title: Intensive consolidation therapy compared with standard consolidation and maintenance therapy for adults with acute myeloid leukaemia aged between 46 and 60 years: final results of the randomized phase III study (AML 8B) of the European Organization for Research and Treatment of Cancer (EORTC) and the Gruppo Italiano Malattie Ematologiche Maligne dell'Adulto (GIMEMA) Leukemia Cooperative Groups.
abstract: The most effective post-remission treatment to maintain complete remission (CR) in adults aged between 46 and 60 years with acute myeloid leukaemia (AML) is uncertain. Previously untreated patients with AML in CR after induction chemotherapy with daunorubicin and cytarabine were randomized between two intensive courses of consolidation therapy containing high-dose cytarabine, combined with amsacrine or daunorubicin and a standard consolidation and maintenance therapy containing standard dose cytarabine and daunorubicin. One hundred fifty-eight CR patients were assigned to the intensive group and 157 patients to the standard group. After a median follow-up of 7.5 years, the 4-year survival rate was 32 % in the intensive group versus 34 % in the standard group (P = 0.29). In the intensive group, the 4-year relapse incidence was lower than in the standard group: 55 and 75 %, respectively (P = 0.0003), whereas treatment-related mortality incidence was higher: 22 versus 3 % (P < 0.0001). Two intensive consolidation courses containing high-dose cytarabine as post-remission treatment in patients with AML aged between 46 and 60 years old did not translate in better long-term outcome despite a 20 % lower relapse incidence. Better supportive care and prevention of treatment-related complications may improve the overall survival after intensified post-remission therapy in this age group.
authors.affiliation: Radboud University Nijmegen Medical Center, The Netherlands. M.Hengeveld@crcn.umcn.nl
authors.forename: Marysia
authors.initials: M
authors.lastname: Hengeveld
authors.forename: Stefan
authors.initials: S
authors.lastname: Suciu
authors.forename: Matthias
authors.initials: M
authors.lastname: Karrasch
authors.forename: Giorgina
authors.initials: G
authors.lastname: Specchia
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Marie
authors.forename: Petra
authors.initials: P
authors.lastname: Muus
authors.forename: Maria C
authors.initials: MC
authors.lastname: Petti
authors.forename: Bruno
authors.initials: B
authors.lastname: Rotoli
authors.forename: Sergio
authors.initials: S
authors.lastname: Amadori
authors.forename: Guiseppe
authors.initials: G
authors.lastname: Fioritoni
authors.forename: Pietro
authors.initials: P
authors.lastname: Leoni
authors.forename: Enrica
authors.initials: E
authors.lastname: Morra
authors.forename: Joseph
authors.initials: J
authors.lastname: Thaler
authors.forename: Luigi
authors.initials: L
authors.lastname: Resegotti
authors.forename: Paola
authors.initials: P
authors.lastname: Fazi
authors.forename: Marco
authors.initials: M
authors.lastname: Vignetti
authors.forename: Franco
authors.initials: F
authors.lastname: Mandelli
authors.forename: Robert
authors.initials: R
authors.lastname: Zittoun
authors.forename: Theo
authors.initials: T
authors.lastname: de Witte
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D060830:Consolidation Chemotherapy / Q000379:methods* / Q000592:standards; D005060:Europe; D005260:Female; D006405:Hematology / Q000379:methods / Q000458:organization & administration; D006801:Humans; D060828:Induction Chemotherapy / Q000379:methods; D007391:International Cooperation; D007558:Italy; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy*; D060046:Maintenance Chemotherapy / Q000379:methods* / Q000592:standards; D008297:Male; D008495:Medical Oncology / Q000379:methods / Q000458:organization & administration; D008875:Middle Aged; D012955:Societies, Medical / Q000458:organization & administration; D016896:Treatment Outcome; D055815:Young Adult