Intermediate-dose cytarabine plus mitoxantrone versus standard-dose cytarabine plus daunorubicin for acute myeloid leukemia in elderly patients
Background - The combination of intermediate-dose cytarabine plus mitoxantrone (IMA) can induce high complete remission rates with acceptable toxicity in elderly patients with acute myeloid leukemia (AML). We present the final results of a randomized-controlled trial comparing IMA with the standard...
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| Main Authors: | , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
2018
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| In: |
Annals of oncology
Year: 2018, Volume: 29, Issue: 4, Pages: 973-978 |
| ISSN: | 1569-8041 |
| DOI: | 10.1093/annonc/mdy030 |
| Online Access: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1093/annonc/mdy030 Verlag, lizenzpflichtig, Volltext: http://www.sciencedirect.com/science/article/pii/S0923753419454756 
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| Author Notes: | C. Röllig, M. Kramer, M. Gabrecht, M. Hänel, R. Herbst, U. Kaiser, N. Schmitz, J. Kullmer, S. Fetscher, H. Link, L. Mantovani-Löffler, U. Krümpelmann, T. Neuhaus, F. Heits, H. Einsele, B. Ritter, M. Bornhäuser, J. Schetelig, C. Thiede, B. Mohr, M. Schaich, U. Platzbecker, K. Schäfer-Eckart, A. Krämer, W.E. Berdel, H. Serve, G. Ehninger & U.S. Schuler, for the Study Alliance Leukemia (SAL) |
| Summary: | Background - The combination of intermediate-dose cytarabine plus mitoxantrone (IMA) can induce high complete remission rates with acceptable toxicity in elderly patients with acute myeloid leukemia (AML). We present the final results of a randomized-controlled trial comparing IMA with the standard 7+3 induction regimen consisting of continuous infusion cytarabine plus daunorubicin (DA). - Patients and methods - Patients with newly diagnosed AML>60years were randomized to receive either intermediate-dose cytarabine (1000mg/m2 twice daily on days 1, 3, 5, 7) plus mitoxantrone (10mg/m2 days 1-3) (IMA) or standard induction therapy with cytarabine (100mg/m2 continuously days 1-7) plus daunorubicin (45mg/m2 days 3-5) (DA). Patients in complete remission after DA received intermediate-dose cytarabine plus amsacrine as consolidation treatment, whereas patients after IMA were consolidated with standard-dose cytarabine plus mitoxantrone. - Results - Between February 2005 and October 2009, 485 patients were randomized; 241 for treatment arm DA and 244 for IMA; 76% of patients were >65years. The complete response rate after DA was 39% [95% confidence interval (95% CI): 33-45] versus 55% (95% CI: 49-61) after IMA (odds ratio 1.89, P=0.001). The 6-week early-death rate was 14% in both arms. Relapse-free survival curves were superimposable in the first year, but separated afterwards, resulting in 3-year relapse-free survival rates of 29% versus 14% in the DA versus IMA arms, respectively (P=0.042). The median overall survival was 10months in both arms (P=0.513). - Conclusion - The dose escalation of cytarabine in induction therapy lead to improved remission rates in the elderly AML patients. This did not translate into a survival advantage, most likely due to differences in consolidation treatment. Thus, effective consolidation strategies need to be further explored. In combination with an effective consolidation strategy, the use of intermediate-dose cytarabine in induction may improve curative treatment for elderly AML patients. |
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| Item Description: | Elektronische Reproduktion der Druckausgabe Available online 7 January 2020 Gesehen am 16.04.2020 |
| Physical Description: | Online Resource |
| ISSN: | 1569-8041 |
| DOI: | 10.1093/annonc/mdy030 |