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Toremifene may help ward off prostate cancer
David Douglas
Last Updated: 2006-09-27 14:15:20 -0400 (Reuters Health)
NEW YORK (Reuters Health) - Treatment with toremifene appears to decrease the incidence of prostate cancer in men with high grade prostatic intraepithelial neoplasia (PIN), researchers report in the September issue of The Journal of Neurology
"For the first time we have preliminary data suggesting a possible therapy that may prevent the development of prostate cancer in men at high risk for developing this disease," lead investigator Dr. David Price told Reuters Health.
"These data are very exciting," he continued, "because we currently have no treatment available for men diagnosed with PIN."
Dr. Price, of Regional Urology, Shreveport, Louisiana and colleagues studied 514 men with high grade PIN and no evidence of prostate cancer. They were randomized to daily treatment with toremifene 20, 40 or 60 mg or to placebo for 12 months.
They underwent pre-study biopsies and were scheduled to receive another at 6 and 12 months.
At 12 months, in the 447 men who underwent at least 1 on-study biopsy, those who received toremifene 20 mg showed a significantly lower cumulative incidence of prostate cancer (24.4% versus 31.2%).
In this group, the researchers calculated that 6.8 cancers were prevented for every 100 patients treated. This, they say, compares favorably with rates in other chemprevention trials.
However, although the 20 and 40 mg doses of toremifene were associated with a lower cumulative incidence of prostate cancer than was placebo, the differences were not significant.
There also were no differences in the incidence of serious adverse incidents in any of the active treatment groups or the placebo group.
Currently, "all we can do when men are diagnosed with PIN is to tell them that they have a precancerous condition, and that we need to do another biopsy on them again in the future," Dr. Price added. "This is stressing for both patients and physicians faced with this problem."
However, he concluded, "although the data presented in this study is promising, I stress that it is preliminary, and further data from the ongoing phase III trial is needed before this can be recommended for patients in general."
J Urol 2006;176:965-971.
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