2024
Analyzing determinants of premature trial discontinuation in leukemia clinical trials
Rotter L, Alhajahjeh A, Stempel J, Grimshaw A, Bewersdorf J, Blaha O, Kewan T, Podoltsev N, Shallis R, Mendez L, Stahl M, Zeidan A. Analyzing determinants of premature trial discontinuation in leukemia clinical trials. Leukemia & Lymphoma 2024, ahead-of-print: 1-9. PMID: 39440622, DOI: 10.1080/10428194.2024.2416565.Peer-Reviewed Original ResearchClinical trialsSlow accrualLeukemia trialsEarly-phase trialsNon-randomized trialsAcademic-sponsored trialsImprove patient outcomesLeukemia clinical trialsSingle-centerTrial discontinuationSponsored trialsSmall trialsLeukemiaEarly terminationPatient outcomesLate-phaseIndependent reviewersTermination ratesComprehensive searchTrials
2021
Hypomethylating Agents and FLT3 Inhibitors As Maintenance Treatment for Acute Myeloid Leukemia and Myelodysplastic Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation–A Systematic Review and Meta-Analysis
Bewersdorf JP, Allen C, Mirza AS, Grimshaw AA, Giri S, Podoltsev NA, Gowda L, Cho C, Tallman MS, Zeidan AM, Stahl M. Hypomethylating Agents and FLT3 Inhibitors As Maintenance Treatment for Acute Myeloid Leukemia and Myelodysplastic Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation–A Systematic Review and Meta-Analysis. Transplantation And Cellular Therapy 2021, 27: 997.e1-997.e11. PMID: 34551341, PMCID: PMC9533376, DOI: 10.1016/j.jtct.2021.09.005.Peer-Reviewed Original ResearchConceptsAcute myeloid leukemiaRelapse-free survivalMaintenance therapyMyelodysplastic syndromeFLT3 inhibitorsAllo-HCTHazard ratioMaintenance treatmentClinical trialsMyeloid leukemiaAllogeneic hematopoietic stem cell transplantationControl groupSystematic reviewAllogeneic hematopoietic cell transplantMeasurable residual disease statusHematopoietic stem cell transplantationMeasurable residual disease testingNon-relapse mortalityHematopoietic cell transplantPre-emptive treatmentResidual disease statusStem cell transplantationFavorable safety profileSame patient cohortRandom-effects modelMulti-institutional study evaluating clinical outcome with allogeneic hematopoietic stem cell transplantation after blinatumomab in patients with B-cell acute lymphoblastic leukemia: real-world data
Badar T, Szabo A, Litzow M, Burkart M, Yurkiewicz I, Dinner S, Hefazi M, Shallis RM, Podoltsev N, Patel AA, Curran E, Wadleigh M, Balasubramanian S, Yang J, Arslan S, Aldoss I, Mattison R, Cenin D, Siebenaller C, Advani A, Liedtke M, Atallah E. Multi-institutional study evaluating clinical outcome with allogeneic hematopoietic stem cell transplantation after blinatumomab in patients with B-cell acute lymphoblastic leukemia: real-world data. Bone Marrow Transplantation 2021, 56: 1998-2004. PMID: 33824440, DOI: 10.1038/s41409-021-01279-w.Peer-Reviewed Original ResearchConceptsOverall survivalCumulative incidenceAllogeneic hematopoietic stem cell transplantationB-cell acute lymphoblastic leukemiaHematopoietic stem cell transplantationAcute lymphocytic leukemia patientsStem cell transplantationAcute lymphoblastic leukemiaLymphocytic leukemia patientsMulti-institutional studyReal-world analysisSevere cGVHDFree survivalClinical outcomesCell transplantationLymphoblastic leukemiaMulti-center dataClinical trialsAlloHCTLeukemia patientsBlinatumomabPatientsSurvivalIncidenceSubsequent salvage
2020
Interferon alpha therapy in essential thrombocythemia and polycythemia vera—a systematic review and meta-analysis
Bewersdorf JP, Giri S, Wang R, Podoltsev N, Williams RT, Tallman MS, Rampal RK, Zeidan AM, Stahl M. Interferon alpha therapy in essential thrombocythemia and polycythemia vera—a systematic review and meta-analysis. Leukemia 2020, 35: 1643-1660. PMID: 32868875, PMCID: PMC7917159, DOI: 10.1038/s41375-020-01020-4.Peer-Reviewed Original ResearchConceptsOverall response ratePEG-IFNPolycythemia veraEssential thrombocythemiaHematologic responsePV patientsResponse rateSystematic reviewMeta-regression analysis resultsSafe long-term treatmentPartial hematologic responseSafety of interferonInterferon-alpha therapyLong-term treatmentRandom-effects modelMeta-regression analysisWeb of ScienceTreatment discontinuationCochrane RegistryAdverse eventsComplete responsePartial responsePrimary outcomeThromboembolic complicationsClinical trialsReal-world outcomes of adult B-cell acute lymphocytic leukemia patients treated with blinatumomab
Badar T, Szabo A, Advani A, Wadleigh M, Arslan S, Khan MA, Aldoss I, Siebenaller C, Schultz E, Hefazi M, Shallis RM, Yurkiewicz I, Podoltsev N, Patel AA, Curran E, Balasubramanian S, Yang J, Mattison RJ, Burkart M, Dinner S, Liedtke M, Litzow MR, Atallah E. Real-world outcomes of adult B-cell acute lymphocytic leukemia patients treated with blinatumomab. Blood Advances 2020, 4: 2308-2316. PMID: 32453836, PMCID: PMC7252553, DOI: 10.1182/bloodadvances.2019001381.Peer-Reviewed Original ResearchConceptsMedian relapse-free survivalAllogeneic hematopoietic cell transplantationHematopoietic cell transplantationRelapse-free survivalAcute lymphoblastic leukemiaOverall survivalCell transplantationRR diseaseClinical trialsComplete remission/complete remissionRetrospective multicenter cohort analysisB-cell acute lymphoblastic leukemiaB-cell acute lymphocytic leukemia patientsCytokine release syndromeIncomplete count recoveryMulticenter cohort analysisAcute lymphocytic leukemia patientsFavorable prognostic significanceLymphocytic leukemia patientsReal-world outcomesConsolidation therapyMRD negativityPrior therapyRelease syndromeComplete remission
2019
Hypomethylating agent (HMA) therapy use and survival in older adults with Refractory Anemia with Excess Blasts (RAEB) in the United States (USA): a large propensity score-matched population-based study†
Davidoff AJ, Hu X, Bewersdorf JP, Wang R, Podoltsev NA, Huntington SF, Gore SD, Ma X, Zeidan AM. Hypomethylating agent (HMA) therapy use and survival in older adults with Refractory Anemia with Excess Blasts (RAEB) in the United States (USA): a large propensity score-matched population-based study†. Leukemia & Lymphoma 2019, 61: 1178-1187. PMID: 31878809, PMCID: PMC7735409, DOI: 10.1080/10428194.2019.1703970.Peer-Reviewed Original ResearchConceptsHigh-risk myelodysplastic syndromeExcess blastsRefractory anemiaOverall survival benefitRetrospective cohort studyMedian OSOS benefitRAEB patientsCohort studySurvival benefitTherapy useMyelodysplastic syndromeClinical trialsLower riskMedicare dataPatientsPropensity scoreOlder adultsDiagnosisAnemiaQuartileUnited StatesAssociationEnd resultOSReal World Outcomes of Adult B-Cell Acute Lymphocytic Leukemia Patients Treated with Blinatumomab
Badar T, Szabo A, Advani A, Wadleigh M, Arslan S, Khan M, Aldoss I, Siebenaller C, Schultz E, Hefazi M, Shallis R, Yurkiewicz I, Podoltsev N, Patel A, Curran E, Balasubramanian S, Yang J, Mattison R, Burkart M, Dinner S, Liedtke M, Litzow M, Atallah E. Real World Outcomes of Adult B-Cell Acute Lymphocytic Leukemia Patients Treated with Blinatumomab. Blood 2019, 134: 3809. DOI: 10.1182/blood-2019-125466.Peer-Reviewed Original ResearchCytokine release syndromeDuration of responseMinimal residual diseaseMedian overall survivalMedian DOROverall survivalTyrosine kinase inhibitorsAllo-HCTMRD negativityComplete remissionB cellsRR diseaseClinical trialsJazz PharmaceuticalsAcute lymphocytic leukemia blastsPhiladelphia chromosome-positive diseaseAllogeneic stem cell transplantationAdvisory CommitteePositive cytotoxic T cellsB-cell acute lymphocytic leukemia patientsCR/CRiEfficacy of blinatumomabG3-4 toxicitiesGenentech/RocheIncomplete count recoveryLandmark Response and Survival Analyses from 102 MDS and CMML Patients Treated with Guadecitabine in a Phase 2 Study Showing That Maximum Response and Survival Is Best Achieved with Adequate Treatment Duration
Savona M, Kantarjian H, Roboz G, O'Connell C, Walsh K, Tibes R, Yee K, Stock W, Griffiths E, Jabbour E, Lunin S, Rosenblat T, Podoltsev N, Issa J, Su X, Azab M, Garcia-Manero G. Landmark Response and Survival Analyses from 102 MDS and CMML Patients Treated with Guadecitabine in a Phase 2 Study Showing That Maximum Response and Survival Is Best Achieved with Adequate Treatment Duration. Blood 2019, 134: 2957. DOI: 10.1182/blood-2019-129962.Peer-Reviewed Original ResearchMDS/CMML patientsMDS/CMMLPhase 2 studyObjective responseCMML patientsSurvival benefitClinical trialsMedian OSMyelodysplastic syndromeAstex PharmaceuticalsSurvival analysisTreatment discontinuationHematological improvementPartial responseComplete responseEarly progressionOtsuka PharmaceuticalDaiichi SankyoLandmark analysisHMA treatmentLandmark responsesCycle 4Prospective phase 2 studyBoehringer IngelheimAdvisory CommitteeAssociation of provider experience and clinical outcomes in patients with myelodysplastic syndromes receiving hypomethylating agents
Zeidan AM, Hu X, Zhu W, Stahl M, Wang R, Huntington SF, Giri S, Bewersdorf JP, Podoltsev NA, Gore SD, Ma X, Davidoff AJ. Association of provider experience and clinical outcomes in patients with myelodysplastic syndromes receiving hypomethylating agents. Leukemia & Lymphoma 2019, 61: 397-408. PMID: 31570040, PMCID: PMC7732188, DOI: 10.1080/10428194.2019.1663423.Peer-Reviewed Original ResearchConceptsMyelodysplastic syndromeOverall survivalHMA cyclesHMA therapyProvider experienceCox proportional hazards modelOlder MDS patientsMedian overall survivalPercent of patientsSEER-Medicare dataMultivariate logistic regressionProportional hazards modelHMA initiationClinical outcomesMDS patientsClinical trialsMedian numberHMA treatmentHazards modelPatientsSignificant associationLogistic regressionPopulation-level survivalSurvivalSyndrome
2016
Selecting initial treatment of acute myeloid leukaemia in older adults
Podoltsev NA, Stahl M, Zeidan AM, Gore SD. Selecting initial treatment of acute myeloid leukaemia in older adults. Blood Reviews 2016, 31: 43-62. PMID: 27745715, DOI: 10.1016/j.blre.2016.09.005.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsAcute myeloid leukemiaTreatment-related mortalityInduction chemotherapyComplete remissionInitial treatmentMyeloid leukemiaNovel agentsOlder adultsMedian overall survivalGroup of patientsPhase III developmentDisease-related characteristicsMechanism of actionCPX-351Overall survivalLow-intensity treatmentClinical trialsTreatment outcomesPatientsRemissionChemotherapyLeukemiaMortalityTreatmentAdultsComparative 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
Comparative Effectiveness of Azacitidine Versus Decitabine Among Older Adults Diagnosed with Higher-Risk Myelodysplastic Syndromes (HR-MDS)
Zeidan A, Long J, Hall J, Wang R, Huntington S, Abel G, Prebet T, Podoltsev N, Gross C, Gore S, Ma X, Davidoff A. Comparative Effectiveness of Azacitidine Versus Decitabine Among Older Adults Diagnosed with Higher-Risk Myelodysplastic Syndromes (HR-MDS). Blood 2015, 126: 3285. DOI: 10.1182/blood.v126.23.3285.3285.Peer-Reviewed Original ResearchHigh-risk myelodysplastic syndromeHR-MDS patientsKaplan-Meier survival curvesEnd of studyHMA initiationMedian OSClinical trialsComorbidity countHazard ratioHigh school educationClinical practiceMultivariate Cox proportional hazards modelSurvival curvesEnd Results-Medicare databaseMedian household incomeRandomized phase III trialReal-world clinical practiceCox proportional hazards modelOlder MDS patientsDisability Status ScoreRetrospective cohort studyOverall survival advantagePhase III trialsYear of diagnosisErythropoiesis-stimulating agentsNorth American Cooperative Group Members' Patterns of Blood Products Transfusion for Patients with Acute Leukemia
Pine A, Lee E, Sekeres M, Steensma D, Prebet T, DeZern A, Komrokji R, Litzow M, Luger S, Stone R, Erba H, Garcia-Manero G, Lee A, Podoltsev N, Barbarotta L, Hendrickson J, Gore S, Zeidan A. North American Cooperative Group Members' Patterns of Blood Products Transfusion for Patients with Acute Leukemia. Blood 2015, 126: 1138. DOI: 10.1182/blood.v126.23.1138.1138.Peer-Reviewed Original ResearchRed blood cell transfusionNon-bleeding patientsBlood cell transfusionBone marrow biopsyBlood product transfusionSouthwest Oncology GroupPlatelet transfusionsOutpatient settingAcute leukemiaPlatelet levelsCell transfusionHemoglobin levelsTransfusion practiceLumbar punctureFibrinogen levelsProduct transfusionHospitalized patientsOncology GroupClinical trialsPlatelet thresholdMost respondersConsensus evidence-based guidelinesMost providersEastern Cooperative Oncology GroupStable hospitalized patients
2009
Phase II Clinical Trial of Paclitaxel Loaded Polymeric Micelle in Patients with Advanced Pancreatic Cancer
Saif M, Podoltsev N, Rubin M, Figueroa J, Lee M, Kwon J, Rowen E, Yu J, Kerr R. Phase II Clinical Trial of Paclitaxel Loaded Polymeric Micelle in Patients with Advanced Pancreatic Cancer. Cancer Investigation 2009, 1-1. DOI: 10.1080/07357900903179591.Peer-Reviewed Original Research
2008
Phase II clinical trial of paclitaxel loaded polymeric micelle (GPM) in patients (pts) with advanced pancreatic cancer (APC): Final results
Podoltsev N, Rubin M, Figueroa J, Lee M, Kwon J, Yu J, Kerr R, Saif M. Phase II clinical trial of paclitaxel loaded polymeric micelle (GPM) in patients (pts) with advanced pancreatic cancer (APC): Final results. Journal Of Clinical Oncology 2008, 26: 4627-4627. DOI: 10.1200/jco.2008.26.15_suppl.4627.Peer-Reviewed Original Research