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 ResearchMeSH KeywordsAntineoplastic Combined Chemotherapy ProtocolsHistone Deacetylase InhibitorsHumansLeukemia, Myeloid, AcuteMyelodysplastic SyndromesConceptsDose-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 ResearchMeSH KeywordsAntineoplastic Combined Chemotherapy ProtocolsCytarabineDaunorubicinHumansIdarubicinLeukemia, Myeloid, AcuteRemission InductionVorinostatConceptsHigh-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 dosesTreatment patterns and real-world effectiveness of rituximab maintenance in older patients with mantle cell lymphoma: a population-based analysis
Di M, Long J, Kothari S, Sethi T, Zeidan A, Podoltsev N, Shallis R, Wang R, Ma X, Huntington S. Treatment patterns and real-world effectiveness of rituximab maintenance in older patients with mantle cell lymphoma: a population-based analysis. Haematologica 2023, 108: 2218-2223. PMID: 36655436, PMCID: PMC10388284, DOI: 10.3324/haematol.2022.282252.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, Murine-DerivedAntineoplastic Combined Chemotherapy ProtocolsHumansLymphoma, Mantle-CellNeoplasm Recurrence, LocalRituximabTreatment Outcome
2020
Maintenance therapy for acute myeloid leukemia: sustaining the pursuit for sustained remission.
Shallis RM, Podoltsev NA. Maintenance therapy for acute myeloid leukemia: sustaining the pursuit for sustained remission. Current Opinion In Hematology 2020, 28: 110-121. PMID: 33394722, DOI: 10.1097/moh.0000000000000637.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsMeSH KeywordsAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorClinical Decision-MakingCombined Modality TherapyDisease ManagementDisease SusceptibilityHematopoietic Stem Cell TransplantationHumansLeukemia, Myeloid, AcuteMaintenance ChemotherapyRandomized Controlled Trials as TopicRemission InductionTreatment OutcomeConceptsAcute myeloid leukemiaMaintenance therapyMeasurable residual diseaseMyeloid leukemiaOral hypomethylating agentPost-transplant settingImmune checkpoint inhibitorsPlacebo-controlled trialHigh-risk diseaseAML patient populationRecent positive findingsMRD statusSustained remissionCheckpoint inhibitorsAML patientsRandomized trialsResidual diseasePatient populationHypomethylating agentMRD techniquesTherapyPositive findingsPatientsBcl-2RemissionPhase 1 dose escalation trial of volasertib in combination with decitabine in patients with acute myeloid leukemia
Cortes J, Podoltsev N, Kantarjian H, Borthakur G, Zeidan AM, Stahl M, Taube T, Fagan N, Rajeswari S, Uy GL. Phase 1 dose escalation trial of volasertib in combination with decitabine in patients with acute myeloid leukemia. International Journal Of Hematology 2020, 113: 92-99. PMID: 32951163, DOI: 10.1007/s12185-020-02994-8.Peer-Reviewed Original ResearchMeSH KeywordsAgedAntineoplastic Combined Chemotherapy ProtocolsCell Cycle ProteinsDecitabineDose-Response Relationship, DrugFebrile NeutropeniaFeeding and Eating DisordersFemaleGene ExpressionHumansLeukemia, Myeloid, AcuteMaleMolecular Targeted TherapyProtein Serine-Threonine KinasesProto-Oncogene ProteinsPteridinesTreatment OutcomeConceptsAcute myeloid leukemiaMyeloid leukemiaCommon treatment-emergent adverse eventsPhase 1 dose-escalation trialTreatment-emergent adverse eventsMTD of volasertibObjective response rateAdverse event profileDose-escalation trialPhase 1 trialAnti-leukemic activityPolo-like kinase 1Febrile neutropeniaEscalation trialAdverse eventsCell cycle kinase inhibitorsAML patientsEvent profilePoor prognosisResponse ratePatientsVolasertibDecitabineKinase inhibitorsNumerous cancers
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 ResearchMeSH KeywordsAdolescentAdultAgedAged, 80 and overAntilymphocyte SerumAntineoplastic Combined Chemotherapy ProtocolsDisease-Free SurvivalFemaleFollow-Up StudiesHumansImmunosuppression TherapyMaleMiddle AgedMyelodysplastic SyndromesPrednisoloneSurvival RateConceptsAnti-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 monotherapyPerformance of the Medical Research Council (MRC) and the Leukemia Research Foundation (LRF) score in predicting survival benefit with hypomethylating agent use in patients with relapsed or refractory acute myeloid leukemia
Stahl M, DeVeaux M, Montesinos P, Itzykson R, Ritchie EK, Sekeres MA, Barnard J, Podoltsev NA, Brunner A, 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, Germing U, Bergua J, Serrano J, Gore SD, Zeidan AM. Performance of the Medical Research Council (MRC) and the Leukemia Research Foundation (LRF) score in predicting survival benefit with hypomethylating agent use in patients with relapsed or refractory acute myeloid leukemia. Leukemia & Lymphoma 2018, 60: 246-249. PMID: 29963936, DOI: 10.1080/10428194.2018.1468893.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsDrug Resistance, NeoplasmFemaleHematopoietic Stem Cell TransplantationHumansLeukemia, Myeloid, AcuteMaleMiddle AgedNeoplasm Recurrence, LocalPrognosisRetrospective StudiesRisk AssessmentRisk FactorsSurvival AnalysisTransplantation, HomologousTreatment OutcomeYoung Adult
2017
A patient with oxaliplatin immune-induced syndrome (OIIS) who also developed leucovorin and palonosetron-associated thrombocytopenia
Curtis SA, Curtis BR, Lee AI, Hendrickson JE, Lacy J, Podoltsev NA. A patient with oxaliplatin immune-induced syndrome (OIIS) who also developed leucovorin and palonosetron-associated thrombocytopenia. Hematology 2017, 23: 429-432. PMID: 29281948, DOI: 10.1080/10245332.2017.1419600.Peer-Reviewed Original ResearchMeSH KeywordsAged, 80 and overAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsAutoantibodiesBlood PlateletsErythrocyte IndicesHemolysisHumansMaleOrganoplatinum CompoundsOxaliplatinPlatelet CountRectal NeoplasmsThrombocytopeniaConceptsDrug-induced immune thrombocytopeniaAutoimmune hemolytic anemiaPlatelet-reactive antibodiesImmune thrombocytopeniaThrombotic microangiopathyAdministration of oxaliplatinCycles of FOLFOXOxaliplatin-induced thrombocytopeniaYear old manAnti-RBC IgGEvans syndromeAntibody testingFirst admissionIgM antibodiesSignificant thrombocytopeniaIgG antibodiesHemolytic anemiaThrombocytopeniaLeucovorinPlatelet IgGOlder menOxaliplatinSyndromeBlood centersPatientsLong-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 ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsAzacitidineDecitabineDNA MethylationFemaleHumansMaleMiddle AgedMyelodysplastic SyndromesPrognosisRetrospective StudiesStem Cell TransplantationSurvival RateSurvivors
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 StatementsMeSH KeywordsAge FactorsAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsClinical Decision-MakingClinical Trials as TopicCombined Modality TherapyDisease ManagementHumansIncidenceLeukemia, Myeloid, AcutePrognosisTreatment OutcomeConceptsAcute 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 outcomesPatientsRemissionChemotherapyLeukemiaMortalityTreatmentAdultsSingle agent blinatumumab as frontline therapy for an 85-year-old patient with B cell precursor acute lymphoblastic leukemia
Kim TK, Xu ML, Podoltsev NA, Prebet T, Barbarotta L, Amin K, Kasberg S, Roche K, Stahl M, Gore SD, Zeidan AM. Single agent blinatumumab as frontline therapy for an 85-year-old patient with B cell precursor acute lymphoblastic leukemia. Annals Of Hematology 2016, 95: 1895-1898. PMID: 27468851, PMCID: PMC10955604, DOI: 10.1007/s00277-016-2761-4.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsMeSH KeywordsAged, 80 and overAntibodies, BispecificAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBone MarrowBreast NeoplasmsCarcinoma, Transitional CellCytarabineFemaleHumansLymphoma, B-CellMercaptopurineMethotrexateNeoplasms, Second PrimaryPrecursor B-Cell Lymphoblastic Leukemia-LymphomaPrednisoneRemission InductionSalvage TherapyUrinary Bladder NeoplasmsVincristine
2014
Enhanced skin toxicity associated with the combination of clofarabine plus cytarabine for the treatment of acute leukemia
Zhang B, Bolognia J, Marks P, Podoltsev N. Enhanced skin toxicity associated with the combination of clofarabine plus cytarabine for the treatment of acute leukemia. Cancer Chemotherapy And Pharmacology 2014, 74: 303-307. PMID: 24908437, DOI: 10.1007/s00280-014-2504-y.Peer-Reviewed Original ResearchMeSH KeywordsAdenine NucleotidesAntineoplastic Combined Chemotherapy ProtocolsArabinonucleosidesClofarabineCytarabineFollow-Up StudiesHumansLeukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaPrognosisRetrospective StudiesSkin DiseasesConceptsAcute leukemiaSkin toxicityCombination of clofarabineInitiation of chemotherapyPalmar-plantar erythrodysesthesiaCutaneous side effectsTwo-drug combinationsDifferent chemotherapeutic agentsCytarabine chemotherapyCytarabine groupResultsTen patientsCutaneous toxicityToxic erythemaCutaneous reactionsSkin findingsMedical recordsInstitutional experienceSevere formSide effectsPatientsBody foldsClofarabineChemotherapeutic agentsChemotherapyLeukemia
2013
Myocardial infarction in a young adult undergoing induction treatment for acute lymphocytic leukemia.
Kadan-Lottick N, Russell R, Podoltsev N. Myocardial infarction in a young adult undergoing induction treatment for acute lymphocytic leukemia. Clinical Advances In Hematology And Oncology 2013, 11: 675-7. PMID: 24518381.Peer-Reviewed Original ResearchAntineoplastic Combined Chemotherapy ProtocolsHumansMaleMyocardial InfarctionPrecursor Cell Lymphoblastic Leukemia-LymphomaChemoimmunotherapy and Withdrawal of Immunosupression for Monomorphic Posttransplant Lymphoproliferative Disorders
Podoltsev N, Zhang B, Yao X, Bustillo I, Deng Y, Cooper DL. Chemoimmunotherapy and Withdrawal of Immunosupression for Monomorphic Posttransplant Lymphoproliferative Disorders. Clinical Lymphoma Myeloma & Leukemia 2013, 13: 716-720. PMID: 24035715, PMCID: PMC3846604, DOI: 10.1016/j.clml.2013.07.006.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, Murine-DerivedAntineoplastic Combined Chemotherapy ProtocolsCyclophosphamideDoxorubicinFemaleGraft RejectionHumansImmunosuppression TherapyImmunotherapyLymphoproliferative DisordersMaleMiddle AgedOrgan TransplantationPrednisoneRituximabTreatment OutcomeVincristineWithholding TreatmentYoung AdultConceptsReduction of immunosuppressionMonomorphic PTLDMedian progression-free survivalMonomorphic posttransplant lymphoproliferative disorderGraft rejection ratePosttransplant lymphoproliferative disorderTreatment-related mortalityProgression-free survivalMulti-institutional settingGraft lossMedian OSComplete responseLymphoproliferative disordersCurrent guidelinesDisease progressionAggressive typePatientsChemoimmunotherapyPTLDComplete withdrawalImmunosuppressionCombination programStepwise approachWithdrawalExcellent results