title: Multicentre phase III trial on fludarabine, cytarabine (Ara-C), and idarubicin versus idarubicin, Ara-C and etoposide for induction treatment of younger, newly diagnosed acute myeloid leukaemia patients.
abstract: Fludarabine plus cytarabine (Ara-C) and idarubicin (FLAI) is an effective and well-tolerated induction regimen for the treatment of acute myeloid leukaemia (AML). This phase III trial compared the efficacy and toxicity of FLAI versus idarubicin plus Ara-C and etoposide (ICE) in 112 newly diagnosed AML patients <60 years. Fifty-seven patients received FLAI, as the first induction-remission course, and 55 patients received ICE. Post-induction treatment consisted of high-dose Ara-C (HDAC). After HDAC, patients in complete remission (CR) received a second consolidation course (mitoxantrone, etoposide, Ara-C) and autologous stem cell transplantation (auto-SCT) or allogeneic (allo)-SCT, according to the age, disease risk and donor availability. After a single induction course, CR rate was 74% in the FLAI arm and 51% in the ICE arm (P = 0.01), while death during induction was 2% and 9% respectively. Both haematological (P = 0.002) and non-haematological (P = 0.0001) toxicities, especially gastrointestinal (i.e. nausea, vomiting, mucositis and diarrhoea), were significantly lower in FLAI arm. In both arms, relapses were more frequent in patients who were not submitted to allo-SCT. After a median follow-up of 17 months, 30% and 38% of the patients are in continuous CR in FLAI and ICE arm respectively. Our prospective randomised study confirmed the anti-leukaemic effect and the low toxic profile of FLAI as induction treatment for newly diagnosed AML patients.
authors.affiliation: Unit of Blood Diseases and Cell Therapy, Brescia University, Brescia, Italy. russo@med.unibs.it
authors.forename: Domenico
authors.initials: D
authors.lastname: Russo
authors.forename: Michele
authors.initials: M
authors.lastname: Malagola
authors.forename: Antonio
authors.initials: A
authors.lastname: de Vivo
authors.forename: Mauro
authors.initials: M
authors.lastname: Fiacchini
authors.forename: Giovanni
authors.initials: G
authors.lastname: Martinelli
authors.forename: Pier P
authors.initials: PP
authors.lastname: Piccaluga
authors.forename: Daniela
authors.initials: D
authors.lastname: Damiani
authors.forename: Anna
authors.initials: A
authors.lastname: Candoni
authors.forename: Angela
authors.initials: A
authors.lastname: Michielutti
authors.forename: Maurizio
authors.initials: M
authors.lastname: Castelli
authors.forename: Nicoletta
authors.initials: N
authors.lastname: Testoni
authors.forename: Emanuela
authors.initials: E
authors.lastname: Ottaviani
authors.forename: Michela
authors.initials: M
authors.lastname: Rondoni
authors.forename: Giancarla
authors.initials: G
authors.lastname: Pricolo
authors.forename: Patrizio
authors.initials: P
authors.lastname: Mazza
authors.forename: Eliana
authors.initials: E
authors.lastname: Zuffa
authors.forename: Alfonso
authors.initials: A
authors.lastname: Zaccaria
authors.forename: Donatella
authors.initials: D
authors.lastname: Raspadori
authors.forename: Monica
authors.initials: M
authors.lastname: Bocchia
authors.forename: Francesco
authors.initials: F
authors.lastname: Lauria
authors.forename: Alessandro
authors.initials: A
authors.lastname: Bonini
authors.forename: Paolo
authors.initials: P
authors.lastname: Avanzini
authors.forename: Luigi
authors.initials: L
authors.lastname: Gugliotta
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Visani
authors.forename: Renato
authors.initials: R
authors.lastname: Fanin
authors.forename: Michele
authors.initials: M
authors.lastname: Baccarani
mesh_terms: D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003561:Cytarabine / Q000008:administration & dosage; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D015255:Idarubicin / Q000008:administration & dosage; D007621:Karyotyping; D007951:Leukemia, Myeloid / Q000188:drug therapy* / Q000235:genetics / Q000601:surgery; D007958:Leukocyte Count; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012074:Remission Induction; D033581:Stem Cell Transplantation; D019172:Transplantation Conditioning; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D014740:Vidarabine / Q000008:administration & dosage / Q000031:analogs & derivatives
chemical_list: D003561:Cytarabine; D005047:Etoposide; D014740:Vidarabine; C024352:fludarabine; D015255:Idarubicin