{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T05:16:22Z","timestamp":1790140582341,"version":"4.0.1"},"reference-count":32,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2024,9,23]],"date-time":"2024-09-23T00:00:00Z","timestamp":1727049600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100013870","name":"Astex Pharmaceuticals","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100013870","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Br J Haematol"],"published-print":{"date-parts":[[2024,11]]},"abstract":"<jats:title>Summary<\/jats:title><jats:p>This study compared decitabine exposure when administered IV (DEC\u2010IV) at a dose of 20\u2009mg\/m<jats:sup>2<\/jats:sup> for 5\u2010days with orally administered decitabine with cedazuridine (DEC\u2010C), as well as the clinical efficacy and safety of DEC\u2010C in patients with acute myeloid leukaemia (AML) who were ineligible for intensive induction chemotherapy. In all, 89 patients were randomised 1:1 to DEC\u2010IV or oral DEC\u2010C (days 1\u20135 in a 28\u2010day treatment cycle), followed by 5\u2009days of the other formulation in the next treatment cycle. All patients received oral DEC\u2010C for subsequent treatment cycles until treatment discontinuation. Equivalent systemic decitabine exposures were demonstrated (5\u2010day area under the curve ratio between the two decitabine formulations of 99.64 [90% confidence interval 91.23%, 108.80%]). Demethylation rates also were similar (\u22641.1% difference). Median overall survival (OS), clinical response and safety profile with oral DEC\u2010C were consistent with those previously observed with DEC\u2010IV. Next\u2010generation sequencing was performed to identify molecular abnormalities that impact OS and <jats:italic>TP53<\/jats:italic> mutations were associated with a poor outcome. These findings support the use of oral DEC\u2010C in patients with AML.<\/jats:p>","DOI":"10.1111\/bjh.19741","type":"journal-article","created":{"date-parts":[[2024,11,16]],"date-time":"2024-11-16T01:17:30Z","timestamp":1731719850000},"page":"1734-1745","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":23,"title":["Oral decitabine\/cedazuridine versus intravenous decitabine for acute myeloid leukaemia: A randomised, crossover, registration, pharmacokinetics study"],"prefix":"10.1111","volume":"205","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1921-7034","authenticated-orcid":false,"given":"Klaus","family":"Geissler","sequence":"first","affiliation":[{"name":"Sigmund Freud PrivatUniversit\u00e4t  Wien Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zdenek","family":"Koristek","sequence":"additional","affiliation":[{"name":"Department of Haematooncology University Hospital Ostrava  Ostrava Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2338-513X","authenticated-orcid":false,"given":"Teresa Bernal","family":"del Castillo","sequence":"additional","affiliation":[{"name":"Hospital Universitario Central de Asturias, Instituo de Investigaci\u00f3n Sanitaria del Principado de Asturias, Instituto Universitario de Oncolog\u00eda del Principado de Asturias  Oviedo Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan","family":"Nov\u00e1k","sequence":"additional","affiliation":[{"name":"Department of Haematology, Third Faculty of Medicine Charles University and Faculty Hospital University, Hospital Kr\u00e1lovsk\u00e9 Vinohrady  Prague Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriela","family":"Rodr\u00edguez\u2010Mac\u00edas","sequence":"additional","affiliation":[{"name":"Hospital General Universitario Gregorio Mara\u00f1\u00f3n  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephan K.","family":"Metzelder","sequence":"additional","affiliation":[{"name":"Philipps University Marburg and University Hospital Gie\u00dfen and Marburg  Marburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arpad","family":"Illes","sequence":"additional","affiliation":[{"name":"Division of Hematology, Department of Internal Medicine, Faculty of Medicine University of Debrecen  Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ji\u0159\u00ed","family":"Mayer","sequence":"additional","affiliation":[{"name":"Fakultn\u00ed Nemocnice Brno and Masaryk University  Brno Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Montserrat","family":"Arnan","sequence":"additional","affiliation":[{"name":"Institut Catal\u00e0 d'Oncologia\u2010Hospital Duran i Reynals  Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mary\u2010Margaret","family":"Keating","sequence":"additional","affiliation":[{"name":"Queen Elizabeth II Health Sciences Centre  Halifax Nova Scotia Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J\u00fcrgen","family":"Krauter","sequence":"additional","affiliation":[{"name":"St\u00e4dtisches Klinikum Braunschweig Klinik f\u00fcr H\u00e4matologie und Onkologie  Braunschweig Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monia","family":"Lunghi","sequence":"additional","affiliation":[{"name":"Azienda Ospedaliero\u2010Universitaria Maggiore Della Carit\u00e0 Novara  Novara Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicola Stefano","family":"Fracchiolla","sequence":"additional","affiliation":[{"name":"Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, SC Ematologia  Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Uwe","family":"Platzbecker","sequence":"additional","affiliation":[{"name":"Universit\u00e4tsklinikum Leipzig  Leipzig Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5439-2172","authenticated-orcid":false,"given":"Valeria","family":"Santini","sequence":"additional","affiliation":[{"name":"MDS Unit, Hematology, AOUC, DMSC Universit\u00e0 degli Studi di Firenze  Firenze Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuri","family":"Sano","sequence":"additional","affiliation":[{"name":"Taiho Oncology, Inc.  Pleasanton California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aram","family":"Oganesian","sequence":"additional","affiliation":[{"name":"Taiho Oncology, Inc.  Pleasanton California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0753-4921","authenticated-orcid":false,"given":"Harold","family":"Keer","sequence":"additional","affiliation":[{"name":"Taiho Oncology, Inc.  Pleasanton California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1186-1650","authenticated-orcid":false,"given":"Michael","family":"L\u00fcbbert","sequence":"additional","affiliation":[{"name":"Department of Haematology, Oncology, and Stem Cell Transplantation University of Freiburg Medical Center, University of Freiburg Faculty of Medicine  Freiburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,9,23]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.blre.2019.04.005"},{"key":"e_1_2_9_3_1","unstructured":"National Comprehensive Cancer Network.Clinical practice guidelines in oncology (NCCN guidelines\u00ae). Acute myeloid leukemia. Version 2.2024\u2014March 22 2024."},{"key":"e_1_2_9_4_1","unstructured":"National Comprehensive Cancer Network.Acute myeloid leukemia. Version 6.2023\u2014October 24 2023."},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.V118.21.3801.3801"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2010.34.4226"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.2019004143"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2352-3026(23)00338-1"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.HS9.0000969844.13426.20"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1112304"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.2022015850"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.2022016867"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/ajh.26892"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41375-023-01884-2"},{"key":"e_1_2_9_15_1","volume-title":"Prescribing information","author":"Dacogen","year":"2021"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2016-03-643544"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1093\/nar\/gnh032"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2003.04.036"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2011.38.9429"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2012971"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.1182\/bloodadvances.2020001779"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.21.02810"},{"key":"e_1_2_9_23_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2018-08-868752"},{"key":"e_1_2_9_24_1","doi-asserted-by":"publisher","DOI":"10.1002\/ajh.26039"},{"key":"e_1_2_9_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2352-3026(24)00033-4"},{"key":"e_1_2_9_26_1","doi-asserted-by":"crossref","unstructured":"MannisGN GriffithsEA SavonaMR OdenikeO RobozGJ O'ConnellCL et\u00a0al.A phase 1 study evaluating ASTX727 (decitabine and cedazuridine) and venetoclax combination therapy in newly diagnosed AML patients unfit for intensive induction chemotherapy. Presented at the American Society of Hematology Annual Meeting. Atlanta GA; December 11\u201313 2021. Abstract 1245 138.","DOI":"10.1182\/blood-2021-146264"},{"key":"e_1_2_9_27_1","volume-title":"Prescribing information","author":"Onureg","year":"2022"},{"key":"e_1_2_9_28_1","unstructured":"Onureg.Summary of Product Characteristics [Internet]. Available from:https:\/\/www.ema.europa.eu\/en\/documents\/product\u2010information\/onureg\u2010epar\u2010product\u2010information_en.pdf"},{"key":"e_1_2_9_29_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41375-023-01999-6"},{"key":"e_1_2_9_30_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.HS9.0000968576.09006.a7"},{"key":"e_1_2_9_31_1","doi-asserted-by":"publisher","DOI":"10.1038\/leu.2017.109"},{"key":"e_1_2_9_32_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2021-153202"},{"key":"e_1_2_9_33_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2022-169509"}],"container-title":["British Journal of Haematology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/bjh.19741","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,9,17]],"date-time":"2025-09-17T08:39:13Z","timestamp":1758098353000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/bjh.19741"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,9,23]]},"references-count":32,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2024,11]]}},"alternative-id":["10.1111\/bjh.19741"],"URL":"https:\/\/doi.org\/10.1111\/bjh.19741","archive":["Portico"],"relation":{},"ISSN":["0007-1048","1365-2141"],"issn-type":[{"value":"0007-1048","type":"print"},{"value":"1365-2141","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,9,23]]},"assertion":[{"value":"2024-06-28","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-08-21","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-09-23","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}