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High-dose cytarabine consolidation with or without additional amsacrine and mitoxantrone in acute myeloid leukemia: results of the prospective randomized AML2003 trial

Purpose - To assess the treatment outcome benefit of multiagent consolidation in young adults with acute myeloid leukemia (AML) in a prospective, randomized, multicenter trial. - Patients and Methods - Between December 2003 and November 2009, 1,179 patients (median age, 48 years; range, 16 to 60 yea...

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Hauptverfasser: Schaich, Markus (VerfasserIn) , Parmentier, Stefani (VerfasserIn) , Kramer, Michael (VerfasserIn) , Illmer, Thomas (VerfasserIn) , Stölzel, Friedrich (VerfasserIn) , Röllig, Christoph (VerfasserIn) , Thiede, Christian (VerfasserIn) , Hänel, Mathias (VerfasserIn) , Schäfer-Eckart, Kerstin (VerfasserIn) , Aulitzky, Walter (VerfasserIn) , Einsele, Hermann (VerfasserIn) , Ho, Anthony Dick (VerfasserIn) , Serve, Hubert (VerfasserIn) , Berdel, Wolfgang E. (VerfasserIn) , Mayer, Jiri (VerfasserIn) , Schmitz, Norbert (VerfasserIn) , Krause, Stefan W. (VerfasserIn) , Neubauer, Andreas (VerfasserIn) , Baldus, Claudia D. (VerfasserIn) , Schetelig, Johannes (VerfasserIn) , Bornhäuser, Martin (VerfasserIn) , Ehninger, Gerhard (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: 2013
In: Journal of clinical oncology
Year: 2013, Jahrgang: 31, Heft: 17, Pages: 2094-2102
ISSN:1527-7755
DOI:10.1200/JCO.2012.46.4743
Online-Zugang:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1200/JCO.2012.46.4743
Verlag, lizenzpflichtig, Volltext: https://ascopubs.org/doi/10.1200/JCO.2012.46.4743
Volltext
Verfasserangaben:Markus Schaich, Stefani Parmentier, Michael Kramer, Thomas Illmer, Friedrich Stölzel, Christoph Röllig, Christian Thiede, Mathias Hänel, Kerstin Schäfer-Eckart, Walter Aulitzky, Hermann Einsele, Anthony D. Ho, Hubert Serve, Wolfgang E. Berdel, Jiri Mayer, Norbert Schmitz, Stefan W. Krause, Andreas Neubauer, Claudia D. Baldus, Johannes Schetelig, Martin Bornhäuser, and Gerhard Ehninger
Beschreibung
Zusammenfassung:Purpose - To assess the treatment outcome benefit of multiagent consolidation in young adults with acute myeloid leukemia (AML) in a prospective, randomized, multicenter trial. - Patients and Methods - Between December 2003 and November 2009, 1,179 patients (median age, 48 years; range, 16 to 60 years) with untreated AML were randomly assigned at diagnosis to receive either standard high-dose cytarabine consolidation with three cycles of 18 g/m2 (3× HD-AraC) or multiagent consolidation with two cycles of mitoxantrone (30 mg/m2) plus cytarabine (12 g/m2) and one cycle of amsacrine (500 mg/m2) plus cytarabine (10 g/m2; MAC/MAMAC/MAC). Allogeneic and autologous hematopoietic stem-cell transplantations were performed in a risk-adapted and priority-based manner. Results - After double induction therapy using a 3 + 7 regimen including standard-dose cytarabine and daunorubicin, complete remission was achieved in 65% of patients. In the primary efficacy population of patients evaluable for consolidation outcomes, consolidation with either 3× HD-AraC or MAC/MAMC/MAC did not result in any significant difference in 3-year overall (69% v 64%; P = .18) or disease-free survival (46% v 48%; P = .99) according to the intention-to-treat analysis. Furthermore, MAC/MAMAC/MAC led to additional GI and hepatic toxicity and a higher rate of infection and bleeding, resulting in significantly shorter 3-year overall survival in the per-protocol analysis compared with 3× HD-AraC (63% v 72%; P = .04). - Conclusion - In younger adults with AML, multiagent consolidation using mitoxantrone and amsacrine in combination with high-dose cytarabine does not improve treatment outcome and confers additional toxicity.
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Beschreibung:Online Resource
ISSN:1527-7755
DOI:10.1200/JCO.2012.46.4743

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