骨髓增生异常综合征和急性髓性白血病患者接

低甲基化剂已被证实对骨髓增生异常综合征（MDS）和急性髓性白血病（AML）患者有效。本研究旨在评估接受地西他滨治疗的MDS和AML患者，加用丙戊酸（一种组蛋白脱乙酰化酶抑制剂）可能获得的受益。结果显示，34%的患者获得完全缓解，且55%的患者获得客观反应。中位生存期为11.9个月，估计的2年生存率为27%。地西他滨联合丙戊酸治疗组与地西他滨单药治疗组间的完全缓解率、总缓解及生存无显著差异。研究表明，地西他滨加用丙戊酸并不能使MDS和老年AML患者的预后得到改善。

该研究提前在线发表于年10月21日《癌症》杂志上（Cancer.Oct21.[Epubaheadofprint]）。

Resultsofphase2randomizedstudyoflow-dosedecitabinewithorwithoutvalproicacidinpatientswithmyelodysplasticsyndromeandacutemyelogenousleukemia.

IssaJP(1),Garcia-ManeroG,HuangX,CortesJ.

BACKGROUND:Hypomethylatingagentshavedemonstratedactivityinpatientswithmyelodysplasticsyndrome(MDS)andacutemyeloidleukemia(AML).Preclinicalandsingle-armtrialshavesuggestedthataddinghistonedeacetylase(HDAC)inhibitorsmaysynergizetheepigeneticmodulationofhypomethylatingagentsandimprovetreatmentresults.METHODS:Theobjectiveofthisstudywastoevaluatethepossiblebenefitofaddingvalproicacid,anHDACinhibitor,todecitabineinthetreatmentofMDSandAML.RESULTS:PatientswithhigherriskMDSorwithAMLaged≥60yearswereeligible.PatientswererandomizedinaBayesianresponse-adaptivedesigntoreceiveintravenousdecitabine20mg/m(2)dailyfor5daysordecitabineplusoralvalproicacid50mg/kgdailyfor7days.Courseswererepeatedevery4to6weeks.Amaximumofpatientsweretobetreated.Intotal,patientsweretreatedonstudy,including87patientswithMDSand62patientswithAML.Themedianpatientagewas69years(range,20-89years;42%ofpatientswereaged≥70years).Overall,34%ofpatientsachieved

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