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10-day decitabine versus 3 + 7 chemotherapy followed by allografting in older patients with acute myeloid leukaemia: an open-label, randomised, controlled, phase 3 trial
The Lancet Haematology, 10 (2023), 11; e879-e889. https://doi.org/10.1016/S2352-3026(23)00273-9
(ORTC Leukemia Group, GIMEMA, and German MDS Study Group) Lübbert, Michael; Wijermans, Pierre W; Kicinski, Michal; Chantepie, Sylvain; Van der Velden, Walter J F M; Noppeney, Richard; Griškevičius, Laimonas; Neubauer, Andreas; Crysandt, Martina; Vrhovac, Radovan; Luppi, Mario; Fuhrmann, Stephan; Audisio, Ernesta; Candoni, Anna; Legrand, Olivier; Foà, Robin; Gaidano, Gianluca; van Lammeren-Venema, Danielle; Posthuma, Eduardus F M; Hoogendoorn, Mels; Giraut, Anne; Stevens-Kroef, Marian; Jansen, Joop H; de Graaf, Aniek O; Efficace, Fabio; Ammatuna, Emanuele; Vilque, Jean-Pierre; Wäsch, Ralph; Becker, Heiko; Blijlevens, Nicole; Dührsen, Ulrich; Baron, Frédéric; Suciu, Stefan; Amadori, Sergio; Venditti, Adriano; Huls, Gerwin Više autora...

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Lübbert, M., Wijermans, P. W., Kicinski, M., Chantepie, S., Van der Velden, W. J. F. M., Noppeney, R. ... Huls, G. (2023). 10-day decitabine versus 3 + 7 chemotherapy followed by allografting in older patients with acute myeloid leukaemia: an open-label, randomised, controlled, phase 3 trial. The Lancet Haematology, 10. (11), e879-e889. doi: 10.1016/S2352-3026(23)00273-9

Lübbert, Michael, et al. "10-day decitabine versus 3 + 7 chemotherapy followed by allografting in older patients with acute myeloid leukaemia: an open-label, randomised, controlled, phase 3 trial." The Lancet Haematology, vol. 10, br. 11, 2023, str. e879-e889. https://doi.org/10.1016/S2352-3026(23)00273-9

Lübbert, Michael, Pierre W Wijermans, Michal Kicinski, Sylvain Chantepie, Walter J F M Van der Velden, Richard Noppeney, Laimonas Griškevičius, et al. "10-day decitabine versus 3 + 7 chemotherapy followed by allografting in older patients with acute myeloid leukaemia: an open-label, randomised, controlled, phase 3 trial." The Lancet Haematology 10, br. 11 (2023): e879-e889. https://doi.org/10.1016/S2352-3026(23)00273-9

Lübbert, M., et al. (2023) '10-day decitabine versus 3 + 7 chemotherapy followed by allografting in older patients with acute myeloid leukaemia: an open-label, randomised, controlled, phase 3 trial', The Lancet Haematology, 10(11), str. e879-e889. doi: 10.1016/S2352-3026(23)00273-9

Lübbert M, Wijermans PW, Kicinski M, Chantepie S, Van der Velden WJFM, Noppeney R, i sur.. 10-day decitabine versus 3 + 7 chemotherapy followed by allografting in older patients with acute myeloid leukaemia: an open-label, randomised, controlled, phase 3 trial. The Lancet Haematology [Internet]. 11.2023. [pristupljeno 06.07.2024.];10(11):e879-e889. doi: 10.1016/S2352-3026(23)00273-9

M. Lübbert, et al., "10-day decitabine versus 3 + 7 chemotherapy followed by allografting in older patients with acute myeloid leukaemia: an open-label, randomised, controlled, phase 3 trial", The Lancet Haematology, vol. 10, br. 11, str. e879-e889, Studeni 2023. [Online]. Dostupno na: https://urn.nsk.hr/urn:nbn:hr:105:992101. [Citirano: 06.07.2024.]

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Naslov (engleski)10-day decitabine versus 3 + 7 chemotherapy followed by allografting in older patients with acute myeloid leukaemia: an open-label, randomised, controlled, phase 3 trial
AutorMichael Lübbert
AutorPierre W Wijermans
AutorMichal Kicinski
AutorSylvain Chantepie
AutorWalter J F M Van der Velden
AutorRichard Noppeney
AutorLaimonas Griškevičius
AutorAndreas Neubauer
AutorMartina Crysandt
AutorRadovan Vrhovac
AutorMario Luppi
AutorStephan Fuhrmann
AutorErnesta Audisio
AutorAnna Candoni
AutorOlivier Legrand
AutorRobin Foà
AutorGianluca Gaidano
AutorDanielle van Lammeren-Venema
AutorEduardus F M Posthuma
AutorMels Hoogendoorn
AutorAnne Giraut
AutorMarian Stevens-Kroef
AutorJoop H Jansen
AutorAniek O de Graaf
AutorFabio Efficace
AutorEmanuele Ammatuna
AutorJean-Pierre Vilque
AutorRalph Wäsch
AutorHeiko Becker
AutorNicole Blijlevens
AutorUlrich Dührsen
AutorFrédéric Baron
AutorStefan Suciu
AutorSergio Amadori
AutorAdriano Venditti
AutorGerwin Huls
KolaboracijaORTC Leukemia Group, GIMEMA, and German MDS Study Group
Autorova ustanovaSveučilište u Zagrebu
Medicinski fakultet
(KATEDRA ZA INTERNU MEDICINU)
Znanstveno / umjetničko
područje, polje i grana		BIOMEDICINA I ZDRAVSTVO
Kliničke medicinske znanosti
Interna medicina
Sažetak (engleski)
Background: Many older patients with acute myeloid leukaemia die or cannot undergo allogeneic haematopoietic stem-cell transplantation (HSCT) due to toxicity caused by intensive chemotherapy. We hypothesised that replacing intensive chemotherapy with decitabine monotherapy could improve outcomes. Methods: This open-label, randomised, controlled, phase 3 trial was conducted at 54 hospitals in nine European countries. Patients aged 60 years and older who were newly diagnosed with acute myeloid leukaemia and had not yet been treated were enrolled if they had an Eastern Cooperative Oncology Group performance status of 2 or less and were eligible for intensive chemotherapy. Patients were randomly assigned (1:1) to receive decitabine or standard chemotherapy (known as 3 + 7). For the decitabine group, decitabine (20 mg/m2) was administered for the first 10 days in the first 28-day cycle, followed by 28-day cycles consisting of 5 days or 10 days of decitabine. For the 3 + 7 group, daunorubicin (60 mg/m2) was administered over the first 3 days and cytarabine (200 mg/m2) over the first 7 days, followed by 1-3 additional chemotherapy cycles. Allogeneic HSCT was strongly encouraged. Overall survival in the intention-to-treat population was the primary endpoint. Safety was assessed in all patients who received the allocated treatment. This trial is registered at ClinicalTrials.gov, NCT02172872, and is closed to new participants. Findings: Between Dec 1, 2014, and Aug 20, 2019, 606 patients were randomly assigned to the decitabine (n=303) or 3 + 7 (n=303) group. Following an interim analysis which showed futility, the IDMC recommended on May 22, 2019, that the study continued as planned considering the risks and benefits for the patients participating in the study. The cutoff date for the final analysis presented here was June 30, 2021. At a median follow-up of 4·0 years (IQR 2·9-4·8), 4-year overall survival was 26% (95% CI 21-32) in the decitabine group versus 30% (24-35) in the 3 + 7 group (hazard ratio for death 1·04 [95% CI 0·86-1·26]; p=0·68). Rates of on-protocol allogeneic HSCT were similar between groups (122 [40%] of 303 patients for decitabine and 118 [39%] of 303 patients for 3+7). Rates of grade 3-5 adverse events were 254 (84%) of 302 patients in the decitabine group and 279 (94%) of 298 patients in the 3 + 7 group. The rates of grade 3-5 infections (41% [125 of 302] vs 53% [158 of 298]), oral mucositis (2% [seven of 302] vs 10% [31 of 298]) and diarrhoea (1% [three of 302] vs 8% [24 of 298]) were lower in the decitabine group than in the 3 + 7 group. Treatment-related deaths were reported for 12% (35 of 302) of patients in the decitabine group and 14% (41 of 298) in the 3 + 7 group. Interpretation: 10-day decitabine did not improve overall survival but showed a better safety profile compared with 3 + 7 chemotherapy in older patients with acute myeloid leukaemia eligible for intensive chemotherapy. Decitabine could be considered a better-tolerated and sufficiently efficacious alternative to 3 + 7 induction in fit older patients with acute myeloid leukaemia without favourable genetics.
Ključne riječi (engleski)
Jezikengleski
Vrsta publikacijeZnanstveni rad - Izvorni znanstveni rad
Status objaveObjavljen
Vrsta recenzijeRecenziran
Verzija publikacijeObjavljena verzija rada (izdavačev PDF)
Naslov časopisaThe Lancet Haematology
Brojčani podacivol. 10, br. 11, str. e879-e889
p-ISSN2352-3026
DOIhttps://doi.org/10.1016/S2352-3026(23)00273-9
URN:NBNurn:nbn:hr:105:992101
Datum objave publikacije2023-11
URL dokumentahttps://linkinghub.elsevier.com/retrieve/pii/S2352302623002739
Vrsta resursaTekst
Prava pristupaOtvoreni pristup
Uvjeti korištenjaIkona licence Zaštićeno autorskim pravom.
Datum i vrijeme pohrane2024-05-09 08:14:30