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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.
- Source :
-
Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2011 Jul 01; Vol. 29 (19), pp. 2696-702. Date of Electronic Publication: 2011 May 23. - Publication Year :
- 2011
-
Abstract
- 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.<br />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.<br />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.<br />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.
- Subjects :
- Adolescent
Adult
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Cytogenetics
Disease-Free Survival
Female
Humans
Male
Middle Aged
Proportional Hazards Models
Prospective Studies
Remission Induction
Risk
Treatment Outcome
Cytarabine administration & dosage
Leukemia, Myeloid, Acute drug therapy
Mitoxantrone administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1527-7755
- Volume :
- 29
- Issue :
- 19
- Database :
- MEDLINE
- Journal :
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 21606413
- Full Text :
- https://doi.org/10.1200/JCO.2010.33.7303