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FDA approves drug for expanded use in
treating aggressive breast cancer
Nov. 20, 2006
Cancer Research for the Ozarks part of clinical trial that led to
decision
The drug Herceptin was approved Nov. 19, 2006 by the Food and Drug
Administration to also include the treatment, in combination with other
drugs, of women with HER-2 positive breast cancer after they have undergone
surgery.
Cancer Research for the Ozarks, the clinical oncology program joint venture
by St. John’s and CoxHealth, was part of the North America clinical trials.
About a half a dozen women from the Ozarks participated.
“The big change is the application of the drug earlier in the disease,”
explains Dr. J. Wendell Goodwin, St. John’s Clinic oncologist and principal
investigator for clinical trials at Cancer Research of the Ozarks.
Goodwin pointed out that physicians have already been using Herceptin in
this manner, however, since the results of these studies were completed and
reported more than a year ago.
“It became a standard of care when the results were presented,” he
explained. “It was a matter of being unethical if we knew how effective it
was and didn’t go ahead with it.”
In both international and the North American clinical trials, the
intravenous medication cut the risk of recurrence of disease by half and
markedly improved survival.
In one of the North American studies, which combined the results of two
similar trials, Herceptin was administered along with chemotherapy, not
afterward as in the international clinical trial.
The concurrent approach proved highly effective. Herceptin treatment was
associated with a 33 percent reduction in the risk of death and an absolute
reduction of 11.8 percentage points in the proportion of women who were
alive and disease-free at three years.
In two North American trials, women with aggressive breast cancer who took
the drug after surgery and chemotherapy had a 52 percent reduction in the
risk of a recurrence, compared with women who did not take the medication.
Goodwin said the studies make it clear that women who have HER2-positive
breast cancers should consider using this medication because it improves
their chances for not having a recurrence significantly.
ABOUT CANCER RESEARCH FOR THE OZARKS
Cancer Research for the Ozarks Community Clinical Oncology Program is a
joint venture by CoxHealth and St. John's.
Affiliate sites are located in Joplin at Freeman Health System and St.
John's Medical Center. Each site actively recruits for the prevention,
cancer control, and treatment trials open within their facility, and is
responsible for registering and following their respective patients.
CRO is one of 63 community clinical oncology programs nationwide began in
the mid 1980s by the National Cancer Instutite to conduct cancer research
with local populations.
For information about clinical trials, call 417-269-4520.
FOR
MEDIA INFORMATION, CONTACT ST. JOHN’S MEDIA RELATIONS AT 417-820-2426 OR
CSCOTT@SPRG.MERCY.NET.
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