title: A multicenter, phase II study of maintenance azacitidine in older patients with acute myeloid leukemia in complete remission after induction chemotherapy.
abstract: Older patients with acute myeloid leukemia (AML) have poor outcomes, with median durations of complete remission lasting less than 1 year. Increased toxicity in older patients limits the delivery of standard consolidation therapies, such as allogeneic stem cell transplant or high-dose cytarabine. Azacitidine, a nucleoside analog/DNA methyltransferase inhibitor, has demonstrated significant activity and favorable tolerability in patients unable to tolerate intensive induction chemotherapy; however, the role of azacitidine in the maintenance setting has not been fully evaluated. We undertook a pilot study of low-dose subcutaneous azacitidine [50 mg/(m(2) day)] for 5 days every 4 weeks) in AML patients ≥60 years of age in first remission following standard induction therapy. The primary objective was to determine the 1-year disease-free survival (DFS); secondary objectives were to determine safety and tolerability. We enrolled 24 patients (median age 68, range 62-81 years), the majority of whom received anthracycline-cytarabine induction regimens. From the time of first complete remission, the estimated 1-year DFS was 50% and the median overall survival was 20.4 months. Thrombocytopenia and neutropenia were the most common grade 3/4 toxicities (50 and 58%, respectively). In our study population, maintenance therapy with subcutaneous azacitidine was safe and well tolerated.
authors.affiliation: H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.
authors.forename: Patrick T
authors.initials: PT
authors.lastname: Griffin
authors.affiliation: H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.
authors.forename: Rami S
authors.initials: RS
authors.lastname: Komrokji
authors.affiliation: Duke University Medical Center, Durham, North Carolina.
authors.forename: Carlos M
authors.initials: CM
authors.lastname: De Castro
authors.affiliation: Duke University Medical Center, Durham, North Carolina.
authors.forename: David A
authors.initials: DA
authors.lastname: Rizzieri
authors.affiliation: Florida Cancer Specialists, Tampa, Florida.
authors.forename: Magda
authors.initials: M
authors.lastname: Melchert
authors.affiliation: H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.
authors.forename: Alan F
authors.initials: AF
authors.lastname: List
authors.affiliation: H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.
authors.forename: Jeffrey E
authors.initials: JE
authors.lastname: Lancet
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D018943:Anthracyclines / Q000627:therapeutic use; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D001374:Azacitidine / Q000008:administration & dosage* / Q000009:adverse effects; D003561:Cytarabine / Q000627:therapeutic use; D005260:Female; D006801:Humans; D060828:Induction Chemotherapy / Q000379:methods*; D007279:Injections, Subcutaneous; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced / Q000473:pathology; D010865:Pilot Projects; D012074:Remission Induction; D016019:Survival Analysis; D013921:Thrombocytopenia / Q000139:chemically induced / Q000473:pathology
chemical_list: D018943:Anthracyclines; D000964:Antimetabolites, Antineoplastic; D003561:Cytarabine; D001374:Azacitidine