Two cycles of risk-adapted consolidation therapy in patients with acute promyelocytic leukemia. Results from the SAL-AIDA2000 trial.

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.

• Authors: 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
• Journal: Annals of hematology (Ann Hematol) Vol. 94 Issue 4 Pg. 557-63 (Apr 2015) ISSN: 1432-0584 [Electronic] Germany
• PMID: 25366167 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Tretinoin
• Idarubicin

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage)
• Consolidation Chemotherapy (methods)
• Drug Administration Schedule
• Female
• Humans
• Idarubicin (administration & dosage)
• Leukemia, Promyelocytic, Acute (drug therapy, mortality)
• Male
• Middle Aged
• Precision Medicine
• Risk
• Survival Analysis
• Tretinoin (administration & dosage)
• Young Adult