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: Je-Hwan Lee, Young-Don Joo, Hawk Kim, Sung Hwa Bae, Min Kyoung Kim, Dae Young Zang, Jung-Lim Lee, Gyeong Won Lee, Jung-Hee Lee, Jae-Hoo Park, Dae-Young Kim, Won-Sik Lee, Hun Mo Ryoo, Myung Soo Hyun, Hyo Jung Kim, Young Joo Min, Yae-Eun Jang, Kyoo-Hyung Lee, Cooperative Study Group A for Hematology
• Journal: Blood (Blood) Vol. 118 Issue 14 Pg. 3832-41 (Oct 06 2011) ISSN: 1528-0020 [Electronic] United States
• PMID: 21828126 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Randomized Controlled Trial)

Chemical References

• Antibiotics, Antineoplastic
• Daunorubicin

Topics

• Adolescent
• Adult
• Antibiotics, Antineoplastic (administration & dosage, therapeutic use)
• Daunorubicin (administration & dosage, therapeutic use)
• Disease-Free Survival
• Female
• Follow-Up Studies
• Humans
• Leukemia, Myeloid, Acute (diagnosis, drug therapy)
• Male
• Middle Aged
• Prognosis
• Remission Induction
• Treatment Outcome
• Young Adult