title: [The first results of treatment for adult acute myeloid leukemia according to the AML-01.10 protocol of the Research Group of the Hematology Centers of Russia].
abstract: OBJECTIVE
  To give the preliminary results of the AML-01.10 Russian multicenter randomized trial to treat adult acute myeloid leukemia (AML), the basic principle of which is to use high-dose anthracycline antibiotics in induction/consolidation.
  
  
  METHODS
  By December 2011, 145 patients with AML had been randomized from 18 hematology centers of 15 cities and towns of the Russian Federation; the median age of all the patients was 44 years. Seventy-one patients were analyzed in August 2011 (a 1.5-year follow-up).
  
  
  RESULTS
  The efficiency of 2 courses 7+3 using high-dose daunorubicin (60 mg/m2 per administration) and continuous infusion of cytarabine during the second course was high and comparable with that in the use of a high-dose HAM protocol as a second induction course and can achieve a complete remission in 74.6%. The protocol toxicity evaluated from its early mortality (11.3%) and its death in complete remission (16.6%) was permissible, particularly by taking into consideration the multicenter pattern of the trial. At the completion of analysis, 53 (68.8%) out of the 77 patients on whom the data on their vital status were available were alive. In this follow-up period, the frequency of recurrences was 19.2% (10/52). Only 3 (4.2%) patients out of the 71 patients in whom the efficiency of the protocol had been completely evaluated underwent allogeneic bone marrow transplantation.
  
  
  CONCLUSIONS
  The total high dose (720 mg/m2) of anthracycline antibiotics, which is used in the period of induction and consolidation, determines the long periods of myelosuppression and intercourse intervals. Protocol deviations (no course of consolidation therapy, lower-dose idarubicin during consolidation therapy, a course of low-dose cytarabine, between the courses of induction and consolidation chemotherapy, and very long intercourse intervals) were recorded in a total of 20 (28%) patients.
authors.forename: E N
authors.initials: EN
authors.lastname: Parovichnikova
authors.forename: G A
authors.initials: GA
authors.lastname: Kliasova
authors.forename: A N
authors.initials: AN
authors.lastname: Sokolov
authors.forename: V V
authors.initials: VV
authors.lastname: Troitskaia
authors.forename: A V
authors.initials: AV
authors.lastname: Kokhno
authors.forename: L A
authors.initials: LA
authors.lastname: Kuz'mina
authors.forename: I I
authors.initials: II
authors.lastname: Shaforostova
authors.forename: V V
authors.initials: VV
authors.lastname: Ryzhko
authors.forename: S K
authors.initials: SK
authors.lastname: Kravchenko
authors.forename: S N
authors.initials: SN
authors.lastname: Bondarenko
authors.forename: V A
authors.initials: VA
authors.lastname: Lapin
authors.forename: A S
authors.initials: AS
authors.lastname: Pristupa
authors.forename: T S
authors.initials: TS
authors.lastname: Konstantinova
authors.forename: T P
authors.initials: TP
authors.lastname: Zagoskina
authors.forename: I V
authors.initials: IV
authors.lastname: Ialykomov
authors.forename: V I
authors.initials: VI
authors.lastname: Moskov
authors.forename: L V
authors.initials: LV
authors.lastname: Anchukova
authors.forename: T S
authors.initials: TS
authors.lastname: Kaporskaia
authors.forename: E M
authors.initials: EM
authors.lastname: Volodicheva
authors.forename: K D
authors.initials: KD
authors.lastname: Kaplanov
authors.forename: E V
authors.initials: EV
authors.lastname: Kondakova
authors.forename: O S
authors.initials: OS
authors.lastname: Samoĭlova
authors.forename: L V
authors.initials: LV
authors.lastname: Gavrilova
authors.forename: S M
authors.initials: SM
authors.lastname: Kulikov
authors.forename: V G
authors.initials: VG
authors.lastname: Savchenko
mesh_terms: D000293:Adolescent; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D016026:Bone Marrow Transplantation / Q000379:methods*; D003131:Combined Modality Therapy; D003561:Cytarabine / Q000008:administration & dosage; D003630:Daunorubicin / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000473:pathology / Q000628:therapy; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D012074:Remission Induction / Q000379:methods; D012426:Russia; D013997:Time Factors; D014184:Transplantation, Homologous; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D003561:Cytarabine; D003630:Daunorubicin