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Imatinib mesylate 400 mg daily is the current standard of care for newly diagnosed, chronic-phase chronic myeloid leukemia (CML). However, phase II studies have suggested that higher-dose therapy might improve hematologic and molecular response rates and thus overall outcomes. Investigators conducted a phase III randomized, multinational study to assess hematologic, cytogenetic, and molecular responses to imatinib 400 mg versus 800 mg daily (the latter dose given as 400 mg twice daily) in 476 patients with newly diagnosed CML; toxicity also was assessed. Patients who received the lower dose could cross over to the higher dose when responses were inadequate, and dose reductions were allowed for toxicity.
Although achievement of major molecula…