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
2013
An Open-Label, Multi-Center, Phase II Study of Patupilone (EPO906), in the Treatment of Recurrent or Progressive Brain Metastases in Patients with Non-Small Cell Lung Cancer (NSCLC) (IN10-2.005)
Nayak L, Abrey L, DeAngelis L, Gadgeel S, Garst J, Govindan R, Kelly K, Omuro A, Peereboom D, Ramnath N, Reimers H, Rigas J, Robbins H, Rosenfeld S, Wen P. An Open-Label, Multi-Center, Phase II Study of Patupilone (EPO906), in the Treatment of Recurrent or Progressive Brain Metastases in Patients with Non-Small Cell Lung Cancer (NSCLC) (IN10-2.005). Neurology 2013, 80 DOI: 10.1212/wnl.80.7_supplement.in10-2.005.Peer-Reviewed Original ResearchAn Open-Label, Multi-Center, Phase II Study of Patupilone (EPO906), in the Treatment of Recurrent or Progressive Brain Metastases in Patients with Non-Small Cell Lung Cancer (NSCLC) (S56.002)
Nayak L, Abrey L, DeAngelis L, Gadgeel S, Garst J, Govindan R, Kelly K, Omuro A, Peereboom D, Ramnath N, Reimers H, Rigas J, Robbins H, Rosenfeld S, Wen P. An Open-Label, Multi-Center, Phase II Study of Patupilone (EPO906), in the Treatment of Recurrent or Progressive Brain Metastases in Patients with Non-Small Cell Lung Cancer (NSCLC) (S56.002). Neurology 2013, 80 DOI: 10.1212/wnl.80.7_supplement.s56.002.Peer-Reviewed Original Research
2010
Efficacy and safety of bevacizumab in active brain metastases from non-small cell lung cancer
De Braganca KC, Janjigian YY, Azzoli CG, Kris MG, Pietanza MC, Nolan CP, Omuro AM, Holodny AI, Lassman AB. Efficacy and safety of bevacizumab in active brain metastases from non-small cell lung cancer. Journal Of Neuro-Oncology 2010, 100: 443-447. PMID: 20440540, PMCID: PMC3246379, DOI: 10.1007/s11060-010-0200-2.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerActive brain metastasesInitiation of bevacizumabSafety of bevacizumabProgression-free survivalBrain metastasesCell lung cancerCNS metastasisOverall survivalLung cancerCentral nervous system metastasesMedian progression-free survivalAccelerated FDA approvalActive CNS metastasesParenchymal brain metastasesProgressive brain metastasesMedian overall survivalNervous system metastasesAdditional safety dataPrimary brain tumorsHigh response rateIntra-tumoral hemorrhageBevacizumab safetyConcurrent anticoagulationCorticosteroid requirements
2007
A phase II trial of vinorelbine and intensive temozolomide for patients with recurrent or progressive brain metastases
Iwamoto FM, Omuro AM, Raizer JJ, Nolan CP, Hormigo A, Lassman AB, Gavrilovic IT, Abrey LE. A phase II trial of vinorelbine and intensive temozolomide for patients with recurrent or progressive brain metastases. Journal Of Neuro-Oncology 2007, 87: 85-90. PMID: 17987262, DOI: 10.1007/s11060-007-9491-3.Peer-Reviewed Original ResearchConceptsKarnofsky Performance ScaleProgressive brain metastasesPhase II trialBrain metastasesII trialResponse rateMedian Karnofsky performance scaleWhole-brain radiation therapyAdequate organ functionBrain metastasis resectionObjective radiographic responseRadiographic response rateSingle-agent temozolomideGrade 3/4 toxicitiesRecurrent brain metastasesPopulation of patientsPrimary tumor siteYears of agePrior therapyStable diseaseVinorelbine 25Metastasis resectionPrimary endpointMethods PatientsOverall survival
2006
Vinorelbine combined with a protracted course of temozolomide for recurrent brain Metastases: a phase I trial
Omuro AM, Raizer JJ, Demopoulos A, Malkin MG, Abrey LE. Vinorelbine combined with a protracted course of temozolomide for recurrent brain Metastases: a phase I trial. Journal Of Neuro-Oncology 2006, 78: 277-280. PMID: 16614943, DOI: 10.1007/s11060-005-9095-8.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Agents, AlkylatingAntineoplastic Agents, PhytogenicAntineoplastic Combined Chemotherapy ProtocolsBrain NeoplasmsBreast NeoplasmsCarcinoma, Non-Small-Cell LungDacarbazineDisease-Free SurvivalDose-Response Relationship, DrugDrug Administration ScheduleFemaleHumansLung NeoplasmsLymphopeniaMaleMaximum Tolerated DoseMiddle AgedNeutropeniaTemozolomideThrombocytopeniaTreatment OutcomeVinblastineVinorelbineConceptsCourses of temozolomideRecurrent brain metastasesBrain metastasesDose of vinorelbineProgressive brain metastasesPhase II trialPhase I trialEfficacy of temozolomideVinorelbine doseII trialStarting doseMedian survivalRadiographic responseI trialMedian ageModest efficacyNew regimenPatient 2Lung cancerPrimary tumorGrade 3PatientsVinorelbineTemozolomideDose