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| Verfasst von: | Schlenk, Richard Friedrich [VerfasserIn]  |
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| | Weber, D. [VerfasserIn] |
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| | Krzykalla, J. [VerfasserIn] |
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| | Kindler, T. [VerfasserIn] |
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| | Wulf, G. [VerfasserIn] |
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| | Hertenstein, B. [VerfasserIn] |
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| | Salih, H. R. [VerfasserIn] |
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| | Südhoff, T. [VerfasserIn] |
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| | Krauter, J. [VerfasserIn] |
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| | Martens, U. [VerfasserIn] |
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| | Wessendorf, S. [VerfasserIn] |
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| | Runde, V. [VerfasserIn] |
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| | Tischler, H. J. [VerfasserIn] |
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| | Bentz, M. [VerfasserIn] |
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| | Koller, E. [VerfasserIn] |
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| | Heuser, M. [VerfasserIn] |
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| | Thol, F. [VerfasserIn] |
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| | Benner, Axel [VerfasserIn] |
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| | Ganser, A. [VerfasserIn] |
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| | Döhner, K. [VerfasserIn] |
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| | Döhner, H. [VerfasserIn] |
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| Titel: | Randomized phase-III study of low-dose cytarabine and etoposide + /− all-trans retinoic acid in older unfit patients with NPM1-mutated acute myeloid leukemia |
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| Verf.angabe: | R.F. Schlenk, D. Weber, J. Krzykalla, T. Kindler, G. Wulf, B. Hertenstein, H.R. Salih, T. Südhoff, J. Krauter, U. Martens, S. Wessendorf, V. Runde, H.J. Tischler, M. Bentz, E. Koller, M. Heuser, F. Thol, A. Benner, A. Ganser, K. Döhner & H. Döhner |
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| E-Jahr: | 2023 |
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| Jahr: | 08 September 2023 |
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| Umfang: | 9 S. |
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| Illustrationen: | Illustrationen |
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| Fussnoten: | Online veröffentlicht: 08. September 2023 ; Gesehen am 08.12.2023 |
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| Titel Quelle: | Enthalten in: Scientific reports |
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| Ort Quelle: | [London] : Macmillan Publishers Limited, part of Springer Nature, 2011 |
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| Jahr Quelle: | 2023 |
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| Band/Heft Quelle: | 13(2023), Artikel-ID 14809, Seite 1-9 |
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| ISSN Quelle: | 2045-2322 |
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| Abstract: | The aim of this randomized clinical trial was to evaluate the impact of all-trans retinoic acid (ATRA) in combination with non-intensive chemotherapy in older unfit patients (> 60 years) with newly diagnosed NPM1-mutated acute myeloid leukemia. Patients were randomized (1:1) to low-dose chemotherapy with or without open-label ATRA 45 mg/m2, days 8-28; the dose of ATRA was reduced to 45 mg/m2, days 8-10 and 15 mg/m2, days 11-28 after 75 patients due to toxicity. Up to 6 cycles of cytarabine 20 mg/day s.c., bid, days 1-7 and etoposide 100 mg/day, p.o. or i.v., days 1-3 with (ATRA) or without ATRA (CONTROL) were intended. The primary endpoint was overall survival (OS). Between May 2011 and September 2016, 144 patients (median age, 77 years; range, 64-92 years) were randomized (72, CONTROL; 72, ATRA). Baseline characteristics were balanced between the two study arms. The median number of treatment cycles was 2 in ATRA and 2.5 in CONTROL. OS was significantly shorter in the ATRA compared to the CONTROL arm (p = 0.023; median OS: 5 months versus 9.2 months, 2-years OS rate: 7% versus 10%, respectively). Rates of CR/CRi were not different between treatment arms; infections were more common in ATRA beyond treatment cycle one. The addition of ATRA to low-dose cytarabine plus etoposide in an older, unfit patient population was not beneficial, but rather led to an inferior outcome. |
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| DOI: | doi:10.1038/s41598-023-41964-y |
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| URL: | Bitte beachten Sie: Dies ist ein Bibliographieeintrag. Ein Volltextzugriff für Mitglieder der Universität besteht hier nur, falls für die entsprechende Zeitschrift/den entsprechenden Sammelband ein Abonnement besteht oder es sich um einen OpenAccess-Titel handelt.
kostenfrei: Volltext: https://doi.org/10.1038/s41598-023-41964-y |
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| | kostenfrei: Volltext: https://www.nature.com/articles/s41598-023-41964-y |
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| | DOI: https://doi.org/10.1038/s41598-023-41964-y |
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| Datenträger: | Online-Ressource |
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| Sprache: | eng |
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| Sach-SW: | Cancer |
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| | Oncology |
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| K10plus-PPN: | 1872968619 |
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| Verknüpfungen: | → Zeitschrift |
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Randomized phase-III study of low-dose cytarabine and etoposide + /− all-trans retinoic acid in older unfit patients with NPM1-mutated acute myeloid leukemia / Schlenk, Richard Friedrich [VerfasserIn]; 08 September 2023 (Online-Ressource)
