.c The Associated Press
By KATHARINE WEBSTER
A new drug cuts the rate of breast cancer deaths by two-thirds among
women at
high risk of getting new tumors, a study has found.
The drug, clodronate, is one of a class of compounds known as
bisphosphonates
that prevent bone loss from osteoporosis and cancer.
Another bisphosphonate, pamidronate, already is given intravenously to
women
whose breast cancer has spread to their bone marrow. It helps prevent
the
painful breakdown of bone caused by bone marrow tumors.
But the study in Thursday's New England Journal of Medicine found that
clodronate capsules - coupled with standard surgery, radiation and
chemotherapy - also prevented the spread of breast cancer to bone marrow
and other organs.
``This is in many ways a very exciting finding,'' said Dr. Harmon Eyre,
chief medical officer of the American Cancer Society.
The study suggests clodronate may interrupt a vicious cycle in which a
hormone produced by cancerous bone-marrow cells increases bone
breakdown, and a
byproduct of bone breakdown stimulates tumor growth, Eyre said. Or it
may act
in some other way to kill cancerous cells, he added.
``In general, these bisphosphonates are very nontoxic drugs and if they
have
this significant positive benefit to cancer patients and can be added to
the
usual chemotherapy or hormonal therapy, that could change the way we
manage
breast cancer,'' he said.
Clodronate is sold in Germany but is not currently available in the
United
States.
German researchers followed 284 patients at the University Hospital
Heidelberg
who underwent surgery for breast cancer from 1990 to 1995 and had at
least one
cancerous cell show up in a very sensitive bone marrow test.
The presence of tumor cells in bone marrow signals a high risk that the
cancer
will spread. However, the women had no detectable secondary tumors, or
metastases, when they entered the study.
Half the women took 1,600 milligrams of clodronate daily for two years
following breast cancer surgery, in addition to standard treatment. The
other
half got standard treatment only.
After an average follow-up of three years, six women or 4 percent of the
women
in the clodronate group had died, compared to 22 women or 15 percent in
the
control group.
Twenty-one percent of the women in the clodronate group developed
secondary
tumors in their bones or other organs, compared to 42 percent of the
women in
the control group. And when members of the clodronate group did develop
new
tumors, they had only half as many as the women in the control group.
One outside observer said he would like to see the study duplicated with
a
longer follow-up period before recommending bisphosphonates for all
high-risk
breast cancer patients.
``The problem is it's a small study, the follow-up is short, and the way
people were selected for the study was a (bone marrow) test we don't
routinely
do,'' said Dr. Eric Winer, head of the breast cancer program at Dana
Farber
Cancer Institute in Boston.
Dr. Linda Vahdat, a breast cancer expert at New York Presbyterian
Hospital,
said a study is needed on whether clodronate helps prevent new tumors in
women
who test negative for cancerous cells in their bone marrow. If so,
treatment
with clodronate could become standard, she said.
The study was led by Dr. Ingo Diel of the University of Heidelberg and
paid
for by a grant from the drug's maker, Boehringer Mannheim. The company
has not
said whether it is seeking U.S. Food and Drug Administration approval
for the
drug.
AP-NY-08-05-98 1700EDT
Copyright 1998 The Associated Press. The information contained in the
AP
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