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Success of Raloxifene to Prevent Breast Cancer is
Encouraging for Senior Women
Osteoporosis drug
Raloxifene as effective as Tamoxifen without side effects
 April 19, 2006 The study released Monday showing
the drug raloxifene, currently used to prevent and treat osteoporosis in
postmenopausal women, works as well as tamoxifen in reducing breast
cancer risk, without some of the side effects, is encouraging news for
female senior citizens, who are at the highest risk of breast cancer.
The disease is expected to strike 213,000 American women this year, with
the majority being over 50 years of age. The results show less uterine
cancer and blood clots from raloxifene.
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Health & Medicine |
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These initial results are from the Study of
Tamoxifen and Raloxifene, or STAR. In STAR, both drugs reduced the risk
of developing invasive breast cancer by about 50 percent.
However, within the study, women who were
prospectively and randomly assigned to take raloxifene daily, and who
were followed for an average of about four years, had 36 percent fewer
uterine cancers and 29 percent fewer blood clots than the women who were
assigned to take tamoxifen.
Uterine cancers, especially endometrial cancers,
are a rare but serious side effect of tamoxifen. Both tamoxifen and
raloxifene are known to increase a woman's risk of blood clots.
STAR, one of the largest breast cancer prevention
clinical trials ever conducted, enrolled 19,747 postmenopausal women who
were at increased risk of the disease. Participants were randomly
assigned to receive either 60 mg of raloxifene (Evistaฎ) or 20 mg of
tamoxifen (Nolvadexฎ) daily for five years.
The trial is coordinated by the National Surgical
Adjuvant Breast and Bowel Project (NSABP), a network of cancer research
professionals, and is sponsored by the National Cancer Institute (NCI),
part of the National Institutes of Health.
"This optimistic news from STAR is a significant
step in breast cancer prevention," said John E. Niederhuber, M.D.,
currently providing leadership at NCI. "These results, once again,
demonstrate the critical importance of clinical trials in our efforts to
establish evidence-based practices."
"In 1998, the landmark Breast Cancer Prevention
Trial showed that tamoxifen could reduce the risk of invasive breast
cancer in premenopausal and postmenopausal women by nearly 50 percent,"
said Norman Wolmark, M.D., NSABP chairman.
"Today, we can tell you that for postmenopausal
women at increased risk of breast cancer, raloxifene is just as
effective, without some of the serious side effects known to occur with
tamoxifen."
Women taking either drug had equivalent numbers of
strokes, heart attacks, and bone fractures. Both raloxifene and
tamoxifen are known to protect bone health; it is estimated that half a
million postmenopausal women are currently taking raloxifene by
prescription to prevent or treat osteoporosis. Additionally, the initial
results from STAR suggest that raloxifene does not increase the risk of
developing a cataract, as tamoxifen does.
"Although no drugs are without side effects,
tamoxifen and raloxifene are vital options for women who are at
increased risk of breast cancer and want to take action," said Leslie
Ford, M.D., associate director for clinical research in NCI's Division
of Cancer Prevention. "For many women, raloxifene's benefits will
outweigh its risks in a way that tamoxifen's benefits do not."
The STAR researchers also tracked known menopausal
side effects that occur with both drugs and monitored the participants'
quality of life. The data show that side effects of both drugs were mild
to moderate in severity, and quality of life was the same for both
drugs.
Participants in STAR are now receiving information
about which drug they were taking. Women assigned to raloxifene will
continue to be provided with the drug until they have completed five
years of treatment. Those women assigned to tamoxifen can choose to
continue taking tamoxifen or to receive raloxifene to complete their
five years of treatment.
Study details include:
★
STAR enrolled 19,747 women. This data analysis is based on the 19,471
women for whom complete study information was available.
★
The numbers of invasive breast cancers in both groups of women were
statistically equivalent. Among the 9,745 women in the raloxifene group,
167 developed invasive breast cancer, compared to 163 of 9,726 women in
the tamoxifen group.
★
More than half of the women who joined STAR had had a hysterectomy and,
therefore, were not at risk of uterine cancer. For those women with a
uterus, 36 of 4,732 who were assigned to take tamoxifen developed
uterine cancers (mainly endometrial cancer) compared to 23 of 4,712
women who were assigned to take raloxifene.
★
In STAR, women in the raloxifene group had 29 percent fewer deep vein
thromboses (blood clots in a major vein) and pulmonary embolisms (blood
clots in the lung) than women in the tamoxifen group. Specifically, 87
of 9,726 women in the tamoxifen group had a deep vein thrombosis
compared to 65 of 9,745 women taking raloxifene. In addition, 54 of
9,726 women taking tamoxifen developed pulmonary embolisms compared to
35 of 9,745 women taking raloxifene.
★
The number of strokes occurring in both groups of women was
statistically equivalent: 53 of 9,726 women in the tamoxifen group and
51 of 9,745 women in the raloxifene group had a stroke during the trial.
There was no difference in deaths from strokes: 6 of 9,726 women in the
tamoxifen group and 4 of 9,745 women in the raloxifene group died from
this event. Women at increased risk of stroke (those with uncontrolled
hypertension or uncontrolled diabetes, or a history of stroke, transient
ischemic attack, or atrial fibrillation) were not eligible to
participate in STAR.
★
While tamoxifen has been shown to reduce, by half, the incidence of
lobular carcinoma in situ (LCIS) and ductal carcinoma in situ (DCIS),
raloxifene did not have an effect on these diagnoses. (LCIS and DCIS are
sometimes called noninvasive breast cancers.) Of the 9,726 women taking
tamoxifen, 57 developed LCIS or DCIS, compared to 81 of 9,745 taking
raloxifene. This result confirms data reported in 2004 in a large study
of raloxifene, the Continued Outcomes Relevant to Evista (or CORE
Trial).
"These results indicate an important and
significant breakthrough in our ongoing battle with breast cancer, and
serve as an example of the value of clinical trials in breast cancer
research and treatment," said Pat Halpin- Murphy, president and founder
of the Pennsylvania Breast Cancer Coalition and board member of the
NSABP.
"Women and their oncologists will soon have the
power to make a decision that could add another option in preventing
invasive breast cancer with fewer side effects because of the efforts of
the many women who volunteered to participate in this prevention study."
Women who participated in STAR were postmenopausal,
at least 35 years old, and had an increased risk of breast cancer as
determined by their age, family history of breast cancer, personal
medical history, age at first menstrual period, and age at first live
birth. Before participating in the study, the women were instructed
about the potential risks and benefits of tamoxifen and raloxifene and
then were asked to sign an informed consent document.
STAR investigators will present additional data at
the 42nd annual meeting of the American Society for Clinical Oncology (ASCO)
from June 2-6, 2006, in Atlanta, Ga. "This is an important and long
awaited trial," said Sandra J. Horning, M.D., president of ASCO, "and we
look forward to further discussion and analysis at the ASCO annual
meeting that will address the observed differences in toxicity and
prevention of non-invasive breast cancers with the two treatment
approaches." A manuscript is also being submitted to a peer-reviewed
journal for publication.
The maker of tamoxifen, AstraZeneca
Pharmaceuticals, Wilmington, Del., and the maker of raloxifene, Eli
Lilly and Company, Indianapolis, Ind., provided their drugs and matching
placebos for the trial without charge to participants. Eli Lilly and
Company also gave NSABP support to defray recruitment costs at the
participating centers and to help local investigators conduct the study.
For more information:
> For more information about STAR visit
NCI's STAR home page at
http://www.cancer.gov/star or at NSABP's Web sites at
http://www.nsabp.pitt.edu or
http://foundation.nsabp.org.
> For a Q&A related to the STAR results, go
to:
http://www.cancer.gov/newscenter/pressreleases/STARresultsQandA.
> For tools used to calculate a woman's risk
of breast cancer, visit
http://cancer.gov/bcrisktool or
http://breastcancerprevention.com.
> Visit
http://www.breastcancerprevention.org/ to calculate your breast
cancer risk.
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