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| Home > Publications database > 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. > print |
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| 100 | 1 | _ | |a Schlenk, Richard |0 P:(DE-He78)d8a0e60e5e095f3161ee0de3712409bc |b 0 |e First author |u dkfz |
| 245 | _ | _ | |a 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. |
| 260 | _ | _ | |a Berlin |c 2016 |b Springer61936 |
| 264 | _ | 1 | |3 online |2 Crossref |b Springer Science and Business Media LLC |c 2016-10-03 |
| 264 | _ | 1 | |3 print |2 Crossref |b Springer Science and Business Media LLC |c 2016-12-01 |
| 264 | _ | 1 | |3 print |2 Crossref |b Springer Science and Business Media LLC |c 2016-12-01 |
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| 520 | _ | _ | |a 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). |
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| 700 | 1 | _ | |a Lübbert, Michael |b 1 |
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| 700 | 1 | _ | |a Lamparter, Alexander |b 3 |
| 700 | 1 | _ | |a Krauter, Jürgen |b 4 |
| 700 | 1 | _ | |a Herr, Wolfgang |b 5 |
| 700 | 1 | _ | |a Martin, Hans |b 6 |
| 700 | 1 | _ | |a Salih, Helmut R |b 7 |
| 700 | 1 | _ | |a Kündgen, Andrea |b 8 |
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| 700 | 1 | _ | |a Götze, Katharina |b 11 |
| 700 | 1 | _ | |a Nachbaur, David |b 12 |
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| 700 | 1 | _ | |a Köhne, Claus-Henning |b 14 |
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| 700 | 1 | _ | |a Gaidzik, Verena I |b 21 |
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| 700 | 1 | _ | |a Weber, Daniela |b 23 |
| 700 | 1 | _ | |a Döhner, Konstanze |b 24 |
| 700 | 1 | _ | |a Ganser, Arnold |b 25 |
| 700 | 1 | _ | |a Döhner, Hartmut |b 26 |
| 700 | 1 | _ | |a Group, German-Austrian Acute Myeloid Leukemia Study |b 27 |e Collaboration Author |
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