2023
Validation of the Composite Complete Response (cCR) Definitions in the International Working Group (IWG) 2023 Criteria in Patients (Pts) with Higher-Risk Myelodysplastic Syndromes/Neoplasms (HR-MDS) Treated with Hypomethylating Agents (HMA) - a Large, Multicenter, Retrospective Analysis from the Validate Database
Bewersdorf J, Kewan T, Blaha O, Stahl M, Al Ali N, DeZern A, Sekeres M, Uy G, Carraway H, Desai P, Griffiths E, Stein E, Brunner A, McMahon C, Zeidner J, Savona M, Stempel J, Chandhok N, Logothetis C, Roboz G, Rolles B, Wang E, Harris A, Amaya M, Hawkins H, Grenet J, Shallis R, Xie Z, Maciejewski J, Sallman D, Della Porta M, Komrokji R, Zeidan A. Validation of the Composite Complete Response (cCR) Definitions in the International Working Group (IWG) 2023 Criteria in Patients (Pts) with Higher-Risk Myelodysplastic Syndromes/Neoplasms (HR-MDS) Treated with Hypomethylating Agents (HMA) - a Large, Multicenter, Retrospective Analysis from the Validate Database. Blood 2023, 142: 324. DOI: 10.1182/blood-2023-180299.Peer-Reviewed Original ResearchImproved OSHypomethylating agentHMA initiationMedian OSResponse assessmentTP53 mutationsResponse definitionsPartial hematologic recoveryPredictors of OSMultivariable Cox modelBone marrow blastsKaplan-Meier analysisLog-rank testOverall response rateEfficacy of therapyMultivariable regression modelsReal-world analysisAllo-HCTBM assessmentBM evaluationHemoglobin thresholdHematologic recoveryMarrow blastsMedian durationMedian ageClassification, risk stratification and response assessment in myelodysplastic syndromes/neoplasms (MDS): A state-of-the-art report on behalf of the International Consortium for MDS (icMDS)
Stahl M, Bewersdorf J, Xie Z, Porta M, Komrokji R, Xu M, Abdel-Wahab O, Taylor J, Steensma D, Starczynowski D, Sekeres M, Sanz G, Sallman D, Roboz G, Platzbecker U, Patnaik M, Padron E, Odenike O, Nimer S, Nazha A, Majeti R, Loghavi S, Little R, List A, Kim T, Hourigan C, Hasserjian R, Halene S, Griffiths E, Gore S, Greenberg P, Figueroa M, Fenaux P, Efficace F, DeZern A, Daver N, Churpek J, Carraway H, Buckstein R, Brunner A, Boultwood J, Borate U, Bejar R, Bennett J, Wei A, Santini V, Savona M, Zeidan A. Classification, risk stratification and response assessment in myelodysplastic syndromes/neoplasms (MDS): A state-of-the-art report on behalf of the International Consortium for MDS (icMDS). Blood Reviews 2023, 62: 101128. PMID: 37704469, DOI: 10.1016/j.blre.2023.101128.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsInternational consensus classificationResponse assessmentWorld Health Organization classificationPatient-centered careRisk assessment toolClinical outcomesRisk stratificationOrganization classificationCentered careTherapeutic benefitTherapeutic outcomesConsensus classificationResponse criteriaInternational ConsortiumNeoplasmsLife assessmentAssessment toolOutcomesReportAssessmentPrognosticationCareStandardising acute myeloid leukaemia classification systems: a perspective from a panel of international experts
Shallis R, Daver N, Altman J, Komrokji R, Pollyea D, Badar T, Bewersdorf J, Bhatt V, de Botton S, de la Fuente Burguera A, Carraway H, Desai P, Dillon R, Duployez N, El Chaer F, Fathi A, Freeman S, Gojo I, Grunwald M, Jonas B, Konopleva M, Lin T, Mannis G, Mascarenhas J, Michaelis L, Mims A, Montesinos P, Pozdnyakova O, Pratz K, Schuh A, Sekeres M, Smith C, Stahl M, Subklewe M, Uy G, Voso M, Walter R, Wang E, Zeidner J, Žučenka A, Zeidan A. Standardising acute myeloid leukaemia classification systems: a perspective from a panel of international experts. The Lancet Haematology 2023, 10: e767-e776. PMID: 37572683, DOI: 10.1016/s2352-3026(23)00159-x.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsAcute myeloid leukemiaMyeloid leukemiaClinical trial eligibilityInternational consensus classificationHeath care providersHealth care providersTrial eligibilityClassification systemResponse assessmentDisease definitionConsensus classificationPatientsDrug developmentLeukemiaConsistent management strategiesInternational expertsRegulatory pathwaysProvidersHematopathologistsCliniciansDiagnosisEvolution of Therapeutic Benefit Measurement Criteria in Myelodysplastic Syndromes/Neoplasms
Stempel J, Xie Z, Bewersdorf J, Stahl M, Zeidan A. Evolution of Therapeutic Benefit Measurement Criteria in Myelodysplastic Syndromes/Neoplasms. The Cancer Journal 2023, 29: 203-211. PMID: 37195777, DOI: 10.1097/ppo.0000000000000666.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsInternational Working Group response criteriaResponse criteriaPhase III clinical trialsIWG 2006 criteriaRisk of progressionPatient-focused outcomesClonal myeloid neoplasmsAcute myeloid leukemiaTherapeutic response assessmentPatient-centered responsesNovel drug developmentHematologic recoveryProgressive cytopeniasClinical trialsIWG criteriaLong-term benefitsMyeloid leukemiaIneffective hematopoiesisMyeloid neoplasmsResponse assessmentDisease severityHow I treat AML incorporating the updated classifications and guidelines
Chaer F, Hourigan C, Zeidan A. How I treat AML incorporating the updated classifications and guidelines. Blood 2023, 141: 2813-2823. PMID: 36758209, PMCID: PMC10447497, DOI: 10.1182/blood.2022017808.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsAcute myeloid leukemiaClinical treatment guidelinesDaily clinical practiceInternational consensus classificationSomatic genetic abnormalitiesGerm-line predispositionWorld Health OrganizationTreatment guidelinesEuropean LeukemiaNetRisk stratificationHematologic malignanciesMyeloid leukemiaNovel therapiesMyeloid neoplasmsResponse assessmentClinical practiceNew treatmentsAML biologyConsensus classificationGenetic abnormalitiesTesting guidelinesHealth OrganizationGenetic driversRecent updatesTreatment
2020
Wide variation in use and interpretation of gene mutation profiling panels among health care providers of patients with myelodysplastic syndromes: results of a large web-based survey
Pine AB, Chokr N, Stahl M, Steensma DP, Sekeres MA, Litzow MR, Luger SM, Stone RM, Greenberg PL, Bejar R, Bewersdorf JP, Gore SD, Zeidan AM. Wide variation in use and interpretation of gene mutation profiling panels among health care providers of patients with myelodysplastic syndromes: results of a large web-based survey. Leukemia & Lymphoma 2020, 61: 1455-1464. PMID: 32026740, DOI: 10.1080/10428194.2020.1723013.Peer-Reviewed Original ResearchConceptsMyelodysplastic syndromeRisk stratificationMolecular profilingNext-generation sequencingWeb-based surveyRole of NGSManagement of patientsUtility of NGSEvidence-based guidelinesHealth care providersLarge web-based surveyMDS patientsPractice patternsTreatment decisionsCare providersResponse assessmentProviders' beliefsPatientsInstitutional guidelinesGene mutationsDiagnosisSyndromeTesting logisticsInterpretation of resultsWide variation
2019
The VITAL Trial: Phase II Trial of Vosaroxin and Infusional Cytarabine for Frontline Treatment of acute Myeloid Leukemia
Strickland S, Podoltsev N, Mohan S, Zeidan A, Childress M, Ayers G, Byrne M, Gore S, Stuart R, Savona M. The VITAL Trial: Phase II Trial of Vosaroxin and Infusional Cytarabine for Frontline Treatment of acute Myeloid Leukemia. Blood 2019, 134: 180. DOI: 10.1182/blood-2019-131520.Peer-Reviewed Original ResearchIntermediate-dose cytarabineCR/CRiAdverse eventsOverall survivalInfusional cytarabineOral mucositisCardiac toxicityResponse assessmentCelgene CorporationAML ptsOral cryotherapyBoehringer IngelheimMedian ageCR rateDay 1Large randomized phase 3 trialsTwo-stage phase II studyClass anticancer quinolone derivativeCR/CRi rateRandomized phase 3 trialHematopoietic stem cell transplantAdvisory CommitteeDaiichi SankyoAcute cardiac toxicityIncomplete count recovery