[The results of a multicenter randomized trial on the treatment of acute myeloid leukemia of adults].
OBJECTIVE
Systematization of the results of 20-year multicenter randomized trial of the efficacy of treatment of acute myeloid leukemia (AML) of adults; presentation of the design of the study of the strategy of consolidation and maintenance therapy after high-dose consolidation initiated in 2007.


METHODS
Treatment outcomes on the protocol AML-01.01 are presented for 354 AML patients from 29 hematological centers located in 22 towns of Russia and 2 towns of Ukraine. The patients were randomized into 3 groups by variant of therapy: 124 patients (62 males and 62 females; age median 42 years) received 4 courses of 7+3+VP-16 and 5 courses of maintenance therapy (7+3 with thioguanin); 130 patients (65 males and 65 females, age median 41 year) received 2 courses of 7+3+VP-16, 2 courses 7+3, maintenance--5 courses 7+3 with thioguanin; 126 patients (57 males and 68 females, age median 40 years) were given 2 courses of 7+3+VP-16, 2 HAD courses, treatment discontinuation.


RESULTS
A complete remission after the first course of 7+3+VP-16 was achieved in 55% patients, after the second course--in 30% after the course 7+3+VP-16 or 7+3 with mitoxantron, in 70%--after NAM. Overall and recurrence-free survival were 18 and 35%; 30 and 20%; 36 and 30%, respectively. There was no significant difference in efficacy of the treatment scheme.


CONCLUSIONS
The multivariate analysis has shown that a leading factor having impact on treatment results was the number of randomized patients: the less patients were randomized, the worse were the results.
Parovichnikova
E N
EN
Savchenko
V G
VG
Isaev
V G
VG
Sokolov
A N
AN
Kulikov
S M
SM
Kliasova
G A
GA
Ryzhko
V V
VV
Kravchenko
S K
SK
Khoroshko
N D
ND
Konstantinova
T S
TS
Zagoskina
T P
TP
Ziuzgin
I S
IS
Rekhtman
G B
GB
Moskov
V I
VI
Sokolova
I V
IV
Anchukova
L V
LV
Lapin
V A
VA
Loginov
A B
AB
Tumakov
V A
VA
Korobkin
A V
AV
Miliutina
G I
GI
Samoĭlova
O S
OS
Mal'tsev
V I
VI
Pristupa
A S
AS
Men'shakova
S N
SN
Domnikova
N P
NP
Gavrilova
L V
LV
Obidina
N A
NA
Porokhina
O V
OV
Kaplanov
K D
KD
Medvedeva
L I
LI
Khuazheva
N K
NK
Pilipenko
G I
GI
Golubeva
M E
ME
Maksimov
A G
AG
Ploskikh
M A
MA
Khlevnaia
N V
NV
D000208:Acute Disease; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007951:Leukemia, Myeloid / Q000188:drug therapy* / Q000401:mortality*; D008297:Male; D008942:Mitoxantrone / Q000008:administration & dosage; D012008:Recurrence; D013866:Thioguanine / Q000008:administration & dosage; D016896:Treatment Outcome