A randomized, placebo-controlled trial (NCIC CTG MAP.2) examining the effects of
exemestane on mammographic breast density, bone density, markers of bone
metabolism and serum lipid levels in postmenopausal women.
Author(s): Cigler T, Richardson H, Yaffe MJ, Fabian CJ, Johnston D, Ingle JN, Nassif E,
Brunner RL, Wood ME, Pater JL, Hu H, Qi S, Tu D, Goss PE.
Affiliation(s): Weill Cornell Medical College, New York, NY, USA.
Publication date & source: 2011, Breast Cancer Res Treat. , 126(2):453-61
We hypothesized that exemestane (EXE) would reduce mammographic breast density
and have unique effects on biomarkers of bone and lipid metabolism. Healthy
postmenopausal women were randomized to EXE (25 mg daily) or placebo (PLAC) for
12 months and followed for a total of 24 months. The primary endpoint was change
in percent breast density (PD) between the baseline and 12-month mammograms and
secondary endpoints were changes in serum lipid levels, bone biomarkers, and bone
mineral density (BMD). Ninety-eight women were randomized (49 to EXE; 49 to PLAC)
and 65 had PD data at baseline and 12 months. Among women treated with EXE, PD
was not significantly changed from baseline at 6, 12, or 24 months and was not
different from PLAC. EXE was associated with significant percentage increase from
baseline in N-telopeptide at 12 months compared with PLAC. No differences in
percent change from baseline in BMD (lumbar spine and femoral neck) were observed
between EXE and PLAC at either 12 or 24 months. Patients on EXE had a
significantly larger percent decrease in total cholesterol than in the PLAC arm
at 6 months and in HDL cholesterol at 3, 6, and 12 months. No significant
differences in percent change in LDL or triglycerides were noted at any time
point between the two treatment arms. EXE administered for 1 year to healthy
postmenopausal women did not result in significant changes in mammographic
density. A reversible increase in the bone resorption marker N-telopeptide
without significant change in bone specific alkaline phosphatase or BMD during
the 12 months treatment period and 1 year later was noted. Changes in lipid
parameters on this trial were modest and reversible.
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