Effect of toremifene in lowering total cholesterol, LDL, and triglycerides and raising HDL in prostate cancer patients on androgen deprivation therapy.
Sub-category:
Prostate Cancer
Category:
Genitourinary Cancer
Meeting:
2007 ASCO Annual Meeting
Session Type and Session Title:
General Poster Session, Genitourinary Cancer
Abstract No:
5124
Citation:
Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings Part I. Vol 25, No. 18S (June 20 Supplement), 2007: 5124
Author(s):
M. Smith, F. Chu, J. Forrest, S. B. Malkowicz, D. Price, P. Sieber, K. G. Barnette, D. Rodriguez, M. S. Steiner
Abstract:
Introduction: Androgen deprivation therapy (ADT) is the standard treatment for men with advanced prostate cancer. ADT has been shown to detrimentally affect lipids (average 9% increase in total cholesterol and 26% increase in triglycerides) and is associated with increased risk of coronary heart disease and myocardial infarction. Toremifene, a selective estrogen receptor modulator (SERM), improves bone mineral density and lipid profiles in women. An ongoing phase III trial will assess the safety and efficacy of toremifene in treating multiple side effects of ADT including osteoporosis, hot flashes, gynecomastia and lipid profiles. Given the emerging recognition of increased cardiovascular risk during ADT, an interim analysis was conducted to assess the effects of toremifene on lipid profiles in the ongoing phase III study. Methods: 1,392 men = 50 years old with histologically documented prostate cancer and receiving ADT were randomized to toremifene (80 mg/day) or placebo. An interim analysis evaluated changes in lipids from baseline to month 12 in the first 197 subjects to complete one-year follow up. The outcomes measured in this interim analysis were total cholesterol, LDL cholesterol, triglycerides, total cholesterol/HDL ratio, and HDL cholesterol. Results: Compared to treatment with placebo, toremifene decreased total cholesterol (7.1%; p=0.001 for between group comparison), LDL cholesterol (9.0%; p=0.003), and triglycerides (20.1%; p=0.009) levels, and the total cholesterol/HDL ratio (11.7%; p<0.001). Toremifene also significantly increased HDL levels (5.4%; p=0.018) compared to placebo. The effects of toremifene were observed in both statin users and nonusers. Conclusions: Toremifene decreases total cholesterol, LDL cholesterol, and triglycerides and increases HDL cholesterol in men receiving ADT for advanced prostate cancer compared to placebo. Conclusions regarding the clinical significance of these observations will be based on the full cohort of patients at the conclusion of the trial.