2024
Oral decitabine–cedazuridine versus intravenous decitabine for myelodysplastic syndromes and chronic myelomonocytic leukaemia (ASCERTAIN): a registrational, randomised, crossover, pharmacokinetics, phase 3 study
Garcia-Manero G, McCloskey J, Griffiths E, Yee K, Zeidan A, Al-Kali A, Deeg H, Patel P, Sabloff M, Keating M, Zhu N, Gabrail N, Fazal S, Maly J, Odenike O, Kantarjian H, DeZern A, O'Connell C, Roboz G, Busque L, Buckstein R, Amin H, Randhawa J, Leber B, Shastri A, Dao K, Oganesian A, Hao Y, Keer H, Azab M, Savona M. Oral decitabine–cedazuridine versus intravenous decitabine for myelodysplastic syndromes and chronic myelomonocytic leukaemia (ASCERTAIN): a registrational, randomised, crossover, pharmacokinetics, phase 3 study. The Lancet Haematology 2024, 11: e15-e26. PMID: 38135371, DOI: 10.1016/s2352-3026(23)00338-1.Peer-Reviewed Original ResearchConceptsChronic myelomonocytic leukemiaIntravenous decitabineMyelodysplastic syndromeMyelomonocytic leukemiaOral therapyPrimary endpointAdverse eventsEastern Cooperative Oncology Group performance status 0Treatment cyclesCycle 1Full treatment dosePerformance status 0Treatment-related deathsFrequent adverse eventsSerious adverse eventsPhase 3 studyPhase 3 trialPotential treatment benefitsCommunity-based clinicsAcute myeloid leukemiaNext treatment cycleTreatment of individualsOral decitabineStatus 0Treatment discontinuation
2023
Reclassification of Ascertain (ASTX727-02) Myelodysplastic Syndrome (MDS) Patients: Outcomes Including Clinical Response, Overall Survival (OS), and Leukemia Free Survival (LFS) Based on IPSS-R and IPSS-M Scoring Systems
Garcia-Manero G, McCloskey J, Griffiths E, Zeidan A, Yee K, Al-Kali A, Deeg H, Patel P, Sabloff M, Keating M, Zhu N, Gabrail N, Fazal S, Maly J, Odenike O, Kantarjian H, DeZern A, O'Connell C, Roboz G, Busque L, Buckstein R, Amin H, Randhawa J, Leber B, Lee S, Chan W, Souza S, Sano Y, Keer H, Savona M. Reclassification of Ascertain (ASTX727-02) Myelodysplastic Syndrome (MDS) Patients: Outcomes Including Clinical Response, Overall Survival (OS), and Leukemia Free Survival (LFS) Based on IPSS-R and IPSS-M Scoring Systems. Blood 2023, 142: 4619. DOI: 10.1182/blood-2023-188258.Peer-Reviewed Original ResearchInternational Prognosis Scoring SystemLow-risk MDSHigh-risk MDSLeukemia-free survivalIPSS-R scoreOverall survivalMDS subjectsClinical outcomesPatient outcomesC-indexConcordance indexScoring systemMDS/CMMLMedian overall survivalDifferent risk stratification systemsHarrell's concordance indexMyelodysplastic syndrome patientsHigh-risk populationRisk stratification systemHigh-risk categoryHR categoriesCycle 2Different risk categoriesTreatment discontinuationClinical response
2022
AML-484 First Results of a Phase II Study (STIMULUS-AML1) Investigating Sabatolimab + Azacitidine + Venetoclax in Patients With Newly Diagnosed Acute Myeloid Leukemia (ND AML)
Zeidan A, Westermann J, Kovacsovics T, Assouline S, Schuh A, Kim H, Macias G, Sanford D, Luskin M, Stein E, Malek K, Lyu J, Stegert M, Esteve J. AML-484 First Results of a Phase II Study (STIMULUS-AML1) Investigating Sabatolimab + Azacitidine + Venetoclax in Patients With Newly Diagnosed Acute Myeloid Leukemia (ND AML). Clinical Lymphoma Myeloma & Leukemia 2022, 22: s255. DOI: 10.1016/s2152-2650(22)01303-9.Peer-Reviewed Original ResearchTreatment-related AEsDose-escalation partDose-limiting toxicityIntensive chemotherapyDosage reductionCohort 2Acute myeloid leukemiaDose interruptionFebrile neutropeniaSerious AEsExpansion cohortStudy patientsTreatment discontinuationAdult patientsDurable responsesNeutrophil countTim-3Agent therapyMyelodysplastic syndromePlatelet countSafety profilePatient outcomesMyeloid leukemiaPatientsDay 1Impact of Hypomethylating Agent Use on Hospital and Emergency Room Visits, and Predictors of Early Discontinuation in Patients With Higher-Risk Myelodysplastic Syndromes
Zeidan AM, Joshi N, Kale H, Wang WJ, Corman S, Salimi T, Epstein RS. Impact of Hypomethylating Agent Use on Hospital and Emergency Room Visits, and Predictors of Early Discontinuation in Patients With Higher-Risk Myelodysplastic Syndromes. Clinical Lymphoma Myeloma & Leukemia 2022, 22: 670-679. PMID: 35614009, DOI: 10.1016/j.clml.2022.04.016.Peer-Reviewed Original ResearchConceptsHigh-risk myelodysplastic syndromeHMA therapyPoor performance statusRate of hospitalizationSEER-Medicare databaseMyelodysplastic syndromeER visitsEarly discontinuationPerformance statusEmergency roomOlder agePredictors of discontinuationEmergency room visitsHigh-risk groupHigh economic burdenTreatment discontinuationExcess blastsMore hospitalizationsNew hospitalizationRefractory anemiaRoom visitsHigh riskDiscontinuationMD diagnosisAgent useA Phase 1/2 Study of the Oral Janus Kinase 1 Inhibitors INCB052793 and Itacitinib Alone or in Combination With Standard Therapies for Advanced Hematologic Malignancies
Zeidan AM, Cook RJ, Bordoni R, Berenson JR, Edenfield WJ, Mohan S, Zhou G, Asatiani E, Srinivas N, Savona MR. A Phase 1/2 Study of the Oral Janus Kinase 1 Inhibitors INCB052793 and Itacitinib Alone or in Combination With Standard Therapies for Advanced Hematologic Malignancies. Clinical Lymphoma Myeloma & Leukemia 2022, 22: 523-534. PMID: 35260349, DOI: 10.1016/j.clml.2022.01.012.Peer-Reviewed Original ResearchConceptsAcute myeloid leukemiaPhase 1/2 studyAdvanced hematologic malignanciesMyelodysplastic syndromeHematologic malignanciesObjective responseStandard therapyRefractory acute myeloid leukemiaPhase 2 doseObjective response rateRefractory multiple myelomaPhase 2Lack of efficacyInhibition of JAK1Janus kinasePhase 1Primary endpointTreatment discontinuationAdverse eventsProgressive diseaseDose escalationStudy treatmentMultiple myelomaMyeloid leukemiaDNA methyltransferase inhibitor
2019
Treatment sequence of lenalidomide and hypomethylating agents and the impact on clinical outcomes for patients with myelodysplastic syndromes
Zeidan AM, Klink AJ, McGuire M, Feinberg B. Treatment sequence of lenalidomide and hypomethylating agents and the impact on clinical outcomes for patients with myelodysplastic syndromes. Leukemia & Lymphoma 2019, 60: 2050-2055. PMID: 30636526, DOI: 10.1080/10428194.2018.1551538.Peer-Reviewed Original ResearchConceptsMyelodysplastic syndromeFirst-line useLonger treatment durationAgent azacitidineTreatment discontinuationClinical outcomesMedian timeInsurance disenrollmentUS payersTreatment durationLenalidomidePatientsTreatment sequenceOptimal sequencingSyndromeSurvivalOutcomesDiscontinuationAzacitidineDecitabineDisenrollment