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
Domenico Russo, Michele Malagola, Antonio de Vivo, Mauro Fiacchini, Giovanni Martinelli, Pier P Piccaluga, Daniela Damiani, Anna Candoni, Angela Michielutti, Maurizio Castelli, Nicoletta Testoni, Emanuela Ottaviani, Michela Rondoni, Giancarla Pricolo, Patrizio Mazza, Eliana Zuffa, Alfonso Zaccaria, Donatella Raspadori, Monica Bocchia, Francesco Lauria, Alessandro Bonini, Paolo Avanzini, Luigi Gugliotta, Giuseppe Visani, Renato Fanin, Michele Baccarani, Domenico Russo, Michele Malagola, Antonio de Vivo, Mauro Fiacchini, Giovanni Martinelli, Pier P Piccaluga, Daniela Damiani, Anna Candoni, Angela Michielutti, Maurizio Castelli, Nicoletta Testoni, Emanuela Ottaviani, Michela Rondoni, Giancarla Pricolo, Patrizio Mazza, Eliana Zuffa, Alfonso Zaccaria, Donatella Raspadori, Monica Bocchia, Francesco Lauria, Alessandro Bonini, Paolo Avanzini, Luigi Gugliotta, Giuseppe Visani, Renato Fanin, Michele Baccarani
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.
Source: PubMed