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

• Published in: Annals of oncology Vol. 20; no. 7; pp. 1203 - 1209
• Main Authors: Hadji, P., Ziller, M., Kieback, D.G., Dornoff, W., Tessen, H.W., Menschik, T., Kuck, J., Melchert, F., Hasenburg, A.
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier Ltd 01-07-2009; Oxford University Press; Oxford Publishing Limited (England)
• Subjects: Aged; Androstadienes - adverse effects; Androstadienes - therapeutic use; Antineoplastic agents; Antineoplastic Agents, Hormonal - adverse effects; aromatase inhibitor; Aromatase Inhibitors - adverse effects; Aromatase Inhibitors - therapeutic use; Biological and medical sciences; Bone Density - drug effects; Bone Density Conservation Agents - adverse effects; bone mineral density; Breast Neoplasms - drug therapy; Chemotherapy, Adjuvant; Diseases of the osteoarticular system; early breast cancer; exemestane; Female; fracture; Gynecology. Andrology. Obstetrics; Humans; Mammary gland diseases; Medical sciences; Middle Aged; osteoporosis; Osteoporosis. Osteomalacia. Paget disease; Pharmacology. Drug treatments; Postmenopause; Prospective Studies; Tamoxifen - adverse effects; Tamoxifen - therapeutic use; Treatment Outcome; Tumors; Europe; Germany; early breast cancer; bone mineral density; exemestane; osteoporosis; aromatase inhibitor; fracture; Steroid; Antineoplastic agent; Breast disease; Antiestrogen; Diseases of the osteoarticular system; Fracture; Antihormone; Estrogen synthase; Osteoarticular system; Prospective; Osteoporosis; Randomization; Selective estrogen receptor modulator; Clinical trial; Non steroid compound; Aromatase inhibitor; Enzyme; Health; Enzyme inhibitor; Breast cancer; Malignant tumor; Exemestane; Trauma; Androstane derivatives; Tamoxifene; Mammary gland diseases; Early; Bone mineral density; Bone; Cancer
• ISSN: 0923-7534; 1569-8041
• DOI: 10.1093/annonc/mdn762

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.