2023
A 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 dosesGilteritinib 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
2021
Venetoclax-based combinations in AML and high-risk MDS prior to and following allogeneic hematopoietic cell transplant
Bewersdorf JP, Derkach A, Gowda L, Menghrajani K, DeWolf S, Ruiz JD, Ponce DM, Shaffer BC, Tamari R, Young JW, Jakubowski AA, Gyurkocza B, Chan A, Xiao W, Glass J, King AC, Cai SF, Daniyan A, Famulare C, Cuello BM, Podoltsev NA, Roshal M, Giralt S, Perales MA, Seropian S, Cho C, Zeidan AM, Prebet T, Stein EM, Tallman MS, Goldberg AD, Stahl M. Venetoclax-based combinations in AML and high-risk MDS prior to and following allogeneic hematopoietic cell transplant. Leukemia & Lymphoma 2021, 62: 3394-3401. PMID: 34477024, PMCID: PMC9012492, DOI: 10.1080/10428194.2021.1966788.Peer-Reviewed Original ResearchConceptsAcute myeloid leukemiaAllogeneic hematopoietic cell transplantAllo-HCTHematopoietic cell transplantSalvage therapyMyelodysplastic syndromeCell transplantMemorial Sloan-Kettering Cancer CenterHigh-risk myelodysplastic syndromeSecond allo-HCTSalvage treatment optionOverall response rateMedian followMedian OSVenetoclax therapyRetrospective studyCancer CenterTreatment optionsOS estimatesMyeloid leukemiaPatientsResponse rateTherapyTransplantMonthsCost-effectiveness of azacitidine and venetoclax in unfit patients with previously untreated acute myeloid leukemia
Patel KK, Zeidan AM, Shallis RM, Prebet T, Podoltsev N, Huntington SF. Cost-effectiveness of azacitidine and venetoclax in unfit patients with previously untreated acute myeloid leukemia. Blood Advances 2021, 5: 994-1002. PMID: 33591323, PMCID: PMC7903235, DOI: 10.1182/bloodadvances.2020003902.Peer-Reviewed Original ResearchConceptsUntreated acute myeloid leukemiaIncremental cost-effectiveness ratioAcute myeloid leukemiaUnfit patientsMyeloid leukemiaLifetime health care costsSignificant price reductionUntreated AML patientsOverall survival curvesUS payer perspectiveCost-effectiveness ratioParametric survival modelingHealth care costsPrice reductionIntensive chemotherapyOverall survivalAML patientsTreatment strategiesCurrent pricingResponse rateCare costsSurvival curvesVenetoclaxClinical settingAzacitidine
2020
Phase 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 cancersInterferon 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 trialsInterferon Therapy in Myelofibrosis: Systematic Review and Meta-analysis
Bewersdorf JP, Giri S, Wang R, Podoltsev N, Williams RT, Rampal RK, Tallman MS, Zeidan AM, Stahl M. Interferon Therapy in Myelofibrosis: Systematic Review and Meta-analysis. Clinical Lymphoma Myeloma & Leukemia 2020, 20: e712-e723. PMID: 32669244, PMCID: PMC7541411, DOI: 10.1016/j.clml.2020.05.018.Peer-Reviewed Original ResearchConceptsOverall response rateTreatment of myelofibrosisPEG-IFNMF patientsResponse rateHematologic responseSystematic reviewFormulations of interferonPartial hematologic responseCochrane Central RegisterComplete hematologic responseRisk of progressionRole of interferonAcute myeloid leukemiaPhiladelphia chromosome-negative myeloproliferative neoplasmsRandom-effects modelBone marrow failureWeb of ScienceTreatment discontinuationCentral RegisterConstitutional symptomsHematologic improvementInterferon therapyAdverse eventsComplete response
2019
Real 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 M, Kuo E, Wang A, Curran E, Shallis R, 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. Blood 2019, 134: 1302. DOI: 10.1182/blood-2019-124882.Peer-Reviewed Original ResearchMedian overall survivalDuration of responseAllo-HCTOverall survivalAcute lymphocytic leukemiaTyrosine kinase inhibitorsComplete remissionB cellsInotuzumab ozogamicinAdverse eventsRefractory B-cell acute lymphocytic leukaemiaJazz PharmaceuticalsResponse rateB-cell acute lymphocytic leukemiaMinimal residual disease negativityAllogeneic stem cell transplantationAdvisory CommitteeB-cell acute lymphocytic leukemia patientsEfficacy of iNOGenentech/RocheIncomplete count recoveryMedian response durationVeno-occlusive diseaseOutcomes of patientsKaplan-Meier method
2017
Preliminary Results from a Phase 1 Study of Gilteritinib in Combination with Induction and Consolidation Chemotherapy in Subjects with Newly Diagnosed Acute Myeloid Leukemia (AML)
Pratz K, Cherry M, Altman J, Cooper B, Cruz J, Jurcic J, Levis M, Lin T, Perl A, Podoltsev N, Schiller G, Liu C, Bahceci E. Preliminary Results from a Phase 1 Study of Gilteritinib in Combination with Induction and Consolidation Chemotherapy in Subjects with Newly Diagnosed Acute Myeloid Leukemia (AML). Blood 2017, 130: 722. DOI: 10.1182/blood.v130.suppl_1.722.722.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsAcute myeloid leukemiaEvent-free survivalDisease-free survivalMedian event-free survivalMedian overall survivalFms-like tyrosine kinase 3Phase 1 studyOverall survivalCRC ratesExpansion doseFebrile neutropeniaIntensive chemotherapyMaintenance therapyDose escalationDaiichi SankyoRefractory (R/R) AMLSerious drug-related treatment-emergent adverse eventsDrug-related treatment-emergent adverse eventsDay 1Response rateComposite complete remission rateHigh-dose cytarabine consolidationMedian disease-free survivalSafety/tolerability profile
2015
Patterns of Venous Thromboembolism Prophylaxis During Treatment of Acute Leukemia: Results of a North American Web-Based Survey
Lee EJ, Smith BD, Merrey JW, Lee AI, Podoltsev NA, Barbarotta L, Litzow MR, Prebet T, Luger SM, Gore S, Streiff MB, Zeidan AM. Patterns of Venous Thromboembolism Prophylaxis During Treatment of Acute Leukemia: Results of a North American Web-Based Survey. Clinical Lymphoma Myeloma & Leukemia 2015, 15: 766-770.e4. PMID: 26363982, PMCID: PMC4663156, DOI: 10.1016/j.clml.2015.07.637.Peer-Reviewed Original ResearchConceptsVenous thromboembolismAcute leukemiaVTE prophylaxisPrevention of VTEPharmacologic VTE prophylaxisVenous thromboembolism prophylaxisEvidence-based guidelinesHigh-quality studiesConsolidation therapyPharmacologic prophylaxisThromboembolism prophylaxisNorth American providersVTE preventionSignificant morbidityProspective studyPatient populationHigh riskProphylaxisLower riskResponse ratePatientsWeb-based surveyLeukemiaSpectrum of practicesAmerican providers