title: Is cytarabine useful in the treatment of acute promyelocytic leukemia? Results of a randomized trial from the European Acute Promyelocytic Leukemia Group.
abstract: OBJECTIVE
  Several phase II studies have suggested that cytarabine (AraC) was not required in the treatment of newly diagnosed acute promyelocytic leukemia (APL) patients receiving all-trans-retinoic acid (ATRA), an anthracycline, and maintenance therapy, and we aimed at confirming this finding in a randomized trial.
  
  
  METHODS
  Newly diagnosed APL patients younger than age 60 years with a WBC count of less than 10,000/microL were randomly assigned to receive either ATRA combined with and followed by three daunorubicin (DNR) plus AraC courses and a 2-year maintenance regimen (AraC group) or the same treatment but without AraC (no AraC group). Patients older than age 60 years and patients with initial WBC count of more than 10,000/microL were not randomly assigned but received risk-adapted treatment, with higher dose of AraC and CNS prophylaxis in patients with WBC counts more than 10,000/microL.
  
  
  RESULTS
  Overall, 328 (96.5%) of 340 patients achieved complete remission (CR). In the AraC and the no AraC groups, the CR rates were 99% and 94% (P = .12), the 2-year cumulative incidence of relapse (CIR) rates were 4.7% and 15.9% (P = .011), the event-free survival (EFS) rates were 93.3% and 77.2% (P = .0021), and survival rates were 97.9% and 89.6% (P = .0066), respectively. In patients younger than age 60 years with WBC counts more than 10,000/microL, the CR, 2-year CIR, EFS, and survival rates were 97.3%, 2.9%, 89%, and 91.9%, respectively.
  
  
  CONCLUSIONS
  These results support a role for AraC in addition to ATRA and anthracyclines in the treatment of newly diagnosed APL, at least using DNR at the cumulative dose we used and with the consolidation and maintenance regimens we used.
authors.affiliation: Assistance Publique-Hôpitaux de Paris, Hôpital Avicenne, Service d'Hématologie Clinique, Paris 13 University, Bobigny, France.
authors.forename: Lionel
authors.initials: L
authors.lastname: Adès
authors.forename: Sylvie
authors.initials: S
authors.lastname: Chevret
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Raffoux
authors.forename: Stephane
authors.initials: S
authors.lastname: de Botton
authors.forename: Agnes
authors.initials: A
authors.lastname: Guerci
authors.forename: Arnaud
authors.initials: A
authors.lastname: Pigneux
authors.forename: Anne Marie
authors.initials: AM
authors.lastname: Stoppa
authors.forename: Thierry
authors.initials: T
authors.lastname: Lamy
authors.forename: Francoise
authors.initials: F
authors.lastname: Rigal-Huguet
authors.forename: Anne
authors.initials: A
authors.lastname: Vekhoff
authors.forename: Sandrine
authors.initials: S
authors.lastname: Meyer-Monard
authors.forename: Frederic
authors.initials: F
authors.lastname: Maloisel
authors.forename: Eric
authors.initials: E
authors.lastname: Deconinck
authors.forename: Augustin
authors.initials: A
authors.lastname: Ferrant
authors.forename: Xavier
authors.initials: X
authors.lastname: Thomas
authors.forename: Nathalie
authors.initials: N
authors.lastname: Fegueux
authors.forename: Christine
authors.initials: C
authors.lastname: Chomienne
authors.forename: Herve
authors.initials: H
authors.lastname: Dombret
authors.forename: Laurent
authors.initials: L
authors.lastname: Degos
authors.forename: Pierre
authors.initials: P
authors.lastname: Fenaux
mesh_terms: D000328:Adult; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003561:Cytarabine / Q000627:therapeutic use*; D003630:Daunorubicin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D015473:Leukemia, Promyelocytic, Acute / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012074:Remission Induction; D016019:Survival Analysis; D014212:Tretinoin / Q000008:administration & dosage
chemical_list: D000964:Antimetabolites, Antineoplastic; D003561:Cytarabine; D014212:Tretinoin; D003630:Daunorubicin