Abstract
Objectives First, to compare the impact of nasally and orally dosed estradiol on breast density; second, to investigate the utility of computer-based automated approaches to the assessment of breast density with reference to traditional methods.Methods Digitized images from two 2-year, randomized, placebo-controlled trials formed the basis of the present post hoc analysis. Active treatments were 1 mg estradiol continuously combined with 0.125 mg trimegestone (oral hormone replacement therapy, HRT) or low-dose (150 or 300 µg estradiol) nasal estradiol cyclically combined with 200 mg micronized progesterone (nasal HRT). The effects on breast density were assessed by a radiologist, providing the BI-RADS® score and the interactive threshold, and by a computer-based approach, providing the measure of stripiness and the HRT-effect specific measure of breast density.Results In the oral HRT trial, active treatment induced a significant increase in breast density, which was consistent in all methods used (all p < 0.05). In contrast, none of the methods detected significant changes in women receiving nasal HRT. The sensitivity of automated methods to discriminate HRT- from placebo-treated women was equal or better than the sensitivity of methods performed by the radiologist.Conclusions The markedly different pharmacokinetic profile of nasal estrogen seems to be associated with better breast safety. Automated computer-based analysis of digitized mammograms provides a sensitive measure of changes in breast density induced by hormones and could serve as a useful tool in future clinical trials.
Published Version
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