Treatment of acute myelogenous leukaemia in patients aged 50-65: idarubicin is more effective than zorubicin for remission induction and prolonged disease-free survival can be obtained using a unique consolidation course. The Goelam Group.
From December 1987 to June 1992, 251 patients aged 50-65 with de novo acute myelogenous leukaemia (AML) were recruited to a multi-institutional randomized clinical trial. Induction therapy consisted of Ara-C (200 mg/ m2, continuous infusion, days 1-7) with either zorubicin (ZRB) (200 mg/m2, i.v., days 1-4) or idarubicin (IDR) (8 mg/ m2, i.v., days 1-5). Consolidation therapy consisted of a single course of intensive chemotherapy with high-dose Ara-C (3 g/m2, 3 h infusion, q 12 h, days 1-4) and m-Amsa (100 mg/m2/d, i.v., days 5-7). The complete remission (CR) rate was (73%) with Ara-C/ IDR versus (60%) with Ara-C/ZRB (P = 0.033). In multivariate analysis, factors found to be significant in predicting CR were normal karyotype and treatment with IDR. With a median follow-up of 73 months, the median disease-free survival (DFS) duration of all CR patients and the probability of CR at 6 years were 17 months and 29%. In multivariate analysis the only factor associated with an increased DFS duration was a normal karyotype. The median event-free survival (EFS) duration for all evaluable patients and the median overall survival duration for all eligible patients were respectively 7 and 12 months without any difference between induction arms. The study shows that in patients aged 50-65 idarabicin is more effective than zorubicin for remission induction. However, the type of anthracycline did not influence overall survival duration. Using a unique consolidation course, we observed a prolonged DFS which compares favourably with results obtained with more prolonged consolidation therapy or maintenance treatment.
Pignon
B
B
Unité d'Hématologie Clinique, Hôpital R. Debré Reims, France.
Witz
F
F
Desablens
B
B
Leprise
P Y
PY
Francois
S
S
Linassier
C
C
Berthou
C
C
Caillot
D
D
Lioure
B
B
Cahn
J Y
JY
Casassus
P
P
Sadoun
A
A
Audhuy
B
B
Guyotat
D
D
Briere
J
J
Vilque
J P
JP
Baranger
L
L
Polin
V
V
Berthaud
P
P
Hurteloup
P
P
Herve
P
P
Harousseau
J L
JL
D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000627:therapeutic use*; D003630:Daunorubicin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D015255:Idarubicin / Q000627:therapeutic use*; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012074:Remission Induction; D016019:Survival Analysis; D015996:Survival Rate; D016896:Treatment Outcome
D000903:Antibiotics, Antineoplastic; C002205:zorubicin; D015255:Idarubicin; D003630:Daunorubicin