title: A randomized trial comparing standard versus high-dose daunorubicin induction in patients with acute myeloid leukemia.
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/m² per day times 3 days) and 194 received high-dose daunorubicin (HD-DN, 90 mg/m² per day times 3 days) in addition to cytarabine (200 mg/m² 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.
authors.affiliation: Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. jhlee3@amc.seoul.kr
authors.forename: Je-Hwan
authors.initials: JH
authors.lastname: Lee
authors.forename: Young-Don
authors.initials: YD
authors.lastname: Joo
authors.forename: Hawk
authors.initials: H
authors.lastname: Kim
authors.forename: Sung Hwa
authors.initials: SH
authors.lastname: Bae
authors.forename: Min Kyoung
authors.initials: MK
authors.lastname: Kim
authors.forename: Dae Young
authors.initials: DY
authors.lastname: Zang
authors.forename: Jung-Lim
authors.initials: JL
authors.lastname: Lee
authors.forename: Gyeong Won
authors.initials: GW
authors.lastname: Lee
authors.forename: Jung-Hee
authors.initials: JH
authors.lastname: Lee
authors.forename: Jae-Hoo
authors.initials: JH
authors.lastname: Park
authors.forename: Dae-Young
authors.initials: DY
authors.lastname: Kim
authors.forename: Won-Sik
authors.initials: WS
authors.lastname: Lee
authors.forename: Hun Mo
authors.initials: HM
authors.lastname: Ryoo
authors.forename: Myung Soo
authors.initials: MS
authors.lastname: Hyun
authors.forename: Hyo Jung
authors.initials: HJ
authors.lastname: Kim
authors.forename: Young Joo
authors.initials: YJ
authors.lastname: Min
authors.forename: Yae-Eun
authors.initials: YE
authors.lastname: Jang
authors.forename: Kyoo-Hyung
authors.initials: KH
authors.lastname: Lee
mesh_terms: D000293:Adolescent; D000328:Adult; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage* / Q000627:therapeutic use; D003630:Daunorubicin / Q000008:administration & dosage* / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000175:diagnosis* / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D012074:Remission Induction; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000903:Antibiotics, Antineoplastic; D003630:Daunorubicin