Azacitidine in the Treatment of Elderly Patients with Acute Myelogenous Leukemia

• Published in: Blood 2009-11, Vol.114 (22), p.4164-4164
• Main Authors: Benjamin, Heather L., Rossetti, James M., Lampkin, Aaron J., Hilton, Christie, Sahovic, Entezam, Abdulhaq, Haifaa, Shadduck, Richard K., Vemulapalli, Namratha, Hercules, Amanda, Lister, John
• Format: Article
• Language: English
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood.V114.22.4164.4164

Abstract 4164 Effective treatment of the elderly patient with acute myelogenous leukemia (AML) remains a challenging task. Elderly patients with AML usually respond poorly to standard induction chemotherapy. Response rates in elderly patients are in the range of 30–50% compared to 80–90% in younger patients. Moreover, prolonged hospitalization with treatment related mortality as high as 30% is typical in this older population. In a prior retrospective analysis done at our institution, azacitidine showed an overall response rate of 60% with limited toxicity when administered to patients older than 55 years of age with AML. We present an interim analysis of the first 13 patients enrolled in our prospective, phase II open label study using single agent azacitidine for elderly patients with AML. This is a prospective, phase II open label study using azacitidine in patients ≥ 60 years with AML. Inclusion criteria: Newly diagnosed AML (de novo or secondary, WHO criteria) and ECOG≤ 2. Promyelocytic (M3) phenotype was excluded. Patients with circulating blast count ≥ 30,000/mcl were treated with hydroxyurea until < 30,000/mcl. Azacitidine was given at a dose of 100 mg/m2 subcutaneously for 5 consecutive days every 28 days until disease progression or significant toxicity. G-CSF was given to patients with neutropenia (ANC < 1000/mcl) during all cycles excluding cycle one. Thirteen patients have been enrolled to date. The mean age of patients is 75 years (range: 66–84). The mean baseline ECOG performance score was 1 with a mean during treatment of 1. Mean baseline bone marrow blast count was 57% (range: 21–100%). Overall response rate using the NCI response criteria (IWG criteria for patients with hematological improvement (HI) only) was 46% (6/13): complete response (CR; n=3; 23%), partial response (PR; n=1; 8%), and HI (n=2; 15%). One additional patient had a 94% reduction in marrow blasts, but failed to achieve transfusion independence. The mean number of days on treatment was 171+ (range: 13–606). The mean number of days hospitalized for diagnosis plus treatment or disease related complication was 21 (range: 7–72) with the majority of therapy being given in the outpatient setting. One patient required prolonged hospitalization after going on to allogeneic transplantation. The mean overall survival from diagnosis for all patients was 246+ days (range: 13–606). The mean overall survival for responders was 399+ days (range: 212–606). One patient continues on therap