In standard adjuvant therapy for breast cancer, chemotherapy is administered every 3 weeks. However, scientists have been testing whether more frequent administration of chemotherapy would more effectively kill rapidly dividing cancer cells. In 2003, the Cancer and Leukemia Group B reported results of their randomized clinical trial of dose-dense chemotherapy, which found that a dose-dense regimen improved disease-free and overall survival in lymph node-positive early-stage breast cancer.
The Italian clinical trials group Gruppo Oncologico Nord Ovest-Mammella InterGruppo (GONO-MIG) launched a randomized clinical trial to determine whether dose-dense treatment increased overall survival and prevented relapse and whether more frequent treatment was safe or increased the level of toxic effects such as anemia, bone pain, white blood cell count, and weakness. A total of 1214 women with early-stage breast cancer were randomly assigned to receive six courses of 5-fluorouracil, epirubicin, and cyclophosphamide (FEC) either every 2 weeks (dose-dense regimen) or every 3 weeks (standard regimen). Women on the dose-dense regimen were also given filgrastim, a drug that stimulates the production of white blood cells.
Marco Venturini, M.D., of the National Cancer Research Institute in Genoa, Italy, and colleagues report that, after a median follow-up of 10.4 years, the dose-dense regimen was associated with a 13% reduced risk of death; however, this reduction was not statistically significant. Women in the dose-dense group experienced higher rates of acute toxic effects from anemia, thrombocytopenia, a
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Contact: Ariel Whitworth
jncimedia@oxfordjournals.org
301-841-1287
Journal of the National Cancer Institute
6-Dec-2005