%0 Journal Article
%A Schlenk, Richard
%A Weber, D.
%A Krzykalla, J.
%A Kindler, T.
%A Wulf, G.
%A Hertenstein, B.
%A Salih, H. R.
%A Südhoff, T.
%A Krauter, J.
%A Martens, U.
%A Wessendorf, S.
%A Runde, V.
%A Tischler, H. J.
%A Bentz, M.
%A Koller, E.
%A Heuser, M.
%A Thol, F.
%A Benner, A.
%A Ganser, A.
%A Döhner, K.
%A Döhner, H.
%T Randomized phase-III study of low-dose cytarabine and etoposide + /- all-trans retinoic acid in older unfit patients with NPM1-mutated acute myeloid leukemia.
%J Scientific reports
%V 13
%N 1
%@ 2045-2322
%C [London]
%I Macmillan Publishers Limited, part of Springer Nature
%M DKFZ-2023-01870
%P 14809
%D 2023
%Z #LA:W010#
%X 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
%K Humans
%K Aged
%K Etoposide: adverse effects
%K Leukemia, Myeloid, Acute: drug therapy
%K Leukemia, Myeloid, Acute: genetics
%K Cytarabine: adverse effects
%K Tretinoin: therapeutic use
%K Nuclear Proteins
%K Etoposide (NLM Chemicals)
%K Cytarabine (NLM Chemicals)
%K Tretinoin (NLM Chemicals)
%K Nuclear Proteins (NLM Chemicals)
%F PUB:(DE-HGF)16
%9 Journal Article
%$ pmid:37684299
%2 pmc:PMC10491626
%R 10.1038/s41598-023-41964-y
%U https://inrepo02.dkfz.de/record/282751