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Toremifene Improves Lipid Profiles in Men Receiving Androgen-Deprivation Therapy for Prostate Cancer: Interim Analysis of a Multicenter Phase III Study

Matthew R. Smith, S. Bruce Malkowicz, Franklin Chu, John Forrest, Paul Sieber, K. Gary Barnette, Domingo Rodriquez, Mitchell S. Steiner

From Massachusetts General Hospital, Boston, MA; University of Pennsylvania, Philadelphia; Urology Associates of Lancaster, Lancaster, PA; San Bernadino Urology Associates, San Bernardino, CA; Urology Specialists of Oklahoma, Tulsa, OK; and GTx Inc, Memphis, TN

Corresponding author: Matthew R. Smith, MD, PhD, Massachusetts General Hospital Cancer Center, Yawkey 7038, 55 Fruit St, Boston, MA 02114; e-mail: smith.matthew{at}mgh.harvard.edu

Purpose: Androgen-deprivation therapy (ADT) is associated with greater risk of incident coronary heart disease and hospital admission for myocardial infarction; treatment-related increases in serum lipids may contribute to greater cardiovascular disease risk. We evaluated the effects of toremifene, a selective estrogen-receptor modulator, on fasting serum lipid levels in men receiving ADT for prostate cancer.

Patients and Methods: In an ongoing, multicenter, double-blind, placebo-controlled phase III fracture-prevention study, 1,389 men receiving ADT for prostate cancer were randomly assigned to receive toremifene (80 mg/d) or placebo. In this interim analysis of 188 patients, changes in fasting serum lipids from baseline to month 12 were compared between the placebo and toremifene groups.

Results: Changes in serum lipids differed significantly between the groups. Mean (± SE) total cholesterol decreased by 1.0% ± 1.7% from baseline to month 12 in the placebo group and decreased by 8.1% ± 1.4% in the toremifene group (P = .001 for between group comparison). Low-density lipoprotein (LDL) cholesterol increased by 0.8% ± 2.5% in the placebo group and decreased by 8.2% ± 2.5% in the toremifene group (P = .003). In contrast, high-density lipoprotein (HDL) cholesterol decreased by 4.9% ± 1.2% in the placebo group and increased by 0.5% ± 2.2% in the toremifene group (P = .018). Triglycerides increased by 6.9% ± 4.2% in the placebo group and decreased by 13.2% ± 3.6% in the toremifene group (P = .003).

Conclusion: Toremifene significantly decreased total cholesterol, LDL cholesterol, and triglycerides, and increased HDL cholesterol in men receiving ADT for prostate cancer.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.