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Submitted on April 23, 2004
Accepted on November 22, 2004
Department of Internal Medicine, University of Virginia Health System, Charlottesville, VA 22908; Service de Pediatric, Hospital Arnaud de Villeneuve, 34295 Montpellier, France; Department of Pathology and Medicine, Penn state University, Hershey Medical Center, Hershey, PA 17033Taylor Technology, Inc. 107 College Road East.Princeton, New Jersey 08540
* To whom correspondence should be addressed.
Richard J. Santen, E-mail: rjs5y{at}virginia.edu
A recent analysis of data from nine studies provided convincing evidence that plasma estradiol measurements predict the risk of breast cancer in normal postmenopausal women. However, the median values detected by the various assays used in this study varied by 5 fold. These and other published data in normal postmenopausal women suggest that assays measuring low plasma estradiol concentrations suffer from problems of sensitivity, specificity and precision. Availability of a practical, low cost, specific, precise, and ultra-sensitive estrogen assay might allow enhanced prediction of the risk of breast cancer and provide an objective means of selecting post-menopausal women for breast cancer prevention. A recombinant cell ultra-sensitive bioassay (RCUB) for estrogen was recently validated for use in pre-pubertal children. We postulated that the RCUB might also prove useful for measurement of post-menopausal levels and designed the present study to examine this possibility.
Thirty normal post-menopausal volunteers provided blood samples for measurement of estrogen by RCUB and, for comparison, by RIA. The estrogenic activity measured by RCUB (11.9 ± 10.9 pmol/L mean±SD) <3.23 ± 2.96 pg/ml, mean±SD> was significantly lower than estradiol levels measured by RIA (43.7 ± 44.0 pmol/L) pg/ml <11.9 ± 12.0 pg/ml> in our volunteer subjects (P < 0.00001). Nonetheless, plasma estradiol levels measured by bioassay were significantly correlated with the estrogenic activity measured by RIA (r = 0.84 and by gas chromatography/ tandem mass spectrometry (r=0.85). To obtain biologic evidence of the validity of the RCUB, we related plasma estrogen levels to body weight and body mass index and found highly significant correlations (r=0.54 and r=0.53 respectively). Surprisingly, 28/30 postmenopausal women were found to have estrogen levels in the pre-pubertal range with the RCUB. The levels detected by RCUB were similar to those previously reported using an ultra-sensitive but less practical yeast bioassay. These results provide validation for the RCUB in postmenopausal women and suggest that it might prove useful for selection of women for drug therapy to prevent breast cancer.
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