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.
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 / Russo, D.; Malagola, M.; De Vivo, A.; Fiacchini, M.; Martinelli, G.; Piccaluga, P. P.; Damiani, D.; Candoni, A.; Michielutti, A.; Castelli, M.; Testoni, N.; Ottaviani, E.; Rondoni, M.; Pricolo, G.; Mazza, P.; Zuffa, E.; Zaccaria, A.; Raspadori, D.; Bocchia, M.; Lauria, F.; Bonini, A.; Avanzini, P.; Gugliotta, L.; Visani, G.; Fanin, R.; Baccarani, M.. - In: BRITISH JOURNAL OF HAEMATOLOGY. - ISSN 0007-1048. - 131:2(2005), pp. 172-179. [10.1111/j.1365-2141.2005.05745.x]