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Lasofoxifene cut breast ca by 81% in phase III trials: fractures decreased 24% at 0.5 mg/day.(NEWS)
SAN ANTONIO -- The investigational selective estrogenreceptor modulator lasofoxifene is shaping up as a pearl of a drug for the prevention of breast cancer, clinical trial results indicate.
Lasofoxifene (Fablyn) slashed the incidence of estrogen receptor--positive breast cancer by 81%, compared with placebo, over a 5-year period in the 8,556-woman phase III PEARL (Postmenopausal Evaluation and Risk Reduction With Lasofoxifene) trial, Andrea Z. LaCroix, Ph.D., reported at the San Antonio Breast Cancer Symposium. That's a considerably more dramatic preventive effect than the roughly 50% reductions seen in earlier placebo-controlled trials of tamoxifen and raloxifene, the two approved agents for primary prevention of breast cancer, added Dr. LaCroix, professor of epidemiology at the University of Washington, Seattle.
Reduction of estrogen receptor-positive breast cancer was a coprimary end point in PEARL, together with nonvertebral fractures, which were decreased by a highly significant 24% in women randomized to lasofoxifene at 0.5 mg/day.
Scientific program cochair Dr. Powel H. Brown, who was not involved in PEARL, hailed the results as "remarkable."
"An 81% reduction in the risk of estrogen receptor-positive breast cancer is an amazing finding. Lasofoxifene was actually more effective than either tamoxifen or raloxifene in reducing the risk of estrogen receptor-positive breast cancer. There was a reduced risk of stroke, which is remarkable as well. These things are supposed to increase the risk of stroke, not reduce it," said Dr. Brown, professor of medicine at Baylor College of Medicine, Houston.
The PEARL participants (aged 59-80 years) were enrolled in 32 countries. All had osteoporosis at entry. They were randomized to placebo or lasofoxifene at 0.25 or 0.5 mg/day.
During 5 years of follow-up, 21 women in the placebo arm developed estrogen receptor-positive breast cancer, as did 11 in the lower-dose and 4 ...
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