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Medline ® Abstract for Reference 14

of 'Induction therapy for acute myeloid leukemia in younger adults'

A randomized trial comparing standard versus high-dose daunorubicin induction in patients with acute myeloid leukemia.
Lee JH, Joo YD, Kim H, Bae SH, Kim MK, Zang DY, Lee JL, Lee GW, Lee JH, Park JH, Kim DY, Lee WS, Ryoo HM, Hyun MS, Kim HJ, Min YJ, Jang YE, Lee KH, Cooperative Study Group A for Hematology
Blood. 2011;118(14):3832. Epub 2011 Aug 9.
We conducted a phase 3 randomized trial comparing 2 different doses of daunorubicin as induction chemotherapy in young adults (60 years of age or younger) with acute myeloid leukemia (AML). Of 383 patients who were analyzed, 189 received standard-dose daunorubicin (SD-DN, 45 mg/m²per day times 3 days) and 194 received high-dose daunorubicin (HD-DN, 90 mg/m²per day times 3 days) in addition to cytarabine (200 mg/m²per day times 7 days) to induce complete remission (CR). The CR rates were 72.0% in the SD-DN arm and 82.5% in the HD-DN arm (P = .014). At a median follow-up of 52.6 months, overall (OS) and event-free (EFS) survival were higher in the HD-DN arm than in the SD-DN arm (OS, 46.8% vs 34.6%, P = .030; EFS, 40.8% vs 28.4%, P = .030). Differences in CR rate and both OS and EFS remained significant after adjusting for other variables (CR, hazard ratio [HR], 1.802, P = .024; OS, HR, 0.739, P = .032; EFS, HR, 0.774, P = .048). The survival benefits of HD-DN therapy were evident principally in patients with intermediate-risk cytogenetic features. The toxicity profiles were similar in the 2 arms. In conclusion, HD-DN improved both the CR rate and survival duration compared withSD-DN in young adults with AML. This study is registered at www.clinicaltrials.gov as #NCT00474006.
Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. jhlee3@amc.seoul.kr