Researchers from the Massachusetts General Hospital have reported at the 2008, 99th annual meeting of the American Association for Cancer Research (AACR) in San Diego, April 12-16.1 that Fareston® (toremifene citrate) decreases the risk of new vertebral fractures in men with prostate cancer receiving androgen deprivation therapy (ADT).

As we all know from our own personal experiences the consequence of ADT includes hypogonadism, which leads to impotence, hot flashes, cardiovascular morbidity, abnormal lipid profiles, and osteoporosis. The use of Bisphosphonates has been effective in preventing or treating bone loss due to ADT. Fareston is a selective estrogen receptor modulator (SERM) that is approved for treatment of advanced breast cancer. It also decreases osteoporosis and prevents fractures in postmenopausal women.

Fareston has also been evaluated in prostate prevention trials in men with early prostatic dysplasia. A previous study from the same researchers reported that the administration of Fareston may improve bone density and improve lipid profiles in men treated with ADT for prostate cancer.

The current study involved 1,389 men with prostate cancer who were receiving ADT. They were randomly allocated to receive Fareston or placebo for a 24 month period. The study revealed that 1.5% of men in the Fareston group had new vertebral fractures compared to 3.5% in the control group.

• Fareston increased bone mineral density of the spine, hip, and femoral neck.
• Fareston increased high-density lipoprotein.
• Fareston also decreased hot flashes and breast pain.
• Fareston was associated with an increased incidence of thromboembolic events than in the control group (17 versus 7).

These data confirm and extend previous observations on the effectiveness of Fareston in patients receiving ADT.

In North American clinical trials with women diagnosed with breast cancer, the most commonly observed side effects with FARESTON® were hot flashes, sweating, nausea, and vaginal discharge. Obviously, we do not have to worry about the vaginal discharge!

1 Smith M, Morton RA, Wallace H, et al. A phase III randomized controlled trial of toremifene to prevent fractures and other adverse effects of androgen therapy in men with prostate cancer. Proceedings of the 99th Annual Meeting of the American Association for Cancer Research;2008;abstract LB-241.

Joel T Nowak MA, MSW