Aromasin exemestane: Additional Phase III data

Researchers at University Health Network and colleagues reported data from a subgroup of 351 postmenopausal women without osteoporosis in the double-blind, international Phase III MAP.3 trial in 4,560 postmenopausal women who were at a moderately increased risk for breast cancer showing that once-daily 25 mg Aromasin significantly reduced mean total volumetric bone mineral density (BMD) from baseline to 2 years at both the distal radius (6.1% vs. 1.8%, p<0.0001) and distal tibia vs. placebo (5% vs. 1.3%, p<0.0001). Aromasin also significantly reduced mean cortical thickness at both the distal radius (7.9% vs. 1.1%, p<0.0001) and distal tibia vs. placebo (7.6% vs. 0.7%, p<0.0001). Furthermore, decline in areal BMD at 2 years, as measured by dual-energy X-ray absorptionmetry, was significantly greater in patients receiving Aromasin at the lumbar spine (2.4% vs. 0.5%, p<0.0001), total hip (1.8% vs. 0.6%, p=0.004) and femoral neck vs. placebo (2.4% vs. 0.8%, p=0.002). The trial was sponsored by the National Cancer Institute of Canada Clinical Trials Group. The researchers concluded that women taking Aromasin for the primary prevention of breast cancer should weight their individual risks and benefits, and that regular bone monitoring plus adequate calcium and vitamin D supplementation are important for women taking the product. Data were published in The Lancet Oncology. ...