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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
biochemistry, genetics and molecular biology
Re-evaluating adjuvant breast cancer trials: Assessing hormone receptor status by immunohistochemical versus extraction assays
Journal of the National Cancer Institute, Volume 98, No. 21, Year 2006
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Description
Background: Tumor levels of steroid hormone receptors, a factor used to select adjuvant treatment for early-stage breast cancer, are currently determined with immunohistochemical assays. These assays have a discordance of 10%-30% with previously used extraction assays. We assessed the concordance and predictive value of hormone receptor status as determined by immunohistochemical and extraction assays on specimens from International Breast Cancer Study Group Trials VIII and IX. These trials predominantly used extraction assays and compared adjuvant chemoendocrine therapy with endocrine therapy alone among pre- and postmenopausal patients with lymph node-negative breast cancer. Trial conclusions were that combination therapy provided a benefit to pre- and postmenopausal patients with estrogen receptor (ER)-negative tumors but not to ER-positive postmenopausal patients. ER-positive premenopausal patients required further study. Methods: Tumor specimens from 571 premenopausal and 976 postmenopausal patients on which extraction assays had determined ER and progesterone receptor (PgR) levels before randomization from October 1, 1988, through October 1, 1999, were re-evaluated with an immunohistochemical assay in a central pathology laboratory. The endpoint was disease-free survival. Hazard ratios of recurrence or death for treatment comparisons were estimated with Cox proportional hazards regression models, and discriminatory ability was evaluated with the c index. All statistical tests were two-sided. Results: Concordance of hormone receptor status determined by both assays ranged from 74% (κ = 0.48) for PgR among postmenopausal patients to 88% (κ = 0.66) for ER in postmenopausal patients. Hazard ratio estimates were similar for the association between disease-free survival and ER status (among all patients) or PgR status (among postmenopausal patients) as determined by the two methods. However, among premenopausal patients treated with endocrine therapy alone, the discriminatory ability of PgR status as determined by immunohistochemical assay was statistically significantly better (c index = 0.60 versus 0.51; P = .003) than that determined by extraction assay, and so immunohistochemically determined PgR status could predict disease-free survival. Conclusions: Trial conclusions in which ER status (for all patients) or PgR status (for postmenopausal patients) was determined by immunohistochemical assay supported those determined by extraction assays. However, among premenopausal patients, trial conclusions drawn from PgR status differed-immunohistochemically determined PgR status could predict response to endocrine therapy, unlike that determined by the extraction assay. © 2006 Oxford University Press.
Authors & Co-Authors
Regan, Meredith M.
Unknown Affiliation
Viale, Giuseppe L.
Unknown Affiliation
Mastropasqua, Mauro Giuseppe
Unknown Affiliation
Maiorano, Eugenio
Unknown Affiliation
Golouh, Rastko
Unknown Affiliation
Carbone, Antonino
Unknown Affiliation
Brown, Bob
Unknown Affiliation
Suurküla, Mart
Unknown Affiliation
Langman, Gerald
Unknown Affiliation
Mazzucchelli, Luca
Unknown Affiliation
Braye, Stephen G.
Unknown Affiliation
Grigolato, Piergiovanni
Unknown Affiliation
Gelber, Richard D.
Unknown Affiliation
Castiglione-Gertsch, Monica
Unknown Affiliation
Price, Karen N.
Unknown Affiliation
Coates, Alan S.
Unknown Affiliation
Goldhirsch, Aaron
Unknown Affiliation
Gusterson, Barry A.
Unknown Affiliation
Statistics
Citations: 143
Authors: 18
Affiliations: 21
Identifiers
Doi:
10.1093/jnci/djj415
ISSN:
00278874
e-ISSN:
14602105
Research Areas
Cancer
Environmental
Study Design
Randomised Control Trial