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Effects of exemestane and tamoxifen on bone health within the Tamoxifen Exemestane Adjuvant Multicentre (TEAM) trial: results of a German, 12-month, prospective, randomised substudy

Identifieur interne : 001085 ( Main/Merge ); précédent : 001084; suivant : 001086

Effects of exemestane and tamoxifen on bone health within the Tamoxifen Exemestane Adjuvant Multicentre (TEAM) trial: results of a German, 12-month, prospective, randomised substudy

Auteurs : P. Hadji [Allemagne] ; M. Ziller [Allemagne] ; D. G. Kieback [Allemagne] ; W. Dornoff [Allemagne] ; H. W. Tessen [Allemagne] ; T. Menschik [France] ; J. Kuck [Allemagne] ; F. Melchert [Allemagne] ; A. Hasenburg [Allemagne]

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RBID : Pascal:09-0309205

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Abstract

Background: Adjuvant treatment of hormone receptor-positive breast cancer in postmenopausal women with aromatase inhibitors may be associated with increased bone loss. Patients and methods: Two hundred patients were randomised to receive exemestane or tamoxifen as adjuvant treatment of hormone receptor-positive breast cancer. Bone mineral density (BMD) was assessed by dual-energy X-ray absorptiometry at baseline and after 6 and 12 months treatment. Results: One hundred and sixty-one patients were assessable. Tamoxifen treatment resulted in a 0.5% increase from baseline in BMD at the spine, which was maintained at 12 months. Exemestane-treated patients experienced a 2.6% decrease from baseline in BMD at the spine at 6 months and a further 0.2% decrease at 12 months. There were significant differences in the changes in BMD between tamoxifen and exemestane at 6 and 12 months (P = 0.0026 and P = 0.0008, respectively). The mean changes in BMD from baseline at the total hip were also significantly different between exemestane and tamoxifen at 6 and 12 months (P = 0.0009 and P = 0.04, respectively). There was no difference between tamoxifen and exemestane in mean changes in BMD from baseline at the femoral neck. Conclusions: Exemestane treatment resulted in an increase in bone loss at 6 months; bone loss stabilised after 6- to 12-month treatment.

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Pascal:09-0309205

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<name sortKey="Hasenburg, A" sort="Hasenburg, A" uniqKey="Hasenburg A" first="A." last="Hasenburg">A. Hasenburg</name>
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<title level="j" type="main">Annals of oncology</title>
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<term>Antineoplastic agent</term>
<term>Aromatase inhibitor</term>
<term>Bone</term>
<term>Bone mineral density</term>
<term>Breast cancer</term>
<term>Clinical trial</term>
<term>Early</term>
<term>Exemestane</term>
<term>Fracture</term>
<term>Germany</term>
<term>Health</term>
<term>Osteoporosis</term>
<term>Prospective</term>
<term>Randomization</term>
<term>Tamoxifene</term>
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<keywords scheme="Pascal" xml:lang="fr">
<term>Exémestane</term>
<term>Tamoxifène</term>
<term>Os</term>
<term>Santé</term>
<term>Essai clinique</term>
<term>Allemagne</term>
<term>Prospective</term>
<term>Randomisation</term>
<term>Inhibiteur de l'aromatase</term>
<term>Densité minérale osseuse</term>
<term>Précoce</term>
<term>Cancer du sein</term>
<term>Fracture</term>
<term>Ostéoporose</term>
<term>Anticancéreux</term>
</keywords>
<keywords scheme="Wicri" type="geographic" xml:lang="fr">
<term>Allemagne</term>
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<term>Prospective</term>
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<div type="abstract" xml:lang="en">Background: Adjuvant treatment of hormone receptor-positive breast cancer in postmenopausal women with aromatase inhibitors may be associated with increased bone loss. Patients and methods: Two hundred patients were randomised to receive exemestane or tamoxifen as adjuvant treatment of hormone receptor-positive breast cancer. Bone mineral density (BMD) was assessed by dual-energy X-ray absorptiometry at baseline and after 6 and 12 months treatment. Results: One hundred and sixty-one patients were assessable. Tamoxifen treatment resulted in a 0.5% increase from baseline in BMD at the spine, which was maintained at 12 months. Exemestane-treated patients experienced a 2.6% decrease from baseline in BMD at the spine at 6 months and a further 0.2% decrease at 12 months. There were significant differences in the changes in BMD between tamoxifen and exemestane at 6 and 12 months (P = 0.0026 and P = 0.0008, respectively). The mean changes in BMD from baseline at the total hip were also significantly different between exemestane and tamoxifen at 6 and 12 months (P = 0.0009 and P = 0.04, respectively). There was no difference between tamoxifen and exemestane in mean changes in BMD from baseline at the femoral neck. Conclusions: Exemestane treatment resulted in an increase in bone loss at 6 months; bone loss stabilised after 6- to 12-month treatment.</div>
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