In a four year clinical trial called the STAR trial, the cancer prevention drug Tamoxifen and the osteoporosis drug Raloxifene were compared side by side in post-menopausal women with a high risk of developing breast cancer. Dr. Powel Brown is the STAR principal investigator at Baylor College of Medicine. He says the results of the study are exciting.
"In my opinion, Raloxifene is now the winner of the STAR trial in that it was equally effective in reducing the incidence of breast cancer, at least invasive breast cancer, and that it was associated with fewer side effects. Simply stated, if you were presented with that option: which would you rather take, Tamoxifen or Raloxifene? with the information we have now, I think a reasonable person would say I'd prefer the Raloxifene medicine."
In the study, both drugs reduced the risk of developing breast cancer by 50 percent. But the FDA-approved Tamoxifen carries an increased incidence of unterine cancer and blood clots. Dr. Therese Bevers is the STAR principal investigator for M.D. Anderson Cancer Center. She says there are about 9 million women in the U.S. who are at high risk of developing breast cancer and Raloxifene could be the drug of choice for prevention.
"Raloxifene was just as effective as Tamoxifen in preventing the invasive breast cancers. We did see that Raloxifene had fewer of the serious risk and side effects as compared to Tamoxifen. Specifically, 36 percent fewer endometrial cancers, 29 percent fewer blood clots related to deep vein thrombosisal pulmonary embolis and fewer risk of cataracts."
Raloxifene also resulted in fewer minor side effects such as hot flashes, cold sweats and gynocological problems. The study is the largest North American breast cancer prevention trial. More than 19,000 women participated in the trial, with Texas contributing the largest number of participants. According to the American Cancer Society, an estmated 13,150 cases of breast cancer are expected to occur in Texas this year. More than 2,500 Texas women will die of the disease in 2006. Raloxifene is approved by the FDA for the prevention and treatment of osteoporosis. The drug's maker, Eli Lilly can now apply to the FDA to have the drug approved for breast cancer prevention. If the company seeks FDA approval, Raloxifene could be available to post-menopausal women with high risk of breast cancer by the end of the year. Laurie Johnson Houston Public Radio News.