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Estrogen- and Progesterone-Receptor Status in ECOG 2197: Comparison of Immunohistochemistry by Local and Central Laboratories and Quantitative Reverse Transcription Polymerase Chain Reaction by Central Laboratory

Sunil S. Badve, Frederick L. Baehner, Robert P. Gray, Barrett H. Childs, Tara Maddala, Mei-Lan Liu, Steve C. Rowley, Steven Shak, Edith D. Perez, Lawrence J. Shulman, Silvana Martino, Nancy E. Davidson, George W. Sledge, Lori J. Goldstein, Joseph A. Sparano

From the Eastern Cooperative Oncology Group, Boston, MA; the University of California, San Francisco, San Francisco, CA; Genomic Health Inc, Redwood City, CA; sanofi-aventis, Bridgewater, NJ; North Central Cancer Treatment Group, Rochester, MN; Cancer and Leukemia Group B, Chicago, IL; and the Southwest Oncology Group, San Antonio, TX

Corresponding author: Sunil Badve, MD, Indiana University School of Medicine, 350 West 11th St CPL-4050, Indianapolis, IN 46202; e-mail: sbadve{at}iupui.edu

Purpose: Central and local laboratory concordance for hormone receptor measurement is therapeutically important. This study compares estrogen receptor (ER) and progesterone receptor (PR) measured by local laboratory immunohistochemistry (IHC), central IHC, and central reverse-transcriptase polymerase chain reaction (RT-PCR) using a proprietary 21-gene assay.

Patients and Methods: A case-control sample of 776 breast cancer patients from Eastern Cooperative Oncology Group (ECOG) study E2197 was evaluated. Central IHC Allred score for ER and PR was obtained using tissue microarrays and 1D5 ER antibody and 636 PR antibody. Quantitative RT-PCR for ER and PR in whole sections was performed using the 21-gene assay.

Results: For ER, the concordance between local and central IHC was 90% (95% CI, 88% to 92%), between local IHC and central RT-PCR was 91% (95% CI, 89% to 93%), and between central IHC and central RT-PCR was 93% (95% CI, 91% to 95%). For PR, the concordance between local IHC and central IHC was 84% (95% CI, 82% to 87%), between local IHC and central RT-PCR was 88% (95% CI, 85% to 90%), and between central IHC and central RT-PCR was 90% (95% CI, 88% to 92%). Although concordance was high, IHC ER-negative cases that were RT-PCR positive were more common than IHC ER-positive cases that were RT-PCR negative. In ER-positive patients, ER expression by central IHC Allred score was marginally associated with recurrence (P = .091), and ER expression by central RT-PCR was significantly associated with recurrence (P = .014). However, recurrence score, which incorporates additional genes/pathways, was a highly significant predictor of recurrence (P < .0001).

Conclusion: There is a high degree of concordance among local IHC, central IHC, and central RT-PCR by the proprietary gene assay for ER and PR status. Although ER expression is marginally associated with relapse in ER-positive patients treated with chemohormonal therapy, recurrence score is a highly significant predictor of recurrence.

Supported by Genomic Health Inc and sanofi-aventis.

Terms in blue are defined in the glossary, found at the end of this article and online at www.jco.org.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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