[Results of clinical trials in the treatment of acute myeloid leukemia in adults during a 7-year period].
OBJECTIVE
Comparison of effectiveness of induction regimens varying in intensity and maintenance variants in patients with acute myeloid leukemia (AML) included in a randomised multicenter trial.


METHODS
Clinical trial 1 enrolled 185 AML patients. Vepesid-free induction was used in 85 patients (group 1), induction with vepesid--in 99 patients (group 2). 223 AML patients entered trial 2. Of them 37 patients were treated for 3 years 7 + 3 with daunorubicin in the dose 45 mg/m2 in the induction phase (group 1), 85 and 101 patients received 7 + 3 with daunorubicin for a year in the dose 45 mg/m2 and 60 mg/m2, respectively, (group 2 and 3).


RESULTS
For group 1 in trial 1 the remission rate, early lethality, resistance were, respectively, 60, 20 and 20%, respectively. For group 2 in trial 1--66, 22 and 12%, respectively. 5-year recurrence-free survival reached 32 and 37% for group 1 and 2, respectively. For trial 2 relevant figures made up 75.5, 16.2, 8.1% for group 1; 60, 17.6 and 22.4% for group 2; 63, 20.8 and 16% for group 3, respectively. The 3.5-year recurrence-free survival in groups 1, 2 and 3, was 16, 46 and 50%, respectively. For both trials, the differences between the groups were insignificant.


CONCLUSIONS
The results evidence that the treatment can be shorter (not 3 but 1 year or even 6 months), the induction more intensive (the dose of anthracycline antibiotics can be elevated up to 60 mg/m2 without a rise in early lethality).
Savchenko
V G
VG
Parovichnikova
E N
EN
Kliasova
G A
GA
Isaev
V G
VG
Pivnik
A V
AV
Khoroshko
N D
ND
Ol'shanskaia
Iu V
IuV
Tikhonova
L Iu
LIu
Maslova
E R
ER
Kulikov
S M
SM
D000208:Acute Disease; D000328:Adult; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003561:Cytarabine / Q000008:administration & dosage; D003630:Daunorubicin / Q000008:administration & dosage; D018572:Disease-Free Survival; D005047:Etoposide / Q000008:administration & dosage; D006801:Humans; D007951:Leukemia, Myeloid / Q000188:drug therapy* / Q000401:mortality; D008875:Middle Aged; D013997:Time Factors; D016896:Treatment Outcome
D000903:Antibiotics, Antineoplastic; D000964:Antimetabolites, Antineoplastic; D000972:Antineoplastic Agents, Phytogenic; D003561:Cytarabine; D005047:Etoposide; D003630:Daunorubicin