{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T09:35:38Z","timestamp":1792143338377,"version":"4.4.0"},"reference-count":28,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"10","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2023,4,1]]},"abstract":"<jats:sec><jats:title>PURPOSE<\/jats:title><jats:p>Hydroxyurea (HY) is a reference treatment of advanced myeloproliferative neoplasms. We conducted a randomized phase III trial comparing decitabine (DAC) and HY in advanced myeloproliferative chronic myelomonocytic leukemias (CMML).<\/jats:p><\/jats:sec><jats:sec><jats:title>PATIENTS AND METHODS<\/jats:title><jats:p>Newly diagnosed myeloproliferative CMML patients with advanced disease were randomly assigned 1:1 to intravenous DAC (20 mg\/m<jats:sup>2<\/jats:sup>\/d days 1-5) or HY (1-4 g\/d) in 28-day cycles. The primary end point was event-free survival (EFS), events being death and acute myelomonocytic leukemia (AML) transformation or progression.<\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p>One-hundred seventy patients received DAC (n = 84) or HY (n = 86). Median age was 72 and 74 years, and median WBC count 32.5 \u00d7 10<jats:sup>9<\/jats:sup>\/L and 31.2 \u00d7 10<jats:sup>9<\/jats:sup>\/L in the DAC and HY arms, respectively. Thirty-three percent of DAC and 31% of HY patients had CMML-2. Patients received a median of five DAC and six HY cycles. With a median follow-up of 17.5 months, median EFS was 12.1 months in the DAC arm and 10.3 months in the HY arm (hazard ratio [HR], 0.83; 95% CI, 0.59 to 1.16; P = .27). There was no significant interaction between treatment effect and blast or platelet count, anemia, CMML Prognostic Scoring System, Groupe Francophone des Myelodysplasies, or CMML Prognostic Scoring System\u2013mol risk. Fifty-three (63%) DAC patients achieved a response compared with 30 (35%) HY patients ( P = .0004). Median duration of response was similar in both arms (DAC, 16.3 months; HY, 17.4 months; P = .90). Median overall survival was 18.4 months in the DAC arm and 21.9 months in the HY arm ( P = .67). Compared with HY, DAC significantly reduced the risk of CMML progression or transformation to acute myelomonocytic leukemia (cause-specific HR, 0.62; 95% CI, 0.41 to 0.94; P = .005) at the expense of death without progression or transformation (cause-specific HR, 1.55; 95% CI, 0.82 to 2.9; P = .04).<\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSION<\/jats:title><jats:p>Compared with HY, frontline treatment with DAC did not improve EFS in patients with advanced myeloproliferative CMML (ClinicalTrials.gov identifier: NCT02214407 ).<\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.22.00437","type":"journal-article","created":{"date-parts":[[2022,12,1]],"date-time":"2022-12-01T21:00:28Z","timestamp":1669928428000},"page":"1888-1897","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":52,"title":["Decitabine Versus Hydroxyurea for Advanced Proliferative Chronic Myelomonocytic Leukemia: Results of a Randomized Phase III Trial Within the EMSCO Network"],"prefix":"10.1200","volume":"41","clinical-trial-number":[{"clinical-trial-number":"nct02214407","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2139-6262","authenticated-orcid":true,"given":"Raphael","family":"Itzykson","sequence":"first","affiliation":[{"name":"Service H\u00e9matologie Adultes, H\u00f4pital Saint-Louis, Assistance Publique-H\u00f4pitaux de Paris, Paris, France"},{"name":"Universit\u00e9 de Paris, G\u00e9nomes, biologie cellulaire et th\u00e9rapeutique U944, INSERM, CNRS, Paris, France"},{"name":"Groupe Francophone des My\u00e9lodysplasies, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5439-2172","authenticated-orcid":true,"given":"Valeria","family":"Santini","sequence":"additional","affiliation":[{"name":"MDS Unit, DMSC; 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