Erschienen in:
01.04.2015 | Original Article
Two cycles of risk-adapted consolidation therapy in patients with acute promyelocytic leukemia. Results from the SAL-AIDA2000 trial
verfasst von:
Christoph Röllig, Kerstin Schäfer-Eckardt, Matthias Hänel, Michael Kramer, Markus Schaich, Christian Thiede, Uta Oelschlägel, Brigitte Mohr, Thomas Wagner, Hermann Einsele, Stefan W. Krause, Heinrich Bodenstein, Sonja Martin, Reingard Stuhlmann, Antony D. Ho, Martin Bornhäuser, Gerhard Ehninger, Ulrich Schuler, Uwe Platzbecker
Erschienen in:
Annals of Hematology
|
Ausgabe 4/2015
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Abstract
The combination of all-trans retinoic acid (ATRA) and idarubicin (AIDA) for induction therapy followed by three cycles of risk-adapted consolidation cycles is considered standard of care for patients with acute promyelocytic leukemia (APL). We report the outcome of 141 patients (median age 51 years; range, 19–82, 31 % ≥60 years) enrolled into the prospective Study Alliance Leukemia (SAL)-AIDA2000 trial, which comprised AIDA-based induction followed by only two courses of risk-adapted consolidation (daunorubicin or mitoxantrone ± cytarabine) followed by 2-year maintenance treatment. The early death rate was 7 % (median age 66 years), and additional 9 % stopped further treatment after induction. The estimated 6-year disease-free survival (DFS) was 80 % in all patients, 84 % in patients ≤60 and 72 % in patients >60 years (p = 0.140). No significant survival differences were observed between the high-risk and the non-high-risk patients (6-year OS 78 vs. 81 %, p = 0.625). Our results confirm the efficacy of a risk-adapted approach in APL patients. Furthermore, long-term outcomes are comparable to the results obtained with three cycles of consolidation. A modification of the number and intensity of conventional consolidation treatment may be a less toxic but equally effective approach and should be considered for further evaluation in randomized clinical trials in APL.