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One versus two high-dose cytarabine-based consolidation before autologous stem cell transplantation for young acute myeloblastic leukaemia patients in first complete remission.

Author(s): Jourdan E, Rigal-Huguet F, Marit G, Vey N, Dastugue N, Fegueux N, Molina L, Gastaut JA, Legros L, Zerazhi H, Cailleres S, Bauduer F, Bordessoule D, Attal M, Blaise D, Pigneux A, BGMT Study Group

Affiliation(s): Hopital Caremeau, CHU Nimes, France.

Publication date & source: 2005-05, Br J Haematol., 129(3):403-10.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

We report on a randomized trial aimed to determine the impact of a second consolidative high-dose cytarabine-based chemotherapy (HiDAC) in patients with acute myeloid leukaemia prior to an autologous stem cell transplantation (ASCT). Patients aged 18-60 years, in complete remission (CR) received a first consolidation with daunorubicin and cytarabine at reduced dose. Patients not allocated to allogeneic transplantation received one course of HiDAC and then were randomized to receive an ASCT immediately (HiDAC 1 group) or after one more course of HiDAC (HiDAC 2 group). Out of the 437 initial patients, 351 achieved CR (80%), of those 277 (79%) were eligible for first HiDAC, and 128 (36%) were randomized (HiDAC 1:65, HiDAC 2:63). Overall survival, leukaemia-free survival and cumulative incidence of relapse and non-relapse deaths were 41% and 53% (P = 0.14), 39% and 48% (P = 0.12), 57% and 47% (P = 0.11), 8% and 8% (P = 0.95) for HiDAC 1 and HiDAC 2 groups, respectively. Further studies are warranted with a larger number of patients to test the place of a second course of HiDAC in this setting.

Page last updated: 2006-01-31

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