2024
Perioperative Modified FOLFIRINOX for Resectable Pancreatic Cancer
Cecchini M, Salem R, Robert M, Czerniak S, Blaha O, Zelterman D, Rajaei M, Townsend J, Cai G, Chowdhury S, Yugawa D, Tseng R, Arbelaez C, Jiao J, Shroyer K, Thumar J, Kortmansky J, Zaheer W, Fischbach N, Persico J, Stein S, Khan S, Cha C, Billingsley K, Kunstman J, Johung K, Wiess C, Muzumdar M, Spickard E, Aushev V, Laliotis G, Jurdi A, Liu M, Escobar-Hoyos L, Lacy J. Perioperative Modified FOLFIRINOX for Resectable Pancreatic Cancer. JAMA Oncology 2024, 10: 1027-1035. PMID: 38900452, PMCID: PMC11190830, DOI: 10.1001/jamaoncol.2024.1575.Peer-Reviewed Original ResearchProgression-free survivalPancreatic ductal adenocarcinomaOverall survivalCtDNA levelsPhase 2 nonrandomized controlled trialAnalysis of circulating tumor DNAMedian progression-free survivalResectable pancreatic ductal adenocarcinomaControlled trialsAssess surgical candidacyBaseline ctDNA levelModified 5-fluorouracilResectable pancreatic cancerPancreatic protocol computed tomographyAssociated with recurrenceTumor molecular featuresAggressive malignant tumorKaplan-Meier estimatesRandomized clinical trialsStandard of careCtDNA-positivePreoperative cyclesNonrandomized controlled trialsUnresectable diseaseModified FOLFIRINOXA Bayesian platform trial design with hybrid control based on multisource exchangeability modelling
Wei W, Blaha O, Esserman D, Zelterman D, Kane M, Liu R, Lin J. A Bayesian platform trial design with hybrid control based on multisource exchangeability modelling. Statistics In Medicine 2024, 43: 2439-2451. PMID: 38594809, PMCID: PMC11325877, DOI: 10.1002/sim.10077.Peer-Reviewed Original Research
2023
AKT/mTOR signaling modulates resistance to endocrine therapy and CDK4/6 inhibition in metastatic breast cancers
Abu-Khalaf M, Alex Hodge K, Hatzis C, Baldelli E, El Gazzah E, Valdes F, Sikov W, Mita M, Denduluri N, Murphy R, Zelterman D, Liotta L, Dunetz B, Dunetz R, Petricoin E, Pierobon M. AKT/mTOR signaling modulates resistance to endocrine therapy and CDK4/6 inhibition in metastatic breast cancers. Npj Precision Oncology 2023, 7: 18. PMID: 36797347, PMCID: PMC9935518, DOI: 10.1038/s41698-023-00360-5.Peer-Reviewed Original ResearchEndocrine therapyProgressive diseaseCDK4/6 inhibitionImmune cellsTumor epitheliumOpen-label multicenter clinical trialMetastatic breast cancer patientsPI3K/AKT/mTOR activationFirst-line treatmentMetastatic breast cancerBreast cancer patientsAkt/mTOR activationMulticenter clinical trialAkt/mTORMBC patientsCancer patientsPredictive markerClinical trialsDisease progressionBreast cancerTreatment selectionTissue biopsiesPatientsNumber of FDAMTOR activationImplicit and Explicit Dehumanization of Older Family Members: Novel Determinants of Elder Abuse Proclivity
Chang E, Monin J, Isenberg N, Zelterman D, Levy B. Implicit and Explicit Dehumanization of Older Family Members: Novel Determinants of Elder Abuse Proclivity. Stigma And Health 2023, 8: 40-48. PMID: 37092028, PMCID: PMC10120856, DOI: 10.1037/sah0000370.Peer-Reviewed Original ResearchExplicit dehumanizationElder abuseSelf-reported factorsOlder personsPsychological factorsOlder family membersCare-recipient healthDehumanizationFamily caregiversCurrent studyCaregiver burdenAbuseMost researchCaregiversProclivityWeb-based surveyRelevant covariatesPersonsCaregiver-based interventionsFamily membersVictimsHealthInterventionRelianceNovel determinant
2022
Regression methods for the appearances of extremes in climate data
Yu C, Blaha O, Kane M, Wei W, Esserman D, Zelterman D. Regression methods for the appearances of extremes in climate data. Environmetrics 2022, 33 DOI: 10.1002/env.2764.Peer-Reviewed Original ResearchHandbook of Statistical Methods for Randomized Controlled Clinical Trials
Zelterman D. Handbook of Statistical Methods for Randomized Controlled Clinical Trials. Technometrics 2022, 64: 424-425. DOI: 10.1080/00401706.2022.2091872.Peer-Reviewed Original ResearchBayesian local exchangeability design for phase II basket trials
Liu Y, Kane M, Esserman D, Blaha O, Zelterman D, Wei W. Bayesian local exchangeability design for phase II basket trials. Statistics In Medicine 2022, 41: 4367-4384. PMID: 35777367, PMCID: PMC10279458, DOI: 10.1002/sim.9514.Peer-Reviewed Original ResearchApplied Multivariate Statistics with R
Zelterman D. Applied Multivariate Statistics with R. Statistics For Biology And Health 2022 DOI: 10.1007/978-3-031-13005-2.Peer-Reviewed Original ResearchLinear algebraStatistical applicationsReal data setsMathematical derivationTime series modelsMultivariate statisticsR implementationNormal distributionTheoretical derivationSeries modelsPractical examplesStatisticsDerivationFactor methodAlgebraProgram RLarge dataData setsGraphical displayAnalytical methodZeltermanLinear regression
2021
Dehumanization of Older Family Members: Novel Determinants of Elder Abuse Proclivity by Caregivers
Chang E, Monin J, Zelterman D, Isenberg N, Levy B. Dehumanization of Older Family Members: Novel Determinants of Elder Abuse Proclivity by Caregivers. Innovation In Aging 2021, 5: 322-322. PMCID: PMC8680248, DOI: 10.1093/geroni/igab046.1250.Peer-Reviewed Original ResearchExplicit dehumanizationDenial of humannessFamily caregiversCaregiver burdenSelf-reported factorsCaregiver Abuse ScreenAge stereotypesAbuse perpetrationOlder personsPsychological factorsOlder family membersCare-recipient healthDehumanizationElder abuseAbuse ScreenCaregiversCurrent studyMost researchProclivityAbuseRelevant covariatesPersonsFamily membersPerpetrationHumannessStructural and Individual Ageism Predicts Elder Abuse Proclivity and Perpetration
Chang E, Monin J, Zelterman D, Levy B. Structural and Individual Ageism Predicts Elder Abuse Proclivity and Perpetration. Innovation In Aging 2021, 5: 89-89. PMCID: PMC8680997, DOI: 10.1093/geroni/igab046.338.Peer-Reviewed Original ResearchImpact of Structural Ageism on Greater Violence Against Older Persons: A Cross-National Study of 56 Countries
Chang E, Monin J, Zelterman D, Levy B. Impact of Structural Ageism on Greater Violence Against Older Persons: A Cross-National Study of 56 Countries. Innovation In Aging 2021, 5: 181-181. PMCID: PMC8969772, DOI: 10.1093/geroni/igab046.683.Peer-Reviewed Original ResearchViolence prevention policiesTypes of violenceWorld Values SurveyPolitical rightsAbstract ViolenceTypes of prejudiceNational policyValues SurveyStructural driversViolenceSocial normsOlder personsPrevention policiesAgeismNegative attitudesPolicyNational studyStigma literatureCountriesPublic healthUnexplored linkRightsPrejudiceNormsPersonsUnified exact design with early stopping rules for single arm clinical trials with multiple endpoints
Wei W, Esserman D, Kane M, Zelterman D. Unified exact design with early stopping rules for single arm clinical trials with multiple endpoints. Statistical Methods In Medical Research 2021, 30: 1575-1588. PMID: 34159859, PMCID: PMC8959087, DOI: 10.1177/09622802211013062.Peer-Reviewed Original ResearchA Phase I Study of APX005M and Cabiralizumab with or without Nivolumab in Patients with Melanoma, Kidney Cancer, or Non–Small Cell Lung Cancer Resistant to Anti-PD-1/PD-L1
Weiss SA, Djureinovic D, Jessel S, Krykbaeva I, Zhang L, Jilaveanu L, Ralabate A, Johnson B, Levit NS, Anderson G, Zelterman D, Wei W, Mahajan A, Trifan O, Bosenberg M, Kaech SM, Perry CJ, Damsky W, Gettinger S, Sznol M, Hurwitz M, Kluger HM. A Phase I Study of APX005M and Cabiralizumab with or without Nivolumab in Patients with Melanoma, Kidney Cancer, or Non–Small Cell Lung Cancer Resistant to Anti-PD-1/PD-L1. Clinical Cancer Research 2021, 27: 4757-4767. PMID: 34140403, PMCID: PMC9236708, DOI: 10.1158/1078-0432.ccr-21-0903.Peer-Reviewed Original ResearchConceptsAnti-PD-1/PD-L1Non-small cell lung cancerCell lung cancerRenal cell carcinomaPD-L1Lung cancerDisease progressionCommon treatment-related adverse eventsPD-1/PD-L1 inhibitorsTreatment-related adverse eventsPhase 2 doseSubstantial clinical challengeUnconfirmed partial responseDose-limiting toxicityPD-L1 inhibitorsPhase I trialDose-escalation designPro-inflammatory cytokinesMultiple tumor typesAsymptomatic elevationStable diseaseIntolerable toxicityAdverse eventsMedian durationPartial responseImpact of structural ageism on greater violence against older persons: a cross-national study of 56 countries
Chang ES, Monin JK, Zelterman D, Levy BR. Impact of structural ageism on greater violence against older persons: a cross-national study of 56 countries. BMJ Open 2021, 11: e042580. PMID: 33986041, PMCID: PMC8126306, DOI: 10.1136/bmjopen-2020-042580.Peer-Reviewed Original ResearchConceptsGreater violenceMadrid International PlanTypes of violencePrevalence of violenceHuman rights protectionCross-national studyPolitical rightsTypes of prejudiceNational policyViolence dataWorld BankNational pollsViolenceUnited NationsSocial normsRights protectionOlder personsInternational PlanAgeismCountriesNegative attitudesStigma measuresPollsPolicyPrevalence rates
2020
Blast MRD AML-1 Trial: Blockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia (AML) 1- an Investigator-Initiated, CTEP-Sponsored, Randomized Phase 2 Study of the Anti-PD-1 Antibody Pembrolizumab in Combination with Conventional Intensive Chemotherapy (IC) As Frontline Therapy in Patients with Acute Myeloid Leukemia (AML)
Zeidan A, Boddu P, Wood B, Zelterman D, Little R, Ivy S, Caldwell A, Sanchez-Espiridion B, Alatrash G, Sharon E, Radich J. Blast MRD AML-1 Trial: Blockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia (AML) 1- an Investigator-Initiated, CTEP-Sponsored, Randomized Phase 2 Study of the Anti-PD-1 Antibody Pembrolizumab in Combination with Conventional Intensive Chemotherapy (IC) As Frontline Therapy in Patients with Acute Myeloid Leukemia (AML). Blood 2020, 136: 15. DOI: 10.1182/blood-2020-139668.Peer-Reviewed Original ResearchMRD-negative complete responsesAcute myeloid leukemiaMinimal residual diseaseEvent-free survivalImmune checkpoint inhibitionPhase 2 studyIntensive chemotherapyDuration of responseComplete responseOverall survivalPD-1AML patientsDay 1Free survivalHematologic improvementInitial treatmentStudy armsResidual diseaseDay IVLeukemia-specific T-cell responsesSingle-arm phase 2 studyPD-1/PD-L1 pathwayTherapy-related acute myeloid leukemiaCancer Therapy Evaluation ProgramImmune cell subsets analysisBlast MRD AML-2: Blockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease (MDR) in Acute Myeloid Leukemia (AML) 2- a Randomized Phase 2 Study of the Venetoclax, Azacitidine, and Pembrolizumab Versus Venetoclax and Azacitidine As First Line Therapy in Older Patients with AML Who Are Ineligible or Who Refuse Intensive Chemotherapy
Zeidan A, Boddu P, Wood B, Zelterman D, Little R, Ivy S, Caldwell A, Sanchez-Espiridion B, Alatrash G, Sharon E, Radich J. Blast MRD AML-2: Blockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease (MDR) in Acute Myeloid Leukemia (AML) 2- a Randomized Phase 2 Study of the Venetoclax, Azacitidine, and Pembrolizumab Versus Venetoclax and Azacitidine As First Line Therapy in Older Patients with AML Who Are Ineligible or Who Refuse Intensive Chemotherapy. Blood 2020, 136: 11-12. DOI: 10.1182/blood-2020-139752.Peer-Reviewed Original ResearchEvent-free survivalDuration of responseMRD-negative CRIntensive chemotherapyOverall survivalDay 1Complete remissionFree survivalHematologic improvementOlder patientsSecondary AMLPD-1Study armsAML patientsInitial treatmentHematologic disordersLeukemia-specific T-cell responsesCancer Therapy Evaluation ProgramCR/complete remissionImmune cell subsets analysisRandomized phase 2 studyRandomized phase 2 trialRandomized phase II studyAllogeneic stem cell transplantBetter long-term clinical outcomesDistributions associated with simultaneous multiple hypothesis testing
Yu C, Zelterman D. Distributions associated with simultaneous multiple hypothesis testing. Journal Of Statistical Distributions And Applications 2020, 7: 9. DOI: 10.1186/s40488-020-00109-6.Peer-Reviewed Original ResearchCDK 4/6 drug target activation mapping of HR+/HER2- metastatic breast cancer for treatment selection and response prediction.
Abu-Khalaf M, Hatzis C, Hodge K, Valdes F, Sikov W, Mita M, Denduluri N, Awerkamp K, Murphy R, Zelterman D, Dunetz B, Petricoin E, Pierobon M. CDK 4/6 drug target activation mapping of HR+/HER2- metastatic breast cancer for treatment selection and response prediction. Journal Of Clinical Oncology 2020, 38: e13029-e13029. DOI: 10.1200/jco.2020.38.15_suppl.e13029.Peer-Reviewed Original ResearchMetastatic breast cancerBreast cancerCyclin D1CDK 4/6 inhibitorsBaseline tumor tissueClass of drugsAdjuvant settingEndocrine therapyTherapy initiationFrontline therapyInhibitor therapyPFS intervalStudy treatmentPredictive markerDisease progressionClinical trialsOutcome dataTreatment selectionPathway biomarkersBiopsy materialAverage age 62Tumor tissuePatientsFinal analysisTop quartile
2019
Allogeneic Stem Cell Transplantation for T-Cell Lymphomas in the Modern Era: A Single Center Experience
Boddu P, Perreault S, Isufi I, Chandhok N, Kim T, Pillai M, Bar N, Prebet T, Zeidan A, Zelterman D, Seropian S, Gowda L, Foss F. Allogeneic Stem Cell Transplantation for T-Cell Lymphomas in the Modern Era: A Single Center Experience. Transplantation And Cellular Therapy 2019, 25: s387. DOI: 10.1016/j.bbmt.2018.12.796.Peer-Reviewed Original ResearchT-cell lymphomaProgression-free survivalTransplant related mortalityCumulative incidenceOverall survivalAutologous stem cell transplant consolidationOne-year progression-free survivalT-cell-rich B-cellT-cell lymphoma typesCutaneous T-cell lymphomaLong-term prospective studiesT-cell lymphoma subtypesPost-transplant relapseReduced intensity regimensTBI/CYHigh-dose chemotherapyNK T cellsSingle-center experienceOverall favorable outcomeKaplan-Meier analysisPretransplant conditioning regimenAllogeneic stem cellsPeripheral T-cell lymphoma subtypesAutologous SCTChronic GVHD
2018
Elevated Levels of CD64 MFI on Monocyte Subsets Are Associated with a History of Stroke in Sickle Cell Disease
Curtis S, Balbuena-Merle R, Devine L, Zelterman D, Roberts J, Dearborn-Tomazos J, Sansing L, Hendrickson J. Elevated Levels of CD64 MFI on Monocyte Subsets Are Associated with a History of Stroke in Sickle Cell Disease. Blood 2018, 132: 1093. DOI: 10.1182/blood-2018-99-117504.Peer-Reviewed Original ResearchHistory of strokeSickle cell diseaseRole of monocytesIschemic strokeTotal neutrophil countComplete blood countMonocyte subsetsStroke historyNeutrophil countIntermediate monocytesMonocyte subtypesBlood countClassical monocytesCell diseaseFuture stroke riskIschemic stroke historyVaso-occlusive crisisPro-inflammatory monocytesPathophysiology of strokeCause of morbidityMultivariate logistic regressionNon-classical monocytesT-testHigh-affinity receptorStudent's t-test