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Study of
breast cancer treatments halted following two deaths from drug
toxicity
May 17, 2005 (HealthDay News) -- A study involving
two chemotherapy drugs used in combination to treat breast cancer
was halted after two patients died and one suffered a serious
complication, French investigators report.
All three women had febrile neutropenia, a
complication of chemotherapy involving a reduction in immune white
blood cells accompanied by fever.
The study authors warn of the possible risks of the
drug combo in a report published in the May 18 issue of the
Journal of the American Medical Association.
"Clinicians should be aware of the potential
toxicity of the doxorubicin-docetaxel regimen," the authors wrote.
This combination should not be used outside of carefully designed
clinical trials, they added.
Certain drug combos have been shown to be superior
to single chemotherapy agents in treating advanced or metastatic
breast cancer, according to the report. However, questions
remain about the optimal administration of these combination
regimens, their safety and cost, the authors added.
Dr. Etienne G.C. Brain, of the Rene Huguenin Cancer
Centre in Saint-Cloud, France, set out to compare the effectiveness
of two chemotherapy regimens in women treated at 11 French cancer
centers from June 1999 through January 2003.
A total of 627 women, aged 18 to 70, participated in
the study. All of them had early-stage breast cancer, with
either a moderate number of lymph nodes involved or no positive
lymph nodes, but a high risk of relapse.
The women were randomly assigned to receive one of
the two regimens: doxorubicin plus docetaxel, or doxorubicin
plus Cyclophosphamide. The drugs were administered in four
courses after surgery.
According to the National Cancer Institute,
doxorubicin is a type of antibiotic used to treat cancer.
Cyclophosphamide, another anti-cancer drug, belongs to the family of
drugs called alkylating agents that interfere with a cell's DNA and
inhibit cancer cell growth. Docetaxel inhibits cell growth by
stopping cell division.
Investigators had intended to examine the safety and
overall survival of patients at five years, but were only able to
collect 24 months of data. The trial was terminated after two
women died, apparently due to drug toxicity, and a third suffered
bowel perforation with peritonitis, an inflammation of the membrane
of the abdomen.
The authors said they observed a much higher rate of
toxic death with the doxorubicin-docetaxel regimen than has been
seen in recent trials involving various chemotherapy regimens.
Febrile neutropenia, the potentially deadly chemo
complication, occurred at a much higher rate (40.8 percent), among
patients on the doxorubicin-docetaxel regimen, than in women on the
other drug combo (7.1 percent). The authors suspect that
doxorubicin plus docetaxel may have severely suppressed patients'
immune systems, contributing to the high rate of toxic death.
More information
The National Cancer Institute has more information
on chemotherapy treatments (www.nci.nih.gov).
Copyright © 2005 ScoutNews LLC. All rights reserved.
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