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The impact of mammalian target of rapamycin inhibition on bone health in postmenopausal women with hormone receptor-positive advanced breast cancer receiving everolimus plus exemestane in the phase IIIb 4EVER trial.


ABSTRACT: Background:Breast cancer and its treatments are associated with a detrimental effect on bone health. Here we report the results of an exploratory analysis assessing changes in levels of biomarkers of bone metabolism in patients enrolled in the phase IIIb 4EVER study. Methods:The 4EVER trial investigated everolimus in combination with exemestane in postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer. In this prespecified exploratory analysis, changes in biomarkers of bone turnover were assessed in patients from baseline to weeks 4, 12, and 24. The serum bone markers assessed were procollagen type 1 N-terminal propeptide (P1NP), C-terminal cross-linking telopeptide of type 1 collagen (CTX), osteocalcin, parathyroid hormone (PTH), and 25-hydroxyvitamin D (25-OH-vitamin D). On-treatment changes in bone markers over time were described per subgroup of interest and efficacy outcomes. Results:Bone marker data were available for 241 of 299 enrolled patients. At the final assessment, P1NP, osteocalcin, PTH, 25-OH-vitamin D (all P?

SUBMITTER: Hadji P 

PROVIDER: S-EPMC6263089 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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The impact of mammalian target of rapamycin inhibition on bone health in postmenopausal women with hormone receptor-positive advanced breast cancer receiving everolimus plus exemestane in the phase IIIb 4EVER trial.

Hadji Peyman P   Stoetzer Oliver O   Decker Thomas T   Kurbacher Christian M CM   Marmé Frederik F   Schneeweiss Andreas A   Mundhenke Christoph C   Distelrath Andrea A   Fasching Peter A PA   Lux Michael P MP   Lüftner Diana D   Janni Wolfgang W   Muth Mathias M   Kreuzeder Julia J   Quiering Claudia C   Grischke Eva-Marie EM   Tesch Hans H  

Journal of bone oncology 20181002


<h4>Background</h4>Breast cancer and its treatments are associated with a detrimental effect on bone health. Here we report the results of an exploratory analysis assessing changes in levels of biomarkers of bone metabolism in patients enrolled in the phase IIIb 4EVER study.<h4>Methods</h4>The 4EVER trial investigated everolimus in combination with exemestane in postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic b  ...[more]

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