2022
A phase 1b study of venetoclax and azacitidine combination in patients with relapsed or refractory myelodysplastic syndromes
Zeidan AM, Borate U, Pollyea DA, Brunner AM, Roncolato F, Garcia JS, Filshie R, Odenike O, Watson AM, Krishnadasan R, Bajel A, Naqvi K, Zha J, Cheng W, Zhou Y, Hoffman D, Harb JG, Potluri J, Garcia‐Manero G. A phase 1b study of venetoclax and azacitidine combination in patients with relapsed or refractory myelodysplastic syndromes. American Journal Of Hematology 2022, 98: 272-281. PMID: 36309981, PMCID: PMC10100228, DOI: 10.1002/ajh.26771.Peer-Reviewed Original ResearchConceptsMedian overall survivalMyelodysplastic syndromeOverall survivalTransfusion independenceHematological improvementTherapy failureHigh-risk myelodysplastic syndromeInternational Working Group criteriaHematological adverse eventsPhase 1b studyRefractory myelodysplastic syndromeStandard of careEfficacy of venetoclaxEffective therapeutic strategyFebrile neutropeniaMarrow CROral venetoclaxComplete remissionAdverse eventsMedian durationAzacitidine treatmentMedian timeMarrow responseMulticenter studyGroup criteria
2018
The use of immunosuppressive therapy in MDS: clinical outcomes and their predictors in a large international patient cohort
Stahl M, DeVeaux M, de Witte T, Neukirchen J, Sekeres MA, Brunner AM, Roboz GJ, Steensma DP, Bhatt VR, Platzbecker U, Cluzeau T, Prata PH, Itzykson R, Fenaux P, Fathi AT, Smith A, Germing U, Ritchie EK, Verma V, Nazha A, Maciejewski JP, Podoltsev NA, Prebet T, Santini V, Gore SD, Komrokji RS, Zeidan AM. The use of immunosuppressive therapy in MDS: clinical outcomes and their predictors in a large international patient cohort. Blood Advances 2018, 2: 1765-1772. PMID: 30037803, PMCID: PMC6058241, DOI: 10.1182/bloodadvances.2018019414.Peer-Reviewed Original ResearchConceptsAnti-thymocyte globulinRBC transfusion independenceImmunosuppressive therapyTransfusion independenceOverall response rateHypocellular bone marrowMyelodysplastic syndromeOverall survivalBone marrowRed blood cell transfusion independenceHorse anti-thymocyte globulinRabbit anti-thymocyte globulinInternational Working Group criteriaCox proportional hazards modelSingle-center natureMedian overall survivalKaplan-Meier methodLarge international cohortLarge international patient cohortProportional hazards modelInternational patient cohortPredictors of benefitParoxysmal nocturnal hemoglobinuriaLogistic regression modelsSteroid monotherapy
2016
The Use of Hypomethylating Agents (HMAs) in Patients with Relapsed and Refractory Acute Myeloid Leukemia (RR-AML): Clinical Outcomes and Their Predictors in a Large International Patient Cohort
Stahl M, Podoltsev N, DeVeaux M, Perreault S, Itzykson R, Ritchie E, Sekeres M, Fathi A, Komrokji R, Bhatt V, Al-Kali A, Cluzeau T, Santini V, Brunner A, Roboz G, Fenaux P, Litzow M, Vey N, Verma V, Germing U, Fernández P, Zelterman D, Kim T, Prebet T, Gore S, Zeidan A. The Use of Hypomethylating Agents (HMAs) in Patients with Relapsed and Refractory Acute Myeloid Leukemia (RR-AML): Clinical Outcomes and Their Predictors in a Large International Patient Cohort. Blood 2016, 128: 1063. DOI: 10.1182/blood.v128.22.1063.1063.Peer-Reviewed Original ResearchMultivariable logistic regression modelRR-AMLMinority of patientsOverall survivalPrior linesHypomethylating agentHMA therapyMedian numberLogistic regression modelsChromosome 7 abnormalitiesStable diseaseBlast percentageHematologic improvementProgressive diseaseHazard ratioClinical outcomesSpeakers bureauMultivariable Cox proportional hazards modelsPeripheral blood blast percentageRefractory acute myeloid leukemiaAllogeneic stem cell transplantationInternational Working Group criteriaWhite blood cell countCox proportional hazards modelBM blast percentageA phase 2 trial of high dose lenalidomide in patients with relapsed/refractory higher‐risk myelodysplastic syndromes and acute myeloid leukaemia with trilineage dysplasia
Zeidan AM, Smith BD, Carraway HE, Gojo I, DeZern A, Gore SD. A phase 2 trial of high dose lenalidomide in patients with relapsed/refractory higher‐risk myelodysplastic syndromes and acute myeloid leukaemia with trilineage dysplasia. British Journal Of Haematology 2016, 176: 241-247. PMID: 27790720, DOI: 10.1111/bjh.14407.Peer-Reviewed Original ResearchConceptsHigh-risk myelodysplastic syndromeHigh-dose lenalidomideAcute myeloid leukemiaOverall survivalTrilineage dysplasiaMyelodysplastic syndromeMyeloid leukemiaNeutropenic fever/infectionInternational Working Group criteriaChemotherapy-ineligible patientsDoses of lenalidomideFever/infectionPoor-risk karyotypeRobust clinical activityMedian overall survivalPhase 2 trialPhase II trialKaplan-Meier methodElderly AMLII trialPrimary endpointFrontline therapyDosing schedulesGroup criteriaLimited therapies
2015
Differential Response to Hypomethylating Agents Based on Sex: A Report on Behalf of the MDS Clinical Research Consortium (MDS CRC)
DeZern A, Zeidan A, Barnard J, Hand W, Al Ali N, Brown F, Zimmerman C, Roboz G, Komrokji R, Garcia-Manero G, Steensma D, Sekeres M. Differential Response to Hypomethylating Agents Based on Sex: A Report on Behalf of the MDS Clinical Research Consortium (MDS CRC). Blood 2015, 126: 2889. DOI: 10.1182/blood.v126.23.2889.2889.Peer-Reviewed Original ResearchHigh-risk myelodysplastic syndromeMedian overall survivalBone marrow blastsFirst-line therapyOverall survivalTime of presentationMyelodysplastic syndromeMedian OSBlast percentageBetter OSMarrow blastsCytogenetic categoriesBone marrow blast percentageMDS Clinical Research ConsortiumStandard first-line therapyInternational Working Group criteriaCox PH analysisCox proportional analysisMarrow blast percentageSpeakers bureauClinical Research ConsortiumLog-rank testDate of deathFuture prospective investigationsMann-Whitney U test