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Breast cancer chemotherapy regimen associated with life-threatening complications

The chemotherapy regimen of doxorubicin plus docetaxel, used to treat breast cancer in a clinical trial, was associated with an increased risk of serious complications, resulting in the premature termination of the trial, according to a study in the May 18 issue of JAMA.

Combinations of certain breast cancer drug classes have proven superior to some single classes alone in advanced or metastatic breast cancer, according to background information in the article. Uncertainties remain regarding the optimal schedule of administration of combination regimens, as well as safety and cost issues, and whether some drugs should be used outside of clinical trials.

Etienne G. C. Brain, M.D., of the Ren Huguenin Cancer Centre, Saint-Cloud, France and colleagues describe the adverse events associated with the chemotherapy in a breast cancer trial. The randomized multicenter study (Reposant sur des Arguments Pronostiques et Prdictifs [RAPP]-01) compared the effectiveness of 2 chemotherapy regimens. The trial included 627 women aged 18-70 years, who had primary unilateral breast cancer and either a moderate number of positive axillary lymph nodes (3 or less) or no positive axillary lymph nodes, but were at a high risk of relapse. Patients were treated at 11 French cancer referral centers from June 1999 through January 2003. Patients received doxorubicin plus docetaxel, or doxorubicin plus cyclophosphamide, given postoperatively for 4 courses.

The trial was terminated prematurely when 2 deaths related to drug toxicity and 1 case of bowel perforation with peritonitis (inflammation of the membrane of the abdomen) occurred among patients with febrile neutropenia (very low level of white blood cells accompanied by fever, a condition that indicates the patient may have a potentially life-threatening infection), all in the doxorubicin-docetaxel group. The incidence of febrile neutropenia was significantly higher with the doxorubicin-docetaxel regimen (40.8 percent)
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Contact: Etienne G. C. Brain, M.D.
e.brain@stcloud-huguenin.org
JAMA and Archives Journals
17-May-2005


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