Susan (602)
631-6555
FOR
IMMEDIATE RELEASE
Monday,
April 17, 2006
CONTACT:
Donna Breckenridge
(520)
626-2277
Initial Results of the Study of Tamoxifen and
Raloxifene (STAR) Released:
Osteoporosis Drug Raloxifene Shown to be as
Effective as Tamoxifen in
Preventing Invasive Breast
Cancer
Initial results of the Study of Tamoxifen and
Raloxifene, or STAR, show
that the drug raloxifene, currently used to prevent
and treat osteoporosis
in postmenopausal women, works as well as tamoxifen in
reducing breast
cancer risk for postmenopausal women at increased risk of the
disease.
The
breast cancer prevention trials ever
conducted.
In STAR, both drugs reduced the risk of developing
invasive breast cancer
by about 50 percent. In addition, 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 enrolled 19,747 postmenopausal women who were at
increased risk of
the disease. At the
were
enrolled, and in
assigned to receive either 60 mg of raloxifene
(Evista®) or 20 mg of
tamoxifen (Nolvadex®) 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 is a great step in our battle to reduce breast cancer
incidence in women at
increased risk in the
Alberts, M.D., co-principal
investigator for the STAR study at the Center. “The NSABP,
the National
Cancer Institute, and all of our wonderful women participants in STAR
in
raloxifene would appear to be a safer drug for breast cancer prevention in
women
at increased risk.”
Ana María López, M.D., M.P.H, also
served as co-principal investigator for the
STAR trial at the
coordinator.
“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.
“Because of the
history of breast cancer in my family, participating in the
trial meant a
lot to me - that I would help other women understand not to
be afraid,” said
Arizona Cancer Center study participant Barbara Abrahams,
who took tamoxifen
for five years “If there’s a study available, go and sign up.
Heidi Fritz,
the study coordinator, made me feel comfortable and a part of
what was going
on. They kept track of everything – every little thing was
reported on.
There was a lot of interaction between Heidi and the STAR
program, and any
other doctors I had who played a role in my healthcare.
I’ll have a
six-month follow-up for the rest of my life.”
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 a large study of
raloxifene in the treatment
of osteoporosis (the Continued Outcomes
Relevant to Evista or CORE Trial) in
2004.
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.
The maker of tamoxifen, AstraZeneca Pharmaceuticals,
the maker of raloxifene, Eli
Lilly and Company,
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 about STAR, including links to media materials and a
fact
sheet, visit NCI's STAR home page at http://www.cancer.gov/star
or
one of NSABP‚s Web sites at http://www.nsabp.pitt.edu
and
http://foundation.nsabp.org.
For
a Q&A related to the STAR results, go to:
http://www.cancer.gov/newscenter/pressreleases/STARresultsQandA.
For
B-roll related to the STAR results, go to www.thenewsmarket.com
for
digitized, downloadable B-roll, or call the NCI Media Relations Branch
at
(301) 496-6641 for a Beta-tape copy.
For tools used to calculate a
woman’s risk of breast cancer, visit
http://cancer.gov/bcrisktool
or http://breastcancerprevention.com.
For
more information about tamoxifen, go to
http://www.cancer.gov/cancertopics/factsheet/Therapy/tamoxifen
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