2019
Real World Outcomes of Adult B-Cell Acute Lymphocytic Leukemia Patients Treated with Inotuzumab Ozogamicin
Badar T, Szabo A, Wadleigh M, Liedtke M, Arslan S, Siebenaller C, Aldoss I, Schultz E, Hefazi M, Litzow M, Kuo E, Wang A, Curran E, Shallis R, Podoltsev N, Balasubramanian S, Yang J, Mattison R, Burkart M, Dinner S, Advani A, Atallah E. Real World Outcomes of Adult B-Cell Acute Lymphocytic Leukemia Patients Treated with Inotuzumab Ozogamicin. Blood 2019, 134: 1302. DOI: 10.1182/blood-2019-124882.Peer-Reviewed Original ResearchMedian overall survivalDuration of responseAllo-HCTOverall survivalAcute lymphocytic leukemiaTyrosine kinase inhibitorsComplete remissionB cellsInotuzumab ozogamicinAdverse eventsRefractory B-cell acute lymphocytic leukaemiaJazz PharmaceuticalsResponse rateB-cell acute lymphocytic leukemiaMinimal residual disease negativityAllogeneic stem cell transplantationAdvisory CommitteeB-cell acute lymphocytic leukemia patientsEfficacy of iNOGenentech/RocheIncomplete count recoveryMedian response durationVeno-occlusive diseaseOutcomes of patientsKaplan-Meier methodReal World Outcomes of Adult B-Cell Acute Lymphocytic Leukemia Patients Treated with Blinatumomab
Badar T, Szabo A, Advani A, Wadleigh M, Arslan S, Khan M, Aldoss I, Siebenaller C, Schultz E, Hefazi M, Shallis R, Yurkiewicz I, Podoltsev N, Patel A, Curran E, Balasubramanian S, Yang J, Mattison R, Burkart M, Dinner S, Liedtke M, Litzow M, Atallah E. Real World Outcomes of Adult B-Cell Acute Lymphocytic Leukemia Patients Treated with Blinatumomab. Blood 2019, 134: 3809. DOI: 10.1182/blood-2019-125466.Peer-Reviewed Original ResearchCytokine release syndromeDuration of responseMinimal residual diseaseMedian overall survivalMedian DOROverall survivalTyrosine kinase inhibitorsAllo-HCTMRD negativityComplete remissionB cellsRR diseaseClinical trialsJazz PharmaceuticalsAcute lymphocytic leukemia blastsPhiladelphia chromosome-positive diseaseAllogeneic stem cell transplantationAdvisory CommitteePositive cytotoxic T cellsB-cell acute lymphocytic leukemia patientsCR/CRiEfficacy of blinatumomabG3-4 toxicitiesGenentech/RocheIncomplete count recoveryThe Impact of the 2011 European Leukemianet (ELN) Guidelines for Philadelphia Chromosome-Negative Classical Myeloproliferative Neoplasms on Therapeutic Phlebotomy and Hydroxyurea Use in Patients with Polycythemia Vera and Essential Thrombocythemia
Podoltsev N, Wang R, Shallis R, Huntington S, Zeidan A, Gore S, Davidoff A, Ma X. The Impact of the 2011 European Leukemianet (ELN) Guidelines for Philadelphia Chromosome-Negative Classical Myeloproliferative Neoplasms on Therapeutic Phlebotomy and Hydroxyurea Use in Patients with Polycythemia Vera and Essential Thrombocythemia. Blood 2019, 134: 2125. DOI: 10.1182/blood-2019-127563.Peer-Reviewed Original ResearchTherapeutic phlebotomyPopulation-based cohortPV patientsELN guidelinesET patientsPolycythemia veraEssential thrombocythemiaGuideline publicationCelgene CorporationCytoreductive therapyHU useMonthly proportionBoehringer IngelheimLarge population-based cohortAdvisory CommitteeDaiichi SankyoOlder adultsEuropean LeukemiaNet guidelinesEnd Results-MedicareProportion of patientsHealthcare Common Procedure Coding System codesPopulation-based studyPatterns of careTreatment of patientsPart D claimsClinical Effectiveness of Hypomethylating Agents (HMAs) and Lenalidomide (Len) in Older Patients (pts) with Refractory Anemia with Ring Sideroblasts: A Large Population-Based Study in the United States (US)
Wang X, Wang R, Zhang C, Zeidan A, Podoltsev N, Huntington S, Gore S, Davidoff A, Ma X. Clinical Effectiveness of Hypomethylating Agents (HMAs) and Lenalidomide (Len) in Older Patients (pts) with Refractory Anemia with Ring Sideroblasts: A Large Population-Based Study in the United States (US). Blood 2019, 134: 4748. DOI: 10.1182/blood-2019-128821.Peer-Reviewed Original ResearchPopulation-based studyLR-MDSMedian overall survivalOverall survivalClinical effectivenessHypomethylating agentCelgene CorporationMedian durationRed blood cellsMedian timeRing sideroblastsBoehringer IngelheimAdvisory CommitteeLarge population-based studyDaiichi SankyoOlder adultsAbnormal erythroid precursorsTransfusion independence rateEnd Results-MedicareHigh-risk MDSErythropoiesis-stimulating agentsKaplan-Meier statisticsComparative clinical effectivenessEnd of studyPart D coveragePhase 1b Study of the Epichaperome Inhibitor PU-H71 Administered Orally with Ruxolitinib Continuation for the Treatment of Patients with Myelofibrosis
Pemmaraju N, Gundabolu K, Pettit K, Talpaz M, Podoltsev N, Schiller G, Eisenberg P, Youssoufian H, Duggan S, Wallner B, Verstovsek S. Phase 1b Study of the Epichaperome Inhibitor PU-H71 Administered Orally with Ruxolitinib Continuation for the Treatment of Patients with Myelofibrosis. Blood 2019, 134: 4178. DOI: 10.1182/blood-2019-130310.Peer-Reviewed Original ResearchPhase 1b studyJazz PharmaceuticalsExpansion cohortPU-H71Daiichi SankyoMyeloproliferative Neoplasm Symptom Assessment Form Total Symptom ScoreInternational Working Group-Myeloproliferative Neoplasms ResearchPeripheral blood mononuclear cellsAdvisory CommitteeDose-expansion cohortsHigh-risk myelofibrosisPhase 2 doseSerum cytokine profilesBaseline platelet countDose-ranging studySpeakers bureauVentricular ejection fractionAST/ALTDose-escalation designTotal symptom scoreBlood mononuclear cellsDisease-related symptomsTreatment of patientsBone marrow histologyPost-PV myelofibrosisPatterns of Care and Clinical Outcomes with 7+3 Induction Chemotherapy for Patients (pts) with Acute Myeloid Leukemia (AML) in the United States (US): A Large Population-Based Study
Zeidan A, Podoltsev N, Wang X, Bewersdorf J, Shallis R, Huntington S, Neparidze N, Giri S, Gore S, Ma X, Davidoff A, Wang R. Patterns of Care and Clinical Outcomes with 7+3 Induction Chemotherapy for Patients (pts) with Acute Myeloid Leukemia (AML) in the United States (US): A Large Population-Based Study. Blood 2019, 134: 116. DOI: 10.1182/blood-2019-126643.Peer-Reviewed Original ResearchBone marrow aspirate/biopsyHigh-volume hospitalsAcute myeloid leukemiaMedium-volume hospitalsAML ptsInduction chemotherapyIntensive care unitAnti-infective medicationsAnti-viral medicationInpatient stayCelgene CorporationAntifungal prophylaxisHospital deathVolume hospitalsHospital volumeMechanical ventilationLarge population-based retrospective cohort studyPopulation-based retrospective cohort studyCytarabine-based induction chemotherapyBoehringer IngelheimAdvisory CommitteeLarge population-based studyDaiichi SankyoInduction-related mortalityMedium-volume institutionsClinical Outcomes of Older Patients (pts) with Acute Myeloid Leukemia (AML) Receiving Hypomethylating Agents (HMAs): A Large Population-Based Study in the United States
Zeidan A, Wang R, Wang X, Shallis R, Podoltsev N, Bewersdorf J, Huntington S, Neparidze N, Giri S, Gore S, Davidoff A, Ma X. Clinical Outcomes of Older Patients (pts) with Acute Myeloid Leukemia (AML) Receiving Hypomethylating Agents (HMAs): A Large Population-Based Study in the United States. Blood 2019, 134: 646. DOI: 10.1182/blood-2019-127398.Peer-Reviewed Original ResearchRBC transfusion dependenceAcute myeloid leukemiaMedian overall survivalTransfusion independenceOverall survivalTransfusion dependenceHypomethylating agentCelgene CorporationHMA initiationIntensive chemotherapyOS probabilityMedian timeMultivariable analysisMultivariable Cox proportional hazards modelsBoehringer IngelheimAdvisory CommitteeCox proportional hazards modelDaiichi SankyoChemotherapy-related hospitalizationMo of diagnosisRBC transfusion independenceImproved overall survivalClinical trial evidenceInferior overall survivalWorse overall survivalIncidence and Risk Factors of Second Malignancies Among Medicare Beneficiaries with Newly-Diagnosed Philadelphia Chromosome-Negative Classical Myeloproliferative Neoplasms Receiving Cytoreductive Therapy with Hydroxyurea
Wang R, Shallis R, Huntington S, Zeidan A, Gore S, Davidoff A, Ma X, Podoltsev N. Incidence and Risk Factors of Second Malignancies Among Medicare Beneficiaries with Newly-Diagnosed Philadelphia Chromosome-Negative Classical Myeloproliferative Neoplasms Receiving Cytoreductive Therapy with Hydroxyurea. Blood 2019, 134: 330. DOI: 10.1182/blood-2019-127568.Peer-Reviewed Original ResearchMyeloid hematological malignanciesHU usersPopulation-based studyHematological malignanciesCumulative incidenceCelgene CorporationMPN diagnosisCytoreductive therapySolid malignanciesGray's testPolycythemia veraMPN patientsEssential thrombocythemiaContinuous Part D coverageBoehringer IngelheimAdvisory CommitteeLarge population-based studyDaiichi SankyoImpact of hydroxyureaRetrospective cohort studyElixhauser comorbidity scorePV/ET myelofibrosisRisk regression modelsSAS version 9.4Part D coverageThe 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 recoveryLandmark Response and Survival Analyses from 102 MDS and CMML Patients Treated with Guadecitabine in a Phase 2 Study Showing That Maximum Response and Survival Is Best Achieved with Adequate Treatment Duration
Savona M, Kantarjian H, Roboz G, O'Connell C, Walsh K, Tibes R, Yee K, Stock W, Griffiths E, Jabbour E, Lunin S, Rosenblat T, Podoltsev N, Issa J, Su X, Azab M, Garcia-Manero G. Landmark Response and Survival Analyses from 102 MDS and CMML Patients Treated with Guadecitabine in a Phase 2 Study Showing That Maximum Response and Survival Is Best Achieved with Adequate Treatment Duration. Blood 2019, 134: 2957. DOI: 10.1182/blood-2019-129962.Peer-Reviewed Original ResearchMDS/CMML patientsMDS/CMMLPhase 2 studyObjective responseCMML patientsSurvival benefitClinical trialsMedian OSMyelodysplastic syndromeAstex PharmaceuticalsSurvival analysisTreatment discontinuationHematological improvementPartial responseComplete responseEarly progressionOtsuka PharmaceuticalDaiichi SankyoLandmark analysisHMA treatmentLandmark responsesCycle 4Prospective phase 2 studyBoehringer IngelheimAdvisory Committee
2018
Characteristics, Treatment Patterns and Outcomes Among Newly Diagnosed Patients (pts) with Acute Myeloid Leukemia (AML) Who Present with Hyperleukocytosis: Findings from a Large International Patient Cohort
Stahl M, Wei W, Montesinos P, Lengline E, Shallis R, Neukirchen J, Bhatt V, Sekeres M, Fathi A, Konig H, Luger S, Khan I, Roboz G, Cluzeau T, Martínez-Cuadron D, Raffoux E, Germing U, Umakanthan J, Mukherjee S, Brunner A, Miller A, McMahon C, Ritchie E, Rodríguez-Veiga R, Itzykson R, Boluda B, Rabian F, Tormo M, Cruz E, Rabinovich E, Yoo B, Podoltsev N, Gore S, Zeidan A. Characteristics, Treatment Patterns and Outcomes Among Newly Diagnosed Patients (pts) with Acute Myeloid Leukemia (AML) Who Present with Hyperleukocytosis: Findings from a Large International Patient Cohort. Blood 2018, 132: 4040. DOI: 10.1182/blood-2018-99-112974.Peer-Reviewed Original ResearchWhite blood cell countMedian overall survivalAcute myeloid leukemiaHematopoietic stem cell transplantIntensive chemotherapyTumor lysis syndromeOverall survivalTime of presentationComplete remissionAstex PharmaceuticalsSpeakers bureauPartial remissionTreatment patternsDaiichi SankyoJazz PharmaceuticalsCleveland Clinic Taussig Cancer InstituteJanssen PharmaceuticalsMedian white blood cell countHigher white blood cell countCelgene CorporationLong-term clinical outcomesAdvisory CommitteeImpact of leukapheresisIncomplete count recoveryMDS International FoundationOutcomes of Patients with Newly-Diagnosed Acute Myeloid Leukemia and Hyperleukocytosis Who Did Not Undergo Intensive Chemotherapy: Results from a Large International Database
Shallis R, Stahl M, Wei W, Montesinos P, Lengline E, Neukirchen J, Bhatt V, Sekeres M, Fathi A, Konig H, Luger S, Khan I, Roboz G, Cluzeau T, Martínez-Cuadron D, Raffoux E, Germing U, Umakanthan J, Mukherjee S, Brunner A, Miller A, McMahon C, Ritchie E, Rodríguez-Veiga R, Itzykson R, Boluda B, Rabian F, Tormo M, Cruz E, Podoltsev N, Gore S, Zeidan A. Outcomes of Patients with Newly-Diagnosed Acute Myeloid Leukemia and Hyperleukocytosis Who Did Not Undergo Intensive Chemotherapy: Results from a Large International Database. Blood 2018, 132: 3999. DOI: 10.1182/blood-2018-99-119755.Peer-Reviewed Original ResearchTumor lysis syndromeIntensive chemotherapyIntensive care unitOverall survivalClinical evidenceAstex PharmaceuticalsSpeakers bureauDaiichi SankyoMedian OSWorse OSAML patientsPlatelet countEastern Cooperative Oncology Group performance statusJazz PharmaceuticalsCleveland Clinic Taussig Cancer InstituteJanssen PharmaceuticalsOne-year OS probabilityCelgene CorporationAdvisory CommitteeMDS International FoundationPoor-risk AMLBest supportive careLow-dose cytarabineMedian overall survivalOutcomes of patientsUpdated Results from a Phase 1 Study of Gilteritinib in Combination with Induction and Consolidation Chemotherapy in Subjects with Newly Diagnosed Acute Myeloid Leukemia (AML)
Pratz K, Cherry M, Altman J, Cooper B, Cruz J, Jurcic J, Levis M, Lin T, Perl A, Podoltsev N, Schiller G, Liu C, Bahceci E. Updated Results from a Phase 1 Study of Gilteritinib in Combination with Induction and Consolidation Chemotherapy in Subjects with Newly Diagnosed Acute Myeloid Leukemia (AML). Blood 2018, 132: 564. DOI: 10.1182/blood-2018-99-110975.Peer-Reviewed Original ResearchAcute myeloid leukemiaClinical trial workSingle-agent maintenance therapyDose-expansion cohortsSafety/tolerabilityFms-like tyrosine kinase 3Phase 1 studyMaintenance therapyAdverse eventsCRC ratesExpansion doseAstellas PharmaFebrile neutropeniaIntensive chemotherapyDay cohortDose escalationDay 1Serious drug-related adverse eventsDrug-related adverse eventsExperienced dose-limiting toxicityHigh-dose cytarabine consolidationMedian disease-free survivalRefractory acute myeloid leukemiaWhite blood cell countAdvisory Committee