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Breast Cancer Chemotherapy Regimen Associated With Life-Threatening Complication
Breast Cancer Chemotherapy Regimen Associated With Life-Threatening
Main Category: Breast Cancer News
Article Date: 21 May 2005 - 9:00am (PDT)
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 René 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 Prédictifs [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) than with the
doxorubicin-cyclophosphamide regimen (7.1 percent). The follow-up has been
too short (24 months) to analyze the primary end point, which was the
disease-free survival rate at 5 years.
"The rate of toxic death has decreased far below 0.10 percent in more
recent trials," the authors write. "We observed a much higher rate of
toxic death (0.63 percent) with the doxorubicin-docetaxel regimen. The
higher rate of febrile neutropenia observed with doxorubicin-docetaxel
than with doxorubicin-cyclophosphamide in our trial may have induced
severe immunosuppression and contributed to the high rate of toxic death,
which was 3 times as much as that observed in [another trial], in which 3
of 7 deaths were attributable to sequential docetaxel immunosuppression
among 1,584 patients (0.19 percent)."
"In conclusion, this study shows that the doxorubicin-docetaxel
combination is associated with an increased risk of severe sepsis and
life-threatening complications. Clinicians should be aware of the
potential toxicity of the doxorubicin-docetaxel regimen and consider the
preventive use of granulocyte colony-stimulating factor (G-CSF) and/or
antibiotics (neither of which was recommended at the time of our trial) in
both the adjuvant and metastatic settings. At this time the
doxorubicin-docetaxel regimen should not be recommended outside of
carefully designed clinical trials," the authors conclude.
(JAMA. 2005;293:2367-2371. Available post-embargo at jama.com)
René Huguenin Cancer Centre was the sponsor of the RAPP-01 trial. This
work was also supported in part by Aventis-Oncology France and the Ligue
Régionale Contre le Cancer du Département des Yvelines. Aventis-Oncology
France supplied the docetaxel.
For More Information: Contact the JAMA/Archives Media Relations Department
at 312/464-JAMA (5262) or email: email@example.com.
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