title: Adding lomustine to idarubicin and cytarabine for induction chemotherapy in older patients with acute myeloid leukemia: the BGMT 95 trial results.
abstract: OBJECTIVE
  Treatment of acute myeloid leukemia (AML) in older patients remains unsatisfactory. The BGMT 95 trial for older patients set out to improve the outcome of these patients by adding a third drug (lomustine) to a 5+7 idarubicin and cytarabine schedule at induction and evaluating intermediate-dose cytarabine as consolidation.
  
  
  METHODS
  A multicenter randomized trial was performed comparing induction therapy with idarubicin and cytarabine, 5+7 (IC) to induction therapy with the same drugs plus lomustine (CCNU), 200 mg\m(2) orally on day 1 (ICL). Patients in complete remission (CR) were then randomized to receive either maintenance therapy or intensification with intermediate-dose cytarabine and idarubicin followed by maintenance therapy.
  
  
  RESULTS
  Between 1995 and 2001, 364 patients (>or=60 years) from ten centers were included. The CR rate was 58% for patients in the IC arm and 67% for patients in the ICL arm (p=0.104). The median overall survival (OS) was 7 and 12 months respectively (p=0.05), but OS at 2 years was not statistically different: 31+/-7% for patients in the ICL arm vs 24+/-6% for those in the IC arm. The two post-remission strategies yielded similar results.
  
  
  CONCLUSIONS
  Adding lomustine to induction with idarubicin and cytarabine therapy did not statistically improve survival in elderly patients with AML. Adding intermediate-dose cytarabine to consolidation therapy did not improve outcome.
authors.affiliation: Service des Maladies du Sang, Hopital du Haut-Leveque, Avenue de Magellan, 33604 Pessac Cedex, France. arnaud.pigneux@chu-bor-deaux.fr
authors.forename: Arnaud
authors.initials: A
authors.lastname: Pigneux
authors.forename: Virginie
authors.initials: V
authors.lastname: Perreau
authors.forename: Eric
authors.initials: E
authors.lastname: Jourdan
authors.forename: Norbert
authors.initials: N
authors.lastname: Vey
authors.forename: Nicole
authors.initials: N
authors.lastname: Dastugue
authors.forename: Françoise
authors.initials: F
authors.lastname: Huguet
authors.forename: Jean-Jacques
authors.initials: JJ
authors.lastname: Sotto
authors.forename: L Rachid
authors.initials: LR
authors.lastname: Salmi
authors.forename: Norbert
authors.initials: N
authors.lastname: Ifrah
authors.forename: Josy
authors.initials: J
authors.lastname: Reiffers
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols; D003561:Cytarabine / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D015255:Idarubicin / Q000009:adverse effects / Q000627:therapeutic use*; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000473:pathology; D008130:Lomustine / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D003561:Cytarabine; D008130:Lomustine; D015255:Idarubicin