Azacitidine Post-Remission Therapy for Elderly Patients with AML: A Randomized Phase-3 Trial (QoLESS AZA-AMLE).

ABSTRACT: This phase-3 randomized multicenter trial evaluated the efficacy of subcutaneous azacitidine (AZA) post-remission therapy vs. best supportive care (BSC) in elderly acute myeloid leukemia (AML) patients. The primary endpoint was the difference in disease-free survival (DFS) from complete remission (CR) to relapse/death. Patients with newly diagnosed AML aged ≥61 years received two courses of induction chemotherapy ("3+7" daunorubicin and cytarabine) followed by consolidation (cytarabine). At CR, 54 patients were randomized (1:1) to receive BSC (N = 27) or AZA (N = 27) at a dose of 50 mg/m² for 7 days every 28 days and the dose increased after the 1st cycle to 75 mg/m² for a further 5 cycles, followed by cycles every 56 days for 4.5 years. At 2 years, median DFS was 6.0

SUBMITTER: Oliva EN 

PROVIDER: S-EPMC10177242 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature