2020
A phase II study of dose-dense temozolomide and lapatinib for recurrent low-grade and anaplastic supratentorial, infratentorial, and spinal cord ependymoma
Gilbert MR, Yuan Y, Wu J, Mendoza T, Vera E, Omuro A, Lieberman F, Robins HI, Gerstner ER, Wu J, Wen PY, Mikkelsen T, Aldape K, Armstrong TS. A phase II study of dose-dense temozolomide and lapatinib for recurrent low-grade and anaplastic supratentorial, infratentorial, and spinal cord ependymoma. Neuro-Oncology 2020, 23: 468-477. PMID: 33085768, PMCID: PMC7992893, DOI: 10.1093/neuonc/noaa240.Peer-Reviewed Original ResearchConceptsProgression-free survivalDose-dense temozolomideMedian progression-free survivalAdult patientsObjective responseSymptom burdenClinical trialsRecurrent ependymomaMD Anderson Symptom Inventory-Brain TumorProspective phase II clinical trialMedian Karnofsky performance statusPhase II clinical trialDemonstrated clinical activityModerate-severe painPatients age 18Phase II studyKarnofsky performance statusProspective clinical trialsSpinal cord tumorsStandard medical treatmentPrimary outcome measureSpinal cord ependymomasDisease-related symptomsExpression of ErbB2Daily lapatinib
2018
RARE-24. OBJECTIVE RESPONSE AND CLINICAL BENEFIT IN RECURRENT EPENDYMOMA IN ADULTS: FINAL REPORT OF CERN 08-02: A PHASE II STUDY OF DOSE-DENSE TEMOZOLOMIDE AND LAPATINIB
Armstrong T, Yuan Y, Wu J, Mendoza T, Vera E, Omuro A, Lieberman F, Robins H, Gerstner E, Wu J, Wen P, Mikkelsen T, Aldape K, Gilbert M. RARE-24. OBJECTIVE RESPONSE AND CLINICAL BENEFIT IN RECURRENT EPENDYMOMA IN ADULTS: FINAL REPORT OF CERN 08-02: A PHASE II STUDY OF DOSE-DENSE TEMOZOLOMIDE AND LAPATINIB. Neuro-Oncology 2018, 20: vi241-vi241. PMCID: PMC6217700, DOI: 10.1093/neuonc/noy148.998.Peer-Reviewed Original ResearchDose-dense temozolomideObjective responseClinical benefitRecurrent ependymomaAdult clinical trialsModerate-severe painStable disease rateStandard salvage regimenPhase II studyRole of chemotherapyProgression-free survivalDisease-related symptomsDaily lapatinibMedian KPSMedian PFSPFS ratesPrior relapseSalvage regimenAutonomic dysfunctionFree survivalPrimary endpointRecurrent diseaseAdult patientsCombination regimenII studyIn Vivo PET Assay of Tumor Glutamine Flux and Metabolism: In-Human Trial of 18F-(2S,4R)-4-Fluoroglutamine.
Dunphy MPS, Harding JJ, Venneti S, Zhang H, Burnazi EM, Bromberg J, Omuro AM, Hsieh JJ, Mellinghoff IK, Staton K, Pressl C, Beattie BJ, Zanzonico PB, Gerecitano JF, Kelsen DP, Weber W, Lyashchenko SK, Kung HF, Lewis JS. In Vivo PET Assay of Tumor Glutamine Flux and Metabolism: In-Human Trial of 18F-(2S,4R)-4-Fluoroglutamine. Radiology 2018, 287: 667-675. PMID: 29388903, PMCID: PMC5929369, DOI: 10.1148/radiol.2017162610.Peer-Reviewed Original ResearchConceptsPositron emission tomographyDifferent cancer typesCancer typesAcid levelsFisher's exact testAmino acid levelsInvestigational new drug applicationGlutamine metabolismInstitutional review boardFluorodeoxyglucose avidityAdult patientsIntravenous bolusAcute fastingAggressive tumorsClinical safetyPotential tumor biomarkerPET scansPatientsExact testHelsinki DeclarationDrug AdministrationNew drug applicationsEmission tomographyTumorsInformed consent
2017
Overall survival in patients with glioblastoma before and after bevacizumab approval
Johnson DR, Omuro AMP, Ravelo A, Sommer N, Guerin A, Ionescu-Ittu R, Shi S, Macalalad A, Uhm JH. Overall survival in patients with glioblastoma before and after bevacizumab approval. Current Medical Research And Opinion 2017, 34: 813-820. PMID: 29025274, DOI: 10.1080/03007995.2017.1392294.Peer-Reviewed Original ResearchConceptsOverall survivalTreatment of patientsBevacizumab approvalProgressive glioblastomaGBM diagnosisUS population-based cancer registry dataPopulation-based cancer registry dataCox proportional hazards regressionLarge population-based studyOS of patientsApproval of bevacizumabGross total resectionKaplan-Meier analysisPopulation-based studyProportional hazards regressionLimited therapeutic optionsCancer registry dataAdjusted hazardAdult patientsMedian ageTotal resectionStudy cohortAggressive diseaseHazards regressionTherapeutic options
2016
A Comprehensive Assessment of Toxicities in Patients with Central Nervous System Lymphoma Undergoing Autologous Stem Cell Transplantation Using Thiotepa, Busulfan, and Cyclophosphamide Conditioning
Scordo M, Bhatt V, Hsu M, Omuro AM, Matasar MJ, DeAngelis LM, Dahi PB, Moskowitz CH, Giralt SA, Sauter CS. A Comprehensive Assessment of Toxicities in Patients with Central Nervous System Lymphoma Undergoing Autologous Stem Cell Transplantation Using Thiotepa, Busulfan, and Cyclophosphamide Conditioning. Transplantation And Cellular Therapy 2016, 23: 38-43. PMID: 27713090, PMCID: PMC5518313, DOI: 10.1016/j.bbmt.2016.09.024.Peer-Reviewed Original ResearchConceptsAutologous stem cell transplantationPrimary central nervous system lymphomaSecondary central nervous system lymphomaCentral nervous system lymphomaProgression-free survivalNervous system lymphomaTransplantation-related mortalityStem cell transplantationOverall survivalSystem lymphomaCyclophosphamide conditioningNonhematologic toxicityCell transplantationTreatment strategiesTime of ASCTFavorable progression-free survivalHigh-dose therapyBusulfan areaBusulfan dosingAdult patientsPatient characteristicsMedian numberToxicity burdenPatientsConsiderable toxicityA randomized, phase 3, open-label study of nivolumab versus temozolomide (TMZ) in combination with radiotherapy (RT) in adult patients (pts) with newly diagnosed, O-6-methylguanine DNA methyltransferase (MGMT)-unmethylated glioblastoma (GBM): CheckMate-498.
Sampson J, Omuro A, Preusser M, Lim M, Butowski N, Cloughesy T, Strauss L, Latek R, Paliwal P, Weller M, Reardon D. A randomized, phase 3, open-label study of nivolumab versus temozolomide (TMZ) in combination with radiotherapy (RT) in adult patients (pts) with newly diagnosed, O-6-methylguanine DNA methyltransferase (MGMT)-unmethylated glioblastoma (GBM): CheckMate-498. Journal Of Clinical Oncology 2016, 34: tps2079-tps2079. DOI: 10.1200/jco.2016.34.15_suppl.tps2079.Peer-Reviewed Original ResearchOpen-label studyAdult patients
2015
Multicenter phase 2 study of patupilone for recurrent or progressive brain metastases from non–small cell lung cancer
Nayak L, DeAngelis LM, Robins HI, Govindan R, Gadgeel S, Kelly K, Rigas JR, Peereboom DM, Rosenfeld SS, Muzikansky A, Zheng M, Urban P, Abrey LE, Omuro A, Wen PY. Multicenter phase 2 study of patupilone for recurrent or progressive brain metastases from non–small cell lung cancer. Cancer 2015, 121: 4165-4172. PMID: 26308485, PMCID: PMC5941922, DOI: 10.1002/cncr.29636.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerProgressive brain metastasesBrain metastasesCell lung cancerAdverse eventsStudy drugLung cancerGrade 3/4 adverse eventsMulticenter phase 2 studyNSCLC brain metastasesSteady-state distribution volumePhase 1/2 studyRecurrent brain metastasesPhase 2 studyProgression-free survivalFirst prospective studyConcentration-time curvePrimary endpointAdult patientsOverall survivalPulmonary embolismMedian agePeripheral neuropathyMedian timeProspective study
2008
Intensive Chemotherapy Followed by Hematopoietic Stem-Cell Rescue for Refractory and Recurrent Primary CNS and Intraocular Lymphoma: Société Française de Greffe de Moëlle Osseuse-Thérapie Cellulaire
Soussain C, Hoang-Xuan K, Taillandier L, Fourme E, Choquet S, Witz F, Casasnovas O, Dupriez B, Souleau B, Taksin AL, Gisselbrecht C, Jaccard A, Omuro A, Sanson M, Janvier M, Kolb B, Zini JM, Leblond V. Intensive Chemotherapy Followed by Hematopoietic Stem-Cell Rescue for Refractory and Recurrent Primary CNS and Intraocular Lymphoma: Société Française de Greffe de Moëlle Osseuse-Thérapie Cellulaire. Journal Of Clinical Oncology 2008, 26: 2512-2518. PMID: 18413641, DOI: 10.1200/jco.2007.13.5533.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBrain NeoplasmsBusulfanCombined Modality TherapyCyclophosphamideCytarabineEtoposideEye NeoplasmsFemaleHematopoietic Stem Cell TransplantationHumansLymphoma, Large B-Cell, DiffuseMaleMiddle AgedNeoplasm Recurrence, LocalProspective StudiesSalvage TherapySurvival RateThiotepaConceptsPrimary CNS lymphomaHematopoietic stem cell rescueStem cell rescueIntensive chemotherapyIntraocular lymphomaAutologous hematopoietic stem cell rescueMedian progression-free survival timeRecurrent primary CNS lymphomaProgression-free survival timeHigh-dose cytarabineMedian overall survivalTreatment-related deathsImmunocompetent adult patientsProspective multicenter trialFirst-line treatmentOverall survival probabilityPFS probabilityCNS lymphomaComplete remissionSalvage treatmentAdult patientsOverall survivalPartial responseRefractory diseaseMulticenter trial
2007
Temozolomide for low-grade gliomas
Kaloshi G, Benouaich-Amiel A, Diakite F, Taillibert S, Lejeune J, Laigle-Donadey F, Renard M, Iraqi W, Idbaih A, Paris S, Capelle L, Duffau H, Cornu P, Simon J, Mokhtari K, Polivka M, Omuro A, Carpentier A, Sanson M, Delattre J, Hoang-Xuan K. Temozolomide for low-grade gliomas. Neurology 2007, 68: 1831-1836. PMID: 17515545, DOI: 10.1212/01.wnl.0000262034.26310.a2.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Agents, AlkylatingBrain NeoplasmsChromosome DeletionChromosomes, Human, Pair 1Chromosomes, Human, Pair 19DacarbazineDNA Mutational AnalysisDrug Resistance, NeoplasmFemaleGene Expression Regulation, NeoplasticGenetic TestingGenotypeGliomaHumansLoss of HeterozygosityMaleMiddle AgedNeoplasm Recurrence, LocalRetrospective StudiesSurvival RateTemozolomideTreatment OutcomeConceptsProgression-free survivalLow-grade gliomasProgressive low-grade gliomaObjective responseMedian progression-free survivalLonger progression-free survivalSingle-center observational studyCenter observational studyMaximum tumor responseStable diseaseProgressive diseaseAdult patientsConsecutive patientsOverall survivalMedian timeTMZ cyclesTemozolomide chemotherapyCentral reviewTumor responseFavorable outcomeMedian numberObservational studyPatientsPredictive impactConventional schedule