Schlenk, Richard F. and Luebbert, Michael and Benner, Axel and Lamparter, Alexander and Krauter, Juergen and Herr, Wolfgang and Martin, Hans and Salih, Helmut R. and Kuendgen, Andrea and Horst, Heinz-A. and Brossart, Peter and Goetze, Katharina and Nachbaur, David and Wattad, Mohammed and Koehne, Claus-Henning and Fiedler, Walter and Bentz, Martin and Wulf, Gerald and Held, Gerhard and Hertenstein, Bernd and Salwender, Hans and Gaidzik, Verena I. and Schlegelberger, Brigitte and Weber, Daniela and Doehner, Konstanze and Ganser, Arnold and Doehner, Hartmut (2016) All-trans retinoic acid as adjunct to intensive treatment in younger adult patients with acute myeloid leukemia: results of the randomized AMLSG 07-04 study. ANNALS OF HEMATOLOGY, 95 (12). pp. 1931-1942. ISSN 0939-5555, 1432-0584
Full text not available from this repository. (Request a copy)Abstract
The aim of this clinical trial was to evaluate the impact of all-trans retinoic acid (ATRA) in combination with chemotherapy and to assess the NPM1 status as biomarker for ATRA therapy in younger adult patients (18-60 years) with acute myeloid leukemia (AML). Patients were randomized for intensive chemotherapy with or without open-label ATRA (45 mg/m(2), days 6-8; 15 mg/m(2), days 9-21). Two cycles of induction therapy were followed by risk-adapted consolidation with high-dose cytarabine or allogeneic hematopoietic cell transplantation. Due to the open label character of the study, analysis was performed on an intention-to-treat (ITT) and a per-protocol (PP) basis. One thousand one hundred patients were randomized (556, STANDARD; 544, ATRA) with 38 patients treated vice versa. Median follow-up for survival was 5.2 years. ITT analyses revealed no difference between ATRA and STANDARD for the total cohort and for the subset of NPM1-mutated AML with respect to event-free (EFS; p = 0.93, p = 0.17) and overall survival (OS; p = 0.24 and p = 0.32, respectively). Pre-specified PP analyses revealed better EFS in NPM1-mutated AML (p = 0.05) and better OS in the total cohort (p = 0.03). Explorative subgroup analyses on an ITT basis revealed better OS (p = 0.05) in ATRA for genetic low-risk patients according to ELN recommendations. The clinical trial is registered at clinicaltrialsregister.eu (EudraCT Number: 2004-004321-95).
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | ACUTE PROMYELOCYTIC LEUKEMIA; COLONY-STIMULATING FACTOR; CYTOSINE-ARABINOSIDE; MYELODYSPLASTIC SYNDROME; ARSENIC TRIOXIDE; MUTATIONS; CHEMOTHERAPY; EXPRESSION; PROGNOSIS; BLASTS; Acute myeloid leukemia; All-trans retinoic acid; Nucleophosmin-1 |
| 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 Apr 2019 07:15 |
| Last Modified: | 12 Apr 2019 07:15 |
| URI: | https://pred.uni-regensburg.de/id/eprint/3917 |
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