of ten 2-mm cores per slide. We analyzed survey data from 80 ER and 80 PgR cores by antibody clone from more than 1200 laboratories. Results. - Laboratories used the ER antibodies SP1 (72{\%}), 6F11 (17{\%}), 1D5 (3{\%}), and the PgR antibodies 1E2 (61{\%}), 16 (12{\%}), PgR-636 (13{\%}), PgR-1294 (8{\%}) in 2015. While 63 of 80 ER cores (79{\%}) were scored similarly using each of the 3 antibodies, there were significant differences for others, with SP1 yielding more positive interpretations. Four cores were scored as ER negative by more than half of the laboratories using 1D5 or 6F11, while SP1 produced positive results in more than 70{\%} of laboratories using that antibody. Despite the greater variety of PgR antibody reagents and greater PgR tumor heterogeneity, 61 of 80 cores (76{\%}) were scored similarly across the 4 PgR antibodies. Conclusions. - Accurate ER and PgR testing in breast cancer is crucial for appropriate treatment. The CAP proficiency testing data demonstrate differences in staining results by ER clone, with SP1 yielding more positive results.",
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