{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T01:38:43Z","timestamp":1760060323603,"version":"build-2065373602"},"reference-count":32,"publisher":"MDPI AG","issue":"16","license":[{"start":{"date-parts":[[2025,8,18]],"date-time":"2025-08-18T00:00:00Z","timestamp":1755475200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Celgene Pharmaceutical"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancers"],"abstract":"<jats:p>Background\/Objectives: After first-line treatment, elderly patients with acute myeloid leukemia (AML) often become unfit to continue intensive chemotherapy despite having achieved a response. This trial aimed to determine the efficacy of maintenance treatment with azacitidine in AML patients who are ineligible to continue intensive treatment after remission. Methods: A single-arm, multicenter, phase II clinical trial (EudraCT: 2010-020432-18) including patients with AML with complete (CR) or partial remission (PR) after one or two cycles of intensive induction chemotherapy and ineligible to continue intensive treatment was conducted. Efficacy was measured as the response rate, progression-free survival (PFS), and overall survival (OS), and was assessed in the intention-to-treat (ITT) population (all patients). Quality of life was also assessed. Results: Thirty-two patients were included, with a mean age of 73.3 years (SD 3.8) (53.1% male); sixteen patients (50.0%) reached the sixth treatment cycle. The best response was CR in 11 patients (68.8%) and PR in 2 patients (12.5%) at cycle six, and CR in 15 patients (46.9%) and PR in 5 patients (15.6%) overall. The median PFS was 6.7 months (95% CI 3.1\u20138.7), and OS was 11.5 months (95% CI 6.6\u201315.9). The daily function (p = 0.0296), cognitive function (p = 0.0412), and social function (p = 0.0275) scales of the EORTC QLQ-C30 questionnaire significantly improved. Thirty-one patients (96.9%) experienced adverse events; six (1.9%) were serious. Conclusions: Azacitidine is a safe and well-tolerated maintenance treatment option for AML patients unfit for intensive therapy following a response to induction, although the single-arm phase II design precludes direct causal inference. Patients achieved promising results regarding PFS and remission rates, with improved quality of life.<\/jats:p>","DOI":"10.3390\/cancers17162678","type":"journal-article","created":{"date-parts":[[2025,8,18]],"date-time":"2025-08-18T11:31:37Z","timestamp":1755516697000},"page":"2678","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Maintenance Treatment with 5-Azacitidine in Patients with Acute Myeloblastic Leukemia Ineligible for Intensive Treatment and with Response After Induction Chemotherapy: A Phase II Clinical Trial"],"prefix":"10.3390","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0009-0002-2724-2766","authenticated-orcid":false,"given":"Alfonso","family":"Fern\u00e1ndez Fern\u00e1ndez","sequence":"first","affiliation":[{"name":"Hospital Universitario Virgen de la Victoria, 29010 M\u00e1laga, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mar\u00eda","family":"Garc\u00eda Fortes","sequence":"additional","affiliation":[{"name":"Hospital Universitario Virgen de la Victoria, 29010 M\u00e1laga, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9622-1649","authenticated-orcid":false,"given":"Mar","family":"Tormo D\u00edaz","sequence":"additional","affiliation":[{"name":"Hospital Cl\u00ednico Universitario de Valencia, 46010 Valencia, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mar\u00eda Luz","family":"Juan Marco","sequence":"additional","affiliation":[{"name":"Hospital Universitario Doctor Peset, 46017 Valencia, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rebeca","family":"Cuello Garc\u00eda","sequence":"additional","affiliation":[{"name":"Hospital Cl\u00ednico Universitario de Valencia, 46010 Valencia, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adolfo","family":"de La Fuente","sequence":"additional","affiliation":[{"name":"MD Anderson Cancer Center Madrid, 28033 Madrid, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Josefina","family":"Serrano L\u00f3pez","sequence":"additional","affiliation":[{"name":"Hospital Universitario Reina Sof\u00eda de C\u00f3rdoba, 14004 C\u00f3rdoba, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M\u00aa \u00c1ngeles","family":"Medina P\u00e9rez","sequence":"additional","affiliation":[{"name":"Hospital Universitario Costal del Sol, Marbella, 29603 M\u00e1laga, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Miguel \u00c1ngel","family":"S\u00e1nchez Chaparro","sequence":"additional","affiliation":[{"name":"Hospital Universitario Virgen de la Victoria, 29010 M\u00e1laga, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8383-3590","authenticated-orcid":false,"given":"Regina","family":"Garc\u00eda Delgado","sequence":"additional","affiliation":[{"name":"Hospital Universitario Virgen de la Victoria, 29010 M\u00e1laga, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2025,8,18]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"70","DOI":"10.1016\/j.blre.2019.04.005","article-title":"Epidemiology of Acute Myeloid Leukemia: Recent Progress and Enduring Challenges","volume":"36","author":"Shallis","year":"2019","journal-title":"Blood Rev."},{"key":"ref_2","first-page":"e3198","article-title":"Acute Myeloid Leukemia: Is That All There Is?","volume":"10","author":"Saif","year":"2018","journal-title":"Cureus"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"365","DOI":"10.1038\/s41568-020-0260-3","article-title":"Dysregulated Haematopoietic Stem Cell Behaviour in Myeloid Leukaemogenesis","volume":"20","author":"Yamashita","year":"2020","journal-title":"Nat. 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