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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.
Authors: Russo, D
Malagola, M
Fiacchini, M
Martinelli, G
Leoncini, L
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
Issue Date: 2005
Project: None 
Fludarabine plus cytarabine (Ara-C) and idarubicin (FLAI) is an effective andwell-tolerated induction regimen for the treatment of acute myeloidleukaemia (AML). This phase III trial compared the efficacy and toxicity ofFLAI versus idarubicin plus Ara-C and etoposide (ICE) in 112 newlydiagnosed AML patients <60 years. Fifty-seven patients received FLAI, as thefirst induction–remission course, and 55 patients received ICE. Postinductiontreatment 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 anddonor availability. After a single induction course, CR rate was 74% in theFLAI arm and 51% in the ICE arm (P ¼ 0Æ01), while death during inductionwas 2% and 9% respectively. Both haematological (P ¼ 0Æ002) and nonhaematological(P ¼ 0Æ0001) toxicities, especially gastrointestinal (i.e.nausea, vomiting, mucositis and diarrhoea), were significantly lower inFLAI arm. In both arms, relapses were more frequent in patients who werenot submitted to allo-SCT. After a median follow-up of 17 months, 30% and38% of the patients are in continuous CR in FLAI and ICE arm respectively.Our prospective randomised study confirmed the anti-leukaemic effect andthe low toxic profile of FLAI as induction treatment for newly diagnosedAML patients.
ISSN: 0007-1048
DOI: 10.1111/j.1365-2141.2005.05745.x
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