title: Clofarabine plus low-dose cytarabine followed by clofarabine plus low-dose cytarabine alternating with decitabine in acute myeloid leukemia frontline therapy for older patients.
abstract: BACKGROUND
  Standard therapy for older patients with acute myeloid leukemia (AML) has a poor outcome. The authors have designed a combination of clofarabine plus low-dose cytarabine followed by a prolonged consolidation alternating with decitabine.
  
  
  METHODS
  Sixty patients with a median age of 70 years (range, 60-81 years) with newly diagnosed AML were included. They received clofarabine 20 mg/m(2) intravenously daily for 5 days plus cytarabine 20 mg subcutaneously twice daily for 10 days. Responding patients continued for up to 17 courses of consolidation therapy including decitabine.
  
  
  RESULTS
  Forty of 59 evaluable patients responded (66%). Complete remission rate was 58%. Median relapse-free survival (RFS) was 14.1 (95% confidence interval [CI], 6.9 to not estimable), and median overall survival (OS) was 12.7 months (95% CI, 8.8 to not estimable). Median OS of responding patients (complete response [CR]/CR with platelet count <100 × 109/L) was 24.2 months (95% CI, 17 to not estimable). Compared with a historical group of patients who received clofarabine plus low-dose cytarabine with a shorter consolidation, RFS was not statistically different. Induction mortality was low (7% at 8 weeks) and toxicities manageable.
  
  
  CONCLUSIONS
  Clofarabine plus low-dose cytarabine alternating with decitabine in consolidation is active in older patients with newly diagnosed AML. The benefits of a prolonged consolidation remain unproven.
authors.affiliation: Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. sfaderl@mdanderson.org
authors.forename: Stefan
authors.initials: S
authors.lastname: Faderl
authors.forename: Farhad
authors.initials: F
authors.lastname: Ravandi
authors.forename: Xuelin
authors.initials: X
authors.lastname: Huang
authors.forename: Xuemei
authors.initials: X
authors.lastname: Wang
authors.forename: Elias
authors.initials: E
authors.lastname: Jabbour
authors.forename: Guillermo
authors.initials: G
authors.lastname: Garcia-Manero
authors.forename: Tapan
authors.initials: T
authors.lastname: Kadia
authors.forename: Alessandra
authors.initials: A
authors.lastname: Ferrajoli
authors.forename: Marina
authors.initials: M
authors.lastname: Konopleva
authors.forename: Gautam
authors.initials: G
authors.lastname: Borthakur
authors.forename: Jan
authors.initials: J
authors.lastname: Burger
authors.forename: Jennie
authors.initials: J
authors.lastname: Feliu
authors.forename: Hagop M
authors.initials: HM
authors.lastname: Kantarjian
mesh_terms: D000227:Adenine Nucleotides / Q000009:adverse effects / Q000627:therapeutic use*; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001087:Arabinonucleosides / Q000009:adverse effects / Q000627:therapeutic use*; D001374:Azacitidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000077866:Clofarabine; D060830:Consolidation Chemotherapy; D003561:Cytarabine / Q000009:adverse effects / Q000627:therapeutic use*; D000077209:Decitabine; D005260:Female; D006801:Humans; D060828:Induction Chemotherapy; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D000227:Adenine Nucleotides; D001087:Arabinonucleosides; D003561:Cytarabine; D000077866:Clofarabine; D000077209:Decitabine; D001374:Azacitidine