title: Repetitive cycles of high-dose cytarabine benefit patients with acute myeloid leukemia and inv(16)(p13q22) or t(16;16)(p13;q22): results from CALGB 8461.
abstract: OBJECTIVE
  To study the impact of repetitive (three to four courses) versus a single course of high-dose cytarabine (HDAC) consolidation therapy on outcome of patients with acute myeloid leukemia (AML) and inv(16)(p13q22) or t(16;16)(p13;q22).
  
  
  METHODS
  We examined the cumulative incidence of relapse (CIR), relapse-free survival (RFS), and overall survival (OS) for 48 adults younger than 60 years with inv(16)/t(16;16) who had attained a complete remission on one of four consecutive clinical trials and were assigned to receive HDAC consolidation therapy. Twenty-eight patients were assigned to either three or four courses of HDAC, and 20 patients were assigned to one course of HDAC followed by alternative intensive consolidation therapy.
  
  
  RESULTS
  Pretreatment features were similar for the two groups. The CIR was significantly decreased in patients assigned to receive three to four cycles of HDAC compared with patients assigned to one course (P=.03; 5-year CIR, 43% v 70%, respectively). The difference in RFS also approached statistical significance (P=.06). In a multivariable analysis that adjusted for potential confounding covariates, only treatment assignment (three to four cycles of HDAC) predicted for superior RFS (P=.02). The OS of both groups was similar (P=.93; 5-year OS, 75% for the three to four cycles of HDAC group v 70% for the one cycle of HDAC group), reflecting a high success rate with stem-cell transplantation salvage treatment administered among patients in both treatment groups.
  
  
  CONCLUSIONS
  We conclude that, in AML patients with inv(16)/t(16;16), repetitive HDAC therapy decreases the likelihood of relapse compared with consolidation regimens including less HDAC.
authors.affiliation: Division of Hematology and Oncology and the Comprehensive Cancer Center, The Ohio State University, B302A Starling Loving Hall, 320 W 10th Ave, Columbus, OH 43210-1240, USA. byrd-3@medctr.osu.edu
authors.forename: John C
authors.initials: JC
authors.lastname: Byrd
authors.forename: Amy S
authors.initials: AS
authors.lastname: Ruppert
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Mrózek
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Carroll
authors.forename: Colin G
authors.initials: CG
authors.lastname: Edwards
authors.forename: Diane C
authors.initials: DC
authors.lastname: Arthur
authors.forename: Mark J
authors.initials: MJ
authors.lastname: Pettenati
authors.forename: Judith
authors.initials: J
authors.lastname: Stamberg
authors.forename: Prasad R K
authors.initials: PR
authors.lastname: Koduru
authors.forename: Joseph O
authors.initials: JO
authors.lastname: Moore
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Mayer
authors.forename: Frederick R
authors.initials: FR
authors.lastname: Davey
authors.forename: Richard A
authors.initials: RA
authors.lastname: Larson
authors.forename: Clara D
authors.initials: CD
authors.lastname: Bloomfield
mesh_terms: D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000704:Analysis of Variance; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage*; D007446:Chromosome Inversion; D002885:Chromosomes, Human, Pair 16; D003561:Cytarabine / Q000008:administration & dosage*; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007951:Leukemia, Myeloid / Q000188:drug therapy* / Q000235:genetics*; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D012008:Recurrence; D016019:Survival Analysis; D014178:Translocation, Genetic; D014481:United States
chemical_list: D000964:Antimetabolites, Antineoplastic; D003561:Cytarabine