2024
Cost-effectiveness of Enasidenib versus conventional care for older patients with IDH2-mutant refractory/relapsed AML
Alhajahjeh A, Patel K, Shallis R, Podoltsev N, Kewan T, Stempel J, Mendez L, Huntington S, Stahl M, Goshua G, Bewersdorf J, Zeidan A. Cost-effectiveness of Enasidenib versus conventional care for older patients with IDH2-mutant refractory/relapsed AML. Leukemia & Lymphoma 2024, ahead-of-print: 1-9. PMID: 39560957, DOI: 10.1080/10428194.2024.2426073.Peer-Reviewed Original ResearchConventional care regimensOlder patientsTreatment of older patientsIDH2 inhibitor enasidenibIncremental cost-effectiveness ratioCost-effectiveness ratioProbabilistic sensitivity analysesR/R AMLRefractory/relapsed AMLEvent-freeCost-effective treatmentEnasidenibCare regimensAMLPatientsCost-effectiveIncremental costLife yearsConventional careR/RIncremental effectSurvivalTreatmentA review of the isocitrate dehydrogenase inhibitors in management of adult patients with AML and MDS
Norman M, Yamartino K, Gerstein R, Shallis R, Mendez L, Podoltsev N, Stahl M, Eighmy W, Zeidan A. A review of the isocitrate dehydrogenase inhibitors in management of adult patients with AML and MDS. Expert Review Of Hematology 2024, 17: 755-767. PMID: 39474840, DOI: 10.1080/17474086.2024.2422554.Peer-Reviewed Original ResearchDiagnosed AMLSurvival benefitManagement of acute myeloid leukemiaDevelopment of oral therapiesIsocitrate dehydrogenase inhibitorsNewly diagnosed AMLManagement of adult patientsPost-transplant maintenanceAcute myeloid leukemiaSingle-arm studyExcellent response ratesIDH inhibitorsRelapsed AMLHypomethylating agentsInhibitor therapyMyelodysplastic syndromeOral therapyCombination therapyPost-transplantMyeloid leukemiaImproved survivalSingle-armAdult patientsAzacitidineRandomized studyGlobal Disparities in the Characteristics and Outcomes of Leukemia Clinical Trials: A Cross-Sectional Study of the ClinicalTrials.gov Database.
Alhajahjeh A, Rotter L, Stempel J, Grimshaw A, Bewersdorf J, Blaha O, Kewan T, Podoltsev N, Shallis R, Mendez L, Stahl M, Zeidan A. Global Disparities in the Characteristics and Outcomes of Leukemia Clinical Trials: A Cross-Sectional Study of the ClinicalTrials.gov Database. JCO Global Oncology 2024, 10: e2400316. PMID: 39621951, DOI: 10.1200/go-24-00316.Peer-Reviewed Original ResearchAnalyzing 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 searchTrialsAplastic anemia in association with multiple myeloma: clinical and pathophysiological insights
Muradashvili T, Liu Y, VanOudenhove J, Gu S, Krause D, Montanari F, Carlino M, Mancuso R, Stempel J, Halene S, Zeidan A, Podoltsev N, Neparidze N. Aplastic anemia in association with multiple myeloma: clinical and pathophysiological insights. Leukemia & Lymphoma 2024, ahead-of-print: 1-8. PMID: 39225418, DOI: 10.1080/10428194.2024.2393260.Peer-Reviewed Original ResearchAplastic anemiaMultiple myelomaImmunosuppressive therapyTransfusion requirementsProgenitor cellsPlasma cell-directed therapyT-cell destructionCell-directed therapiesInhibition of erythroid colony formationErythroid colony formationLevels of IL8Severe AAImmune cytopeniasPartial responseMM patientsHematopoietic stemSerum testsPartial improvementPathophysiological insightsPatientsImmune systemPlatelet apoptosisCytopeniasColony formationMyelomaUnveiling the Shadows: Thiamine Deficiency Manifesting as Sudden-Onset Blindness in a Patient With Leukemia
Ramachandran S, Stempel J, Podoltsev N, Mahajan A. Unveiling the Shadows: Thiamine Deficiency Manifesting as Sudden-Onset Blindness in a Patient With Leukemia. Clinical Lymphoma Myeloma & Leukemia 2024, 24: s160. DOI: 10.1016/s2152-2650(24)00425-7.Peer-Reviewed Original ResearchALL-408 Unveiling the Shadows: Thiamine Deficiency Manifesting As Sudden-Onset Blindness in a Patient With Leukemia
Ramachandran S, Stempel J, Podoltsev N, Mahajan A. ALL-408 Unveiling the Shadows: Thiamine Deficiency Manifesting As Sudden-Onset Blindness in a Patient With Leukemia. Clinical Lymphoma Myeloma & Leukemia 2024, 24: s268. DOI: 10.1016/s2152-2650(24)01106-6.Peer-Reviewed Original ResearchWernicke's encephalopathyThiamine deficiencyB-ALLHematologic malignanciesDiagnostic challengePhiladelphia chromosome-positive B-cell acute lymphoblastic leukemiaB-cell acute lymphoblastic leukemiaTreated with hyper-CVADHigh index of suspicionPrevent permanent neurological damageDasatinib dose reductionSudden onset blindnessIndex of suspicionAcute lymphoblastic leukemiaLoss of vibratory sensationPh+ B-ALLCerebrospinal fluid analysisSevere neurological dysfunctionCancer-directed therapyPermanent neurological damageVitamin B1 levelsAtypical neurological findingsHyper-CVADOphthalmologic examBilateral blindnessA phase 1 trial of venetoclax in combination with liposomal vincristine in patients with relapsed or refractory B‐cell or T‐cell acute lymphoblastic leukemia: Results from the ECOG‐ACRIN EA9152 protocol
Palmisiano N, Lee J, Claxton D, Paietta E, Alkhateeb H, Park J, Podoltsev N, Atallah E, Schaar D, Dinner S, Webster J, Luger S, Litzow M. A phase 1 trial of venetoclax in combination with liposomal vincristine in patients with relapsed or refractory B‐cell or T‐cell acute lymphoblastic leukemia: Results from the ECOG‐ACRIN EA9152 protocol. EJHaem 2024, 5: 951-956. PMID: 39415930, PMCID: PMC11474352, DOI: 10.1002/jha2.991.Peer-Reviewed Original ResearchAcute lymphoblastic leukemiaMaximum tolerated doseT-cell acute lymphoblastic leukemiaLymphoblastic lymphomaLymphoblastic leukemiaTreatment-related adverse eventsDose level 3MRD-negative responseDose level 2Dose-limiting toxicityPhase I portionDose-escalation designPhase I/II trialPhase 1 trialPhase I objectivesPhase 2 portionAcute lymphoblastic leukemia subjectsEscalation designTolerated doseLiposomal vincristinePreclinical dataTherapeutic challengeEfficacy outcomesT cellsT-ALLLongitudinal Curriculum to Address Wellness and Professional Development in a Hematology/Oncology Fellowship Program
Srikumar T, Stempel J, Goldberg S, Podoltsev N, Braun D, Lee A, Sanft T. Longitudinal Curriculum to Address Wellness and Professional Development in a Hematology/Oncology Fellowship Program. EMJ Oncology 2024, 1: 37-39. DOI: 10.33590/oncolamj/zgwb5064.Peer-Reviewed Original ResearchPhase 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-MRTLongitudinal curriculum to address wellness and professional development in a hematology/oncology fellowship program.
Srikumar T, Stempel J, Goldberg S, Podoltsev N, Braun D, Lee A, Sanft T. Longitudinal curriculum to address wellness and professional development in a hematology/oncology fellowship program. Journal Of Clinical Oncology 2024, 42: 9004-9004. DOI: 10.1200/jco.2024.42.16_suppl.9004.Peer-Reviewed Original ResearchNeeds assessmentLongitudinal curriculumPatient Health Questionnaire 2Score of self-efficacyGeneral Self-Efficacy ScaleFellowship programsBaseline needs assessmentFaculty-led sessionsProfessional boundary settingSelf-Efficacy ScaleLevels of depressionProfessional developmentFirst-year fellowsDidactic sessionsPrevent burnoutChi-square testAcademic yearDebriefing sessionsQuestionnaire 2Baseline assessmentSelf-efficacyProfessional development skillsDepressed moodLeadership skillsBurnoutHematocrit control and thrombotic risk in patients with polycythemia vera treated with ruxolitinib in clinical practice
Chojecki A, Boselli D, Dortilus A, Hamadeh I, Begley S, Chen T, Bose R, Podoltsev N, Zeidan A, Balmaceda N, Yacoub A, Ai J, Knight T, Ragon B, Shah N, Sanikommu S, Symanowski J, Mesa R, Grunwald M. Hematocrit control and thrombotic risk in patients with polycythemia vera treated with ruxolitinib in clinical practice. Annals Of Hematology 2024, 103: 2837-2843. PMID: 38662203, PMCID: PMC11283405, DOI: 10.1007/s00277-024-05735-7.Peer-Reviewed Original ResearchFollow-up durationPolycythemia veraThrombotic riskClinical practiceMedian follow-up durationHematocrit controlHematocrit levelsCohort study of patientsLow thrombotic riskUS Food and Drug AdministrationMonths of treatmentRisk of thrombosisStudy of patientsJanus kinase inhibitorsResponse to hydroxyureaFood and Drug AdministrationRed blood cell productionBlood cell productionCytoreductive treatmentPainful splenomegalyDose adjustmentMyeloproliferative neoplasmsPlatelet countThrombotic eventsArterial thrombosesChallenges in management of older patients with chronic myeloid leukemia
Stempel J, Shallis R, Wong R, Podoltsev N. Challenges in management of older patients with chronic myeloid leukemia. Leukemia & Lymphoma 2024, 65: 1219-1232. PMID: 38652861, DOI: 10.1080/10428194.2024.2342559.Peer-Reviewed Original ResearchChronic myeloid leukemiaTyrosine kinase inhibitorsTreatment-free remissionOlder patientsMyeloid leukemiaTyrosine kinase inhibitor dosingGeneration tyrosine kinase inhibitorsManagement of older patientsSecond-line agentsSurvival of patientsSide effect profileFront-line optionPrevalence of comorbiditiesImproved survivalCardiovascular toleranceEffect profileFavorable outcomeKinase inhibitorsPrevent progressionPatientsPersonalized treatmentQuality of lifeTreatment goalsOptimal careDiscontinuation strategiesCost-effectiveness of adding quizartinib to induction chemotherapy for patients with FLT3-mutant acute myeloid leukemia
Bewersdorf J, Patel K, Shallis R, Podoltsev N, Kewan T, Stempel J, Mendez L, Stahl M, Stein E, Huntington S, Goshua G, Zeidan A. Cost-effectiveness of adding quizartinib to induction chemotherapy for patients with FLT3-mutant acute myeloid leukemia. Leukemia & Lymphoma 2024, 65: 1136-1144. PMID: 38648559, PMCID: PMC11265977, DOI: 10.1080/10428194.2024.2344052.Peer-Reviewed Original ResearchQuality-adjusted life yearsCompletion of consolidation therapyFLT3-mutant acute myeloid leukemiaAllogeneic hematopoietic cell transplantationIncremental cost-effectiveness ratioProbabilistic sensitivity analysesImproved overall survivalHematopoietic cell transplantationPartitioned survival analysis modelAcute myeloid leukemiaCost-effectiveness ratioFLT3 inhibitor quizartinibHealth economic implicationsConsolidation therapyInduction chemotherapyAverage wholesale priceOverall survivalCell transplantationContinuous therapyMyeloid leukemiaITD mutationQuizartinibIncremental costCost-effective optionLife yearsProviding 0.1 Full-Time Equivalent (FTE) Support to Fellowship Core Faculty Improves Faculty Involvement in Fellowship Education and Recruitment
Butt A, Christian J, Kress A, Lu B, Hurwitz M, Goldberg S, Podoltsev N, Gilkes L, Lee A. Providing 0.1 Full-Time Equivalent (FTE) Support to Fellowship Core Faculty Improves Faculty Involvement in Fellowship Education and Recruitment. Journal Of Cancer Education 2024, 39: 325-334. PMID: 38430454, DOI: 10.1007/s13187-024-02414-z.Peer-Reviewed Original ResearchFull-time equivalent supportFull-time equivalentAmerican Council for Graduate Medical EducationCore facultyFellowship programsFellowship educationGraduate Medical EducationImprove job satisfactionCF programPotential unintended consequencesMedical educationSalary supportSurvey respondentsIncreased participationMedical oncologyUnintended consequencesSubspecialty fellowshipsIncreased senseSense of commitmentJob satisfactionFellowshipEducationFaculty involvement
2023
A multicenter phase Ib trial of the histone deacetylase inhibitor entinostat in combination with pembrolizumab in patients with myelodysplastic syndromes/neoplasms or acute myeloid leukemia refractory to hypomethylating agents
Bewersdorf J, Shallis R, Sharon E, Park S, Ramaswamy R, Roe C, Irish J, Caldwell A, Wei W, Yacoub A, Madanat Y, Zeidner J, Altman J, Odenike O, Yerrabothala S, Kovacsovics T, Podoltsev N, Halene S, Little R, Piekarz R, Gore S, Kim T, Zeidan A. A multicenter phase Ib trial of the histone deacetylase inhibitor entinostat in combination with pembrolizumab in patients with myelodysplastic syndromes/neoplasms or acute myeloid leukemia refractory to hypomethylating agents. Annals Of Hematology 2023, 103: 105-116. PMID: 38036712, DOI: 10.1007/s00277-023-05552-4.Peer-Reviewed Original ResearchConceptsDose-limiting toxicityAcute myeloid leukemiaMarrow complete remissionPhase Ib trialAdverse eventsIb trialDose escalationNCI Cancer Therapy Evaluation ProgramAcute myeloid leukemia refractoryHematologic adverse eventsProtocol-defined responseDose level 1Anti-PD1 therapyAnti-PD1 antibodyDose-escalation designLimited clinical efficacySystems immunology approachHistone deacetylase inhibitor entinostatLeukemia refractoryMCR patientsComplete remissionRespiratory failureSuppressor cellsEscalation designClinical efficacyA randomized phase III study of standard versus high-dose cytarabine with or without vorinostat for AML
Garcia-Manero G, Podoltsev N, Othus M, Pagel J, Radich J, Fang M, Rizzieri D, Marcucci G, Strickland S, Litzow M, Savoie M, Medeiros B, Sekeres M, Lin T, Uy G, Powell B, Kolitz J, Larson R, Stone R, Claxton D, Essell J, Luger S, Mohan S, Moseley A, Appelbaum F, Erba H. A randomized phase III study of standard versus high-dose cytarabine with or without vorinostat for AML. Leukemia 2023, 38: 58-66. PMID: 37935977, DOI: 10.1038/s41375-023-02073-x.Peer-Reviewed Original ResearchConceptsHigh-dose cytarabineAcute myeloid leukemiaDose cytarabineRandomized phase III studyUnfavorable-risk cytogeneticsRandomized multicenter trialOverall remission ratePhase III studyHigh response rateHistone deacetylase inhibitorsInduction therapyFree survivalPrimary endpointRemission rateUntreated patientsIII studyOverall survivalYounger patientsMulticenter trialImproved outcomesMyeloid leukemiaCytogenetic subsetsCytarabineResponse rateHigh dosesStatin use, survival and incidence of thrombosis among older patients with polycythemia vera and essential thrombocythemia
Podoltsev N, Wang R, Shallis R, Stempel J, Di M, Neparidze N, Zeidan A, Huntington S, Giri S, Hull S, Gore S, Ma X. Statin use, survival and incidence of thrombosis among older patients with polycythemia vera and essential thrombocythemia. Cancer Medicine 2023, 12: 18889-18900. PMID: 37702132, PMCID: PMC10557879, DOI: 10.1002/cam4.6528.Peer-Reviewed Original ResearchConceptsIncidence of thrombosisPolycythemia veraEssential thrombocythemiaStatin useOlder adultsEnd Results-Medicare databasePopulation-based cohort studyArterial thrombotic eventsSurvival of patientsUse of statinsClaims-based studyRisk of thrombosisCardiovascular morbidityCause mortalityTreatment weighting (IPTW) approachCohort studyOlder patientsOverall survivalThrombotic eventsVenous thrombosisPatient populationPrevious registryStatinsTherapeutic strategiesET subgroupOlder patients with chronic myeloid leukemia face suboptimal molecular testing and tyrosine kinase inhibitor adherence
Shallis R, Wang R, Zeidan A, Huntington S, Neparidze N, Stempel J, Mendez L, Di M, Ma X, Podoltsev N. Older patients with chronic myeloid leukemia face suboptimal molecular testing and tyrosine kinase inhibitor adherence. Blood Advances 2023, 7: 3213-3224. PMID: 36939371, PMCID: PMC10338212, DOI: 10.1182/bloodadvances.2022009074.Peer-Reviewed Original ResearchConceptsChronic myeloid leukemiaTKI adherenceTKI initiationOlder patientsMyeloid leukemiaEnd Results-Medicare databaseTyrosine kinase inhibitor usePolymerase chain reaction testingQuantitative polymerase chain reaction testingOlder patient populationCare of patientsHealth care accessReal-world studyReal-world evidenceLow socioeconomic statusLow-income subsidyFirst yearInfluenza vaccinationInhibitor useWorse survivalTKI treatmentMultivariable analysisPatient populationOptimal monitoringCare accessGilteritinib in Combination With Induction and Consolidation Chemotherapy and as Maintenance Therapy: A Phase IB Study in Patients With Newly Diagnosed AML
Pratz K, Cherry M, Altman J, Cooper B, Podoltsev N, Cruz J, Lin T, Schiller G, Jurcic J, Asch A, Wu R, Hill J, Gill S, James A, Rich E, Hasabou N, Perl A, Levis M. Gilteritinib in Combination With Induction and Consolidation Chemotherapy and as Maintenance Therapy: A Phase IB Study in Patients With Newly Diagnosed AML. Journal Of Clinical Oncology 2023, 41: 4236-4246. PMID: 37379495, DOI: 10.1200/jco.22.02721.Peer-Reviewed Original ResearchConceptsPhase Ib studyMaintenance therapyConsolidation chemotherapyDose escalationFLT3 inhibitorsIb studyHigh-dose cytarabine consolidationMedian overall survival timeSingle-agent maintenance therapyComplete response rateHigher trough levelsOverall survival timeCytarabine consolidationChemotherapy regimenDose expansionAdult patientsIntensive inductionTrough levelsCount recoveryMedian timeRandomized trialsInduction cyclesSurvival timeDay 1Response rate