Mueller-Tidow, C. and Tschanter, P. and Roellig, C. and Thiede, C. and Koschmieder, A. and Stelljes, M. and Koschmieder, S. and Dugas, M. and Gerss, J. and Butterfass-Bahloul, T. and Wagner, R. and Eveslage, M. and Thiem, U. and Krause, S. W. and Kaiser, U. and Kunzmann, V. and Steffen, B. and Noppeney, R. and Herr, W. and Baldus, C. D. and Schmitz, N. and Goetze, K. and Reichle, A. and Kaufmann, M. and Neubauer, A. and Schaefer-Eckart, K. and Haenel, M. and Peceny, R. and Frickhofen, N. and Kiehl, M. and Giagounidis, A. and Goerner, M. and Repp, R. and Link, H. and Kiani, A. and Naumann, R. and Bruemmendorf, Th and Serve, H. and Ehninger, G. and Berdel, W. E. and 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). pp. 555-561. ISSN 0887-6924, 1476-5551
Full text not available from this repository. (Request a copy)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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | CONVENTIONAL CARE REGIMENS; ELDERLY-PATIENTS; DNMT3A MUTATIONS; DNA METHYLATION; OPEN-LABEL; PHASE-III; 5-AZACYTIDINE; OUTCOMES; RECOMMENDATIONS; DECITABINE; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin III (Hämatologie und Internistische Onkologie) |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 12 Mar 2019 09:58 |
| Last Modified: | 12 Mar 2019 09:58 |
| URI: | https://pred.uni-regensburg.de/id/eprint/2328 |
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