WEDNESDAY, Sept. 23 (HealthDay News) -- Doubling the conventional dose of daunorubicin significantly improves complete remission rates and often overall survival in patients with previously untreated acute myeloid leukemia (AML), according to two studies in the Sept. 24 New England Journal of Medicine.
Bob Lowenberg, M.D., from Erasmus University Medical Center in Rotterdam, Netherlands, and colleagues randomly assigned 813 elderly patients with newly diagnosed AML to cytarabine-based chemotherapy involving daunorubicin at either the conventional dose of 45 mg/m2 or at 90 mg/m2. After a median follow-up of 40 months, they found that patients receiving the higher daunorubicin dose had a higher rate of complete remission, achieved faster than the conventional dose with similar toxicity.
Hugo F. Fernandez, M.D., from the University of South Florida in Tampa, and colleagues randomly assigned 657 adults with untreated AML to cytarabine-based chemotherapy involving daunorubicin at 45 or 90 mg/m2. After a median follow-up of 25.2 months, they found that patients receiving the higher daunorubicin dose had a higher rate of complete remission and median overall survival, with similar toxicity as the conventional dose.
"Do we have a new standard of care in AML?" ask the authors of an accompanying editorial. "The lack of an increase in toxic effects and the benefit in overall survival strongly argue for incorporating high-dose daunorubicin into the initial treatment of younger patients with AML, at least those with favorable- and intermediate-risk cytogenetic profiles, unless an increased rate of toxic effects is feared when high-dose daunorubicin is used in association with new agents, such as FLT3 inhibitors, currently in ongoing trials."
Funding from Wyeth Pharmaceuticals and Immunex was used to perform laboratory correlative studies in the Fernandez study. Both editorial authors reported financial and consulting relationships with pharmaceutical companies.
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