Annals of Oncology Advance Access published online on February 13, 2009
Annals of Oncology, doi:10.1093/annonc/mdn762
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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
1 Department of Gynecology, University Hospital of Giessen and Marburg, Marburg
2 Helios Kliniken, Aue
3 Klinikum Mutterhaus der Borromaerinnen, Trier
4 Onkologische Schwerpunktpraxis, Goslar, Germany
5 Pfizer, Specialty Brand Team Europe, Paris, France
6 Independent Clinical Research Consulting, Bölschestrasse, Berlin
7 University of Mannheim, Mannheim
8 Freiburg University, Frauenklinik, Freiburg, Germany
* Correspondence to: Prof. P. Hadji, University Hospital of Giessen and Marburg, Baldingerstrasse, 35033 Marburg, Germany. Tel: +49-6421-286-6486; Fax: +49-6421-286-7070; E-mail: hadji{at}med.uni-marburg.de
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.
aromatase inhibitor, bone mineral density, early breast cancer, exemestane, fracture, osteoporosis
Received for publication September 5, 2008. Revision received November 20, 2008. Accepted for publication November 24, 2008.