Roellig C, Kramer M, Gabrecht M, Haenel MH, Herbst R, Kaiser U, Schmitz N, Kullmer J, Fetscher S, Link H, Mantoyani-Loeffler L, Kruempelmann U, Neuhaus T, Heits F, Einsele H, Ritter B, Bornhaeuser M, Schetelig J, Thiede C, Mohr B, Schaich M, Platzbecker U, Schaefer-Eckart K, Kraemer A, Berdel WE, Serve H, Ehninger G, Schuler US (2018)
Publication Type: Journal article
Publication year: 2018
Book Volume: 29
Pages Range: 973-978
Journal Issue: 4
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 > 60 years were randomized to receive either intermediate-dose cytarabine (1000 mg/m2 twice daily on days 1, 3, 5, 7) plus mitoxantrone (10 mg/m2 days 1-3) (IMA) or standard induction therapy with cytarabine (100 mg/m2 continuously days 1-7) plus daunorubicin (45 mg/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 > 65 years. 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 10 months 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.
APA:
Roellig, C., Kramer, M., Gabrecht, M., Haenel, M.H., Herbst, R., Kaiser, U.,... Schuler, U.S. (2018). Intermediate-dose cytarabine plus mitoxantrone versus standard-dose cytarabine plus daunorubicin for acute myeloid leukemia in elderly patients. Annals of Oncology, 29(4), 973-978. https://doi.org/10.1093/annonc/mdy030
MLA:
Roellig, C., et al. "Intermediate-dose cytarabine plus mitoxantrone versus standard-dose cytarabine plus daunorubicin for acute myeloid leukemia in elderly patients." Annals of Oncology 29.4 (2018): 973-978.
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