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| Home > Publications database > Randomized phase-III study of low-dose cytarabine and etoposide + /- all-trans retinoic acid in older unfit patients with NPM1-mutated acute myeloid leukemia. > print |
| Home > Publications database > Randomized phase-III study of low-dose cytarabine and etoposide + /- all-trans retinoic acid in older unfit patients with NPM1-mutated acute myeloid leukemia. > print |
| 001 | 282751 | ||
| 005 | 20240229155046.0 | ||
| 024 | 7 | _ | |a 10.1038/s41598-023-41964-y |2 doi |
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| 100 | 1 | _ | |a Schlenk, Richard |0 P:(DE-He78)d8a0e60e5e095f3161ee0de3712409bc |b 0 |e First author |u dkfz |
| 245 | _ | _ | |a Randomized phase-III study of low-dose cytarabine and etoposide + /- all-trans retinoic acid in older unfit patients with NPM1-mutated acute myeloid leukemia. |
| 260 | _ | _ | |a [London] |c 2023 |b Macmillan Publishers Limited, part of Springer Nature |
| 336 | 7 | _ | |a article |2 DRIVER |
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| 500 | _ | _ | |a #LA:W010# |
| 520 | _ | _ | |a 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.The clinical trial is registered at clinicaltrialsregister.eu (EudraCT Number: 2010-023409-37, first posted 14/12/2010). |
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| 650 | _ | 7 | |a Etoposide |0 6PLQ3CP4P3 |2 NLM Chemicals |
| 650 | _ | 7 | |a Cytarabine |0 04079A1RDZ |2 NLM Chemicals |
| 650 | _ | 7 | |a Tretinoin |0 5688UTC01R |2 NLM Chemicals |
| 650 | _ | 7 | |a Nuclear Proteins |2 NLM Chemicals |
| 650 | _ | 2 | |a Humans |2 MeSH |
| 650 | _ | 2 | |a Aged |2 MeSH |
| 650 | _ | 2 | |a Etoposide: adverse effects |2 MeSH |
| 650 | _ | 2 | |a Leukemia, Myeloid, Acute: drug therapy |2 MeSH |
| 650 | _ | 2 | |a Leukemia, Myeloid, Acute: genetics |2 MeSH |
| 650 | _ | 2 | |a Cytarabine: adverse effects |2 MeSH |
| 650 | _ | 2 | |a Tretinoin: therapeutic use |2 MeSH |
| 650 | _ | 2 | |a Nuclear Proteins |2 MeSH |
| 700 | 1 | _ | |a Weber, D. |b 1 |
| 700 | 1 | _ | |a Krzykalla, J. |0 P:(DE-He78)5a7a75d1b29b770f98f1bb2062fc3df9 |b 2 |u dkfz |
| 700 | 1 | _ | |a Kindler, T. |b 3 |
| 700 | 1 | _ | |a Wulf, G. |b 4 |
| 700 | 1 | _ | |a Hertenstein, B. |b 5 |
| 700 | 1 | _ | |a Salih, H. R. |b 6 |
| 700 | 1 | _ | |a Südhoff, T. |b 7 |
| 700 | 1 | _ | |a Krauter, J. |b 8 |
| 700 | 1 | _ | |a Martens, U. |b 9 |
| 700 | 1 | _ | |a Wessendorf, S. |b 10 |
| 700 | 1 | _ | |a Runde, V. |b 11 |
| 700 | 1 | _ | |a Tischler, H. J. |b 12 |
| 700 | 1 | _ | |a Bentz, M. |b 13 |
| 700 | 1 | _ | |a Koller, E. |b 14 |
| 700 | 1 | _ | |a Heuser, M. |b 15 |
| 700 | 1 | _ | |a Thol, F. |b 16 |
| 700 | 1 | _ | |a Benner, A. |0 P:(DE-He78)e15dfa1260625c69d6690a197392a994 |b 17 |u dkfz |
| 700 | 1 | _ | |a Ganser, A. |b 18 |
| 700 | 1 | _ | |a Döhner, K. |b 19 |
| 700 | 1 | _ | |a Döhner, H. |b 20 |
| 773 | _ | _ | |a 10.1038/s41598-023-41964-y |g Vol. 13, no. 1, p. 14809 |0 PERI:(DE-600)2615211-3 |n 1 |p 14809 |t Scientific reports |v 13 |y 2023 |x 2045-2322 |
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