One versus two high-dose cytarabine-based consolidation before autologous stem cell transplantation for young acute myeloblastic leukaemia patients in first complete remission.
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.
Jourdan
Eric
E
Hôpital Caremeau, CHU Nîmes, France.
Rigal-Huguet
Françoise
F
Marit
Gerald
G
Vey
Norbert
N
Dastugue
Nicole
N
Fegueux
Nathalie
N
Molina
Lysiane
L
Gastaut
Jean-Albert
JA
Legros
Laurence
L
Zerazhi
Hacene
H
Cailleres
Sylvie
S
Bauduer
Frédéric
F
Bordessoule
Dominique
D
Attal
Michel
M
Blaise
Didier
D
Pigneux
Arnaud
A
D000293:Adolescent; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003561:Cytarabine / Q000008:administration & dosage*; D003630:Daunorubicin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D012008:Recurrence; D012074:Remission Induction; D012307:Risk Factors; D016019:Survival Analysis
D003561:Cytarabine; D003630:Daunorubicin