2022
Health-related quality of life (HRQoL) with enasidenib versus conventional care regimens in older patients with late-stage mutant-IDH2 relapsed or refractory acute myeloid leukemia (R/R AML).
Dinardo C, Montesinos P, Schuh A, Papayannidis C, Vyas P, Wei A, Zeidan A, Chen C, Lord-Bessen J, Yu P, Shi L, Guo S, Bluemmert I, Yu X, Hasan M, Regueira P, De Botton S. Health-related quality of life (HRQoL) with enasidenib versus conventional care regimens in older patients with late-stage mutant-IDH2 relapsed or refractory acute myeloid leukemia (R/R AML). Journal Of Clinical Oncology 2022, 40: 7032-7032. DOI: 10.1200/jco.2022.40.16_suppl.7032.Peer-Reviewed Original ResearchConventional care regimensEvent-free survivalEQ-5DR AMLCare regimensGlobal health status/QoLRefractory acute myeloid leukemiaVisual analog scale scoreWorse event-free survivalEORTC QLQ-C30 questionnaireSecondary trial endpointsComplete remission rateAnalog scale scoreHealth-related qualityMean HRQoL scoresQLQ-C30 questionnaireClinical efficacy measuresUtility indexMean EQ-5DAcute myeloid leukemiaQLQ-C30 domainsYears of ageLow response rateHRQOL endpointsOlder pts
2021
Outcomes for Patients with Late-Stage Mutant-IDH2 (m IDH2) Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) Treated with Enasidenib Vs Other Lower-Intensity Therapies in the Randomized, Phase 3 IDHentify Trial
DiNardo C, Montesinos P, Schuh A, Papayannidis C, Vyas P, Wei A, Zeidan A, Bluemmert I, Yu X, Hasan M, Martin-Regueira P, de Botton S. Outcomes for Patients with Late-Stage Mutant-IDH2 (m IDH2) Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) Treated with Enasidenib Vs Other Lower-Intensity Therapies in the Randomized, Phase 3 IDHentify Trial. Blood 2021, 138: 1243. DOI: 10.1182/blood-2021-147593.Peer-Reviewed Original ResearchClinical Trials CommitteeBest supportive careEvent-free survivalBristol-Myers SquibbIntermediate-dose cytarabineMedian overall survivalR AMLOverall survivalHematologic improvementTransfusion independenceTrials CommitteeCurrent equity holderSpeakers bureauDaiichi SankyoRefractory acute myeloid leukemiaAdvisory CommitteeAdverse-risk AMLConventional care regimensLow-dose cytarabineMedian age overallPrimary refractory AMLStudy drug doseOpen-label trialLow-intensity therapyOverall response rate
2019
Enasidenib Plus Azacitidine Significantly Improves Complete Remission and Overall Response Compared with Azacitidine Alone in Patients with Newly Diagnosed Acute Myeloid Leukemia (AML) with Isocitrate Dehydrogenase 2 (IDH2) Mutations: Interim Phase II Results from an Ongoing, Randomized Study
DiNardo C, Schuh A, Stein E, Fernandez P, Wei A, De Botton S, Zeidan A, Fathi A, Quek L, Kantarjian H, Frattini M, Lersch F, Gong J, Franovic A, MacBeth K, Vyas P, Döhner H. Enasidenib Plus Azacitidine Significantly Improves Complete Remission and Overall Response Compared with Azacitidine Alone in Patients with Newly Diagnosed Acute Myeloid Leukemia (AML) with Isocitrate Dehydrogenase 2 (IDH2) Mutations: Interim Phase II Results from an Ongoing, Randomized Study. Blood 2019, 134: 643. DOI: 10.1182/blood-2019-130362.Peer-Reviewed Original ResearchOverall response rateAcute myeloid leukemiaDuration of responseMorphologic leukemia-free stateBone marrow mononuclear cellsAZA armComplete remissionIntensive chemotherapyCelgene CorporationResponse rateDaiichi SankyoVariant allele frequencySpeakers bureauPTC TherapeuticsPartial remissionData cutoffGrade 3Phase I/II studyMedian DORAdvisory CommitteeSeattle GeneticsForty-sevenConventional care regimensIDH differentiation syndromePoor-risk cytogenetics
2017
Hypomethylating agent (HMA) therapy use and survival in older patients with higher risk myelodysplastic syndromes (HR-MDS) in the United States (USA): A large population-based study.
Zeidan A, Hu X, Long J, Wang R, Huntington S, Podoltsev N, Giri S, Stahl M, Gore S, Ma X, Davidoff A. Hypomethylating agent (HMA) therapy use and survival in older patients with higher risk myelodysplastic syndromes (HR-MDS) in the United States (USA): A large population-based study. Journal Of Clinical Oncology 2017, 35: 7057-7057. DOI: 10.1200/jco.2017.35.15_suppl.7057.Peer-Reviewed Original ResearchOverall survivalHR-MDSDiagnosis yearUS population-based analysisEnd Results-Medicare dataHigh-risk myelodysplastic syndromeLarge population-based studyConventional care regimensMedian overall survivalRetrospective cohort studyRisk myelodysplastic syndromesPopulation-based studyRecent registry dataPopulation-based analysisUse of decitabineAZA-001Unselected natureCohort studyConventional careExcess blastsOlder patientsTherapy usePatient selectionSurvival prolongationCare regimens