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MAAUA 68th Annual Meeting Abstracts
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Toremifene Demonstrates Reduction In Fracture Risk In Men Less Than 80 Years Of Age on androgen deprivation therapy
Robert Given1, Greg Eure1, *Michael Brawer2
1Urology of Virginia, Sentara Medical Group, Norfolk, VA;2GTx, Inc, Memphis, TN
Introduction:
Androgen deprivation therapy (ADT) in prostate cancer is associated with increased fracture risk. In a Phase III trial toremifene, a selective estrogen receptor modulator (SERM), significantly decreased fracture incidence in men receiving ADT.
There was an increase in venous thromboembolic events (VTE) primarily in men on toremifene ≥80 years of age . VTEs occurred in 1.5% and 2.5% of men <80, ≥80 respectively in the overall study. We sought to identify the patient population with the greatest benefit/risk profile.
Materials & Methods:
In this subset analysis of men <80 years of age receiving ADT for prostate cancer, 430 men received toremifene 80 mg and 417 received placebo. The primary endpoint was new vertebral fractures. Secondary endpoints included fragility fractures and bone mineral density (BMD).
Results:
Toremifene demonstrated a 79.5% relative risk reduction in the incidence of new vertebral fractures (CI0.95: 29.8%-94.0%; P<0.005). Absolute reduction was 3.8% (4.8% placebo, 1.0% toremifene). Toremifene significantly increased BMD at sites measured (P<0.001 for all comparisons). There was a concomitant decrease in bone turnover markers (P<0.001 for all comparisons. VTEs occurred in 2.1% of the toremifene versus 1.0% (P=0.26) placebo group. Other adverse events were similar between groups
Conclusions:
Toremifene significantly decreased the incidence of new vertebral fractures in men <80 years receiving ADT. Toremifene significantly improved BMD. Risk of VTE was lower than the overall study population. These results suggest an improved benefit/risk profile in men <80 receiving ADT.
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