New Advances in Prostate Cancer Treatment
May 15, 2005 - 2:23:00 AM
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Toremifene May Reduce Cancer Risk in Men with Precancerous Prostate Cells
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By American Society of Clinical Oncology,
[RxPG] In a multicenter phase IIb study, the hormone drug toremifene (Acopodene) reduced the risk of prostate cancer development by nearly half in men with prostatic intraepithelial neoplasia (PIN), a precancerous condition that can progress to prostate cancer.
This is the first time that a drug has shown promise for lowering the incidence of prostate cancer in men with PIN, said lead author David Price, MD, Director of Urologic Oncology and Clinical Research at Regional Urology, LLC in Shreveport, Louisiana. Toremifene, a hormonal therapy commonly used to treat women with advanced breast cancer, may work by blocking a particular estrogen receptor that has been implicated in prostate cancer development.
While PIN does not always lead to prostate cancer, prostate cancer usually develops in men with PIN. Approximately 10% of men who undergo prostate biopsies are diagnosed with PIN, and more than 30% of men with PIN will be diagnosed with prostate cancer within a year. Currently, there is no effective treatment for PIN men with this condition receive periodic biopsies, and many live with a fear of developing cancer. Prostate cancer is the most common cancer in men in the United States more than 200,000 cases are expected to be diagnosed in 2005.
In this study, 514 men with PIN were randomly assigned to receive 20 mg, 40 mg, or 60 mg of toremifene or a placebo for one year, undergoing prostate biopsies at six and 12 months. The trial was completed in May 2004.
The cumulative incidence of prostate cancer was 31.2% in the placebo group at one year. Patients treated with 20 mg of toremifene for six months had a 22% reduction in prostate cancer, while patients who completed an entire year of treatment had a 48% reduction in prostate cancer risk (24.4% cumulative incidence). For the groups that received 40 mg and 60 mg of toremifene, the 12-month incidence of prostate cancer was also lower, but not statistically significant (18% and 25.3% risk reductions, respectively).
Toremifene was generally well tolerated, with the incidence of adverse events occurring at a similar rate in the toremifene-treated groups as the placebo group; the exception was fatigue, which occurred in 5% of patients treated with toremifene versus 3% of the placebo group.
While these data are promising, more clinical trials are needed to determine whether toremifene should be widely prescribed to men with prostatic intraepithelial neoplasia, Dr. Price added.
Publication:
American Society of Clinical Oncology Annual Meeting
On the web:
www.asco.org 
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Additional information about the news article
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Double-Blind, Placebo-Controlled Trial of Toremifene for the Prevention of Prostate Cancer in Men with High-Grade Prostatic Intraepithelial Neoplasia
D. Price, B. Stein, E. Goluboff, P. Sieber, D. Bostwick, G. Barnette, R. Boger, M. S. Steiner
Background: Toremifene, a selective estrogen receptor modulator (SERM) marketed for the treatment of breast cancer, appears to have promise in preventing prostate cancer. A randomized, double-blind, placebo-controlled study was conducted to determine the incidence of prostate cancer in men with high-grade prostatic intraepithelial neoplasia (PIN) treated with toremifene.
Methods: 514 patients with high-grade PIN and no evidence of prostate cancer at study entry were randomized to oral toremifene 20, 40, or 60 mg or placebo QD for 12 months. Patients were rebiopsied at 6 and 12 months (minimum 8 cores per biopsy). Initial and subsequent biopsies were evaluated by a central pathologist (Bostwick Laboratories) for diagnosis of high-grade PIN and prostate cancer. Cumulative risk reduction and 12-month point-estimate risk reduction were compared between each toremifene group and placebo with Mantel-Cox and Cochran-Mantel-Haenszel, respectively, stratified by study center.
Results: The number of evaluable patients (defined as having one on-study biopsy and being compliant with the protocol) was 447. Prostate cancer was diagnosed among significantly fewer patients taking toremifene 20 mg compared with placebo during the study based upon both 6-month and 12-month biopsy data (24.4% vs. 31.2% cumulative incidence, p<0<0
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