Here's what WSJ said today:
The Wall Street Journal -- April 8, 1998
Technology & Health:
Pill Shown to Prevent Breast
Cancer
In Clinical Trial Is Viewed With
Caution
----
By Ron Winslow
Staff Reporter of The Wall Street Journal
News that a pill can help prevent breast cancer provides many women and
their doctors with a new tool to battle the disease, but it raises a host of
thorny questions over who should take it and who should prescribe it.
A major, federally sponsored study shows that the drug, known as
tamoxifen, can reduce the incidence of breast cancer among women at
heightened risk of the disease by 45%. But tamoxifen comes with well
established side effects and risks for other serious problems that for many
women may offset the benefits.
"You need to be clear about what the risks are so you're not trading one
disease for another," said Georgia Wiesner, a medical director at the
Center for Human Genetics at University Hospitals, Cleveland.
That is just one of the challenges posed by the study's findings, which
nevertheless were widely viewed as a milestone in the scientific effort to
develop drugs and other strategies to prevent breast cancer, which afflicts
about one in nine women by the time they reach age 80. "This is the first
time a medication can be given that can alter the incidence of breast
cancer," noted Dr. Wiesner. "That's really exciting."
Zeneca Group PLC, which markets tamoxifen under the brand name
Nolvadex, said it plans to work with the U.S. Food and Drug
Administration to determine the next steps needed to get the drug approved
for breast cancer prevention. The FDA said it is already in contact with the
National Cancer Institute, chief sponsor of the trial, to obtain the data and
that it will review the results within six months of getting them. Until then,
doctors can prescribe it as a breast cancer preventive, but Zeneca can't
advertise or market tamoxifen for that purpose.
In the study, which involved 13,388 women all at a higher risk of getting
breast cancer than the general population, 85 women who were taking
tamoxifen for an average of four years developed breast cancer compared
with 154 women who took a placebo or dummy pill. But 33 women in the
tamoxifen arm developed endometrial cancer compared with 14 in the
placebo group, while 17 tamoxifen subjects suffered blood clots in their
lungs compared with six in the placebo group. An additional 130 women
taking the drug developed deep vein thrombosis, or blood clots in major
blood vessels, compared with 19 who were given a placebo.
The 45% reduction in breast cancer was considered strong enough by the
study's directors that they halted the trial 14 months before its scheduled
conclusion so women in the placebo arm could consider taking the drug
after consulting with their physicians.
The initial results suggest that younger women on the drug -- those under
age 50 -- suffered the same amount of adverse effects as their counterparts
on the placebo, indicating that for them, tamoxifen offers significant benefit
with low risk.
But for many women over 50, the choices may be harder. Cindy Pearson,
executive director of the National Women's Health Network, a nonprofit
patient organization, pointed out, for example, that among women over 50
and who hadn't had a hysterectomy, tamoxifen was associated with 20
fewer cases of breast cancer, but 22 more cases of serious complications.
(Women who had had a hysterectomy were at lower risk of major
complications since they aren't susceptible to endometrial cancer, a cancer
of the lining of the uterus.)
"That means 2% of the women got help, 2% got hurt," Ms. Pearson said.
"Women can decide how they want to play the odds, but they need to
know the odds."
Cancer experts said doctors, especially those in general practice, such as
internists and obstetrician gynecologists, should exercise caution in
prescribing the drug to their patients. Since most women who haven't been
diagnosed with cancer don't see an oncologist regularly, they are likely to
first raise questions about tamoxifen with their OB/GYNs or primary-care
doctors.
"I would be a little wary in general practice of giving a woman tamoxifen
without having a full assessment of her risk, without knowing the
downside," said Robert Shenk, medical director of the breast center at
University Hospitals.
And Bruce Chabner, clinical director of the cancer center at Massachusetts
General Hospital, Boston, said it will take months before even cancer
experts had a handle on how best to recommend the drug for individual
patients. "The public has to realize that stopping a clinical study is one thing.
Changing the practice of medical care another." He said results of the
report need to be reviewed, published and digested "before doctors go off
prescribing tamoxifen for everybody."
Officials at the National Cancer Institute of the National Institutes of Health
are analyzing the data in an effort to provide more guidance in their use.
The FDA originally approved the drug for metastatic breast cancer in
December 1977 and has gradually broadened the indication. Researchers
got the idea to try to use tamoxifen as a preventive medicine while they
were testing the drug in clinical trials. They noticed during these studies that
there was a reduced incidence of breast cancer in the healthy breasts of
women suffering from cancer in one breast.
---
Rochelle Sharpe contributed to this article. |
