Bone drug prevents one type of breast cancer, study says

11 june 2008--The osteoporosis drug Evista can help prevent breast cancer -- but only the type fueled by the hormone estrogen, researchers reported on Tuesday.
So-called estrogen-receptor-positive breast cancer is the most common type and women who took Eli Lilly and Co's Evista were 55 percent less likely to develop this type of cancer than women taking a placebo, the researchers reported in the Journal of the National Cancer Institute.
Evista, known generically as raloxifene, is already approved for reducing the risk of breast cancer in women past menopause who have osteoporosis.
Because it acts on estrogen, scientists had assumed it would be more effective against estrogen-receptor-positive breast cancer but no one had demonstrated this.
Dr. Deborah Grady of the University of California, San Francisco and colleagues tested this, using a group of 10,000 women who originally volunteered for a study to see if the drug can lower the risk of heart disease.
The Raloxifene Use for the Heart (RUTH) trial showed that the drug did not protect against heart disease. But it did reduce the risk of invasive breast cancer by 44 percent over 5.6 years, compared with women not taking the drug.
Half the women got Evista and half got a placebo. Those who took raloxifene had a 55 percent reduction in the risk of developing invasive ER-positive breast cancer.
There was no reduction in the risk of other types of breast cancer, including noninvasive breast cancer, often called carcinoma in situ.
Raloxifene is a selective estrogen receptor modulator, or SERM, and prevents osteoporosis in a different way than other types of drugs known as bisphosphonates.
"Overall, clinical evidence is accumulating that the SERMs hold great promise in being able to control multiple diseases," Craig Jordan of the Fox Chase Cancer Research Center in Philadelphia wrote in a commentary.
"This is the good news because, until recently, it was generally believed that hormone replacement therapy was the answer to controlling the development of coronary heart disease and osteoporosis but at the price of an enhanced risk of invasive breast cancer," Jordan said.

US approves Lilly's Evista for breast cancer prevention

Fri Sep 14, 5:36 PM ET
US drug regulators have authorized the sale and use of a drug marketed as Evista to prevent aggressive breast cancer in post-menopausal women.
The drug, produced by US-based Eli Lilly, already has US Food and Drug Administration approval to prevent osteoporosis among postmenopausal women.
The approval "provides an important new option for women at heightened risk of breast cancer," said Steven Galson, director of the US Food and Drug Administration's Center for Drug Evaluation and Research. However, he cautioned that side effects are serious.
Users of the drug must watch out for side effects such as blood clots in legs and lungs, which can cause deadly stroke.
The drug is the second treatment authorized in the United States to cut the risk of invasive breast cancers, ones that can metathesize into other tissues.
Breast cancer is the second leading cause of cancer deaths among women in the United States -- 26 percent of all cancers among women.
The company warns women who are pregnant or could become pregnant not to use the drug, which in any case should not be used with hormones such as estrogen.

FDA Advisers Recommend Raloxifene (Evista) for Prevention of Breast Cancer

ROCKVILLE, Md., July 25 -- An FDA advisory panel has recommended that the agency approve raloxifene (Evista) for prevention of breast cancer in high-risk postmenopausal women.
For that indication, the panel voted 10 to 4. By a closer vote -- 8 to 6 -- the panel said raloxifene's label should be amended to allow its use for prevention of breast cancer in women with osteoporosis.
Raloxifene, a selective estrogen receptor modulator (SERM), was approved in 1997 for treatment and preventions of osteoporosis.
The FDA is expected to act by the end of September. Although the agency is not required to follow the advice of its advisory panels, it generally does.
David Harrington, Ph.D., of the Dana-Farber Cancer Institute in Boston, noted that tamoxifen, although effective, is also difficult to tolerate. Raloxifene, by comparison, is well tolerated by most women and approval of the drug would offer women another option.
A trial of 19,747 women was reported in April 2006 showing that raloxifene was as effective as tamoxifen for preventing breast cancer in high-risk women.
Results of that study, the STAR trial (Study of Tamoxifen and Raloxifene), made headlines when they were first reported at a National Surgical Adjuvant Breast and Bowel Project (NSABP) press conference.
The results were reported in greater detail when they were presented at the American Society of Clinical Oncology meeting in June 2006 and simultaneously published in the Journal of the American Medical Association.
(ASCO: Evista or Tamoxifen? The Trade-Offs in Preventing Breast Cancer)
The STAR trial randomized women to daily treatment with 60 mg of Evista or 20 mg of tamoxifen, and the women were followed for almost four years.
In previous studies tamoxifen was shown to reduce breast cancer risk by 50%. In STAR "the ability of [Evista] to reduce breast cancer was equal to tamoxifen," said Victor Vogel, M.D., M.H.S., who was director of the STAR protocol.
But there were more cases of lobular carcinoma in situ or ductal carcinoma in situ among women taking Evista than among women randomized to tamoxifen.
The START researchers have consistently downplayed this, saying this difference (81 cases in the Evista arm versus 57 cases among women taking tamoxifen) were not "really cancer., not really life-threatening disease," said Leslie Ford, M.D., associate director for clinical research at the National Cancer Institute's Division of Cancer Prevention.
Still, Len Lichtenfeld, M.D., deputy chief medical officer for the American Cancer Society, said that lobular carcinoma in situ and ductal carcinoma in situ are not insignificant events for women who are diagnosed with these conditions, which are often termed "pre-cancers". He noted that both "increase the risk of invasive cancer and both conditions are treated." (See Evista Prevents Invasive Breast Cancer in High Risk Post-Menopausal Women)
In June, the STAR trialists also revealed that women with intact uteri and women who were sexually active had more dose-limiting side effects with raloxifene than with tamoxifen.
A month later, the New England Journal of Medicine published results of the RUTH trial, a study of 10,000 postmenopausal women, that reported 44% reduction in the risk of breast cancer for raloxifene compared with placebo, but there was also a 49% increase in the relative risk of fatal stroke. (See Evista Prevents Breast Cancer but Increases Risk of Fatal Strokes)
Some panelists voiced concern about safety issues raised in those trials, which prompted the panel to recommend that the FDA establish limits for how long women should take raloxifene. They also said the FDA should require post-marketing studies to track safety.
One advocacy group, Breast Cancer Action, which is based in San Francisco, said the benefits of the drug don't outweigh the risks for most women.
In a statement, Barbara Brenner, executive director of Breast Cancer Action, said the "relatively few number of women who may avoid breast cancer by taking raloxifene is far outweighed by the risk of blood clots and strokes from the drug that thousands of other women will experience."

Lilly Drug Cuts Some Breast Cancer Risk: FDA Staff

BOSTON (Reuters) Jul 20 - Eli Lilly & Co.'s osteoporosis drug Evista reduces the risk of breast cancer in some patients, but at a cost of an increased risk of serious side effects, U.S. regulatory reviewers said in documents released on Friday.
Food and Drug Administration staff said Evista reduces the risk of invasive breast cancer in certain patients. But they said they will ask an advisory panel that meets Tuesday to weigh the benefit against serious risks, such as deep vein thrombosis, pulmonary embolism and possibly stroke death.
Evista is already approved to treat osteoporosis in women past menopause. The company is seeking approval to promote the drug for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and postmenopausal women at high risk for breast cancer.
Studies showed Evista cut the risk of breast cancer in postmenopausal women whose cancer needs the hormone estrogen to grow. There appeared to be no reduction in risk in patients whose cancers do not need estrogen to grow, the reviewers said.
Studies provide less support for the proposed new use to reduce the chances of invasive breast cancer in postmenopausal women at high risk of developing breast cancer, the reviewers said. A trial known as STAR compared Evista to a drug called tamoxifen in postmenopausal women with a high risk of developing invasive breast cancer.
Reviewers found Evista was not better than tamoxifen.