title: Cytarabine dose of 36 g/m² compared with 12 g/m² within first consolidation in acute myeloid leukemia: results of patients enrolled onto the prospective randomized AML96 study.
abstract: OBJECTIVE
  To assess the optimal cumulative dose of cytarabine for treatment of young adults with acute myeloid leukemia (AML) within a prospective multicenter treatment trial.
  
  
  METHODS
  Between 1996 and 2003, 933 patients (median age, 47 years; range 15 to 60 years) with untreated AML were randomly assigned at diagnosis to receive cytarabine within the first consolidation therapy at either a intermediate-dose of 12 g/m² (I-MAC) or a high-dose of 36 g/m² (H-MAC) combined with mitoxantrone. Autologous hematopoietic stem-cell transplantation or intermediate-dose cytarabine (10 g/m²) were offered as second consolidation. Patients with a matched donor could receive an allogeneic transplantation in a risk-adapted manner.
  
  
  RESULTS
  After double induction therapy including intermediate-dose cytarabine (10 g/m²), mitoxantrone, etoposide, and amsacrine, complete remission was achieved in 66% of patients. In the primary efficacy analysis population, a consolidation with either I-MAC or H-MAC did not result in significant differences in the 5-year overall (30% v 33%; P = .77) or disease-free survival (37% v 38%; P = .86) according to the intention-to-treat analysis. Besides a prolongation of neutropenia and higher transfusion demands in the H-MAC arm, rates of serious adverse events were comparable in the two groups.
  
  
  CONCLUSIONS
  In young adults with AML receiving intermediate-dose cytarabine induction, intensification of the cytarabine dose beyond 12 g/m² within first consolidation did not improve treatment outcome.
authors: Medizinische Klinik I, Universitätsklinikum C.G. Carus, Dresden, Germany. markus.schaich@uniklinikum-dresden.de
authors: Markus
authors: M
authors: Schaich
authors: Christoph
authors: C
authors: Röllig
authors: Silke
authors: S
authors: Soucek
authors: Michael
authors: M
authors: Kramer
authors: Christian
authors: C
authors: Thiede
authors: Brigitte
authors: B
authors: Mohr
authors: Uta
authors: U
authors: Oelschlaegel
authors: Norbert
authors: N
authors: Schmitz
authors: Reingard
authors: R
authors: Stuhlmann
authors: Hannes
authors: H
authors: Wandt
authors: Kerstin
authors: K
authors: Schäfer-Eckart
authors: Walter
authors: W
authors: Aulitzky
authors: Martin
authors: M
authors: Kaufmann
authors: Heinrich
authors: H
authors: Bodenstein
authors: Joachim
authors: J
authors: Tischler
authors: Anthony
authors: A
authors: Ho
authors: Alwin
authors: A
authors: Krämer
authors: Martin
authors: M
authors: Bornhäuser
authors: Johannes
authors: J
authors: Schetelig
authors: Gerhard
authors: G
authors: Ehninger