title: Addition of lomustine to idarubicin and cytarabine improves the outcome of elderly patients with de novo acute myeloid leukemia: a report from the GOELAMS.
abstract: OBJECTIVE
  No significant improvement in treatment outcome has been seen in elderly patients with acute myeloid leukemia (AML) over the past 20 years. This retrospective analysis investigated the prognostic factors for complete remission (CR) and survival in older patients with AML.
  
  
  METHODS
  The study involved 847 patients older than 60 years enrolled onto three trials carried out in France between 1995 and 2005. Induction therapy consisted of idarubicin (8 mg/m(2), days 1 through 5) and cytarabine (100 mg/m(2), days 1 through 7; group I, 339 patients) or the same drugs plus lomustine (200 mg/m(2) orally on day 1; group II, 508 patients). Consolidation therapy consisted of anthracycline and cytarabine courses at lower doses, preceded or not by a first course of intermediate-dose cytarabine.
  
  
  RESULTS
  The rate of CR was significantly higher in patients in group II compared with group I (68% v 58%; P = .002). The rate of toxic death was similar in the two groups. In multivariate analysis, two prognostic factors were linked to CR: nonadverse cytogenetic (P < .003) and addition of lomustine to induction chemotherapy (P = .002). Median overall survival was significantly improved in patients treated with lomustine (median and SE, 12.7 +/- 2.2 months v 8.7 +/- 2.7 months; P = .004). In multivariate analysis, five prognostic factors positively affected overall survival: addition of lomustine (P = .002), age < or = 69 years (P < .001), Eastern Cooperative Oncology Group performance status lower than 2 (P = .002), French-American-British subgroup 1/2 (P = .02), and nonadverse cytogenetic (P < .001).
  
  
  CONCLUSIONS
  Lomustine improves the rate of CR and survival in elderly patients with de novo AML when added to standard induction therapy.
authors.affiliation: Hopital du Haut-Leveque, Pessac, France.
authors.forename: Arnaud
authors.initials: A
authors.lastname: Pigneux
authors.forename: Jean-Luc
authors.initials: JL
authors.lastname: Harousseau
authors.forename: Francis
authors.initials: F
authors.lastname: Witz
authors.forename: Mathieu
authors.initials: M
authors.lastname: Sauvezie
authors.forename: Marie-Christine
authors.initials: MC
authors.lastname: Bene
authors.forename: Isabelle
authors.initials: I
authors.lastname: Luquet
authors.forename: Mathilde
authors.initials: M
authors.lastname: Hunault-Berger
authors.forename: Christian
authors.initials: C
authors.lastname: Recher
authors.forename: Bruno
authors.initials: B
authors.lastname: Lioure
authors.forename: Chantal
authors.initials: C
authors.lastname: Himberlin
authors.forename: Martine
authors.initials: M
authors.lastname: Escoffre-Barbe
authors.forename: Christian
authors.initials: C
authors.lastname: Berthou
authors.forename: Severine
authors.initials: S
authors.lastname: Lissandre
authors.forename: Nathalie
authors.initials: N
authors.lastname: Fegueux
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Cahn
authors.forename: Eric
authors.initials: E
authors.lastname: Jourdan
authors.forename: François
authors.initials: F
authors.lastname: Dreyfus
authors.forename: Josy
authors.initials: J
authors.lastname: Reiffers
authors.forename: Noël
authors.initials: N
authors.lastname: Milpied
authors.forename: Norbert
authors.initials: N
authors.lastname: Ifrah
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D015331:Cohort Studies; D003561:Cytarabine / Q000008:administration & dosage; D005260:Female; D006801:Humans; D015255:Idarubicin / Q000008:administration & dosage; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008130:Lomustine / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D016032:Randomized Controlled Trials as Topic; D012074:Remission Induction; D012189:Retrospective Studies; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D003561:Cytarabine; D008130:Lomustine; D015255:Idarubicin