2024
Cost-Effectiveness of Eltrombopag Plus Immunosuppressive Therapy Versus Immunosuppressive Therapy Alone in Adults with Severe Aplastic Anemia in the United States
Potnis K, Ito S, Patel K, Shallis R, Podoltsev N, Kewan T, Stempel J, Mendez L, Huntington S, Stahl M, Zeidan A, Bewersdorf J, Goshua G. Cost-Effectiveness of Eltrombopag Plus Immunosuppressive Therapy Versus Immunosuppressive Therapy Alone in Adults with Severe Aplastic Anemia in the United States. Blood 2024, 144: 3644. DOI: 10.1182/blood-2024-204312.Peer-Reviewed Original ResearchSevere aplastic anemiaTreatment of severe aplastic anemiaQuality-adjusted life yearsAplastic anemiaIncremental net monetary benefitDeterministic sensitivity analysisProbabilistic sensitivity analysesImmunosuppressive therapyNewly diagnosed severe aplastic anemiaCost-effectiveness of eltrombopagOral thrombopoietin receptor agonistPatients treated with eltrombopagUntreated severe aplastic anemiaHematopoietic stem cell transplantationCost-effective therapeutic strategyDevelopment of adverse eventsLonger-term follow-up dataRACE trialsLater-line therapyThrombopoietin receptor agonistsPhase I/II trialSecond-line therapyStem cell transplantationU.S. payer perspectiveFirst-line treatmentAddition of Blinatumomab to Consolidation Therapy Among Older Newly Diagnosed Patients (pts) with BCR::ABL1 Negative B-Lineage Acute Lymphoblastic Leukemia (ALL) in the ECOG-ACRIN E1910 Randomized Phase III Trial
Podoltsev N, Sun Z, Litzow M, Paietta E, Roberts K, Zhang Y, Racevskis J, Lazarus H, Rowe J, Arber D, Wieduwilt M, Liedtke M, Bergeron J, Wood B, Zhao Y, Wu G, Chang T, Zhang W, Pratz K, Dinner S, Frey N, Gore S, Bhatnagar B, Atallah E, Uy G, Jeyakumar D, Lin T, Willman C, DeAngelo D, Patel S, Elliott M, Advani A, Tzachanis D, Vachhani P, Roy R, Sharon E, Little R, Erba H, Stone R, Mullighan C, Tallman M, Luger S, Mattison R. Addition of Blinatumomab to Consolidation Therapy Among Older Newly Diagnosed Patients (pts) with BCR::ABL1 Negative B-Lineage Acute Lymphoblastic Leukemia (ALL) in the ECOG-ACRIN E1910 Randomized Phase III Trial. Blood 2024, 144: 4211-4211. DOI: 10.1182/blood-2024-207143.Peer-Reviewed Original ResearchHematopoietic stem cell transplantationRelapse free survivalAcute lymphoblastic leukemiaWhite blood cell countOlder ptsOverall survivalBone marrowAllogeneic hematopoietic stem cell transplantationB-lineage acute lymphoblastic leukemiaRandomized phase III trialFlow cytometryMulti-color flow cytometryStratified multivariable Cox modelsIncreased treatment toxicityPeripheral blood blastsStratified log-rank testImprovement of OSHigh dose methotrexateImproved overall survivalMedian follow-upStem cell transplantationKaplan-Meier methodPhase III trialsEstimates of OSLog-rank testEfficacy and Safety of Pembrolizumab Added to Azacitidine Plus Venetoclax for Patients with Acute Myeloid Leukemia: Results from an Investigator-Initiated, Multi-Center, CTEP-Sponsored Randomized, Phase II Trial (BLAST AML-2)
Stempel J, Uy G, Dinner S, Gojo I, Reed D, Roy R, Byrd K, Yerrabothala S, Lai C, Doucette K, Caldwell A, Blaha O, Podoltsev N, Mendez L, Bewersdorf J, Kewan T, Wistuba I, Alatrash G, Haymaker C, Streicher H, Sharon E, Little R, Gore S, Radich J, Wood B, Zeidan A, Shallis R. Efficacy and Safety of Pembrolizumab Added to Azacitidine Plus Venetoclax for Patients with Acute Myeloid Leukemia: Results from an Investigator-Initiated, Multi-Center, CTEP-Sponsored Randomized, Phase II Trial (BLAST AML-2). Blood 2024, 144: 736. DOI: 10.1182/blood-2024-210370.Peer-Reviewed Original ResearchPhase II trialTreatment-related AEsII trialFrequent treatment-related AEsSafety run-in periodAllogeneic stem cell transplantationNo dose limiting toxicitiesRandomized phase II trialAML-2Multi-centerControl armSafety of pembrolizumabDose-limiting toxicityPD-1 inhibitionAnti-PD1 antibodyIncomplete count recoveryFLT3 wild-typeIntermediate cytogenetic riskStem cell transplantationAcute myeloid leukemiaActivated T cellsRun-in periodIntention-to-treat analysisCancer Immune MonitoringLong-term survivalToxicity and Efficacy of Isavuconazole Vs Voriconazole As Anti-Fungal Prophylaxis for Patients with Acute Myeloid Leukemia
Hunter C, Bewersdorf J, Mendez L, Podoltsev N, Zeidan A, Eighmy W, Roeder H, Malinis M, Shallis R. Toxicity and Efficacy of Isavuconazole Vs Voriconazole As Anti-Fungal Prophylaxis for Patients with Acute Myeloid Leukemia. Blood 2024, 144: 1480-1480. DOI: 10.1182/blood-2024-211250.Peer-Reviewed Original ResearchInvasive fungal infectionsAcute myeloid leukemiaAntifungal prophylaxisDiagnosed AMLDrug-drug interactionsTransaminase elevationVisual disturbancesRates of invasive fungal infectionsInvasive fungal infections incidenceBaseline ANCCD4 countMyeloid leukemiaAllogeneic stem cell transplantationAnti-fungal prophylaxisAcute myeloid leukemia diagnosisDuration of neutropeniaBaseline CD4 countLess-intensive therapyStem cell transplantationPatient baseline characteristicsSide effect profileCandida sppTriazole agentsWilcoxon rank sum testAntifungal voriconazoleRisk Factors and Predictors of Outcomes after Invasive Fungal Infection Among Patients with Acute Myeloid Leukemia
Hunter C, Bewersdorf J, Mendez L, Podoltsev N, Zeidan A, Eighmy W, Roeder H, Malinis M, Shallis R. Risk Factors and Predictors of Outcomes after Invasive Fungal Infection Among Patients with Acute Myeloid Leukemia. Blood 2024, 144: 4253. DOI: 10.1182/blood-2024-211426.Peer-Reviewed Original ResearchInvasive fungal infection diagnosisInvasive fungal infectionsAcute myeloid leukemiaInvasive Fungal Infection GroupAntifungal prophylaxis agentAntifungal prophylaxisCases of invasive fungal infectionsRates of invasive fungal infectionsFungal infectionsMyeloid leukemiaPrevent invasive fungal infectionsMycoses Study Group Education and Research ConsortiumRate of mortalityIFI patientsAllogeneic stem cell transplantationRisk factorsConsensus definitionAssociated with early mortalityNon-IFI groupSingle-gene mutationsPeriod of neutropeniaDays of neutropeniaAcute myeloid leukemia subtypesStem cell transplantationKaplan-Meier methodPhase 3 randomized double-blind study evaluating selinexor, an XPO1 inhibitor, plus ruxolitinib in JAKi-naïve myelofibrosis.
Mascarenhas J, Maher K, Rampal R, Bose P, Podoltsev N, Hong J, Wang X, Kye S, Harrison C. Phase 3 randomized double-blind study evaluating selinexor, an XPO1 inhibitor, plus ruxolitinib in JAKi-naïve myelofibrosis. Journal Of Clinical Oncology 2024, 42: tps6594-tps6594. DOI: 10.1200/jco.2024.42.16_suppl.tps6594.Peer-Reviewed Original ResearchXPO1 inhibitorsIntent-to-treat populationCo-primary study endpointsBaseline platelet countTreatment-related AEsPlacebo-controlled studyStem cell transplantationPhase 1 portionPhase 3 trialYears of ageNausea prophylaxisOral selinexorIntermediate-1Intermediate-2Anemia responseMF patientsTreatment discontinuationDouble-blindCell transplantationMyeloproliferative neoplasmsSecondary endpointsPlatelet countSpleen volumeRuxolitinib treatmentIWG-MRT
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
Sequencing of novel agents in relapsed/refractory B‐cell acute lymphoblastic leukemia: Blinatumomab and inotuzumab ozogamicin may have comparable efficacy as first or second novel agent therapy in relapsed/refractory acute lymphoblastic leukemia
Badar T, Szabo A, Dinner S, Liedtke M, Burkart M, Shallis RM, Yurkiewicz IR, Kuo E, Khan MA, Balasubramanian S, Yang J, Hefazi M, Podoltsev N, Patel A, Curran E, Wang A, Arslan S, Aldoss I, Siebenaller C, Mattison RJ, Litzow MR, Wadleigh M, Advani AS, Atallah E. Sequencing of novel agents in relapsed/refractory B‐cell acute lymphoblastic leukemia: Blinatumomab and inotuzumab ozogamicin may have comparable efficacy as first or second novel agent therapy in relapsed/refractory acute lymphoblastic leukemia. Cancer 2020, 127: 1039-1048. PMID: 33259056, DOI: 10.1002/cncr.33340.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAged, 80 and overAntibodies, BispecificAntineoplastic Agents, ImmunologicalDrug Administration ScheduleDrug Resistance, NeoplasmFemaleHematopoietic Stem Cell TransplantationHumansInotuzumab OzogamicinMaleMiddle AgedPrecursor Cell Lymphoblastic Leukemia-LymphomaRemission InductionRetrospective StudiesTreatment OutcomeWithholding TreatmentYoung AdultConceptsAcute lymphoblastic leukemiaRefractory B-cell acute lymphoblastic leukemiaB-cell acute lymphoblastic leukemiaMedian overall survivalINO groupNovel agentsOverall survivalLymphoblastic leukemiaComplete remissionInotuzumab ozogamicinNA therapyComparable efficacyRelapsed/refractory (r/r) B-cell acute lymphoblastic leukemiaAllogeneic hematopoietic stem cell transplantationCR/CRi rateIncomplete count recovery (CRi) ratesRefractory acute lymphoblastic leukemiaHematopoietic stem cell transplantationNovel agent therapyOutcomes of patientsStem cell transplantationBlinatumomab groupCRi rateTreatment discontinuationAdverse eventsCui bono? Finding the value of allogeneic stem cell transplantation for lower-risk myelodysplastic syndromes
Shallis RM, Podoltsev NA, Gowda L, Zeidan AM, Gore SD. Cui bono? Finding the value of allogeneic stem cell transplantation for lower-risk myelodysplastic syndromes. Expert Review Of Hematology 2020, 13: 447-460. PMID: 32182435, DOI: 10.1080/17474086.2020.1744433.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsAllogeneic stem cell transplantationStem cell transplantationAcute myeloid leukemiaMyelodysplastic syndromeMDS patientsRisk stratificationCell transplantationPrognostic toolLower-risk myelodysplastic syndromesHigh-risk myelodysplastic syndromeLow-risk MDS patientsSevere bone marrow failureLow-risk diseaseLow-risk patientsOnly curative optionPrognosis of patientsBone marrow failureAggressive therapyCurative optionPrognostic impactEtiologic roleDisease progressionMyeloid leukemiaAlloSCTPatientsReal-World Outcomes of Adult B-Cell Acute Lymphocytic Leukemia Patients Treated With Inotuzumab Ozogamicin
Badar T, Szabo A, Wadleigh M, Liedtke M, Arslan S, Siebenaller C, Aldoss I, Schultz E, Hefazi M, Litzow MR, Kuo E, Wang A, Curran E, Shallis RM, Podoltsev N, Balasubramanian S, Yang J, Mattison R, Burkart M, Dinner S, Advani A, Atallah E. Real-World Outcomes of Adult B-Cell Acute Lymphocytic Leukemia Patients Treated With Inotuzumab Ozogamicin. Clinical Lymphoma Myeloma & Leukemia 2020, 20: 556-560.e2. PMID: 32291234, DOI: 10.1016/j.clml.2020.03.004.Peer-Reviewed Original ResearchConceptsB-cell acute lymphocytic leukemia patientsAcute lymphocytic leukemia patientsAllo-HCTLymphocytic leukemia patientsInotuzumab ozogamicinOverall survivalLeukemia patientsAllogeneic hematopoietic stem cell transplantationMinimal residual disease negativityHematopoietic stem cell transplantationCommon grade 3Efficacy of iNOHigher adverse eventsMedian overall survivalMulticenter cohort analysisVeno-occlusive diseaseDuration of responseStem cell transplantationOverall response rateINO initiationComplete remissionMedian durationAdverse eventsMedian ageCumulative dose
2018
Allogeneic Hematopoietic Stem Cell Transplantation Following the Use of Hypomethylating Agents among Patients with Relapsed or Refractory AML: Findings from an International Retrospective Study
Stahl M, DeVeaux M, Montesinos P, Itzykson R, Ritchie EK, Sekeres MA, Majhail N, Barnard J, Podoltsev NA, Brunner AM, Komrokji RS, Bhatt VR, Al-Kali A, Cluzeau T, Santini V, Roboz GJ, Fenaux P, Litzow M, Fathi AT, Perreault S, Kim TK, Prebet T, Vey N, Verma V, Kobbe G, Bergua J, Serrano J, Gore SD, Zeidan AM. Allogeneic Hematopoietic Stem Cell Transplantation Following the Use of Hypomethylating Agents among Patients with Relapsed or Refractory AML: Findings from an International Retrospective Study. Transplantation And Cellular Therapy 2018, 24: 1754-1758. PMID: 29649620, DOI: 10.1016/j.bbmt.2018.03.025.Peer-Reviewed Original ResearchConceptsHematopoietic stem cell transplantationAllogeneic hematopoietic stem cell transplantationHMA therapyStem cell transplantationComplete remissionCell transplantationUnrelated hematopoietic stem cell transplantationInternational retrospective studyLimited treatment optionsAcute myeloid leukemiaChronic GVHDMedian OSPrimary refractoryRR-AMLConditioning regimenRefractory AMLPatients patientsUnrelated donorsEntire cohortPoor prognosisRetrospective studyTreatment optionsMyeloid leukemiaInternational cohortHypomethylating agent
2017
Long-term survival of older patients with MDS treated with HMA therapy without subsequent stem cell transplantation
Zeidan AM, Stahl M, Hu X, Wang R, Huntington SF, Podoltsev NA, Gore SD, Ma X, Davidoff AJ. Long-term survival of older patients with MDS treated with HMA therapy without subsequent stem cell transplantation. Blood 2017, 131: 818-821. PMID: 29259002, PMCID: PMC6410557, DOI: 10.1182/blood-2017-10-811729.Peer-Reviewed Original ResearchConceptsSubsequent stem cell transplantationStem cell transplantationLong-term survivalHMA therapyOlder patientsCell transplantationPatientsTransplantationTherapy