Azacitidine in combination with intensive induction chemotherapy in older patients with acute myeloid leukemia: The AML-AZA trial of the study alliance leukemia

Mueller-Tidow C, Tschanter P, Roellig C, Thiede C, Koschmieder A, Stelljes M, Koschmieder S, Dugas M, Gerss J, Butterfass-Bahloul T, Wagner R, Eveslage M, Thiem U, Krause S, Kaiser U, Kunzmann V, Steffen B, Noppeney R, Herr W, Baldus CD, Schmitz N, Goetze K, Reichle A, Kaufmann M, Neubauer A, Schaefer-Eckart K, Haenel M, Peceny R, Frickhofen N, Kiehl M, Giagounidis A, Goerner M, Repp R, Link H, Kiani A, Naumann R, Bruemmendorf T, Serve H, Ehninger G, Berdel WE, Krug U (2016)

Publication Type: Journal article

Publication year: 2016

Journal

Book Volume: 30

Pages Range: 555-61

Journal Issue: 3

DOI: 10.1038/leu.2015.306

Abstract

DNA methylation changes are a constant feature of acute myeloid leukemia. Hypomethylating drugs such as azacitidine are active in acute myeloid leukemia (AML) as monotherapy. Azacitidine monotherapy is not curative. The AML-AZA trial tested the hypothesis that DNA methyltransferase inhibitors such as azacitidine can improve chemotherapy outcome in AML. This randomized, controlled trial compared the efficacy of azacitidine applied before each cycle of intensive chemotherapy with chemotherapy alone in older patients with untreated AML. Event-free survival (EFS) was the primary end point. In total, 214 patients with a median age of 70 years were randomized to azacitidine/chemotherapy (arm-A) or chemotherapy (arm-B). More arm-A patients (39/105; 37%) than arm-B (25/109; 23%) showed adverse cytogenetics (P=0.057). Adverse events were more frequent in arm-A (15.44) versus 13.52 in arm-B, (P=0.26), but early death rates did not differ significantly (30-day mortality: 6% versus 5%, P=0.76). Median EFS was 6 months in both arms (P=0.96). Median overall survival was 15 months for patients in arm-A compared with 21 months in arm-B (P=0.35). Azacitidine added to standard chemotherapy increases toxicity in older patients with AML, but provides no additional benefit for unselected patients.

Authors with CRIS profile

Involved external institutions

Goethe-Universität Frankfurt am Main Germany (DE) Gemeinschaftsklinikum Mittelrhein Germany (DE) Klinikum Chemnitz Germany (DE) Charité - Universitätsmedizin Berlin Germany (DE) Westfälische Wilhelms-Universität (WWU) Münster Germany (DE) Universitätsklinikum Carl Gustav Carus Dresden Germany (DE) Universitätsklinikum Aachen (UKA) Germany (DE) Klinikum Bayreuth Germany (DE) Westpfalz-Klinikum Germany (DE) Klinikum am Bruderwald Germany (DE) Klinikum Bielefeld Germany (DE) Marien Hospital Düsseldorf Germany (DE) Klinikum Frankfurt (Oder) Germany (DE) Horst-Schmidt-Kliniken Germany (DE) Klinikum Osnabrück Germany (DE) Philipps-Universität Marburg Germany (DE) Robert-Bosch-Krankenhaus Germany (DE) Universität Regensburg Germany (DE) Klinikum Nürnberg Germany (DE) Asklepios Kliniken Germany (DE) Ruhr-Universität Bochum (RUB) Germany (DE) Klinikum der Universität München (Großhadern und Innenstadt) Germany (DE) Universität Duisburg-Essen (UDE) Germany (DE) Julius-Maximilians-Universität Würzburg Germany (DE) St. Bernward Krankenhaus Germany (DE) Universitätsklinikum Münster Germany (DE) Martin-Luther-Universität Halle-Wittenberg (MLU) Germany (DE)

How to cite

APA:

Mueller-Tidow, C., Tschanter, P., Roellig, C., Thiede, C., Koschmieder, A., Stelljes, M.,... Krug, U. (2016). Azacitidine in combination with intensive induction chemotherapy in older patients with acute myeloid leukemia: The AML-AZA trial of the study alliance leukemia. Leukemia, 30(3), 555-61. https://doi.org/10.1038/leu.2015.306

MLA:

Mueller-Tidow, C., et al. "Azacitidine in combination with intensive induction chemotherapy in older patients with acute myeloid leukemia: The AML-AZA trial of the study alliance leukemia." Leukemia 30.3 (2016): 555-61.

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