2023
Efficacy and safety of luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naive, transfusion-dependent, lower-risk myelodysplastic syndromes (COMMANDS): interim analysis of a phase 3, open-label, randomised controlled trial
Platzbecker U, Della Porta M, Santini V, Zeidan A, Komrokji R, Shortt J, Valcarcel D, Jonasova A, Dimicoli-Salazar S, Tiong I, Lin C, Li J, Zhang J, Giuseppi A, Kreitz S, Pozharskaya V, Keeperman K, Rose S, Shetty J, Hayati S, Vodala S, Prebet T, Degulys A, Paolini S, Cluzeau T, Fenaux P, Garcia-Manero G. Efficacy and safety of luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naive, transfusion-dependent, lower-risk myelodysplastic syndromes (COMMANDS): interim analysis of a phase 3, open-label, randomised controlled trial. The Lancet 2023, 402: 373-385. PMID: 37311468, DOI: 10.1016/s0140-6736(23)00874-7.Peer-Reviewed Original ResearchConceptsLower-risk myelodysplastic syndromesRed blood cell transfusion independenceEpoetin alfa groupErythropoiesis-stimulating agentsEpoetin alfaMyelodysplastic syndromeInterim analysisPrimary endpointAdverse eventsAlfa groupTransfusion independenceLower riskBody weightTreatment-emergent adverse eventsTreatment-related adverse eventsRed blood cell transfusionDurable clinical efficacyMean hemoglobin increaseMedian treatment exposureBlood cell transfusionCOVID-19 pneumoniaSubgroup of patientsWeeks of treatmentTreatment of anemiaAcute myeloid leukemia
2016
Myelodysplastic Syndromes, Version 2.2017, NCCN Clinical Practice Guidelines in Oncology.
Greenberg PL, Stone RM, Al-Kali A, Barta SK, Bejar R, Bennett JM, Carraway H, De Castro CM, Deeg HJ, DeZern AE, Fathi AT, Frankfurt O, Gaensler K, Garcia-Manero G, Griffiths EA, Head D, Horsfall R, Johnson RA, Juckett M, Klimek VM, Komrokji R, Kujawski LA, Maness LJ, O'Donnell MR, Pollyea DA, Shami PJ, Stein BL, Walker AR, Westervelt P, Zeidan A, Shead DA, Smith C. Myelodysplastic Syndromes, Version 2.2017, NCCN Clinical Practice Guidelines in Oncology. Journal Of The National Comprehensive Cancer Network 2016, 15: 60-87. PMID: 28040720, DOI: 10.6004/jnccn.2017.0007.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsMyelodysplastic syndromeNCCN Clinical Practice GuidelinesHigh-intensity therapyPresence of cytopeniasLow-intensity therapyClinical practice guidelinesVariable disease courseTreatment of anemiaBetter treatment guidanceSupportive careDisease courseTherapeutic optionsPractice guidelinesDiagnostic criteriaTreatment approachesMyeloid disordersHeterogenous groupMolecular abnormalitiesTreatment guidanceDiagnostic classificationPatientsSyndromeTherapyTreatmentGuidelines
2012
Association Between FDA Safety Warnings, CMS Coverage Restrictions and Adherence to Guidelines for ESA Use in Patients with Myelodysplastic Syndromes
Hendrick F, Davidoff A, Zeidan A, Gore S, Baer M. Association Between FDA Safety Warnings, CMS Coverage Restrictions and Adherence to Guidelines for ESA Use in Patients with Myelodysplastic Syndromes. Blood 2012, 120: 971. DOI: 10.1182/blood.v120.21.971.971.Peer-Reviewed Original ResearchErythropoiesis stimulating agentsCMS national coverage determinationsFDA safety warningsESA useNational Coverage DeterminationMyelodysplastic syndromeESA initiationSerum EPO levelsMDS patientsUse of ESAsEPO levelsChronic renal failureOff-label indicationsProportion of patientsChemotherapy-related anemiaSpecific clinical parametersOff-label useTreatment of anemiaEnd of studySerum erythropoietin levelsLikelihood of responseLogistic regression modelsThromboembolic eventsTransfusion useAdverse eventsMedicare Prescription Drug Coverage and Home Use of Erythropoiesis-Stimulating Agents for MDS-Associated Anemia: A Medicare-Database Analysis.
Davidoff A, Hendrick F, Stuart B, Zeidan A, Shenolikar R, Gore S, Baer M. Medicare Prescription Drug Coverage and Home Use of Erythropoiesis-Stimulating Agents for MDS-Associated Anemia: A Medicare-Database Analysis. Blood 2012, 120: 3176. DOI: 10.1182/blood.v120.21.3176.3176.Peer-Reviewed Original ResearchErythropoiesis stimulating agentsLow-income subsidyPart D claimsMyelodysplastic syndromePart D plansPrior authorizationStudy cohortD claimsOOP paymentsMDS diagnosisPart DUse of ESAsPart D.Lower-risk myelodysplastic syndromesPoor functional statusChronic renal failureD plansErythropoiesis-stimulating agentsMultivariate logistic regressionTreatment of anemiaPart D coverageMedicare Part APlan characteristicsPrescription drug coveragePatient-level observations