2024
Clinical activity, pharmacokinetics, and pharmacodynamics of oral hypomethylating agents for myelodysplastic syndromes/neoplasms and acute myeloid leukemia: A multidisciplinary review
Haumschild R, Kennerly-Shah J, Barbarotta L, Zeidan A. Clinical activity, pharmacokinetics, and pharmacodynamics of oral hypomethylating agents for myelodysplastic syndromes/neoplasms and acute myeloid leukemia: A multidisciplinary review. Journal Of Oncology Pharmacy Practice 2024, 30: 721-736. PMID: 38509812, PMCID: PMC11118786, DOI: 10.1177/10781552241238979.Peer-Reviewed Original ResearchOral hypomethylating agentsAcute myeloid leukemiaHypomethylating agentsPK-PD profilesPharmacokinetic (PK)-pharmacodynamicMyeloid leukemiaTreatment selectionPK-PDConcentration-time curveIntravenous (IVImprove treatment outcomesCC-486IV decitabineOral azacitidineMaintenance therapySubcutaneous azacitidineNo significant differenceImprove quality of lifeAzacitidineClinical trialsClinical activityTreatment outcomesDisease settingsDecitabineDisease outcome
2022
Cost-Effectiveness of Azacitidine and Ivosidenib in Newly Diagnosed Older, Intensive Chemotherapy-Ineligible Patients with IDH1-Mutant Acute Myeloid Leukemia
Bewersdorf J, Patel K, Goshua G, Shallis R, Podoltsev N, Stahl M, Stempel J, Stein E, Huntington S, Zeidan A. Cost-Effectiveness of Azacitidine and Ivosidenib in Newly Diagnosed Older, Intensive Chemotherapy-Ineligible Patients with IDH1-Mutant Acute Myeloid Leukemia. Blood 2022, 140: 319-321. DOI: 10.1182/blood-2022-158465.Peer-Reviewed Original ResearchPoster: 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. Poster: 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: s125. DOI: 10.1016/s2152-2650(22)00747-9.Peer-Reviewed Original ResearchProspective comparison of outcomes with azacitidine and decitabine in patients with AML ineligible for intensive chemotherapy
Zeidan AM, Fenaux P, Gobbi M, Mayer J, Roboz GJ, Krauter J, Robak T, Kantarjian HM, Novák J, Jedrzejczak WW, Thomas X, Ojeda-Uribe M, Miyazaki Y, Min YH, Yeh SP, Brandwein JM, Gercheva L, Demeter J, Griffiths EA, Yee KWL, Issa JJ, Bewersdorf JP, Keer H, Hao Y, Azab M, Döhner H. Prospective comparison of outcomes with azacitidine and decitabine in patients with AML ineligible for intensive chemotherapy. Blood 2022, 140: 285-289. PMID: 35507690, PMCID: PMC9305088, DOI: 10.1182/blood.2022015832.Peer-Reviewed Original ResearchP582: FIRST RESULTS OF A PHASE II STUDY (STIMULUS‐AML1) INVESTIGATING SABATOLIMAB + AZACITIDINE + VENETOCLAX IN PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA
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. P582: FIRST RESULTS OF A PHASE II STUDY (STIMULUS‐AML1) INVESTIGATING SABATOLIMAB + AZACITIDINE + VENETOCLAX IN PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA. HemaSphere 2022, 6: 481-482. DOI: 10.1097/01.hs9.0000845216.33320.a2.Peer-Reviewed Original ResearchA randomized phase 2 trial of azacitidine with or without durvalumab as first-line therapy for older patients with AML
Zeidan AM, Boss I, Beach C, Copeland WB, Thompson E, Fox BA, Hasle VE, Hellmann A, Taussig D, Tormo M, Voso MT, Cavenagh J, O'Connor T, Previtali A, Rose S, Silverman LR. A randomized phase 2 trial of azacitidine with or without durvalumab as first-line therapy for older patients with AML. Blood Advances 2022, 6: 2219-2229. PMID: 34933333, PMCID: PMC9006260, DOI: 10.1182/bloodadvances.2021006138.Peer-Reviewed Original ResearchConceptsAcute myeloid leukemiaFirst-line therapyOlder patientsDay 1First-line combination therapyTreatment-emergent adverse eventsRandomized phase 2 trialSafety of durvalumabNew safety signalsPD-L1 expressionPhase 2 studyPhase 2 trialDuration of responseOverall response rateDurvalumab 1500Adverse eventsOverall survivalClinical efficacyCombination therapyMyeloid leukemiaSafety signalsTreatment responseCombination treatmentAzacitidineResponse rate
2021
Injectable Hypomethylating Agents for Management of Myelodysplastic Syndromes: Patients’ Perspectives on Treatment
Zeidan AM, Jayade S, Schmier J, Botteman M, Hassan A, Ruiters D, Hill K, Joshi N. Injectable Hypomethylating Agents for Management of Myelodysplastic Syndromes: Patients’ Perspectives on Treatment. Clinical Lymphoma Myeloma & Leukemia 2021, 22: e185-e198. PMID: 34674983, DOI: 10.1016/j.clml.2021.09.009.Peer-Reviewed Original ResearchConceptsMDS patientsAdult MDS patientsMedian patient agePain/discomfortMost MDS patientsOnline cross-sectional surveyDaily activitiesCross-sectional surveyPatient advocacy groupsPatient ageMyelodysplastic syndromeSC administrationSubcutaneous administrationTreatment administrationSC therapyTreatment challengesPatient's perspectiveHypomethylating agentRisk scoreHMA treatmentMD treatmentPatientsAdministrationAzacitidinePainP53 Topic: AS08-Treatment/AS08g-Clinical trials - Phase II-III PHASE 3 VERONA STUDY ASSESSING THE SAFETY AND EFFICACY OF VENETOCLAX WITH AZACITIDINE IN PATIENTS WITH NEWLY DIAGNOSED HIGHER-RISK MYELODYSPLASTIC SYNDROMES
Zeidan A, Garcia J, Fenaux P, Platzbecker U, Miyazaki Y, Xiao Z, Zhou Y, Naqvi K, Kye S, Manero G. P53 Topic: AS08-Treatment/AS08g-Clinical trials - Phase II-III PHASE 3 VERONA STUDY ASSESSING THE SAFETY AND EFFICACY OF VENETOCLAX WITH AZACITIDINE IN PATIENTS WITH NEWLY DIAGNOSED HIGHER-RISK MYELODYSPLASTIC SYNDROMES. Leukemia Research 2021, 108: 106681.52. DOI: 10.1016/j.leukres.2021.106681.52.Peer-Reviewed Original Research
2020
Health-related quality of life (HRQoL) in patients with untreated higher-risk myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), and chronic myelomonocytic leukemia (CMML) receiving glasdegib + azacitidine (AZA).
Wang E, Bell T, Zeidan A, Bhattacharyya H, Kudla A, Chan G, Sekeres M. Health-related quality of life (HRQoL) in patients with untreated higher-risk myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), and chronic myelomonocytic leukemia (CMML) receiving glasdegib + azacitidine (AZA). Journal Of Clinical Oncology 2020, 38: 7527-7527. DOI: 10.1200/jco.2020.38.15_suppl.7527.Peer-Reviewed Original ResearchChronic myelomonocytic leukemiaAcute myeloid leukemiaMyelodysplastic syndromeIntensive chemotherapyGlobal ImpressionAML cohortAML/myelodysplastic syndromeHigh-risk myelodysplastic syndromeMD Anderson Symptom InventoryFirst-line treatment optionLower symptom burdenPhase Ib studyEnd of treatmentQuality of lifeStudy medicationRemission rateOverall survivalSymptom burdenMDS cohortTreatment optionsMyeloid leukemiaMedian numberMyelomonocytic leukemiaGlasdegibAzacitidineClinical 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 differences
2019
Mutant IDH1 Inhibitor Ivosidenib (IVO; AG-120) in Combination with Azacitidine (AZA) for Newly Diagnosed Acute Myeloid Leukemia (ND AML)
DiNardo C, Stein A, Stein E, Fathi A, Frankfurt O, Schuh A, Döhner H, Martinelli G, Raffoux E, Tan P, Zeidan A, de Botton S, Kantarjian H, Stone R, Lam D, Wang X, Gong J, Kapsalis S, Hickman D, Zhang V, Winkler T, Daigle S, Vyas P. Mutant IDH1 Inhibitor Ivosidenib (IVO; AG-120) in Combination with Azacitidine (AZA) for Newly Diagnosed Acute Myeloid Leukemia (ND AML). Clinical Lymphoma Myeloma & Leukemia 2019, 19: s217-s218. DOI: 10.1016/j.clml.2019.07.090.Peer-Reviewed Original ResearchTreatment 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
2016
Hypomethylating Agent Therapy and Survival Among Older Patients with Chronic Myelomonocytic Leukemia in the United States: A Large Population-Based Study
Zeidan A, Hu X, Long J, Wang R, Huntington S, Podoltsev N, Gore S, Ma X, Davidoff A. Hypomethylating Agent Therapy and Survival Among Older Patients with Chronic Myelomonocytic Leukemia in the United States: A Large Population-Based Study. Blood 2016, 128: 394. DOI: 10.1182/blood.v128.22.394.394.Peer-Reviewed Original ResearchChronic myelomonocytic leukemiaMyelodysplastic syndromeSurvival benefitHigh-risk myelodysplastic syndromeDemonstrated survival benefitRetrospective cohort studyRisk myelodysplastic syndromesUse of HMAsAgent azacitidineLack of evidenceCohort studyClinical entityMyelomonocytic leukemiaBiologic evidenceOlder adultsAzacitidineUnited StatesHMAsEnd resultPatientsSyndromeLeukemiaDecitabineEpidemiology
2015
Azacitidine with or without Entinostat for the treatment of therapy‐related myeloid neoplasm: further results of the E1905 North American Leukemia Intergroup study
Prebet T, Sun Z, Ketterling RP, Zeidan A, Greenberg P, Herman J, Juckett M, Smith MR, Malick L, Paietta E, Czader M, Figueroa M, Gabrilove J, Erba HP, Tallman MS, Litzow M, Gore SD, intergroup T. Azacitidine with or without Entinostat for the treatment of therapy‐related myeloid neoplasm: further results of the E1905 North American Leukemia Intergroup study. British Journal Of Haematology 2015, 172: 384-391. PMID: 26577691, PMCID: PMC4794257, DOI: 10.1111/bjh.13832.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntimetabolites, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsAzacitidineBenzamidesDrug Administration ScheduleFemaleHumansKaplan-Meier EstimateLeukemia, Myeloid, AcuteMaleMiddle AgedMyelodysplastic SyndromesNeoplasms, Second PrimaryPyridinesTreatment OutcomeConceptsTherapy-related myeloid neoplasmsMyeloid neoplasmsDe novo MDS/AMLRandomized phase 2 studyCombination of azacitidineLeukemia intergroup studyMedian overall survivalPhase 2 studyMDS/AMLSerious late effectsHistone deacetylase inhibitor entinostatAZA monotherapyCombination armNormalization rateOverall survivalIntergroup studyTreatment of cancerPoor responseLate effectsMedian numberAzacitidinePatientsSingle agentResponse rateConventional treatmentLenalidomide Treatment for Lower Risk Nondeletion 5q Myelodysplastic Syndromes Patients Yields Higher Response Rates When Used Before Azacitidine
Zeidan AM, Ali N, Padron E, Lancet J, List A, Komrokji RS. Lenalidomide Treatment for Lower Risk Nondeletion 5q Myelodysplastic Syndromes Patients Yields Higher Response Rates When Used Before Azacitidine. Clinical Lymphoma Myeloma & Leukemia 2015, 15: 705-710. PMID: 26440749, DOI: 10.1016/j.clml.2015.08.083.Peer-Reviewed Original ResearchConceptsLower-risk myelodysplastic syndromesFirst-line therapyErythropoiesis-stimulating agentsFailure of treatmentTreatment failureInternational Working Group 2006 criteriaResponse rateSecond-line therapyMyelodysplastic syndrome patientsHigh response rateChromosome 5q deletionAzacitidine useHematologic improvementLenalidomide treatmentOverall survivalAnemic patientsMyelodysplastic syndromeSyndrome patientsLarge cohortLenalidomideAzacitidinePatientsLeukemic progressionClinical databaseTherapy
2013
P-124 Application of the French Prognostic Score to assess overall survival in a US-based cohort of patients treated with azacitidine
Zeidan A, Zhuoxin S, Prebet T, Greenberg P, Juckett M, Smith M, Paietta E, Gabrilove J, Erba H, Gore S, Tallman M. P-124 Application of the French Prognostic Score to assess overall survival in a US-based cohort of patients treated with azacitidine. Leukemia Research 2013, 37: s79-s80. DOI: 10.1016/s0145-2126(13)70172-3.Peer-Reviewed Original Research