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67th Annual Meeting Abstracts
Improvement In Breast Tenderness Demonstrated In Men On Toremifene 80mg Compared To Placebo In Phase III ADT Trial
David McLeod1, Robert W Given2, Gregg W Eure2, *Ronald Morton3
1Walter Reed Army Medical Center, Center for Prostate Disease Research, Washington, DC;2Urology of Virginia, Norfolk, VA;3GTx, Inc, Memphis, TN
Introduction:
Androgen deprivation therapy (ADT) results in castrate levels of testosterone and estrogen which lead to estrogen deficiencies; e.g., gynecomastia. A recent randomized, double-blind, placebo controlled trial showed toremifene 80 mg prevents fractures in men on ADT. Because of the prevalence of gynecomastia in this population, we assessed the effect of toremifene on the incidence and severity of breast enlargement and tenderness.
Materials & Methods:
1389 men with PCa were randomized to receive toremifene or placebo. The primary endpoint was new morphometric vertebral fractures. Secondary endpoints included gynecomastia, hot flashes and changes in BMD and lipids. The modified intent to treat (MITT) population (446 toremifene and 467 placebo subjects) was defined as men who received at least 1 dose of study medication and had at least 1 on-study radiograph. Breast tenderness was assessed on initial physical examination and subsequently scored as 1st or 2nd degree worsening, unchanged, or 1st or 2nd degree improved. Each assessment was performed at baseline and months 3, 6, 12, 18, and 24.
Results:
A positive effect on breast tenderness was observed with more subjects scored as improved and fewer subjects scored as worsened in the toremifene group compared to placebo (p=0.0034). In subjects with documented use of bicalutamide (toremifene=99, placebo=101) there was a highly significant improvement in breast tenderness (p=0.0008).
Conclusions:
Toremifene demonstrated a positive effect on mastalgia in men on ADT. These results suggest that treatment with a SERM can reduce breast tenderness in this patient population.
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