Premium
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
Author(s) -
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
Publication year - 2008
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/j.1365-2141.2008.07400.x
Subject(s) - medicine , daunorubicin , cytarabine , randomized controlled trial , gastroenterology , incidence (geometry) , surgery , univariate analysis , leukemia , multivariate analysis , physics , optics
Summary 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/m 2 days 1–3) or DNX (80 mg/m 2 days 1–3) plus cytarabine (AraC; 100 mg/m 2 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.