title: Decitabine in patients with newly diagnosed and relapsed acute myeloid leukemia.
abstract: Treatment options for older patients with acute myeloid leukemia (AML) and for patients with relapsed/refractory AML are limited, and outcomes are poor. Decitabine, a hypomethylating agent, is active in patients with myelodysplastic syndrome (MDS) and AML, but its optimal dose and schedule are unknown. We report the efficacy and safety of repeated 10-day cycles of decitabine 20 mg/m(2) administered intravenously over 1 h in 52 newly diagnosed and 102 relapsed/refractory patients. Repeated 10-day cycles of decitabine produced a complete response (CR) in 40% of newly diagnosed older patients with AML, many of whom had adverse prognostic features. The median overall survival (OS) was 318 days but there was prolonged survival in responders of 481 days. Relapsed/refractory patients had a CR rate of 15.7% with a median OS of 177 days. Extramedullary toxicity was mild and the regimen was well tolerated for ongoing post-remission, outpatient maintenance cycles. Responses were durable for over 1 year.
authors.affiliation: Leukemia Program, Weill Medical College of Cornell University and The New York Presbyterian Hospital, New York, NY 10065, USA. ritchie@med.cornell.edu
authors.forename: Ellen K
authors.initials: EK
authors.lastname: Ritchie
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Feldman
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Christos
authors.forename: Sarah D
authors.initials: SD
authors.lastname: Rohan
authors.forename: Catherine B
authors.initials: CB
authors.lastname: Lagassa
authors.forename: Cindy
authors.initials: C
authors.lastname: Ippoliti
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Scandura
authors.forename: Karen
authors.initials: K
authors.lastname: Carlson
authors.forename: Gail J
authors.initials: GJ
authors.lastname: Roboz
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001374:Azacitidine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D015331:Cohort Studies; D000077209:Decitabine; D005260:Female; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D012074:Remission Induction; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D000077209:Decitabine; D001374:Azacitidine