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- Title
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.
- Authors
Latagliata, Roberto; Breccia, Massimo; Fazi, Paola; Iacobelli, Simona; Martinelli, Giovanni; Di Raimondo, Francesco; Sborgia, Marco; Fabbiano, Francesco; Pirrotta, Maria Teresa; Zaccaria, Alfonso; Amadori, Sergio; Caramatti, Cecilia; Falzetti, Franca; Candoni, Anna; Mattei, Daniele; Morselli, Monica; Alimena, Giuliana; Vignetti, Marco; Baccarani, Michele; Mandelli, Franco
- Abstract
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.
- Subjects
MYELOID leukemia; BONE marrow diseases; MEDICAL research; MEDICAL experimentation on humans; CLINICAL trials
- Publication
British Journal of Haematology, 2008, Vol 143, Issue 5, p681
- ISSN
0007-1048
- Publication type
Article
- DOI
10.1111/j.1365-2141.2008.07400.x