2024
Intensive induction chemotherapy vs hypomethylating agents in combination with venetoclax in NPM1-mutant AML
Bewersdorf J, Shimony S, Shallis R, Liu Y, Berton G, Schaefer E, Zeidan A, Goldberg A, Stein E, Marcucci G, Bystrom R, Lindsley R, Chen E, Perez J, Stein A, Pullarkat V, Aldoss I, DeAngelo D, Neuberg D, Stone R, Garciaz S, Ball B, Stahl M. Intensive induction chemotherapy vs hypomethylating agents in combination with venetoclax in NPM1-mutant AML. Blood Advances 2024, 8: 4845-4855. PMID: 38941537, PMCID: PMC11416634, DOI: 10.1182/bloodadvances.2024012858.Peer-Reviewed Original ResearchIntensive induction chemotherapyAcute myeloid leukemiaNPM1-Mutant Acute Myeloid LeukemiaInduction chemotherapyHypomethylating agentsMulticenter retrospective cohort study of patientsPatients treated with ICAllogeneic stem cell transplantationRetrospective cohort study of patientsMulticenter retrospective cohort studyCohort study of patientsComposite complete remissionStem cell transplantationYears-oldFLT3-ITD mutationStudy of patientsStandard of careNormal cytogeneticsComplete remissionCell transplantationNPM1 mutationsMyeloid leukemiaFLT3-ITDYounger patientsOlder patientsReal‐world outcomes of intensive induction approaches in core binding factor acute myeloid leukemia
Rojek A, McCormick B, Cwykiel J, Odetola O, Abaza Y, Nai N, Foucar C, Achar R, Shallis R, Bradshaw D, Standridge M, Kota V, Murthy S, Badar T, Patel A. Real‐world outcomes of intensive induction approaches in core binding factor acute myeloid leukemia. EJHaem 2024, 5: 728-737. PMID: 39157611, PMCID: PMC11327707, DOI: 10.1002/jha2.981.Peer-Reviewed Original ResearchPatients treated with ICEvent-free survivalTreated with ICCore binding factor acute myeloid leukemiaGemtuzumab ozogamicinIntensive chemotherapyCBF-AMLAcute myeloid leukemiaKIT inhibitorsOverall survivalEuropean LeukemiaNetMyeloid leukemiaThree-year overall survivalMedian follow-upInduction treatment regimensAntibody-drug conjugatesStatistically significant differenceImproved OSFavorable riskSurvival benefitTreatment regimensProspective studyFollow-upCompare outcomesAcademic centersPrognostic impact of 'multi-hit' versus 'single hit' TP53 alteration in patients with acute myeloid leukemia: results from the Consortium on Myeloid Malignancies and Neoplastic Diseases.
Badar T, Nanaa A, Atallah E, Shallis R, Craver E, Li Z, Goldberg A, Saliba A, Patel A, Bewersdorf J, Duvall A, Burkart M, Bradshaw D, Abaza Y, Stahl M, Palmisiano N, Murthy G, Zeidan A, Kota V, Patnaik M, Litzow M. Prognostic impact of 'multi-hit' versus 'single hit' TP53 alteration in patients with acute myeloid leukemia: results from the Consortium on Myeloid Malignancies and Neoplastic Diseases. Haematologica 2024 PMID: 38813716, DOI: 10.3324/haematol.2024.285000.Peer-Reviewed Original ResearchAcute myeloid leukemiaMyelodysplastic syndromeComplex cytogeneticsMyeloid leukemiaAllogeneic hematopoietic stem cell transplantationLower-risk myelodysplastic syndromesHematopoietic stem cell transplantationHigher-risk myelodysplastic syndromesOutcomes of SHStem cell transplantationAllo-HCTTP53 alterationsPrognostic impactMyeloid malignanciesTP53 mutationsCell transplantationFLT3-ITDIDH1 mutationMultivariate analysisSupportive careUS academic institutionsNeoplastic diseasePatientsSuperior EFSPredicting outcomeChallenges 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 yearsComparing venetoclax in combination with hypomethylating agents to hypomethylating agent-based therapies for treatment naive TP53-mutated acute myeloid leukemia: results from the Consortium on Myeloid Malignancies and Neoplastic Diseases (COMMAND)
Badar T, Nanaa A, Atallah E, Shallis R, Guilherme S, Goldberg A, Saliba A, Patel A, Bewersdorf J, DuVall A, Bradshaw D, Abaza Y, Murthy G, Palmisiano N, Zeidan A, Kota V, Litzow M. Comparing venetoclax in combination with hypomethylating agents to hypomethylating agent-based therapies for treatment naive TP53-mutated acute myeloid leukemia: results from the Consortium on Myeloid Malignancies and Neoplastic Diseases (COMMAND). Blood Cancer Journal 2024, 14: 32. PMID: 38378617, PMCID: PMC10879201, DOI: 10.1038/s41408-024-01000-2.Peer-Reviewed Original ResearchClinical outcomes of hypomethylating agents plus Venetoclax as frontline treatment in patients 75 years and older with acute myeloid leukemia: Real‐world data from eight US academic centers
Abaza Y, Winer E, Murthy S, Shallis R, Matthews A, Badar T, Geramita E, Kota V, Swaroop A, Doukas P, Bradshaw D, Helenowski I, Liu Y, Zhang H, Im A, Litzow M, Perl A, Atallah E, Altman J. Clinical outcomes of hypomethylating agents plus Venetoclax as frontline treatment in patients 75 years and older with acute myeloid leukemia: Real‐world data from eight US academic centers. American Journal Of Hematology 2024, 99: 606-614. PMID: 38342997, DOI: 10.1002/ajh.27231.Peer-Reviewed Original ResearchAcute myeloid leukemiaHypomethylating agentsOverall survivalElderly patientsMedian OSMyeloid leukemiaTP53-mutated acute myeloid leukemiaNewly diagnosed acute myeloid leukemiaFailure of hypomethylating agentsMedian duration of responseDiagnosed AMLVIALE-A trialMedian overall survivalIncomplete count recoveryDuration of responseMulticenter retrospective studySingle-center studyTreatment of patientsStandard of careCR/CRi rateIntensive chemotherapyCount recoveryMedian durationFrontline treatmentRetrospective study
2023
Intensive Induction Chemotherapy Vs Hypomethylating Agents + Venetoclax (HMA/VEN) in NPM1-Mutant Newly Diagnosed Acute Myeloid Leukemia (AML) - a Multicenter Cohort Study
Bewersdorf J, Shimony S, Shallis R, Liu Y, Schaefer E, Zeidan A, Goldberg A, Stein E, Marcucci G, Lindsley R, Chen E, Ramos J, Stein A, DeAngelo D, Neuberg D, Stone R, Ball B, Stahl M. Intensive Induction Chemotherapy Vs Hypomethylating Agents + Venetoclax (HMA/VEN) in NPM1-Mutant Newly Diagnosed Acute Myeloid Leukemia (AML) - a Multicenter Cohort Study. Blood 2023, 142: 2964. DOI: 10.1182/blood-2023-174285.Peer-Reviewed Original ResearchNPM1 mutant acute myeloid leukemiaIntensive induction chemotherapyAcute myeloid leukemiaComposite complete responseMedian overall survivalOverall survivalComplete responseAllo-SCTPt ageAbnormal cytogeneticsCohort studyMyelodysplastic syndromePolymerase chain reactionClinical trialsMyeloid leukemiaNPM1 mutationsLarge multicenter retrospective cohort studyTime-varying covariatesMulticenter retrospective cohort studyAllogeneic stem cell transplantationPrior myelodysplastic syndromeMulticenter cohort studyRetrospective cohort studyStem cell transplantationPrior chemotherapy exposureIntensive Induction Chemotherapy with or without Gemtuzumab Ozogamicin Among Patients with Core-Binding Factor Acute Myeloid Leukemia
Rojek A, McCormick B, Cwykiel J, Odetola O, Abaza Y, Achar R, Shallis R, Bradshaw D, Standridge M, Kota V, Badar T, Patel A. Intensive Induction Chemotherapy with or without Gemtuzumab Ozogamicin Among Patients with Core-Binding Factor Acute Myeloid Leukemia. Blood 2023, 142: 2889. DOI: 10.1182/blood-2023-177758.Peer-Reviewed Original ResearchRelapse-free survivalAddition of GOFactor acute myeloid leukemiaGemtuzumab ozogamicinIntensive chemotherapyIntensive induction chemotherapyOverall survivalAcute myeloid leukemiaCBF-AMLComplete responseKIT inhibitorsInduction chemotherapyRemission rateProspective studyPolymerase chain reactionMyeloid leukemiaCore binding factor acute myeloid leukemiaAllogeneic stem cell transplantationMulti-center retrospective studyCore-binding factor acute myeloid leukemiaMeasurable residual disease testingAnthracycline-based inductionEuropean LeukemiaNet guidelinesFavorable-risk AMLInduction-related mortalityComparable Survival of Treatment Naïve TP53 Mutated Acute Myeloid Leukemia Treated with Hypomethylating Agent Compared to Hypomethylating Agent Plus Venetoclax Based Therapy
Badar T, Atallah E, Shallis R, Patel A, De Camargo Correia G, Goldberg A, Saliba A, Bewersdorf J, Duvall A, Bradshaw D, Abaza Y, Murthy S, Palmisiano N, Kota V, Litzow M. Comparable Survival of Treatment Naïve TP53 Mutated Acute Myeloid Leukemia Treated with Hypomethylating Agent Compared to Hypomethylating Agent Plus Venetoclax Based Therapy. Blood 2023, 142: 592. DOI: 10.1182/blood-2023-184626.Peer-Reviewed Original ResearchAcute myeloid leukemiaComplete remission rateOverall survivalDuration of responseMultivariable analysisComplex cytogeneticsAllo-HCTRemission rateMyeloid leukemiaAllogeneic stem cell transplantSecondary acute myeloid leukemiaAdverse-risk diseaseCR/CRiMedian overall survivalOutcome of ptsResults Baseline characteristicsKaplan-Meier methodMore effective treatment strategiesSignificant univariate predictorsStem cell transplantEffective treatment strategiesReal-world studyLogistic regression modelsMedian followVEN groupTreatment Patterns Among Patients with Relapsed/Refractory Core-Binding Factor Acute Myeloid Leukemia after Intensive Induction Chemotherapy
Rojek A, McCormick B, Cwykiel J, Odetola O, Abaza Y, Achar R, Shallis R, Bradshaw D, Standridge M, Kota V, Badar T, Patel A. Treatment Patterns Among Patients with Relapsed/Refractory Core-Binding Factor Acute Myeloid Leukemia after Intensive Induction Chemotherapy. Blood 2023, 142: 1484. DOI: 10.1182/blood-2023-185163.Peer-Reviewed Original ResearchCore-binding factor acute myeloid leukemiaFactor acute myeloid leukemiaIntensive induction chemotherapyOutcome of ptsInitial complete remissionLine therapyComplete remissionLong-term outcomesAcute myeloid leukemiaCBF-AMLPolymerase chain reactionR diseaseInduction chemotherapyMedian OSFirst relapseIntensive inductionInitial diagnosisMyeloid leukemiaMolecular testingNext-generation sequencingKIT inhibitorsMulti-center retrospective studyMeasurable residual disease testingAnthracycline-based inductionEuropean LeukemiaNet guidelinesOlder 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 accessSecond malignancies among older patients with classical myeloproliferative neoplasms treated with hydroxyurea
Wang R, Shallis R, Stempel JM, Huntington SF, Zeidan AM, Gore SD, Ma X, Podoltsev NA. Second malignancies among older patients with classical myeloproliferative neoplasms treated with hydroxyurea. Blood Advances 2023, 7: 734-743. PMID: 35917456, PMCID: PMC9989521, DOI: 10.1182/bloodadvances.2022008259.Peer-Reviewed Original ResearchConceptsSecond malignanciesAcute myeloid leukemiaOlder patientsMyelodysplastic syndromeMyeloproliferative neoplasmsHU usersHigh riskPolycythemia veraEssential thrombocythemiaRisk of SMAML/myelodysplastic syndromeClassical Philadelphia chromosome-negative myeloproliferative neoplasmsImpact of hydroxyureaRetrospective cohort studyUse of hydroxyureaPhiladelphia chromosome-negative myeloproliferative neoplasmsClassical myeloproliferative neoplasmsCumulative incidence probabilityCohort studyCytoreductive therapyPatient characteristicsMedian ageHU useMyeloid leukemiaSecondary myelofibrosis
2022
Venetoclax-based salvage therapy in patients with relapsed/refractory acute myeloid leukemia previously treated with FLT3 or IDH1/2 inhibitors
Bewersdorf JP, Shallis RM, Derkach A, Goldberg AD, Stein A, Stein EM, Marcucci G, Zeidan AM, Shimony S, DeAngelo DJ, Stone RM, Aldoss I, Ball BJ, Stahl M. Venetoclax-based salvage therapy in patients with relapsed/refractory acute myeloid leukemia previously treated with FLT3 or IDH1/2 inhibitors. Leukemia & Lymphoma 2022, 64: 188-196. PMID: 36287540, PMCID: PMC9905301, DOI: 10.1080/10428194.2022.2136952.Peer-Reviewed Original ResearchConceptsAcute myeloid leukemiaSalvage therapyIDH1/2 inhibitorsIDH2 inhibitorsMyeloid leukemiaResponse rateRefractory acute myeloid leukemiaEffective salvage therapyLow-dose cytarabineMedian overall survivalRetrospective cohort studyOverall response rateLow response rateCohort studyOverall survivalAML patientsTreatment optionsFLT3 inhibitorsITD mutationPatientsTherapyFLT3Little dataVenetoclaxInhibitorsEfficacy of FLT3 and IDH1/2 inhibitors in patients with acute myeloid leukemia previously treated with venetoclax
Bewersdorf JP, Shallis RM, Derkach A, Goldberg AD, Stein A, Stein EM, Marcucci G, Zeidan AM, Shimony S, DeAngelo DJ, Stone RM, Aldoss I, Ball BJ, Stahl M. Efficacy of FLT3 and IDH1/2 inhibitors in patients with acute myeloid leukemia previously treated with venetoclax. Leukemia Research 2022, 122: 106942. PMID: 36108424, DOI: 10.1016/j.leukres.2022.106942.Peer-Reviewed Original ResearchConceptsAcute myeloid leukemiaIDH2 inhibitorsMyeloid leukemiaResponse rateRetrospective cohort studyOverall response rateRAS pathway mutationsNovel therapeutic strategiesMedian OSR AMLCohort studyShorter OSLandmark trialsTargeted agentsFrontline treatmentMutant FLT3Combination therapyTreatment optionsIDH1/2 inhibitorsDisease progressionTherapeutic strategiesPatientsSmall molecule inhibitorsVenetoclaxTherapyAre We Moving the Needle for Patients with TP53-Mutated Acute Myeloid Leukemia?
Shallis RM, Bewersdorf JP, Stahl MF, Halene S, Zeidan AM. Are We Moving the Needle for Patients with TP53-Mutated Acute Myeloid Leukemia? Cancers 2022, 14: 2434. PMID: 35626039, PMCID: PMC9140008, DOI: 10.3390/cancers14102434.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsAcute myeloid leukemiaMyeloid leukemiaAllogeneic hematopoietic stem cell transplantationHematopoietic stem cell transplantationCD47/SIRPαIntensive induction therapyAvailable therapeutic optionsStem cell transplantationStandard of careAvailable clinical dataTesting of agentsInduction therapyMedian overallRefractory settingAggressive treatmentTim-3Immune checkpointsPreclinical rationaleTherapeutic optionsCell transplantationEfficacy dataClinical dataPatientsMolecular subgroupsTherapeutic agentsCost-effectiveness of liposomal cytarabine/daunorubicin in patients with newly diagnosed acute myeloid leukemia
Bewersdorf JP, Patel KK, Goshua G, Shallis RM, Podoltsev NA, Huntington SF, Zeidan AM. Cost-effectiveness of liposomal cytarabine/daunorubicin in patients with newly diagnosed acute myeloid leukemia. Blood 2022, 139: 1766-1770. PMID: 35298594, PMCID: PMC8931513, DOI: 10.1182/blood.2021014401.Peer-Reviewed Original ResearchAgent Orange and dioxin-induced myeloid leukemia: a weaponized vehicle of leukemogenesis
Shallis RM, Gore SD. Agent Orange and dioxin-induced myeloid leukemia: a weaponized vehicle of leukemogenesis. Leukemia & Lymphoma 2022, 63: 1534-1543. PMID: 35105250, DOI: 10.1080/10428194.2022.2034156.Peer-Reviewed Original Research
2021
Clinical and Molecular Approach to Adult-Onset, Neoplastic Monocytosis
Shallis RM, Siddon AJ, Zeidan AM. Clinical and Molecular Approach to Adult-Onset, Neoplastic Monocytosis. Current Hematologic Malignancy Reports 2021, 16: 276-285. PMID: 33890194, DOI: 10.1007/s11899-021-00632-6.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsPersistent monocytosisAppropriate diagnosisMyelomonocytic leukemiaPCM1-JAK2 fusionChronic myelomonocytic leukemiaAcute myeloid leukemiaAcute myelomonocytic leukemiaNegative predictive valuePurpose of ReviewInMyelodysplastic syndromeReactive monocytosisFGFR1 rearrangementAdult onsetMyeloid leukemiaMonocytosisBCR-ABL1Predictive valueASXL1 mutationsMyeloproliferative neoplasmsDiagnostic approachCytometric analysisMarrow tissuesLeukemiaDiagnosisMonocytic differentiationCost-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