THURSDAY, March 17 (HealthDay News) -- A high-dose regimen of cytarabine as induction therapy for acute myeloid leukemia (AML) offers no advantage over more conservative dosing and results in a higher incidence of toxic effects, according to research published in the March 17 issue of the New England Journal of Medicine.
Bob Löwenberg, M.D., of the Erasmus University Medical Center in Rotterdam, Netherlands, and colleagues compared induction regimens in newly diagnosed AML patients, 431 of whom received an intermediate dose of cytarabine and 429 of whom received a high dose. The researchers assessed rates of complete remission and survival, as well as toxic effects.
At a median follow-up of five years, the researchers found no significant differences between the two groups in complete remission rates, probability of relapse, event-free survival, or overall survival. The high-dose regimen, however, resulted in more grade 3 and 4 toxic effects, longer hospitalization, and delayed neutrophil and platelet recovery.
"Induction therapy with cytarabine at the lower dose already produced maximal anti-leukemic effects for all response end points, suggesting a plateau in the dose-response relationship above this dose level. High-dose cytarabine results in excessive toxic effects without therapeutic benefit," the authors write.
Several authors disclosed financial relationships with pharmaceutical companies, including Novartis and Roche. One author disclosed involvement with a patent related to the study.
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