title: [The results of a multicenter randomized trial on the treatment of acute myeloid leukemia of adults].
abstract: 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.
authors.forename: E N
authors.initials: EN
authors.lastname: Parovichnikova
authors.forename: V G
authors.initials: VG
authors.lastname: Savchenko
authors.forename: V G
authors.initials: VG
authors.lastname: Isaev
authors.forename: A N
authors.initials: AN
authors.lastname: Sokolov
authors.forename: S M
authors.initials: SM
authors.lastname: Kulikov
authors.forename: G A
authors.initials: GA
authors.lastname: Kliasova
authors.forename: V V
authors.initials: VV
authors.lastname: Ryzhko
authors.forename: S K
authors.initials: SK
authors.lastname: Kravchenko
authors.forename: N D
authors.initials: ND
authors.lastname: Khoroshko
authors.forename: T S
authors.initials: TS
authors.lastname: Konstantinova
authors.forename: T P
authors.initials: TP
authors.lastname: Zagoskina
authors.forename: I S
authors.initials: IS
authors.lastname: Ziuzgin
authors.forename: G B
authors.initials: GB
authors.lastname: Rekhtman
authors.forename: V I
authors.initials: VI
authors.lastname: Moskov
authors.forename: I V
authors.initials: IV
authors.lastname: Sokolova
authors.forename: L V
authors.initials: LV
authors.lastname: Anchukova
authors.forename: V A
authors.initials: VA
authors.lastname: Lapin
authors.forename: A B
authors.initials: AB
authors.lastname: Loginov
authors.forename: V A
authors.initials: VA
authors.lastname: Tumakov
authors.forename: A V
authors.initials: AV
authors.lastname: Korobkin
authors.forename: G I
authors.initials: GI
authors.lastname: Miliutina
authors.forename: O S
authors.initials: OS
authors.lastname: Samoĭlova
authors.forename: V I
authors.initials: VI
authors.lastname: Mal'tsev
authors.forename: A S
authors.initials: AS
authors.lastname: Pristupa
authors.forename: S N
authors.initials: SN
authors.lastname: Men'shakova
authors.forename: N P
authors.initials: NP
authors.lastname: Domnikova
authors.forename: L V
authors.initials: LV
authors.lastname: Gavrilova
authors.forename: N A
authors.initials: NA
authors.lastname: Obidina
authors.forename: O V
authors.initials: OV
authors.lastname: Porokhina
authors.forename: K D
authors.initials: KD
authors.lastname: Kaplanov
authors.forename: L I
authors.initials: LI
authors.lastname: Medvedeva
authors.forename: N K
authors.initials: NK
authors.lastname: Khuazheva
authors.forename: G I
authors.initials: GI
authors.lastname: Pilipenko
authors.forename: M E
authors.initials: ME
authors.lastname: Golubeva
authors.forename: A G
authors.initials: AG
authors.lastname: Maksimov
authors.forename: M A
authors.initials: MA
authors.lastname: Ploskikh
authors.forename: N V
authors.initials: NV
authors.lastname: Khlevnaia
mesh_terms: 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