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This Phase II study assessed the efficacy and safety of elacytarabine in patients with advanced stage acute myeloid leukaemia (<jats:styled-content style=\"fixed-case\">AML<\/jats:styled-content>). Patients received 2000\u00a0mg\/m<jats:sup>2<\/jats:sup> per d continuously i.v. during days 1\u20135 every 3\u00a0weeks. Patients were matched by six risk factors with historical controls; remission rate (assessed after 1 or 2 cycles) and 6\u2010month survival were compared. Sixty\u2010one patients, median age 58\u00a0years, were enrolled; 52% had five or six risk factors. The remission rate was 18% (95% confidence interval: 9\u201330%) vs. 4% in controls (<jats:italic>P<\/jats:italic>\u00a0&lt;\u00a00\u00b70001), 6\u2010month survival rate was 43%, median overall survival was 5\u00b73\u00a0months (vs. 1\u00b75\u00a0months);\u00a010 patients (16%) were referred for stem cell transplantation after treatment. Side effects were predictable and manageable. The most common grade 3\/4 non\u2010haematological adverse events were febrile neutropenia, hypokalemia, fatigue, hyponatraemia, dyspnoea and pyrexia. Thirty\u2010day all\u2010cause mortality, after start of treatment, was 13% vs. 25% in controls. Elacytarabine has monotherapy activity in patients with advanced AML. This study provides proof\u2010of\u2010concept that lipid esterification of nucleoside analogues is clinically relevant.<\/jats:p>","DOI":"10.1111\/j.1365-2141.2012.09186.x","type":"journal-article","created":{"date-parts":[[2012,6,15]],"date-time":"2012-06-15T15:50:38Z","timestamp":1339775438000},"page":"581-588","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":27,"title":["Elacytarabine has single\u2010agent activity in patients \u2028with advanced acute myeloid leukaemia"],"prefix":"10.1111","volume":"158","author":[{"given":"Susan","family":"O'Brien","sequence":"first","affiliation":[{"name":"Department of Leukemia University of Texas MD Anderson Cancer Center Houston TX USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David A.","family":"Rizzieri","sequence":"additional","affiliation":[{"name":"Cellular Therapy Duke University Medical Center  Durham NC USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Norbert","family":"Vey","sequence":"additional","affiliation":[{"name":"Groupe Francophone des Myelodysplasies (GFM)  Bobigny France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Farhad","family":"Ravandi","sequence":"additional","affiliation":[{"name":"Department of Leukemia U.T. 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