1. A randomized trial comparing standard versus high-dose daunorubicin induction in patients with acute myeloid leukemia.
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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, and Lee, Kyoo-Hyung
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CLINICAL trials , *ACUTE myeloid leukemia , *SURVIVAL analysis (Biometry) , *CYTARABINE , *HUMAN cytogenetics , *DRUG dosage , *DRUG therapy , *PATIENTS - 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 [ABSTRACT FROM AUTHOR]
- Published
- 2011
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