This randomized phase III clinical trial explored the efficacy of DaunoXome (DNX) versus Daunorubicin (DNR) in acute myeloid leukaemia (AML) patients aged >60 years. Three hundred and one AML patients were randomized to receive DNR (45 mg/m2 days 1-3) or DNX (80 mg/m2 days 1-3) plus cytarabine (AraC; 100 mg/m2 days 1-7). Patients in complete remission (CR) received a course of the same drugs as consolidation and then were randomized for maintenance with AraC+ all trans retinoic acid or no further treatment. Among 153 patients in the DNR arm, 78 (51.0%) achieved CR, 55 (35.9%) were resistant and 20 (13.1%) died during induction. Among 148 patients in the DNX arm, 73 (49.3%) achieved CR, 47 (31.8%) were resistant and 28 (18.9%) died during induction. Univariate analysis showed no difference as to induction results. After CR, DNX showed a higher incidence of early deaths (12.5% vs. 2.6% at 6 months, P = 0.053) but a lower incidence of relapse beyond 6 months (59% vs. 78% at 24 months, P = 0.064), with a cross in overall survival (OS) and disease-free survival (DFS) curves and a later advantage for DNX arm after 12 months from diagnosis. DNX seems to improve OS and DFS in the long-term follow-up, because of a reduction in late relapses. © 2008 The Authors.
Liposomal daunorubicin versus standard daunorubicin: Long term follow-up of the GIMEMA GSI 103 AMLE randomized trial in patients older than 60 years with acute myelogenous leukaemia / Latagliata, R.; Breccia, M.; Fazi, P.; Iacobelli, S.; Martinelli, G.; Di Raimondo, F.; Sborgia, M.; Fabbiano, F.; Pirrotta, M. T.; Zaccaria, A.; Amadori, S.; Caramatti, C.; Falzetti, F.; Candoni, A.; Mattei, D.; Morselli, M.; Alimena, G.; Vignetti, M.; Baccarani, M.; Mandelli, F.. - In: BRITISH JOURNAL OF HAEMATOLOGY. - ISSN 0007-1048. - 143:5(2008), pp. 681-689. [10.1111/j.1365-2141.2008.07400.x]