Azacitidine prolongs overall survival compared with conventional care regimens in elderly patients with low bone marrow blast count acute myeloid leukemia
Phase 2 or 3 results paper on Azacitidine in Acute myeloid leukaemia, in Journal of Clinical Oncology (2010), one of the most cited Europe PMC records with Azacitidine in its title.
Overview
Purpose: In a phase III randomized trial, azacitidine significantly prolonged overall survival (OS) compared with conventional care regimens (CCRs) in patients with intermediate-2- and high-risk myelodysplastic syndromes. Approximately one third of these patients were classified as having acute myeloid leukemia (AML) under current WHO criteria. This analysis compared the effects of azacitidine versus CCR on OS in this subgroup.
Patients and methods: Patients were randomly assigned to receive subcutaneous azacitidine 75 mg/m(2)/d or CCR (best supportive care [BSC] only, low-dose cytarabine (LDAC), or intensive chemotherapy [IC]).
Results: Of the 113 elderly patients (median age, 70 years) randomly assigned to receive azacitidine (n = 55) or CCR (n = 58; 47% BSC, 34% LDAC, 19% IC), 86% were considered unfit for IC. At a median follow-up of 20.1 months, median OS for azacitidine-treated patients was 24.5 months compared with 16.0 months for CCR-treated patients (hazard ratio = 0.47; 95% CI, 0.28 to 0.79; P =.005), and 2-year OS rates were 50% and 16%, respectively (P =.001). Two-year OS rates were higher with azacitidine versus CCR in patients considered unfit for IC (P =.0003). Azacitidine was associated with fewer total days in hospital (P <.0001) than CCR.
Conclusion: In older adult patients with low marrow blast count (20% to 30%) WHO-defined AML, azacitidine significantly prolongs OS and significantly improves several patient morbidity measures compared with CCR.
Indexed on Europe PMC as PubMed record 20026804 (DOI 10.1200/jco.2009.23.8329). Its title names Azacitidine and its text names Acute myeloid leukaemia; PubMed types it as a clinical trial report (Clinical Trial, Phase III, Comparative Study, Research Support, Non-U.S. Gov't, Multicenter Study, Randomized Controlled Trial). It was matched automatically to the idea "Shorter venetoclax courses in unfit AML" and no figure has been checked by an editor.
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