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

作者：Lee Je Hwan; Joo Young Don; Kim Hawk; Bae Sung Hwa; Kim Min Kyoung; Zang Dae Young; Lee Jung Lim; Lee Gyeong Won; Lee Jung Hee; Park Jae Hoo; Kim Dae Young; Lee Won Sik; Ryoo Hun Mo; Hyun Myung Soo; Kim Hyo Jung; Min Young Joo; Jang Yae Eun; Lee Kyoo Hyung

来源：Blood, 2011, 118(14): 3832-3841.

DOI：10.1182/blood-2011-06-361410

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)

• 出版日期2011-10-6