2021
Cost-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
High dose cyclophosphamide for cytoreduction in patients with acute myeloid leukemia with hyperleukocytosis or leukostasis
Zhao J, Bewersdorf JP, Jaszczur S, Kowalski A, Perreault S, Schiffer M, Gore S, Podoltsev N, Prebet T, Shallis R, Zeidan AM. High dose cyclophosphamide for cytoreduction in patients with acute myeloid leukemia with hyperleukocytosis or leukostasis. Leukemia & Lymphoma 2020, 62: 1195-1202. PMID: 33325761, DOI: 10.1080/10428194.2020.1856835.Peer-Reviewed Original ResearchConceptsWhite blood cell countHigh-dose cyclophosphamideAcute myeloid leukemiaMyeloid leukemiaDose cyclophosphamideBlast phase chronic myeloid leukemiaMedian white blood cell countPhase chronic myeloid leukemiaAdverse effectsSymptoms of leukostasisTumor lysis syndromeDay of admissionBlood cell countChronic myeloid leukemiaEvaluable patientsLeukostasis symptomsIntensive chemotherapyIntravascular coagulopathyLysis syndromePrimary endpointHemorrhagic cystitisEarly mortalityMedical emergencyCell countPatientsClinical outcomes and characteristics of patients with TP53-mutated acute myeloid leukemia or myelodysplastic syndromes: a single center experience*
Bewersdorf JP, Shallis RM, Gowda L, Wei W, Hager K, Isufi I, Kim TK, Pillai MM, Seropian S, Podoltsev NA, Gore SD, Siddon AJ, Zeidan AM. Clinical outcomes and characteristics of patients with TP53-mutated acute myeloid leukemia or myelodysplastic syndromes: a single center experience*. Leukemia & Lymphoma 2020, 61: 2180-2190. PMID: 32362171, PMCID: PMC7603787, DOI: 10.1080/10428194.2020.1759051.Peer-Reviewed Original ResearchConceptsAcute myeloid leukemiaMedian overall survivalTherapy-related malignanciesOverall survivalMyelodysplastic syndromeMyeloid leukemiaAllogeneic hematopoietic stem cell transplantLonger median overall survivalSingle-center retrospective studyComplex karyotypeHematopoietic stem cell transplantIntensive chemotherapy approachesYale Cancer CenterCharacteristics of patientsSingle-center experienceMinority of patientsStem cell transplantLong-term survivalLow response rateIntensive chemotherapyCenter experienceClinicopathologic characteristicsAdverse prognosisAML patientsCell transplantManagement of hyperleukocytosis and impact of leukapheresis among patients with acute myeloid leukemia (AML) on short- and long-term clinical outcomes: a large, retrospective, multicenter, international study
Stahl M, Shallis RM, Wei W, Montesinos P, Lengline E, Neukirchen J, Bhatt VR, Sekeres MA, Fathi AT, Konig H, Luger S, Khan I, Roboz GJ, Cluzeau T, Martínez-Cuadron D, Raffoux E, Germing U, Umakanthan JM, Mukherjee S, Brunner AM, Miller A, McMahon CM, Ritchie EK, Rodríguez-Veiga R, Itzykson R, Boluda B, Rabian F, Tormo M, Acuña-Cruz E, Rabinovich E, Yoo B, Cano I, Podoltsev NA, Bewersdorf JP, Gore S, Zeidan AM. Management of hyperleukocytosis and impact of leukapheresis among patients with acute myeloid leukemia (AML) on short- and long-term clinical outcomes: a large, retrospective, multicenter, international study. Leukemia 2020, 34: 3149-3160. PMID: 32132655, PMCID: PMC8155811, DOI: 10.1038/s41375-020-0783-3.Peer-Reviewed Original ResearchConceptsAcute myeloid leukemiaOverall survivalMyeloid leukemiaMultivariate analysisLong-term clinical outcomesComposite complete remissionImpact of leukapheresisManagement of hyperleukocytosisMedian overall survivalThirty-day mortalityHigh-quality evidenceWhite cell countProportional hazards modelUse of leukapheresisLogistic regression modelsSignificant resource useIntensive chemotherapyComplete remissionHazard ratioClinical outcomesInferior outcomesUnadjusted analysesQuality evidencePotential complicationsOdds ratioPatterns of care and clinical outcomes of patients with newly diagnosed acute myeloid leukemia presenting with hyperleukocytosis who do not receive intensive chemotherapy
Shallis RM, Stahl M, Wei W, Montesinos P, Lengline E, Neukirchen J, Bhatt VR, Sekeres MA, Fathi AT, Konig H, Luger S, Khan I, Roboz GJ, Cluzeau T, Martínez-Cuadron D, Raffoux E, Germing U, Umakanthan JM, Mukhereje S, Brunner AM, Miller A, McMahon CM, Ritchie EK, Rodríguez-Veiga R, Itzykson R, Boluda B, Rabian F, Tormo M, Acuña-Cruz E, Rabinovich E, Yoo B, Cano I, Podoltsev NA, Bewersdorf JP, Gore S, Zeidan AM. Patterns of care and clinical outcomes of patients with newly diagnosed acute myeloid leukemia presenting with hyperleukocytosis who do not receive intensive chemotherapy. Leukemia & Lymphoma 2020, 61: 1220-1225. PMID: 32100599, PMCID: PMC8273667, DOI: 10.1080/10428194.2020.1728753.Peer-Reviewed Original Research
2019
Clinical Outcomes of Older Patients (pts) with Acute Myeloid Leukemia (AML) Receiving Hypomethylating Agents (HMAs): A Large Population-Based Study in the United States
Zeidan A, Wang R, Wang X, Shallis R, Podoltsev N, Bewersdorf J, Huntington S, Neparidze N, Giri S, Gore S, Davidoff A, Ma X. Clinical Outcomes of Older Patients (pts) with Acute Myeloid Leukemia (AML) Receiving Hypomethylating Agents (HMAs): A Large Population-Based Study in the United States. Blood 2019, 134: 646. DOI: 10.1182/blood-2019-127398.Peer-Reviewed Original ResearchRBC transfusion dependenceAcute myeloid leukemiaMedian overall survivalTransfusion independenceOverall survivalTransfusion dependenceHypomethylating agentCelgene CorporationHMA initiationIntensive chemotherapyOS probabilityMedian timeMultivariable analysisMultivariable Cox proportional hazards modelsBoehringer IngelheimAdvisory CommitteeCox proportional hazards modelDaiichi SankyoChemotherapy-related hospitalizationMo of diagnosisRBC transfusion independenceImproved overall survivalClinical trial evidenceInferior overall survivalWorse overall survival
2018
Updated 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. Updated 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 2018, 132: 564. DOI: 10.1182/blood-2018-99-110975.Peer-Reviewed Original ResearchAcute myeloid leukemiaClinical trial workSingle-agent maintenance therapyDose-expansion cohortsSafety/tolerabilityFms-like tyrosine kinase 3Phase 1 studyMaintenance therapyAdverse eventsCRC ratesExpansion doseAstellas PharmaFebrile neutropeniaIntensive chemotherapyDay cohortDose escalationDay 1Serious drug-related adverse eventsDrug-related adverse eventsExperienced dose-limiting toxicityHigh-dose cytarabine consolidationMedian disease-free survivalRefractory acute myeloid leukemiaWhite blood cell countAdvisory CommitteeCharacteristics, Treatment Patterns and Outcomes Among Newly Diagnosed Patients (pts) with Acute Myeloid Leukemia (AML) Who Present with Hyperleukocytosis: Findings from a Large International Patient Cohort
Stahl M, Wei W, Montesinos P, Lengline E, Shallis R, Neukirchen J, Bhatt V, Sekeres M, Fathi A, Konig H, Luger S, Khan I, Roboz G, Cluzeau T, Martínez-Cuadron D, Raffoux E, Germing U, Umakanthan J, Mukherjee S, Brunner A, Miller A, McMahon C, Ritchie E, Rodríguez-Veiga R, Itzykson R, Boluda B, Rabian F, Tormo M, Cruz E, Rabinovich E, Yoo B, Podoltsev N, Gore S, Zeidan A. Characteristics, Treatment Patterns and Outcomes Among Newly Diagnosed Patients (pts) with Acute Myeloid Leukemia (AML) Who Present with Hyperleukocytosis: Findings from a Large International Patient Cohort. Blood 2018, 132: 4040. DOI: 10.1182/blood-2018-99-112974.Peer-Reviewed Original ResearchWhite blood cell countMedian overall survivalAcute myeloid leukemiaHematopoietic stem cell transplantIntensive chemotherapyTumor lysis syndromeOverall survivalTime of presentationComplete remissionAstex PharmaceuticalsSpeakers bureauPartial remissionTreatment patternsDaiichi SankyoJazz PharmaceuticalsCleveland Clinic Taussig Cancer InstituteJanssen PharmaceuticalsMedian white blood cell countHigher white blood cell countCelgene CorporationLong-term clinical outcomesAdvisory CommitteeImpact of leukapheresisIncomplete count recoveryMDS International FoundationOutcomes of Patients with Newly-Diagnosed Acute Myeloid Leukemia and Hyperleukocytosis Who Did Not Undergo Intensive Chemotherapy: Results from a Large International Database
Shallis R, Stahl M, Wei W, Montesinos P, Lengline E, Neukirchen J, Bhatt V, Sekeres M, Fathi A, Konig H, Luger S, Khan I, Roboz G, Cluzeau T, Martínez-Cuadron D, Raffoux E, Germing U, Umakanthan J, Mukherjee S, Brunner A, Miller A, McMahon C, Ritchie E, Rodríguez-Veiga R, Itzykson R, Boluda B, Rabian F, Tormo M, Cruz E, Podoltsev N, Gore S, Zeidan A. Outcomes of Patients with Newly-Diagnosed Acute Myeloid Leukemia and Hyperleukocytosis Who Did Not Undergo Intensive Chemotherapy: Results from a Large International Database. Blood 2018, 132: 3999. DOI: 10.1182/blood-2018-99-119755.Peer-Reviewed Original ResearchTumor lysis syndromeIntensive chemotherapyIntensive care unitOverall survivalClinical evidenceAstex PharmaceuticalsSpeakers bureauDaiichi SankyoMedian OSWorse OSAML patientsPlatelet countEastern Cooperative Oncology Group performance statusJazz PharmaceuticalsCleveland Clinic Taussig Cancer InstituteJanssen PharmaceuticalsOne-year OS probabilityCelgene CorporationAdvisory CommitteeMDS International FoundationPoor-risk AMLBest supportive careLow-dose cytarabineMedian overall survivalOutcomes of patientsBe careful of the masquerades: differentiating secondary myelodysplasia from myelodysplastic syndromes in clinical practice
Shallis RM, Xu ML, Podoltsev NA, Curtis SA, Considine BT, Khanna SR, Siddon AJ, Zeidan AM. Be careful of the masquerades: differentiating secondary myelodysplasia from myelodysplastic syndromes in clinical practice. Annals Of Hematology 2018, 97: 2333-2343. PMID: 30109425, DOI: 10.1007/s00277-018-3474-7.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsMyelodysplastic syndromeSecondary myelodysplasiaSecondary causesAllogeneic hematopoietic cell transplantationDiagnosis of MDSRepresentative case seriesUnderlying myelodysplastic syndromeHematopoietic cell transplantationLack of efficacyHematologists/oncologistsMeticulous exclusionResultant cytopeniasIntensive chemotherapyCase seriesMorphologic reviewCell transplantationDiagnostic dilemmaSuch therapyMalignant processExpert hematopathologistsClinical practiceMyelodysplasiaCytogenetic abnormalitiesPatientsSpecialized physicians
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 profileGuadecitabine (SGI-110) in treatment-naive patients with acute myeloid leukaemia: phase 2 results from a multicentre, randomised, phase 1/2 trial
Kantarjian HM, Roboz GJ, Kropf PL, Yee KWL, O'Connell CL, Tibes R, Walsh KJ, Podoltsev NA, Griffiths EA, Jabbour E, Garcia-Manero G, Rizzieri D, Stock W, Savona MR, Rosenblat TL, Berdeja JG, Ravandi F, Rock EP, Hao Y, Azab M, Issa JJ. Guadecitabine (SGI-110) in treatment-naive patients with acute myeloid leukaemia: phase 2 results from a multicentre, randomised, phase 1/2 trial. The Lancet Oncology 2017, 18: 1317-1326. PMID: 28844816, PMCID: PMC5925750, DOI: 10.1016/s1470-2045(17)30576-4.Peer-Reviewed Original ResearchMeSH KeywordsAdultAge FactorsAgedAged, 80 and overAzacitidineDisease-Free SurvivalDose-Response Relationship, DrugDrug Administration ScheduleHumansInfusions, IntravenousKaplan-Meier EstimateLeukemia, Myeloid, AcuteMaximum Tolerated DoseMiddle AgedNeoplasm InvasivenessNeoplasm StagingPatient SafetyPrognosisProspective StudiesRemission InductionRisk AssessmentSurvival AnalysisTreatment OutcomeConceptsAcute myeloid leukemiaComposite complete responseTreatment-naive patientsTreatment-naive acute myeloid leukaemiaAdverse eventsMyeloid leukemiaComplete responseFebrile neutropeniaIntensive chemotherapyMyelodysplastic syndromeTreatment cyclesCommon serious adverse eventsRefractory acute myeloid leukemiaPhase 2 resultsFrequent grade 3Worse adverse eventsSerious adverse eventsPhase 2 studyPhase 3 studyCohort of patientsPhase 1 studyComplete tumor responseStandard of careNumber of patientsEffective treatment schedule