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The use of cytarabine-based regimens during induction and consolidation therapy for acute myeloid leukemia (AML) is an accepted standard of care. To determine whether lowering the standard dose of cytarabine would provide equivalent efficacy with less toxicity, European investigators conducted a multicenter, randomized trial of standard, high-dose (HD) cytarabine versus intermediate-dose (ID) cytarabine in 860 patients with newly diagnosed AML or myelodysplastic syndrome (MDS) and excess blasts.
Patients in the HD group received 1000 mg/m2 of cytarabine (twice daily for 5 days) during induction cycle 1 followed by 2000 mg/m2 of cytarabine (twice daily on days 1, 2, 4, and 6) during cycle 2. Patients in the ID group received 200 mg/m2 of cyta…