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Senior Citizen Health & Medicine
Raloxifene Makes Huge Reduction in Breast Cancer
Risk for Older Women, Especially with Disease in Family
89% reduction with family history of the
disease, 58% without
September 13, 2006 – Older women – the most likely
to develop breast cancer – and in particular those women with a family
history of the disease, found reason for a feeling of relief from the
release of a study showing Raloxifene clearly reduces their risk from
developing invasive breast cancer. Raloxifene, trade name Evista,
is a drug to prevent and treat osteoporosis and has not been approved by the federal Food and Drug Administration as an
agent to prevent breast cancer.
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Health & Medicine |
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Raloxifene, the study says, protects postmenopausal
women from developing invasive breast cancer whether they are at high or
low risk of developing the disease.
Published in the September 1 issue of Clinical
Cancer Research, the report also says that the drug appears to reduce
risk in women with a family history of breast cancer down to a similar
level to women without affected relatives.
Compared with a placebo drug, the study found that
use of raloxifene was associated with a 58 percent reduction in breast
cancer risk in women without a family history of the disease, and an 89
percent reduction in risk for women with a family history of breast
cancer.
But the researchers say they cannot explain why
protection seems greatest in women who may be genetically predisposed to
develop the disease.
"We don't know what to make of this observation,"
said Marc E. Lippman, M.D., professor in the Department of Internal
Medicine at the University of Michigan and the study's lead author. "It
could be due to chance, or there may be other factors at work that we
don't know about."
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About Raloxifene - Medline Plus |
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Why is this medication prescribed?
Raloxifene is used to prevent and treat
osteoporosis, a disease common in women past menopause, which
results in bones that break easily. Raloxifene is in a class of
medications called selective estrogen receptor modulators (SERMs).
It works by acting similar to estrogen, a female hormone
produced by the body. Like estrogen, raloxifene increases the
density of bone.
How should this medicine be used?
Raloxifene comes as a tablet to take by
mouth. It is usually taken once a day at any time, with or
without food. To help you remember to take raloxifene, take it
around the same time every day. Follow the directions on your
prescription label carefully, and ask your doctor or pharmacist
to explain any part you do not understand. Take raloxifene
exactly as directed. Do not take more or less of it or take it
more often than prescribed by your doctor.
Continue to take raloxifene even if you
feel well. Do not stop taking raloxifene without talking to your
doctor.
Ask your pharmacist or doctor for a copy
of the manufacturer's information for the patient.
Other uses for this medicine
This medication may be prescribed for
other uses; ask your doctor or pharmacist for more information.
There is interest in possible beneficial effects of raloxifene
on breast cancer risk in women.
Read more about Raloxifene at Medline
Plus -
click here
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"But our bottom-line analysis as to why raloxifene
universally reduces the risk of developing invasive cancer in women
without a family history is that it interferes with the duration and
concentration of estrogen, which acts as a tumor promoter in the
majority of breast cancers," said Dr. Lippman.
The research team conducted a new analysis of the
first large study of raloxifene, which tested the ability of the drug to
prevent vertebral fractures in 7,705 postmenopausal women diagnosed with
osteoporosis.
The secondary endpoint of this multi-center,
double-blind trial, known as MORE (Multiple Outcomes of Raloxifene
Evaluation) was the drug's effect on breast cancer development; results,
announced in 1999, demonstrated a 72 percent reduction in invasive
breast cancer incidence after four years of raloxifene treatment,
compared to use of a placebo.
The MORE trial was then extended four years to
further evaluate the effect of raloxifene on breast cancer incidence in
4,011 of the original participants. Results of this trial, known as CORE
(Continuing Outcomes Relevant to Evista), showed that eight years of
raloxifene treatment was associated with a 66 percent decrease in
invasive breast cancer incidence.
The current study was undertaken to assess the
effect of raloxifene on level of breast cancer risk (higher versus
lower) using data from both MORE and CORE.
Women at higher risk for breast cancer are
generally older and have a greater lifetime exposure to estrogen, and
the researchers found that this association held true in the reanalysis.
But they also found that raloxifene reduced breast cancer risk in both
women at lower and those at higher breast cancer risk, except for those
women who had measurably low levels of estradiol, the major estrogen
hormone in humans.
"In each variable commonly associated with a higher
risk for developing breast cancer - age older than 65, age at menopause,
a body mass index greater than 25, higher estradiol levels, prior use of
estrogen replacement and a family history of breast cancer - use of
raloxifene reduced incidence of breast cancer when compared to a placebo
drug," Dr. Lippman said. "But it also reduced incidence in each of those
variables that should have lowered risk, such as younger age, later
menopause, etc., compared to use of a placebo drug."
"We don't define the lowest limit of risk, the
point at which toxicity associated with use of raloxifene outweighs the
benefits," he said.
Dr. Lippman stressed that he cannot comment on how
raloxifene in this study measures up to tamoxifen use in general. He
explains that although these findings come on the heels of the June
publication of the 19,747-participant STAR trial, which evaluated
tamoxifen against raloxifene in reducing breast cancer risk, no
comparison can be made between the MORE, CORE and STAR clinical trials.
"These studies looked at two different groups of
women," Dr. Lippman said. "Women enrolled in STAR were at high risk for
developing breast cancer, so presumably, they had higher levels of
estrogen in general.
Women who participated in MORE and CORE were older
and had osteoporoses and it is assumed that these women generally have
lower levels of estrogen, because that is a risk factor for development
of the disorder."
Notes:
Co-authors of the study include investigators
from the University of Pittsburgh, the Angeles Clinic and Research
Institute, California Pacific Medical Center Research Institute, and Eli
Lilly & Company, which manufactures raloxifene.
The mission of the American Association for
Cancer Research is to prevent and cure cancer. Founded in 1907, AACR is
the world's oldest and largest professional organization dedicated to
advancing cancer research. The membership includes more than 24,000
basic, translational, and clinical researchers; health care
professionals; and cancer survivors and advocates in the United States
and more than 60 other countries.
AACR publishes five major peer-reviewed journals:
Cancer Research; Clinical Cancer Research; Molecular Cancer
Therapeutics; Molecular Cancer Research; and Cancer Epidemiology,
Biomarkers & Prevention. Its most recent publication, CR, is a magazine
for cancer survivors, patient advocates, their families, physicians, and
scientists. It provides a forum for sharing essential, evidence-based
information and perspectives on progress in cancer research,
survivorship, and advocacy.
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