title: Ten-day decitabine as initial therapy for newly diagnosed patients with acute myeloid leukemia unfit for intensive chemotherapy.
abstract: We retrospectively reviewed outcomes in 45 previously untreated patients with acute myeloid leukemia (AML) considered unfit for chemotherapy who were treated with 10-day courses of decitabine 20 mg/m(2) daily outside of a clinical trial, with no cut-offs for organ function or performance status (PS). Nineteen had Eastern Cooperative Group performance status (ECOG PS) ≥ 2, and 39 had ≥ 2 comorbidities. Fourteen patients (31%) achieved complete remission (CR) and five (11%) CR with incomplete count recovery, for an overall response rate of 42%, after a median of 2 (range, 1-4) courses. The only pretreatment characteristic that differed significantly between responders and non-responders was percent marrow blasts (median 42% vs. 65%; p = 0.01). Median overall survival was 9.0 months; it was 19.4 and 2.3 months for responders and non-responders, respectively (p < 0.001). Thus 10-day decitabine therapy has efficacy in patients with AML considered unfit for chemotherapy, and may serve as a backbone for the addition of other novel agents.
authors.affiliation: University of Maryland Greenebaum Cancer Center , Baltimore MD , USA.
authors.forename: Bhavana
authors.initials: B
authors.lastname: Bhatnagar
authors.forename: Vu H
authors.initials: VH
authors.lastname: Duong
authors.forename: Theodore S
authors.initials: TS
authors.lastname: Gourdin
authors.forename: Michael L
authors.initials: ML
authors.lastname: Tidwell
authors.forename: Ching
authors.initials: C
authors.lastname: Chen
authors.forename: Yi
authors.initials: Y
authors.lastname: Ning
authors.forename: Ashkan
authors.initials: A
authors.lastname: Emadi
authors.forename: Edward A
authors.initials: EA
authors.lastname: Sausville
authors.forename: Maria R
authors.initials: MR
authors.lastname: Baer
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001374:Azacitidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000077209:Decitabine; D005260:Female; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D012074:Remission Induction; D012189:Retrospective Studies; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D000077209:Decitabine; D001374:Azacitidine
keywords: Decitabine; acute myeloid leukemia; demethylating agents; elderly