2024
Health-Related Quality of Life of Luspatercept Versus Epoetin Alfa in Red Blood Cell Transfusion-Dependent Lower-Risk Myelodysplastic Syndromes: Results from the Final Datacut of the Phase 3 COMMANDS Study
Oliva E, Platzbecker U, Della Porta M, Garcia-Manero G, Santini V, Fenaux P, Shortt J, Komrokji R, Pelligra C, Guo S, Yucel A, Glassberg M, Eliason L, Hnoosh A, Miteva D, Rose S, Kreitz S, Sekeres M, Zeidan A. Health-Related Quality of Life of Luspatercept Versus Epoetin Alfa in Red Blood Cell Transfusion-Dependent Lower-Risk Myelodysplastic Syndromes: Results from the Final Datacut of the Phase 3 COMMANDS Study. Blood 2024, 144: 3216. DOI: 10.1182/blood-2024-198374.Peer-Reviewed Original ResearchLower-risk myelodysplastic syndromesReduction of red blood cellsFunctional Assessment of Cancer Therapy-AnemiaClinically important differenceEpoetin alfaMyelodysplastic syndromeRevised International Prognostic Scoring SystemInternational Prognostic Scoring SystemHealth-related qualityClinically important difference thresholdImprovement of cytopeniasMean haemoglobin increaseRBC transfusion independencePrognostic Scoring SystemPhase 3 studyStratified Cox proportional hazard regressionsFront-line treatmentOnset of improvementQLQ-C30Cox proportional hazards regressionEORTC QLQ-C30Treatment of anemiaProportional hazards regressionSuperior treatment effectsPost-baseline assessmentToward a more patient‐centered drug development process in clinical trials for patients with myelodysplastic syndromes/neoplasms (MDS): Practical considerations from the International Consortium for MDS (icMDS)
Efficace F, Buckstein R, Abel G, Giesinger J, Fenaux P, Bewersdorf J, Brunner A, Bejar R, Borate U, DeZern A, Greenberg P, Roboz G, Savona M, Sparano F, Boultwood J, Komrokji R, Sallman D, Xie Z, Sanz G, Carraway H, Taylor J, Nimer S, Della Porta M, Santini V, Stahl M, Platzbecker U, Sekeres M, Zeidan A. Toward a more patient‐centered drug development process in clinical trials for patients with myelodysplastic syndromes/neoplasms (MDS): Practical considerations from the International Consortium for MDS (icMDS). HemaSphere 2024, 8: e69. PMID: 38774655, PMCID: PMC11106800, DOI: 10.1002/hem3.69.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsPatient-reported outcomesPatient-reported outcome dataHealth-related qualityPatient-reported outcome endpointsHealth-related quality of lifeClinical trialsImprove patients' health-related qualityPatients' health-related qualityPatient-reported outcome itemsQuality of lifeTime-to-event analysisRandomized controlled trialsTreatment decision-makingPatient carePatient populationTreatment advancesControlled trialsPatientsIncurable diseaseAssessment strategiesHRQoLBenefit/risk assessmentDrug development processTrialsTherapy
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
2020
AML-205: Health-Related Quality of Life in Patients with Untreated Higher-Risk Myelodysplastic Syndromes, Acute Myeloid Leukemia, and Chronic Myelomonocytic Leukemia Receiving Glasdegib + Azacitidine
Wang E, Bell T, Zeidan A, Bhattcharyya H, Kudla A, Chan G, Sekeres M. AML-205: Health-Related Quality of Life in Patients with Untreated Higher-Risk Myelodysplastic Syndromes, Acute Myeloid Leukemia, and Chronic Myelomonocytic Leukemia Receiving Glasdegib + Azacitidine. Clinical Lymphoma Myeloma & Leukemia 2020, 20: s191. DOI: 10.1016/s2152-2650(20)30732-1.Peer-Reviewed Original ResearchHigh-risk myelodysplastic syndromeAcute myeloid leukemiaChronic myelomonocytic leukemiaPatient Global ImpressionMyelodysplastic syndromeIntensive chemotherapyPatient's impressionGlobal ImpressionAML cohortMDS cohortMyeloid leukemiaAML/myelodysplastic syndromeMD Anderson Symptom InventoryFirst-line treatment optionLower symptom burdenHRQoL of patientsOpen-label studyHealth-related qualityPatient-reported outcomesEnd of treatmentMain outcome measuresTotal symptom severityQuality of lifeTrend of improvementStudy medication