{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,16]],"date-time":"2026-04-16T17:53:02Z","timestamp":1776361982063,"version":"3.51.2"},"reference-count":50,"publisher":"Wiley","issue":"23","license":[{"start":{"date-parts":[[2022,10,8]],"date-time":"2022-10-08T00:00:00Z","timestamp":1665187200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["acsjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer"],"published-print":{"date-parts":[[2022,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Low\u2010dose azacitidine (AZA) regimens, primarily 5\u2010day AZA, have been used in lower risk myelodysplastic syndrome (LrMDS) but they have yet to be directly compared to the standard 7\u2010day, uninterrupted dosing schedule.<\/jats:p><\/jats:sec><jats:sec><jats:title>Method<\/jats:title><jats:p>In this phase 2, multicenter, randomized trial, 55 patients with adult LrMDS (low and intermediate\u20101 risk by international prognostic scoring system [IPSS]) were randomly assigned and received either 5\u2010day (<jats:italic>n<\/jats:italic>\u00a0=\u00a026) or 7\u2010day (<jats:italic>n<\/jats:italic>\u00a0=\u00a029) AZA between March 2012 and August 2020. The trial was stopped prematurely because of the slow accrual of patients. The primary end point was the overall response rate (ORR) of the 5\u2010day AZA as compared to that of the 7\u2010day regimen.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Median patient age was 59\u00a0years, and IPSS intermediate\u20101 risk comprised the majority (81.8%). The median number of cycles in both arms was six. In the ITT subset (<jats:italic>n<\/jats:italic>\u00a0=\u00a053), in each of the 5\u2010day and 7\u2010day arms, the ORR of 48.0% and 39.3%, hematologic improvement of 44.0% and 39.3%, and RBC transfusion independence of 35.3% and 40.0% were observed respectively, and none of these findings were significantly different between the two arms. A cytogenetic response rate was significantly higher in the 7\u2010day arm (8.3% and 53.8%, <jats:italic>p<\/jats:italic>\u00a0=\u00a0.027). Survival and adverse events were similar between the groups, although gastrointestinal toxicities, grade \u22653 thrombocytopenia, and febrile neutropenia were less frequent in the 5\u2010day arm.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The 5\u2010day AZA in LrMDS showed comparable efficacy to a 7\u2010day regimen in terms of similar overall response and other outcomes, despite significantly higher rates of cytogenetic responses in the 7\u2010day regimen.<\/jats:p><\/jats:sec><jats:sec><jats:title>Lay summary<\/jats:title><jats:p>\n<jats:list list-type=\"bullet\">\n<jats:list-item><jats:p>Azacitidine (75\u00a0mg\/m<jats:sup>2<\/jats:sup>\/day for 7 consecutive days per 28\u2010day cycle) has shown survival benefit in patients with higher risk myelodysplastic syndrome (MDS).<\/jats:p><\/jats:list-item>\n<jats:list-item><jats:p>Although the use of azacitidine is less\u2010well studied for lower risk MDS, it is generally accepted as a feasible option for lower risk MDS (LrMDS).<\/jats:p><\/jats:list-item>\n<\/jats:list>\n<\/jats:p><\/jats:sec>","DOI":"10.1002\/cncr.34492","type":"journal-article","created":{"date-parts":[[2022,10,8]],"date-time":"2022-10-08T05:11:26Z","timestamp":1665205886000},"page":"4095-4108","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Five\u2010day versus 7\u2010day treatment regimen with azacitidine in lower risk myelodysplastic syndrome: A phase 2, multicenter, randomized trial"],"prefix":"10.1002","volume":"128","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2845-2933","authenticated-orcid":false,"given":"Silvia","family":"Park","sequence":"first","affiliation":[{"name":"Department of Hematology Seoul St. Mary's Hematology Hospital College of Medicine Catholic University of Korea  Seoul Korea"},{"name":"Leukemia Research Institute College of Medicine Catholic University of Korea  Seoul 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