Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings.
Vol 23, No 16S (June 1 Supplement), 2005: 531
© 2005 American Society of Clinical Oncology

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Abstract

Changes in bone metabolism after 2 years’ treatment with exemestane (E) in postmenopausal women with early breast cancer (EBC) at low risk: Follow-up (FU) results of a randomized placebo-controlled study

Haukeland Sykehus, Bergen, Norway; Sentralsjukehuset i Rogaland, Stavanger, Norway; Det Norske Radiumhospital, Oslo, Norway; Universitetetsykehuset i Nord-Norge, Tromso, Norway; St. Olavs Hosp, Trondheim, Norway; Ullevål Universitetssykehus, Oslo, Norway; Pharmacia Italia S. p. A. /Pfizer Group, Milano, Italy

531

Background: Aromatase inhibitors may increase bone loss. We reported (Proc Am Soc Clin Oncol 2004; 23:6, Abs 518) that a 2-year treatment with E (Aromasin), a steroidal aromatase inactivator, had a non-significant effect on annual rate of bone mineral density (BMD) loss in the lumbar spine (LS) and a small significant effect on the femoral neck (FN) as compared to placebo (P) in EBC patients (pts). E treatment induced a significant increase in all bone turnover markers. Methods: Randomized, double-blind study evaluating the effect of E (25 mg/day p.o.) or P on bone metabolism in 147 pts. BMD in the LS and the FN was measured by dual-absorptiometry before, during (at 6, 12 and 24 months) treatment and at 1-year FU after discontinuation. Bone resorption and formation markers were also assessed. Here we report results for the 57 pts on E and 64 pts on P evaluated for BMD up to 1-year FU. Results: At 1-year FU LS BMD loss in the E group improved as compared to end of treatment (mean % change from baseline at month 24 and 1-year FU: –3.59% and - 2.16%, t-test: p= 0.0003), albeit remaining greater than P (mean % change at 1-year FU: –1.61%). The effects seen in the FN BMD at the end of E therapy extended up to 1-year FU (mean % change at month 24 and 1-year FU: –4.42% and –4.28%, t-test: p= NS) and remained greater than P (mean % change at 1-year FU: –2.73%). Within 6 month of E withdrawal, bone resorption markers returned to or below baseline values and were not significantly different from P, while bone formation markers remained moderately increased. Conclusions: After E withdrawal, the LS BMD tended to normalize while the FN BMD loss stabilized; the effect on bone resorption but not on formation markers faded within 3–6 months after withdrawal.

Author Disclosure

Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Pharmacia Italia S.p.A./ Pfizer Group AstraZeneca, Novartis, Pfizer

Abstract presentation from the 2005 ASCO Annual Meeting