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: | , , , , , , , , , , , , , , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
May 23, 2011
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| 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 |
| 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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| 245 | 1 | 0 | |a Cytarabine dose of 36 g/m2 compared with 12 g/m2 within first consolidation in acute myeloid leukemia |b results of patients enrolled onto the prospective randomized AML96 study |c 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 |
| 246 | 3 | 3 | |a Cytarabine dose of 36 g/m 2 compared with 12 g/m 2 within first consolidation in acute myeloid leukemia |
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| 520 | |a 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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