2024
MDS-157 Overall Survival (OS), Clinical Benefit, and Durable Red Blood Cell (RBC) Transfusion Independence (TI) With Imetelstat in the IMerge Phase 3 Trial of RBC-Transfusion Dependent (TD) Lower-Risk Myelodysplastic Syndromes (LR-MDS)
Santini V, Komrokji R, Sekeres M, Savona M, Fenaux P, Madanat Y, Oliva E, Buckstein R, Annaášová A, Germing U, Mittelman M, Thepot S, Riggs J, Dougherty S, Berry T, Navada S, Xia Q, Sun L, Zeidan A, Platzbecker U. MDS-157 Overall Survival (OS), Clinical Benefit, and Durable Red Blood Cell (RBC) Transfusion Independence (TI) With Imetelstat in the IMerge Phase 3 Trial of RBC-Transfusion Dependent (TD) Lower-Risk Myelodysplastic Syndromes (LR-MDS). Clinical Lymphoma Myeloma & Leukemia 2024, 24: s386-s387. DOI: 10.1016/s2152-2650(24)01345-4.Peer-Reviewed Original ResearchLower-risk myelodysplastic syndromesNon-del(5q) lower-risk myelodysplastic syndromesErythropoiesis-stimulating agentsRBC-TIOverall survivalRBC-TDNon-del(5qClinical benefitRed blood cellsHemoglobin increaseRBC transfusion dependenceStratified log-rank testMedian follow-upKaplan-Meier methodLog-rank testWithdrawal of consentMedian OSOS ratesHemoglobin riseMyelodysplastic syndromeOS analysisHemoglobin levelsAssess OSPlaceboImetelstat
2023
Comparison of the Revised 4 Th (2016) and 5 Th (2022) Editions of the World Health Organization (WHO) Classification in a Cohort of Patients with Lower-Risk Myelodysplastic Syndromes/Neoplasms (MDS) - a Glam Registry (REGLAM) Analysis
Iastrebner M, Zeidan A, Arbelbide J, Velloso E, Pereira T, Boada M, Crisp R, Pereyra P, Reyes J, Zappa M, perez-Jacobo F, Dela Peña Celaya J, Moreno E, Abello V, Solano M, Cuervo D, Espinosa D, Casas C, Montoya L, Enrico A, Prates V, Chavez E, Ontiveros-Austria J, Kornblihtt L, Leon A, Toledo V, Negri L, Serrano J, Sánchez A, Rodriguez-Zuñiga A, Stevenazzi M, Goldschmidt V, Grille S. Comparison of the Revised 4 Th (2016) and 5 Th (2022) Editions of the World Health Organization (WHO) Classification in a Cohort of Patients with Lower-Risk Myelodysplastic Syndromes/Neoplasms (MDS) - a Glam Registry (REGLAM) Analysis. Blood 2023, 142: 5179. DOI: 10.1182/blood-2023-185122.Peer-Reviewed Original ResearchProgression-free survivalTime of diagnosisAcute myeloid leukemiaMDS-MLDOverall survivalMDS patientsMDS-RSInternational Prognostic Scoring SystemLow-risk MDS patientsWorld Health Organization classificationLR-MDS patientsMedian blast countRisk MDS patientsCohort of patientsKaplan-Meier methodPrognostic scoring systemClassification of patientsNon-Hispanic whitesMDS-EB2PFS probabilityWHO 2016Baseline characteristicsBlast countMedian ageMeier methodDurable Continuous Transfusion Independence (TI) with Imetelstat in IMerge Phase 3 for Patients with Heavily Transfused Non-Del(5q) Lower-Risk Myelodysplastic Syndromes (LR-MDS) Relapsed/Refractory (R/R) to or Ineligible for Erythropoiesis-Stimulating Agents (ESAs)
Platzbecker U, Komrokji R, Zeidan A, Fenaux P, Sekeres M, Savona M, Madanat Y, Jonášová A, Illmer T, Sherman L, Berry T, Riggs J, Xia Q, Navada S, Wan Y, Huang F, Feller F, Santini V. Durable Continuous Transfusion Independence (TI) with Imetelstat in IMerge Phase 3 for Patients with Heavily Transfused Non-Del(5q) Lower-Risk Myelodysplastic Syndromes (LR-MDS) Relapsed/Refractory (R/R) to or Ineligible for Erythropoiesis-Stimulating Agents (ESAs). Blood 2023, 142: 4605. DOI: 10.1182/blood-2023-181154.Peer-Reviewed Original ResearchLower-risk myelodysplastic syndromesErythropoiesis stimulating agentsPhase 3 trialTransfusion independenceVariant allele frequencyEnd pointTransfusion burdenAdverse eventsRed blood cell transfusionExploratory end pointsFrequent adverse eventsPrimary end pointRBC transfusion burdenReversible grade 3Secondary end pointsBlood cell transfusionDisease-modifying activityKaplan-Meier methodDuration of responseLoss of responseAdditional baseline characteristicsHigh telomerase activityCell transfusionBaseline characteristicsClinical responseTreatment Patterns and Outcomes of Patients with Acute Myeloid Leukemia (AML) from 2013 to 2022: A Connect ® Myeloid Registry Study
Grinblatt D, Roboz G, Pollyea D, Sekeres M, Scott B, Seiter K, Zeidan A, Patel J, Garcia-Manero G, Komrokji R, Savona M, Degutis I, Kiselev P, Yu E, Heydendael W, Qiu Y, Vergara S, McBride A, Erba H. Treatment Patterns and Outcomes of Patients with Acute Myeloid Leukemia (AML) from 2013 to 2022: A Connect ® Myeloid Registry Study. Blood 2023, 142: 593. DOI: 10.1182/blood-2023-189963.Peer-Reviewed Original ResearchAcute myeloid leukemiaYears of ageMedian overall survivalProportion of patientsOverall survivalRate of transplantGroup 2Group 1Molecular testingTreatment patternsAML cohortMedian (95% CI) OSMyeloid diseasesReal-world clinical practiceWorld Health Organization criteriaIntensive chemotherapy regimensLow-intensity chemotherapyObservational cohort studyOutcomes of patientsFirst-line treatmentKaplan-Meier methodProspective observational studyYear of diagnosisDate of diagnosisTreatment of patientsImpact of Type of Hypomethylating Agent (HMA) Used on Outcomes of Patients (Pts) with Higher-Risk Myelodysplastic Syndromes/Neoplasms (HR-MDS) - a Large, Multicenter, Retrospective Analysis
Bewersdorf J, Kewan T, Blaha O, Stahl M, Al Ali N, DeZern A, Sekeres M, Uy G, Carraway H, Desai P, Griffiths E, Stein E, Brunner A, McMahon C, Zeidner J, Savona M, Stempel J, Chandhok N, Ramaswamy R, Roboz G, Rolles B, Wang E, Harris A, Amaya M, Hawkins H, Grenet J, Gurnari C, Shallis R, Xie Z, Maciejewski J, Sallman D, Della Porta M, Komrokji R, Zeidan A. Impact of Type of Hypomethylating Agent (HMA) Used on Outcomes of Patients (Pts) with Higher-Risk Myelodysplastic Syndromes/Neoplasms (HR-MDS) - a Large, Multicenter, Retrospective Analysis. Blood 2023, 142: 4613. DOI: 10.1182/blood-2023-178728.Peer-Reviewed Original ResearchCox multivariable regression modelOverall survivalHMA initiationHypomethylating agentMultivariable regression modelsTP53 mutationsAllo-HCTComplete remissionComplex karyotypePartner drugsBone marrowSurvival analysisAllogeneic hematopoietic cell transplantMultivariable Cox regression modelsTreatment typeOverall responseAdverse genetic featuresMedian overall survivalOutcomes of patientsHematopoietic cell transplantAdverse overall survivalKaplan-Meier methodCox regression modelLog-rank testPredictors of response
2021
Characteristics and Clinical Outcome of Patients with Clonal Cytopenias of Undetermined Significance: A Large Retrospective Multi-Center International Study
Xie Z, Hyun M, Komrokji R, Zeidan A, Madanat Y, Zeidner J, Coombs C, Griffiths E, Lai C, Kishtagari A, Foran J, Badar T, Yi C, Desai P, Ades L, Osman A, Taylor J, Deeg H, Brunner A, Carraway H, Al Ali N, Bewersdorf J, Prebet T, Singh A, Tsai C, Chandhok N, Soong D, Patnaik M, Savona M, Al-Kali A. Characteristics and Clinical Outcome of Patients with Clonal Cytopenias of Undetermined Significance: A Large Retrospective Multi-Center International Study. Blood 2021, 138: 2158. DOI: 10.1182/blood-2021-146254.Peer-Reviewed Original ResearchClinical Trials CommitteeProgression-free survivalIndependent review committeeOverall survivalTrials CommitteeDisease progressionBristol-Myers SquibbMyeloid neoplasmsResponse rateFunctional pathway analysisSpeakers bureauUndetermined significanceMultivariable modelClonal cytopeniaReview CommitteeMedian progression-free survivalBoehringer IngelheimAdvisory CommitteeMulti-centre international studyCG abnormalitiesCox proportional hazards modelGene panelDaiichi SankyoBaseline clinical dataKaplan-Meier method
2019
Chromosome 1 abnormalities and clinical outcomes in multiple myeloma in the era of novel agents.
Giri S, Huntington S, Wang R, Zeidan A, Podoltsev N, Gore S, Ma X, Gross C, Davidoff A, Neparidze N. Chromosome 1 abnormalities and clinical outcomes in multiple myeloma in the era of novel agents. Journal Of Clinical Oncology 2019, 37: 8044-8044. DOI: 10.1200/jco.2019.37.15_suppl.8044.Peer-Reviewed Original ResearchOverall survivalMultiple myelomaPerformance statusMultivariable Cox survival analysisMedian overall survivalPoor performance statusLines of therapyKaplan-Meier methodCox regression analysisDays of diagnosisWorse overall survivalCox survival analysisLog-rank testReal-world treatmentCommon genetic mutationsHigh-risk mutationsSitu hybridization testingElectronic health recordsISS stageReal-world practiceMedian ageMeier methodOS independentPrimary outcomeSpecific regimens
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
2017
A phase I trial of ipilimumab (ipi) in patients (pts) with myelodysplastic syndromes (MDS) after hypomethylating agent (HMAs) failure.
Zeidan A, Knaus H, Robinson T, Zeidner J, Blackford A, Rizzieri D, Frattini M, Levy M, Schroeder M, Ferguson A, Sheldon K, Dezern A, Gojo I, Gore S, Streicher H, Luznik L, Duffield A, Smith B. A phase I trial of ipilimumab (ipi) in patients (pts) with myelodysplastic syndromes (MDS) after hypomethylating agent (HMAs) failure. Journal Of Clinical Oncology 2017, 35: 7010-7010. DOI: 10.1200/jco.2017.35.15_suppl.7010.Peer-Reviewed Original ResearchImmune-related adverse eventsOverall survivalMyelodysplastic syndromeHMA failureDose levelsMarrow complete responsePhase 1b studyCTLA-4 blockadeMedian overall survivalImmune checkpoint blockadeKaplan-Meier methodPhase I trialPoor overall survivalExpression of ICOST cell activationDrug discontinuationHR-MDSStable diseaseSystemic steroidsAdverse eventsCheckpoint blockadeClinical responseMaintenance doseObjective responseAllogeneic transplantation
2016
A 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 therapiesComparative clinical effectiveness of azacitidine versus decitabine in older patients with myelodysplastic syndromes
Zeidan AM, Davidoff AJ, Long JB, Hu X, Wang R, Ma X, Gross CP, Abel GA, Huntington SF, Podoltsev NA, Hajime U, Prebet T, Gore SD. Comparative clinical effectiveness of azacitidine versus decitabine in older patients with myelodysplastic syndromes. British Journal Of Haematology 2016, 175: 829-840. PMID: 27650975, DOI: 10.1111/bjh.14305.Peer-Reviewed Original ResearchConceptsMyelodysplastic syndromeRAEB patientsMedian survivalClinical trialsMultivariate Cox proportional hazards modelCox proportional hazards modelKaplan-Meier methodPopulation-based survivalSignificant survival differenceComparative clinical effectivenessProportional hazards modelAgent azacitidineHMA initiationExcess blastsOlder patientsRandomized trialsHistological subtypesRefractory anemiaClinical effectivenessSurvival differencesSubset analysisSurvival advantageHazards modelPatientsDecitabine
2015
Lack of Association Between Costs of Care and Overall Survival (OS) Among Medicare Beneficiaries with Myelodysplastic Syndromes (MDS) in the United States (US)
Zeidan A, Wang R, Davidoff A, Gore S, Soulos P, Huntington S, Gross C, Ma X. Lack of Association Between Costs of Care and Overall Survival (OS) Among Medicare Beneficiaries with Myelodysplastic Syndromes (MDS) in the United States (US). Blood 2015, 126: 873. DOI: 10.1182/blood.v126.23.873.873.Peer-Reviewed Original ResearchDisability Status ScoreOverall survivalMyelodysplastic syndromeMDS patientsCost of careStudy cohortLack of associationHistologic subtypeStatus scoreMedicare beneficiariesEnd Results-Medicare databaseProportional hazards regression modelsOverall study cohortMedian overall survivalOutcomes of patientsElixhauser comorbidity scoreDate of diagnosisEntire study cohortKaplan-Meier methodHazards regression modelsDisease-related costsNon-white raceEnd of studyDate of deathMedicare Part AComparing the prognostic value of risk stratifying models for patients with lower‐risk myelodysplastic syndromes: Is one model better?
Zeidan AM, Sekeres MA, Wang X, Al Ali N, Garcia‐Manero G, Steensma DP, Roboz G, Barnard J, Padron E, DeZern A, Maciejewski JP, List AF, Komrokji RS, Consortium O. Comparing the prognostic value of risk stratifying models for patients with lower‐risk myelodysplastic syndromes: Is one model better? American Journal Of Hematology 2015, 90: 1036-1040. PMID: 26284571, DOI: 10.1002/ajh.24173.Peer-Reviewed Original ResearchConceptsInternational Prognostic Scoring SystemIPSS-R categoryLR-MDSHarrell's C-indexOverall survivalC-indexLower-risk myelodysplastic syndromesRevised International Prognostic Scoring SystemActual overall survivalMedian overall survivalVaried survival outcomesKaplan-Meier methodPrognostic scoring systemDisease-modifying therapiesCategory 3Eligible patientsPoor OSPrognostic utilitySurvival outcomesMyelodysplastic syndromePrognostic valueLarge cohortPatientsEarly interventionScoring systemComparing the Prognostic Value of Risk stratifying Models for Patients with Lower‐Risk Myelodysplastic Syndromes: Is one model better?
Zeidan A, Sekeres M, Wang X, Al Ali N, Garcia‐Manero G, Steensma D, Roboz G, Barnard J, Padron E, Dezern A, Maciejewski J, List A, Komrokji R. Comparing the Prognostic Value of Risk stratifying Models for Patients with Lower‐Risk Myelodysplastic Syndromes: Is one model better? American Journal Of Hematology 2015 PMCID: PMC4751065, DOI: 10.1002/ajh.24170.Peer-Reviewed Original ResearchInternational Prognostic Scoring SystemIPSS-R categoryLR-MDSHarrell's C-indexOverall survivalC-indexLower-risk myelodysplastic syndromesRevised International Prognostic Scoring SystemActual overall survivalMedian overall survivalVaried survival outcomesKaplan-Meier methodPrognostic scoring systemDisease-modifying therapiesCategory 3Eligible patientsPoor OSPrognostic utilitySurvival outcomesMyelodysplastic syndromePrognostic valueLarge cohortPatientsEarly interventionScoring system