Details

Autor(en) / Beteiligte

• Röllig, C.
• Kramer, M.
• Gabrecht, M.
• Hänel, M.
• Herbst, R.
• Kaiser, U.
• Schmitz, N.
• Kullmer, J.
• Fetscher, S.
• Link, H.
• Mantovani-Löffler, L.
• Krümpelmann, U.
• Neuhaus, T.
• Heits, F.
• Einsele, H.
• Ritter, B.
• Bornhäuser, M.
• Schetelig, J.
• Thiede, C.
• Mohr, B.
• Schaich, M.
• Platzbecker, U.
• Schäfer-Eckart, K.
• Krämer, A.
• Berdel, W.E.
• Serve, H.
• Ehninger, G.
• Schuler, U.S.

Titel

Intermediate-dose cytarabine plus mitoxantrone versus standard-dose cytarabine plus daunorubicin for acute myeloid leukemia in elderly patients

Ist Teil von

• Annals of oncology, 2018-04, Vol.29 (4), p.973-978

Ort / Verlag

England: Elsevier Ltd

Erscheinungsjahr

2018

Quelle

MEDLINE

Beschreibungen/Notizen

• 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 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. 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). 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.