ORLANDO — Toremifene citrate, a selective estrogen receptor modulator, increased bone mineral density and improved lipid levels in men receiving androgen deprivation therapy for advanced prostate cancer, investigators reported at a symposium on prostate cancer sponsored by the American Society of Clinical Oncology.
In a planned interim analysis, toremifene (80 mg/day) given orally for 12 months significantly increased BMD in the lumbar spine, hip, and femoral neck in men randomized to the drug. Conversely, men who received placebo experienced decreases in BMD at these sites, said lead investigator Dr. Matthew R. Smith, of the department of medicine at Massachusetts General Hospital and Harvard Medical School, Boston.
In a second interim analysis of lipid results, toremifene significantly decreased total cholesterol by an average of 7.1%, and also decreased LDL cholesterol by 9.0% and triglyceride levels by 20.1%. The total cholesterol: HDL cholesterol ratio dropped an average of 11.7%, whereas HDL cholesterol levels increased by 5.4%, Dr. Smith said at the symposium, which was cosponsored by the Society of Urologic Oncology and the American Society for Therapeutic Radiology and Oncology.
Androgen deprivation therapy, either with bilateral orchiectomy or treatment with GnRH agonists, is the mainstay of treatment for metastatic prostate cancer. This therapy has also become routine for many men with nonmetastatic disease. But the treatment is not without considerable side effects, including an increased risk of fracture and cardiovascular disease.
Currently, about a third of the estimated 2 million prostate cancer survivors in the United States receive treatment with GnRH agonists, and this expanded use in a greater proportion of men—especially in those who have long life expectancies—has heightened concerns about these deleterious effects, Dr. Smith said.
In the study, 1,392 men aged 50 years and older who were on androgen deprivation therapy for metastatic disease were randomly assigned to toremifene or placebo for 2 years. These analyses were done at the midpoint of the randomized, controlled trial; BMD and changes in lipid profiles were secondary end points. The primary end point, vertebral fractures in the two arms, will be analyzed at the end of 2 years.
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