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 effectSurvivalTreatmentPrognostic 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 S, 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, 109: 3533-3542. PMID: 38813716, PMCID: PMC11532685, 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 strategies
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 ResearchNCCN Guidelines® Insights: Myelodysplastic Syndromes, Version 3.2022.
Greenberg PL, Stone RM, Al-Kali A, Bennett JM, Borate U, Brunner AM, Chai-Ho W, Curtin P, de Castro CM, Deeg HJ, DeZern AE, Dinner S, Foucar C, Gaensler K, Garcia-Manero G, Griffiths EA, Head D, Jonas BA, Keel S, Madanat Y, Maness LJ, Mangan J, McCurdy S, McMahon C, Patel B, Reddy VV, Sallman DA, Shallis R, Shami PJ, Thota S, Varshavsky-Yanovsky AN, Westervelt P, Hollinger E, Shead DA, Hochstetler C. NCCN Guidelines® Insights: Myelodysplastic Syndromes, Version 3.2022. Journal Of The National Comprehensive Cancer Network 2022, 20: 106-117. PMID: 35130502, DOI: 10.6004/jnccn.2022.0009.Peer-Reviewed Original ResearchConceptsMyelodysplastic syndromeNCCN guidelinesHigh-risk myelodysplastic syndromeNCCN Guidelines InsightsSupportive care recommendationsManagement of patientsClinical evidencePrognostic significanceTreatment recommendationsCare recommendationsMultidisciplinary panelHigh-risk assessmentPredisposition syndromeBiologic factorsSyndromeMDS expertsGuidelinesImportant advancesPatientsRecommendationsTherapyDiagnosis
2021
Management of the Older Patient with Myelodysplastic Syndrome
Shallis RM, Zeidan AM. Management of the Older Patient with Myelodysplastic Syndrome. Drugs & Aging 2021, 38: 751-767. PMID: 34342860, DOI: 10.1007/s40266-021-00881-3.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsMyelodysplastic syndromeOlder patientsAllogeneic hematopoietic stem cell transplantationHematopoietic stem cell transplantationPrevalence of frailtyMajority of patientsStem cell transplantationPatient-specific factorsDrug-drug interactionsQuality of lifeAbsolute contraindicationPalliative therapyCare therapyCurative therapyIntensive therapyCell transplantationOptimal treatmentSubgroup analysisPatientsPsychosocial issuesSyndromeTherapyPersonalized treatmentAge associatesOlder populationPeri‐transfusion quality‐of‐life assessment for patients with myelodysplastic syndromes
Abel GA, Klepin HD, Magnavita ES, Jaung T, Lu W, Shallis RM, Hantel A, Bahl NE, Dellinger‐Johnson R, Winer ES, Zeidan AM. Peri‐transfusion quality‐of‐life assessment for patients with myelodysplastic syndromes. Transfusion 2021, 61: 2830-2836. PMID: 34251040, DOI: 10.1111/trf.16584.Peer-Reviewed Original ResearchConceptsRed cell transfusionCell transfusionMyelodysplastic syndromeFollow-up questionnaireTransfusion decisionsQoL assessmentProportion of patientsProspective pilot studyQoL 1Repeat transfusionHemoglobin levelsPatients' qualityScore 7TransfusionPatientsStudy designQoLPilot studySignificant increaseSyndromeLife assessmentSignificant changesDaysQuestionnaireAssessmentEmerging agents and regimens for polycythemia vera and essential thrombocythemia
Shallis RM, Podoltsev NA. Emerging agents and regimens for polycythemia vera and essential thrombocythemia. Biomarker Research 2021, 9: 40. PMID: 34049597, PMCID: PMC8161993, DOI: 10.1186/s40364-021-00298-5.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsPolycythemia veraEssential thrombocythemiaPV/ETDisease progression controlEarly efficacy signalsThrombotic risk reductionOutcomes of patientsPhase 1/2 trialNew JAK inhibitorsRed blood cell precursorsJAK-STAT pathway activationBlood cell precursorsHepcidin mimeticsTherapeutic phlebotomyDisease courseSymptom burdenEfficacy signalsHematologic parametersNovel agentsNew agentsJAK inhibitorsET pathogenesisProgression controlPatientsPathway activationMulti-institutional study evaluating clinical outcome with allogeneic hematopoietic stem cell transplantation after blinatumomab in patients with B-cell acute lymphoblastic leukemia: real-world data
Badar T, Szabo A, Litzow M, Burkart M, Yurkiewicz I, Dinner S, Hefazi M, Shallis RM, Podoltsev N, Patel AA, Curran E, Wadleigh M, Balasubramanian S, Yang J, Arslan S, Aldoss I, Mattison R, Cenin D, Siebenaller C, Advani A, Liedtke M, Atallah E. Multi-institutional study evaluating clinical outcome with allogeneic hematopoietic stem cell transplantation after blinatumomab in patients with B-cell acute lymphoblastic leukemia: real-world data. Bone Marrow Transplantation 2021, 56: 1998-2004. PMID: 33824440, DOI: 10.1038/s41409-021-01279-w.Peer-Reviewed Original ResearchConceptsOverall survivalCumulative incidenceAllogeneic hematopoietic stem cell transplantationB-cell acute lymphoblastic leukemiaHematopoietic stem cell transplantationAcute lymphocytic leukemia patientsStem cell transplantationAcute lymphoblastic leukemiaLymphocytic leukemia patientsMulti-institutional studyReal-world analysisSevere cGVHDFree survivalClinical outcomesCell transplantationLymphoblastic leukemiaMulti-center dataClinical trialsAlloHCTLeukemia patientsBlinatumomabPatientsSurvivalIncidenceSubsequent salvageChallenges in the Evaluation and Management of Toxicities Arising From Immune Checkpoint Inhibitor Therapy for Patients With Myeloid Malignancies
Shallis RM, Bewersdorf JP, Swoboda DM, Wei W, Gowda L, Prebet T, Halene S, Pillai MM, Parker T, Neparidze N, Podoltsev NA, Seropian S, Sallman DA, Gore SD, Zeidan AM. Challenges in the Evaluation and Management of Toxicities Arising From Immune Checkpoint Inhibitor Therapy for Patients With Myeloid Malignancies. Clinical Lymphoma Myeloma & Leukemia 2021, 21: e483-e487. PMID: 33551344, DOI: 10.1016/j.clml.2021.01.003.Peer-Reviewed Original Research
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-2RemissionHigh 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 countPatientsChallenging the concept of de novo acute myeloid leukemia: Environmental and occupational leukemogens hiding in our midst
Shallis RM, Weiss JJ, Deziel NC, Gore SD. Challenging the concept of de novo acute myeloid leukemia: Environmental and occupational leukemogens hiding in our midst. Blood Reviews 2020, 47: 100760. PMID: 32988660, DOI: 10.1016/j.blre.2020.100760.Peer-Reviewed Original ResearchConceptsAcute myeloid leukemiaDe novo acute myeloid leukemiaNovo acute myeloid leukemiaMyeloid leukemiaRisk of AMLTherapy-related acute myeloid leukemiaParticular chemotherapeutic agentsOccupational exposureIndividual patientsMyeloid neoplasmsGermline predispositionAccidental exposureLeukemogenChemotherapeutic agentsMarrow microenvironmentLeukemiaEnvironmental agentsAcceptable exposure limitsCell acquisitionPatientsExposure limitsExposureInescapable exposureAmbient exposureRiskSpecial considerations in the management of adult patients with acute leukaemias and myeloid neoplasms in the COVID-19 era: recommendations from a panel of international experts
Zeidan AM, Boddu PC, Patnaik MM, Bewersdorf JP, Stahl M, Rampal RK, Shallis R, Steensma DP, Savona MR, Sekeres MA, Roboz GJ, DeAngelo DJ, Schuh AC, Padron E, Zeidner JF, Walter RB, Onida F, Fathi A, DeZern A, Hobbs G, Stein EM, Vyas P, Wei AH, Bowen DT, Montesinos P, Griffiths EA, Verma AK, Keyzner A, Bar-Natan M, Navada SC, Kremyanskaya M, Goldberg AD, Al-Kali A, Heaney ML, Nazha A, Salman H, Luger S, Pratz KW, Konig H, Komrokji R, Deininger M, Cirici BX, Bhatt VR, Silverman LR, Erba HP, Fenaux P, Platzbecker U, Santini V, Wang ES, Tallman MS, Stone RM, Mascarenhas J. Special considerations in the management of adult patients with acute leukaemias and myeloid neoplasms in the COVID-19 era: recommendations from a panel of international experts. The Lancet Haematology 2020, 7: e601-e612. PMID: 32563283, PMCID: PMC7302757, DOI: 10.1016/s2352-3026(20)30205-2.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsAcute leukemiaMyeloid neoplasmsSevere acute respiratory syndrome coronavirus 2Acute respiratory syndrome coronavirus 2Respiratory syndrome coronavirus 2COVID-19 pandemicClinical trial participationSyndrome coronavirus 2Care of patientsPost-infection outcomesGlobal public health crisisHealth care infrastructureInternational expertsAdult patientsPublic health crisisSupportive careCoronavirus 2Trial participationHigh-income countriesOngoing COVID-19 pandemicGeneral populationPatientsHealth care environmentNeoplasmsLeukemiaImmune checkpoint inhibition in myeloid malignancies: Moving beyond the PD-1/PD-L1 and CTLA-4 pathways
Bewersdorf JP, Shallis RM, Zeidan AM. Immune checkpoint inhibition in myeloid malignancies: Moving beyond the PD-1/PD-L1 and CTLA-4 pathways. Blood Reviews 2020, 45: 100709. PMID: 32487480, DOI: 10.1016/j.blre.2020.100709.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsImmune checkpoint inhibitorsMyeloid malignanciesPD-1/PD-L1CTLA-4 pathwayImmune checkpoint inhibitionAcute myeloid leukemiaSafe combination therapyICI therapyImmunologic landscapeCheckpoint inhibitorsDisease coursePD-L1Checkpoint inhibitionMyelodysplastic syndromeCombination therapyMechanisms of resistanceClinical trialsMyeloid leukemiaClinical developmentPotential biomarkersNovel targetPatientsMalignancyTherapyBiomarkersClinical outcomes of older patients with AML receiving hypomethylating agents: a large population-based study in the United States
Zeidan AM, Wang R, Wang X, Shallis RM, Podoltsev NA, Bewersdorf JP, Huntington SF, Neparidze N, Giri S, Gore SD, Davidoff AJ, Ma X. Clinical outcomes of older patients with AML receiving hypomethylating agents: a large population-based study in the United States. Blood Advances 2020, 4: 2192-2201. PMID: 32433746, PMCID: PMC7252544, DOI: 10.1182/bloodadvances.2020001779.Peer-Reviewed Original ResearchConceptsAcute myeloid leukemiaDecitabine-treated patientsTransfusion independenceRed blood cell transfusion independenceLarge population-based studyOlder AML patientsRBC transfusion independenceEnd Results-MedicarePopulation-based studyStandard of careAgent azacitidineMedian survivalOlder patientsIntensive therapyAML patientsClinical outcomesClinical benefitMyeloid leukemiaMortality riskPatientsAzacitidineDecitabineOlder adultsOne-thirdMeaningful differencesIsolated trisomy 11 in patients with acute myeloid leukemia – is the prognosis not as grim as previously thought?*
Bewersdorf JP, Shallis RM, Diadamo A, Gowda L, Podoltsev NA, Siddon A, Zeidan AM. Isolated trisomy 11 in patients with acute myeloid leukemia – is the prognosis not as grim as previously thought?*. Leukemia & Lymphoma 2020, 61: 2254-2257. PMID: 32338096, PMCID: PMC7485109, DOI: 10.1080/10428194.2020.1755858.Peer-Reviewed Original Research