Drug Improves BMD, Lipids in ADT Recipients

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ORLANDO—Toremifene increases bone mineral density (BMD) and improves lipid profiles in men receiving androgen deprivation therapy (ADT) for advanced prostate cancer, according to findings presented here at the third annual Prostate Cancer Symposium.

Toremifene citrate is an oral selective estrogen-receptor modulator (SERM) that helps oppose the ac-tions of estrogen in the body. Licensed in the United States under the brand name Fareston, toremifene citrate is approved for use in advanced breast cancer. It is being evaluated for preventing prostate cancer under the brand name Acapodene.

The new findings are based on a planned interim analysis of data on 200 men from an ongoing study of 1,392 men aged 50 years and older treated with ADT for at least six months. The 200 men were at elevated risk of fracture either because they were older than 70 years or had evidence of osteoporosis or osteopenia as determined by dual energy X-ray absorptiometry at baseline. The subjects were randomly assigned to receive toremifene 80 mg/day or placebo. The interim analysis looked at 12-month changes in the first 200 men in the 24-month study.

At 12 months, toremifene-treated patients experienced a mean 1.6% increase in lumbar spine BMD and mean 0.7% and 0.2% BMI increases in the total hip and femoral neck. In contrast, men in the placebo arm experienced a mean 0.7% decrease in lumbar spine BMI and mean 1.3% and 1.3% decreases in total hip and femoral neck BMI.

In previous randomized trials of SERMs, similar BMD improvements translated into significant decreases in fracture risk, according to lead researcher Matthew R. Smith, MD, PhD, who presented study findings. Compared with placebo recipients, toremifene-treated patients had significant decreases in total and LDL cholesterol and triglyceride levels (7.1%, 9.0%, and 20.1% decreases, respectively). In addition, toremifene significantly increased HDL cholesterol levels by 5.4%.

"This favorable improvement in lipid profiles may translate into an improvement in cardiovascular outcomes in men on androgen deprivation therapy," said Dr. Smith, associate professor of medicine at Harvard Medical School and Director of Research in Genitourinary Malignancies at Massachusetts General Hospital Cancer Center in Boston. In previous studies, other agents, including bisphosphonates, have also been associated with significant im-provements in BMD in men receiving ADT for prostate cancer, he noted.

"However, these results suggest that toremifene has the potential not only to reduce the risk of fractures in men with advanced prostate cancer, but also to improve lipid levels, addressing another significant side effect of the standard treatment for this disease."

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