Long-term effect of exemestane therapy on bone mineral density supported by bisphosphonates: Results of 5-year adjuvant treatment in postmenopausal women with early-stage breast cancer.

PURPOSE: Unlike anastrozole, the effect of long-term exemestane (EXE) therapy on bone mineral density (BMD) is still unknown. We assessed changes in BMD from baseline to 5 years of EXE treatment.

METHODS: Postmenopausal women with endocrine-responsive breast cancer receiving EXE as adjuvant therapy were enrolled in this study. EXE was administered for 5 years. The BMD of the lumbar spine (LS) and femoral neck (FN) was assessed by dual-energy X-ray absorptiometry at baseline and after 6 months and 1, 2, 3, 4, 5 and 6 years. Oral bisphosphonate (Bis) treatment was initiated when patients were diagnosed with osteoporosis with a T-score of -2.5 or lower.

RESULTS: Eighty-one patients were enrolled in the study between 2005 and 2010. The median follow-up period was 54.9 months. Forty-two patients were administered Bis. Overall, the BMD of the LS increased by 7.3% from baseline and that of the FN increased by 3.4% with 5 years of EXE treatment. At the sixth year (i.e. 1 year after the treatment), BMD of the LS increased by 7.2% and that of the FN increased by 5.7%. Furthermore, the BMD of the FN increased by 12.0% in patients treated upfront with Bis and by 1.2% in those not treated with Bis (P = 0.0262). Fractures developed in nine patients (11.1%) and seven (8.6%) had fragility fractures.

CONCLUSION: Oral Bis improves BMD of the FN in patients with osteoporosis. Five-year EXE treatment with proper addition of Bis helps maintain the BMD of the LS and FN at the sixth year.