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
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 survivalA phase II trial of temozolomide and vinorelbine for patients with recurrent brain metastases
Iwamoto F, Omuro A, Raizer J, Nolan C, Hormigo A, Lassman A, Gavrilovic I, Abrey L. A phase II trial of temozolomide and vinorelbine for patients with recurrent brain metastases. Journal Of Clinical Oncology 2007, 25: 2050-2050. DOI: 10.1200/jco.2007.25.18_suppl.2050.Peer-Reviewed Original ResearchPhase II trialRecurrent brain metastasesObjective radiographic responseBrain metastasesII trialRadiographic responseResponse rateWhole-brain radiation therapyAdequate organ functionBrain metastasis resectionSingle-agent temozolomideGrade 3/4 toxicitiesPhase I trialPhase II componentPopulation of patientsFavorable toxicity profileBlood-brain barrierPrimary tumor siteHead/neckTwo-stage clinical trialAssessable patientsMedian KPSMedian PFSPrior therapyMetastasis resection
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