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000282751 1001_ $$0P:(DE-He78)d8a0e60e5e095f3161ee0de3712409bc$$aSchlenk, Richard$$b0$$eFirst author$$udkfz
000282751 245__ $$aRandomized phase-III study of low-dose cytarabine and etoposide + /- all-trans retinoic acid in older unfit patients with NPM1-mutated acute myeloid leukemia.
000282751 260__ $$a[London]$$bMacmillan Publishers Limited, part of Springer Nature$$c2023
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000282751 520__ $$aThe 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.The clinical trial is registered at clinicaltrialsregister.eu (EudraCT Number: 2010-023409-37, first posted 14/12/2010).
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000282751 650_7 $$06PLQ3CP4P3$$2NLM Chemicals$$aEtoposide
000282751 650_7 $$004079A1RDZ$$2NLM Chemicals$$aCytarabine
000282751 650_7 $$05688UTC01R$$2NLM Chemicals$$aTretinoin
000282751 650_7 $$2NLM Chemicals$$aNuclear Proteins
000282751 650_2 $$2MeSH$$aHumans
000282751 650_2 $$2MeSH$$aAged
000282751 650_2 $$2MeSH$$aEtoposide: adverse effects
000282751 650_2 $$2MeSH$$aLeukemia, Myeloid, Acute: drug therapy
000282751 650_2 $$2MeSH$$aLeukemia, Myeloid, Acute: genetics
000282751 650_2 $$2MeSH$$aCytarabine: adverse effects
000282751 650_2 $$2MeSH$$aTretinoin: therapeutic use
000282751 650_2 $$2MeSH$$aNuclear Proteins
000282751 7001_ $$aWeber, D.$$b1
000282751 7001_ $$0P:(DE-He78)5a7a75d1b29b770f98f1bb2062fc3df9$$aKrzykalla, J.$$b2$$udkfz
000282751 7001_ $$aKindler, T.$$b3
000282751 7001_ $$aWulf, G.$$b4
000282751 7001_ $$aHertenstein, B.$$b5
000282751 7001_ $$aSalih, H. R.$$b6
000282751 7001_ $$aSüdhoff, T.$$b7
000282751 7001_ $$aKrauter, J.$$b8
000282751 7001_ $$aMartens, U.$$b9
000282751 7001_ $$aWessendorf, S.$$b10
000282751 7001_ $$aRunde, V.$$b11
000282751 7001_ $$aTischler, H. J.$$b12
000282751 7001_ $$aBentz, M.$$b13
000282751 7001_ $$aKoller, E.$$b14
000282751 7001_ $$aHeuser, M.$$b15
000282751 7001_ $$aThol, F.$$b16
000282751 7001_ $$0P:(DE-He78)e15dfa1260625c69d6690a197392a994$$aBenner, A.$$b17$$udkfz
000282751 7001_ $$aGanser, A.$$b18
000282751 7001_ $$aDöhner, K.$$b19
000282751 7001_ $$aDöhner, H.$$b20
000282751 773__ $$0PERI:(DE-600)2615211-3$$a10.1038/s41598-023-41964-y$$gVol. 13, no. 1, p. 14809$$n1$$p14809$$tScientific reports$$v13$$x2045-2322$$y2023
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