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PRESS RELEASE: Tamoxifen's Benefit Greatest for Preventing Hormone-Dependent
Breast Cancer
Tamoxifen reduces the risk of developing breast cancer, but its
benefits appear to be limited to women at high risk of the hormone-dependent
form of the disease, according to an updated analysis of data
from a major trial of tamoxifen. The findings appear in the January
15 issue of the Journal of the National Cancer Institute.
Tamoxifen is a selective estrogen receptor modulator that has
been shown in prevention trials to reduce the incidence of estrogen
receptor-positive (ER+) breast cancers.
However, use of tamoxifen
has also been associated with an increase in risk of endometrial
cancer and blood clots in the lungs. Because of these risks,
the drug is not recommended as a preventive agent for the general
population.
Several major trials have attempted to identify a subgroup of
high-risk, healthy women that would benefit from tamoxifen. In
the Italian Randomized Trial of Tamoxifen, 5,408 women who had
undergone a hysterectomy were randomly assigned to receive either
tamoxifen or a placebo.
An earlier published analysis of the
results showed no statistically significant difference in breast
cancer incidence between the group receiving tamoxifen and the
group receiving a placebo.
In the current update of that data with a median follow-up of
81.2 months, Umberto Veronesi, M.D., and Peter Boyle, Ph.D.,
of the European Institute of Oncology in Milan, and their colleagues
of the Italian Tamoxifen Study Group found that tamoxifen reduced
the risk of breast cancer by 82% in women at high risk for ER+
breast cancer.
In contrast, tamoxifen use had no significant
effect among women at low risk for the disease. Factors that
have been suggested to predispose a woman to the ER+ form of
the disease include having at least one functioning ovary, having
begun menstruation at or before age 13, not having had children
before age 24, and being taller than 160 cm (about 5 feet 3 inches).
In addition, among women who had used hormone replacement therapy
(HRT) and were in the high-risk group, there was a statistically
significant difference in favor of tamoxifen.
The authors note if these findings can be confirmed, it may be
possible to limit tamoxifen use for breast cancer prevention
to women who are most likely to benefit from the drug.
In an accompanying editorial, Victor G. Vogel, M.D., and Shelly
Lo, M.D., of the University of Pittsburgh School of Medicine,
say that this updated analysis confirms tamoxifen's role in breast
cancer chemoprevention. "What remains unknown is whether this
demonstrated reduction in the incidence of breast cancer will
ultimately lead to an increased survival or overall health benefit
for women at risk, or whether women previously taking HRT should
consider tamoxifen for chemoprevention," they write.
They point out that newer agents being evaluated for breast cancer
reduction, such as raloxifene and aromatase inhibitors, may be
effective without increasing the risk of uterine cancer. "Continued
follow-up of the patients in these trials will help to answer
these questions in the near future," they conclude.
[01/15/2003; Journal of the National Cancer Institute]
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