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 studyPhase I Study of Ruxolitinib in Combination with Abemaciclib for Patients with Primary or Post-Polycythemia Vera/Essential Thrombocythemia Myelofibrosis
Bewersdorf J, Derkach A, Zeidan A, Stein E, Mauro M, Podoltsev N, Rampal R. Phase I Study of Ruxolitinib in Combination with Abemaciclib for Patients with Primary or Post-Polycythemia Vera/Essential Thrombocythemia Myelofibrosis. Blood 2024, 144: 6659-6659. DOI: 10.1182/blood-2024-194918.Peer-Reviewed Original ResearchDose-limiting toxicityCancer Institute Common Terminology Criteria for Adverse EventsTreatment-related adverse eventsAdverse eventsDose levelsCombination therapySpleen volumeInhibitor abemaciclibGrade 3Patients discontinued treatment due to adverse eventsNational Cancer Institute Common Terminology Criteria for Adverse EventsPhase I dose-escalation trialTreatment due to adverse eventsCommon Terminology Criteria for Adverse EventsDisease progressionRecommended phase II doseMulticenter Phase IPlanned dose levelsGrade 3 thrombocytopeniaMedian overall survivalPhase II doseBone marrow blastsBone marrow fibrosisClinically significant bleedingData cut-offUse of Calcineurin Inhibitor (CNI) and Eltrombopag (EPAG) Among Patients with Acquired Aplastic Anemia (AA) in the United States: Results from a Large National Database
Stempel J, Wang R, Lee A, Ma X, Podoltsev N. Use of Calcineurin Inhibitor (CNI) and Eltrombopag (EPAG) Among Patients with Acquired Aplastic Anemia (AA) in the United States: Results from a Large National Database. Blood 2024, 144: 2319. DOI: 10.1182/blood-2024-202185.Peer-Reviewed Original ResearchHorse anti-thymocyte globulinLow transfusion burdenAcquired aplastic anemiaCalcineurin inhibitor levelsCalcineurin inhibitorsSevere AARed blood cellsEltrombopag therapyTransfusion burdenMedian proportion of daysTransfusion of red blood cellsCalcineurin inhibitor agentsMedian starting doseAnti-thymocyte globulinDiagnosis to initiationTransplant-ineligible patientsBone marrow failureRare autoimmune disorderReduce transfusion requirementsBaseline red blood cellRetrospective cohort studyStudent's t-testProportion of daysBlue Cross Blue ShieldElixhauser comorbidity scoreAddition 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 testEducational Impact of Live and Online Enduring CME Activities Presented at the 65th ASH Annual Meeting on Hematology/Oncology Specialists Evaluated Using Pre-/Post-Education Assessments
Worst M, Friedman H, Bomba S, Whitney M, Cameron D, Middleton D, Warren C, Kadkhoda H, Podoltsev N. Educational Impact of Live and Online Enduring CME Activities Presented at the 65th ASH Annual Meeting on Hematology/Oncology Specialists Evaluated Using Pre-/Post-Education Assessments. Blood 2024, 144: 2445-2445. DOI: 10.1182/blood-2024-208458.Peer-Reviewed Original ResearchStatistically significant improvementCME activitySickle Cell Disease AssociationAmerican Society of HematologyEducational impactPost-education assessmentsClinical care decisionsOnline CME activitiesCare of patientsLearning themesAmerican Society of Hematology Annual MeetingHealth equityCare planningSignificant improvementHealthcare teamEndurance activitiesEndurance participantsCare decisionsIndividualized careEducational portfolioIn-personClinical knowledgeSignificant levels of changesCE creditConfidence questionsImmune Landscape and Outcomes of Patients with RNA Splicing Factor-Mutant Acute Myeloid Leukemia and Myelodysplastic Syndromes Treated with Azacitidine +/- the Anti-PD-L1 Antibody Durvalumab
Bewersdorf J, Hasle V, Shallis R, Thompson E, De Menezes D, Rose S, Boss I, Mendez L, Podoltsev N, Stahl M, Kewan T, Halene S, Haferlach T, Fox B, Zeidan A. Immune Landscape and Outcomes of Patients with RNA Splicing Factor-Mutant Acute Myeloid Leukemia and Myelodysplastic Syndromes Treated with Azacitidine +/- the Anti-PD-L1 Antibody Durvalumab. Blood 2024, 144: 4585. DOI: 10.1182/blood-2024-194929.Peer-Reviewed Original ResearchAcute myeloid leukemiaAnti-PD-L1 antibody durvalumabOverall response rateMyelodysplastic syndromeComplete responseBM aspiratesMyeloid leukemiaInternational Working GroupBone marrowMyelodysplastic syndromes treated with azacitidineAcute myeloid leukemia ptsWild-type acute myeloid leukemiaSecondary acute myeloid leukemiaResponse criteriaAnti-PD-L1Immune checkpoint inhibitorsTreated with azacitidineOutcomes of patientsAny-cause deathGeneration of neoantigensVariant allele frequencySusceptible to treatmentMarrow CRAdverse cytogeneticsCheckpoint inhibitorsCost-Effectiveness of Allogeneic Hematopoietic Stem Cell Transplantation Versus Consolidation Chemotherapy for Patients with Intermediate Risk Acute Myeloid Leukemia
Alhajahjeh A, Patel K, Shallis R, Podoltsev N, Kewan T, Stempel J, Mendez L, Huntington S, Stahl M, Zeidan A, Goshua G, Bewersdorf J. Cost-Effectiveness of Allogeneic Hematopoietic Stem Cell Transplantation Versus Consolidation Chemotherapy for Patients with Intermediate Risk Acute Myeloid Leukemia. Blood 2024, 144: 788. DOI: 10.1182/blood-2024-201535.Peer-Reviewed Original ResearchHematopoietic stem cell transplantationUpfront hematopoietic stem cell transplantationDisease-free survivalAcute myeloid leukemiaIntermediate risk acute myeloid leukemiaConsolidation chemotherapyCurative therapeutic modalityOverall survivalOne-way sensitivity analysesEuropean LeukemiaNetIncremental net monetary benefitMyeloid leukemiaMortality associated with hematopoietic stem cell transplantationCost-effective strategyTherapeutic modalitiesFavorable risk AMLSalvage hematopoietic stem cell transplantationAllogeneic hematopoietic stem cell transplantationCycles of consolidation chemotherapyUS health system perspectiveDiagnosed AMLFollow-up of patientsSurvival analysisHigh-dose cytarabineLines of therapyCost-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 treatmentEfficacy 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 methodGlobal 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, 65: 2182-2189. 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 ResearchLongitudinal 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 skillsBurnout