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Panel’s Report Urges Breast Cancer Drugs for Healthy Higher-Risk Women Breast Cancer Drugs Urged for Healthy High-Risk Women
(35 minutes later)
Should healthy women take drugs to lower their risk of breast cancer?Should healthy women take drugs to lower their risk of breast cancer?
On Monday, an influential panel of experts said that the answer is yes, but only for certain women who are at increased risk because of breast cancer in the family or a personal history of breast lumps or other problems. Two drugs, tamoxifen and raloxifene, can lower the risk, and may be worth taking even though both can have serious adverse effects like blood clots and strokes, the experts said.On Monday, an influential panel of experts said that the answer is yes, but only for certain women who are at increased risk because of breast cancer in the family or a personal history of breast lumps or other problems. Two drugs, tamoxifen and raloxifene, can lower the risk, and may be worth taking even though both can have serious adverse effects like blood clots and strokes, the experts said.
The panel, the United States Preventive Services Task Force, recommended that for healthy women ages 40 to 70, doctors help assess the odds of breast cancer and offer to prescribe one of the drugs for patients whose risk is above average — but only if their chances of developing blood clots and strokes is low.The panel, the United States Preventive Services Task Force, recommended that for healthy women ages 40 to 70, doctors help assess the odds of breast cancer and offer to prescribe one of the drugs for patients whose risk is above average — but only if their chances of developing blood clots and strokes is low.
Because of the adverse effects, the panel also advised that the drugs not be prescribed for women unless they are at increased risk of breast cancer.Because of the adverse effects, the panel also advised that the drugs not be prescribed for women unless they are at increased risk of breast cancer.
“There is evidence of benefit for certain women,” said Dr. Wanda K. Nicholson, a task force member and an associate professor of obstetrics and gynecology at the University of North Carolina School of Medicine in Chapel Hill.“There is evidence of benefit for certain women,” said Dr. Wanda K. Nicholson, a task force member and an associate professor of obstetrics and gynecology at the University of North Carolina School of Medicine in Chapel Hill.
Dr. Nicholson said she recommended the drugs for some of her own higher-risk patients. Some take them; some choose not to.Dr. Nicholson said she recommended the drugs for some of her own higher-risk patients. Some take them; some choose not to.
“The take-home point for women is to have that initial conversation with their provider,” she said.“The take-home point for women is to have that initial conversation with their provider,” she said.
The task force recommendations are being published in draft form and are open for public comment until May 13. An analysis of research on which the recommendations were based is also being published on Monday in Annals of Internal Medicine. The task force recommendations are being published in draft form and are open for public comment until May 13. An analysis of research on which the recommendations were based was also being published in Annals of Internal Medicine. The advice matches that given by the task force in 2002 (the group re-evaluates many of its subjects once a decade), though the earlier report stopped short of telling doctors to offer to prescribe the drugs. Members of the group said they relied on a wealth of new data that helped confirm and clarify the risks and benefits of the two drugs, and how they measure up against one another.
Tamoxifen and raloxifene have been recommended for years for women whose odds of developing breast cancer are higher than average. Both drugs block the effects of estrogen, and can lower the risk of the type of breast cancer whose growth is stimulated by the hormone. About 75 percent of breast cancers fall into that category. Tamoxifen is more commonly used to prevent recurrences in women who have already had breast cancer, and raloxifene is most often prescribed to prevent fractures in women with osteoporosis. Tamoxifen and raloxifene have been recommended for years for women whose odds of developing breast cancer are higher than average. Both drugs block the effects of estrogen, and can lower the risk of the type of breast cancer whose growth is stimulated by the hormone. About 75 percent of breast cancers fall into that category. Tamoxifen is more commonly used to prevent recurrences in women who have already had breast cancer, and raloxifene is most often prescribed to prevent fractures in women with osteoporosis. Tamoxifen can also decrease the risk of fractures.
Tamoxifen can also lower the risk of fractures. Doctors may see these drugs as a rare opportunity to lower the risk of cancer, but some women see them as simply trading one risk for another. Many healthy women, even if they are at increased risk, refuse the drugs, asking why they should take pills to lower the odds of a disease they may never get anyway, especially when the drugs can have dangerous or unpleasant side effects.
Doctors may see these drugs as a rare opportunity to lower the risk of cancer, but some women see them as simply trading one risk for another. Many healthy women, even if they are at increased risk, refuse the drugs, asking why they should take pills to lower the odds of a disease they may never get anyway, especially when the drugs can have dangerous or unpleasant side effects. Besides increasing the risk of blood clots and strokes, the drugs can also cause hot flashes and vaginal problems that can ruin a woman’s sex life. In addition, tamoxifen can lead to cataracts and uterine cancer. Besides increasing the risk of blood clots and strokes, the drugs can also cause hot flashes and vaginal problems like dryness and pain that can damage a woman’s sex life. In addition, tamoxifen can lead to cataracts and uterine cancer.
In the United States, 232,000 new cases of breast cancer are expected this year, and about 40,000 women will die from the disease.In the United States, 232,000 new cases of breast cancer are expected this year, and about 40,000 women will die from the disease.
The group estimated that among 1,000 women with an increased risk of breast cancer, there would be 23.5 cases of invasive breast cancer over five years. If the women took one of the drugs, 7 to 9 cases would be prevented over five years.The group estimated that among 1,000 women with an increased risk of breast cancer, there would be 23.5 cases of invasive breast cancer over five years. If the women took one of the drugs, 7 to 9 cases would be prevented over five years.
But an extra 4 to 7 women per 1,000 taking the drugs would develop blood clots during that time, and there would be 4 extra cases of uterine cancer per 1,000 women taking tamoxifen — an approximate doubling of both of those risks. But an extra 4 to 7 women per 1,000 taking the drugs would develop blood clots during that time, and there would be 4 extra cases of uterine cancer per 1,000 women taking tamoxifen — an approximate doubling of both of those risks. Women who had surgery to remove the uterus would not have to worry about that type of cancer.
The task force considered a woman likely to benefit from the drugs if her odds of developing breast cancer during the next five years were 3 percent or higher. One common method of estimating the risk uses an online tool that asks a series of questions about the patient’s age and her personal and family medical history. It then calculates an estimated risk, and compares it to the average for women of that age. The task force considered a woman likely to benefit from the drugs if her odds of developing breast cancer during the next five years were 3 percent or higher. One common method of estimating the risk uses an online tool that asks a series of questions about the patient’s health and family history. It calculates her risk, and compares it to the average for women of that age.
According to this method, at age 40 the average woman has a 0.6 percent risk of developing breast cancer over the next five years; at age 50, 1.3 percent; at age 60, 1.8 percent; at age 70, 2.2 percent. Plugging risk factors into the calculator, like mothers or sisters with breast cancer, or a personal history of breast biopsies, even benign ones, makes the risk go up. At age 40 the average woman has a 0.6 percent risk of developing breast cancer over the next five years; at age 50, 1.3 percent; at age 60, 1.8 percent; at age 70, 2.2 percent. Plugging risk factors into the calculator, like mothers or sisters with breast cancer, or a personal history of breast biopsies, makes the risk go up.
But experts warn that although these estimates can be useful in predicting the risk for large populations of women, they do not work very well for individuals. But experts warn that although these estimates can be useful in predicting the risk for large populations, they do not work very well for individuals.
The report from the task force states: “Most women identified as ‘high risk’ will not develop breast cancer, and the majority of breast cancer cases will arise in women who are not identified as having increased risk.” The group also noted that the type of risk calculator generally used is not recommended for women who are known or suspected to have mutations in BRCA genes, which greatly increase the risk of breast cancer. The report from the task force states: “Most women identified as ‘high risk’ will not develop breast cancer, and the majority of breast cancer cases will arise in women who are not identified as having increased risk.” The group also noted that the type of risk calculator generally used is not recommended for women with mutations in BRCA genes, which greatly increase the risk of breast cancer.
Dr. Heidi Nelson, a research professor at Oregon Health and Science University in Portland, Oregon, who directed the data analysis used by the task force, said it was an especially difficult dilemma to weigh the risks and benefits of prescribing drugs with significant risks to healthy people. Dr. Heidi Nelson, a research professor at Oregon Health and Science University in Portland, Oregon, led a team that analyzed several large controlled studies. They found that the drugs could reduce the incidence of invasive cancer by 30 percent to 68 percent, compared with placebos. A new finding is that tamoxifen had a greater protective effect than raloxifene. But it was more likely to cause blood clots. Women over 50 were more likely to develop blood clots from the drugs, or uterine cancer while taking tamoxifen.
She and other researchers analyzed multiple studies that found that the drugs could reduce the incidence of invasive cancer by 30 percent to 68 percent, compared with placebos. When the drugs were compared with each other, tamoxifen had a greater protective effect than raloxifene. But it was more likely to cause blood clots. Older women, meaning those over 50, were more likely to develop blood clots from the drugs, and to develop uterine cancer while taking tamoxifen. Dr. Nelson noted that some studies found women would be more willing to take the drugs if they could prevent breast cancer entirely, rather than just lowering the risk, or if the drugs had no side effects.
Dr. Nelson noted that some studies found women would be more willing to take the drugs if they could truly prevent breast cancer entirely, rather than just lowering the risk, or if the drugs had no side effects. One thing that might help doctors and patients, she said, is to keep in mind that the adverse effects were more common in older women. In addition, she said, younger women who had had biopsies showing a condition called atypical hyperplasia did seem to be at added risk and might be among the best candidates for taking the drugs. She said the data suggested that a five-year course of treatment could have protective effects that would continue even when the drugs were stopped.
One thing that might help doctors and patients, she said, is to keep in mind that the adverse effects were more common in older women. In addition, she said, some risk factors seemed to carry more weight than others, and younger women who had had biopsies showing a condition called atypical hyperplasia did seem to be at added risk and might be among the best candidates for taking the drugs. She said the data suggested that a five-year course of treatment could have protective effects that would continue even when the drugs were stopped.