A randomized trial comparing standard versus high-dose daunorubicin induction in patients with acute myeloid leukemia

Title
A randomized trial comparing standard versus high-dose daunorubicin induction in patients with acute myeloid leukemia
Author(s)
김민경현명수이제환[이제환]주영돈[주영돈]김혁[김혁]배성화[배성화]장대영[장대영]이정림[이정림]이경원[이경원]이정희[이정희]박재후[박재후]김대영[김대영]이원식[이원식]류헌모[류헌모]김효정[김효정]민영주[민영주]장예은[장예은]이규형[이규형]
Keywords
ACUTE NONLYMPHOCYTIC LEUKEMIA; ACUTE MYELOGENOUS LEUKEMIA; ACUTE MYELOCYTIC-LEUKEMIA; SOUTHWEST-ONCOLOGY-GROUP; MARROW TRANSPLANTATION; CYTOSINE-ARABINOSIDE; REMISSION INDUCTION; GROUP-B; MAINTENANCE; THERAPY
Issue Date
201110
Publisher
AMER SOC HEMATOLOGY
Citation
BLOOD, v.118, no.14, pp.3832 - 3841
Abstract
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/m(2) per day times 3 days) and 194 received high-dose daunorubicin (HD-DN, 90 mg/m(2) per day times 3 days) in addition to cytarabine (200 mg/m(2) per 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 with SD-DN in young adults with AML. This study is registered at www.clinicaltrials.gov as #NCT00474006. (Blood. 2011;118(14):3832-3841)
URI
http://hdl.handle.net/YU.REPOSITORY/24462http://dx.doi.org/10.1182/blood-2011-06-361410
ISSN
0006-4971
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의과대학 > 내과학교실 > Articles
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