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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

Purpose - - To assess the optimal cumulative dose of cytarabine for treatment of young adults with acute myeloid leukemia (AML) within a prospective multicenter treatment trial. - - Patients and Methods - - Between 1996 and 2003, 933 patients (median age, 47 years; range 15 to 60 years) with untr...

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Main Authors: Schaich, Markus (Author) , Röllig, Christoph (Author) , Soucek, Silke (Author) , Kramer, Michael (Author) , Thiede, Christian (Author) , Mohr, Brigitte (Author) , Oelschlaegel, Uta (Author) , Schmitz, Norbert (Author) , Stuhlmann, Reingard (Author) , Wandt, Hannes (Author) , Schäfer-Eckart, Kerstin (Author) , Aulitzky, Walter (Author) , Kaufmann, Martin (Author) , Bodenstein, Heinrich (Author) , Tischler, Joachim (Author) , Ho, Anthony Dick (Author) , Krämer, Alwin (Author) , Bornhäuser, Martin (Author) , Schetelig, Johannes (Author) , Ehninger, Gerhard (Author)
Format: Article (Journal)
Language:English
Published: May 23, 2011
In: Journal of clinical oncology
Year: 2011, Volume: 29, Issue: 19, Pages: 2696-2702
ISSN:1527-7755
DOI:10.1200/JCO.2010.33.7303
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1200/JCO.2010.33.7303
Verlag, lizenzpflichtig, Volltext: https://ascopubs.org/doi/10.1200/JCO.2010.33.7303
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Author Notes:Markus Schaich, Christoph Röllig, Silke Soucek, Michael Kramer, Christian Thiede, Brigitte Mohr, Uta Oelschlaegel, Norbert Schmitz, Reingard Stuhlmann, Hannes Wandt, Kerstin Schäfer-Eckart, Walter Aulitzky, Martin Kaufmann, Heinrich Bodenstein, Joachim Tischler, Anthony Ho, Alwin Krämer, Martin Bornhäuser, Johannes Schetelig, and Gerhard Ehninger
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Summary:Purpose - - To assess the optimal cumulative dose of cytarabine for treatment of young adults with acute myeloid leukemia (AML) within a prospective multicenter treatment trial. - - Patients and 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. - - Conclusion - - 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.
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Physical Description:Online Resource
ISSN:1527-7755
DOI:10.1200/JCO.2010.33.7303

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