Details

Autor(en) / Beteiligte

• SCHAICH, Markus
• PARMENTIER, Stefani
• EINSELE, Hermann
• HO, Anthony D
• SERVE, Hubert
• BERDEL, Wolfgang E
• MAYER, Jiri
• SCHMITZ, Norbert
• KRAUSE, Stefan W
• NEUBAUER, Andreas
• BALDUS, Claudia D
• SCHETELIG, Johannes
• KRAMER, Michael
• BORNHAUSER, Martin
• EHNINGER, Gerhard
• ILLMER, Thomas
• STÖLZEL, Friedrich
• RÖLLIG, Christoph
• THIEDE, Christian
• HÄNEL, Mathias
• SCHÄFER-ECKART, Kerstin
• AULITZKY, Walter

Titel

High-Dose Cytarabine Consolidation With or Without Additional Amsacrine and Mitoxantrone in Acute Myeloid Leukemia: Results of the Prospective Randomized AML2003 Trial

Ist Teil von

• Journal of clinical oncology, 2013-06, Vol.31 (17), p.2094-2102

Ort / Verlag

Alexandria, VA: American Society of Clinical Oncology

Erscheinungsjahr

2013

Link zum Volltext

Quelle

Alma/SFX Local Collection

Beschreibungen/Notizen

• To assess the treatment outcome benefit of multiagent consolidation in young adults with acute myeloid leukemia (AML) in a prospective, randomized, multicenter trial. 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/m(2) (3× HD-AraC) or multiagent consolidation with two cycles of mitoxantrone (30 mg/m(2)) plus cytarabine (12 g/m(2)) and one cycle of amsacrine (500 mg/m(2)) plus cytarabine (10 g/m(2); MAC/MAMAC/MAC). Allogeneic and autologous hematopoietic stem-cell transplantations were performed in a risk-adapted and priority-based manner. 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). 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.