2008
Bayesian adaptive design for targeted therapy development in lung cancer — a step toward personalized medicine
Xian Zhou, Suyu Liu, Kim ES, Herbst RS, Lee JJ. Bayesian adaptive design for targeted therapy development in lung cancer — a step toward personalized medicine. Clinical Trials 2008, 5: 181-193. PMID: 18559407, PMCID: PMC5481999, DOI: 10.1177/1740774508091815.Peer-Reviewed Original ResearchConceptsDisease control rateBiomarker profilesControl rateTrial designRandomization ratesEffective agentLung cancerAdvanced stage non-small cell lung cancerStage non-small cell lung cancerNon-small cell lung cancerBaseline biopsy samplesPatient's biomarker profileCell lung cancerEarly stopping ruleEvaluable patientsPrimary endpointMore patientsPersonalized medicineAdaptive randomization designEffective treatmentBiomarker assessmentBiopsy samplesPatientsBayesian adaptive designIndividual tumors
2005
Clinically Meaningful Improvement in Symptoms and Quality of Life for Patients With Non-Small-Cell Lung Cancer Receiving Gefitinib in a Randomized Controlled Trial
Cella D, Herbst RS, Lynch TJ, Prager D, Belani CP, Schiller JH, Heyes A, Ochs JS, Wolf MK, Kay AC, Kris MG, Natale RB. Clinically Meaningful Improvement in Symptoms and Quality of Life for Patients With Non-Small-Cell Lung Cancer Receiving Gefitinib in a Randomized Controlled Trial. Journal Of Clinical Oncology 2005, 23: 2946-2954. PMID: 15699477, DOI: 10.1200/jco.2005.05.153.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAgedAged, 80 and overAntineoplastic AgentsCarcinoma, Non-Small-Cell LungDose-Response Relationship, DrugDouble-Blind MethodEndpoint DeterminationFemaleGefitinibHealth StatusHumansLung NeoplasmsMaleMiddle AgedQuality of LifeQuinazolinesSensitivity and SpecificitySurvival AnalysisConceptsLung Cancer SubscaleSymptom improvementTumor responseQuality of lifeCancer Therapy-Lung (FACT-L) questionnairePivotal phase II trialMedian overall survival timeCoprimary end pointsPrior chemotherapy regimensProtocol-specified analysisSymptom improvement ratePhase II trialBetter overall survivalCell lung cancerOverall survival timeGefitinib 250Radiographic regressionChemotherapy regimensStable diseaseII trialMost patientsOverall survivalRadiographic responseSymptomatic patientsNSCLC patients
2004
A phase I surrogate endpoint study of SU6668 in patients with solid tumors
Xiong HQ, Herbst R, Faria SC, Scholz C, Davis D, Jackson EF, Madden T, McConkey D, Hicks M, Hess K, Charnsangavej C, Abbruzzese JL. A phase I surrogate endpoint study of SU6668 in patients with solid tumors. Investigational New Drugs 2004, 22: 459-466. PMID: 15292716, DOI: 10.1023/b:drug.0000036688.96453.8d.Peer-Reviewed Original ResearchConceptsCore needle biopsyBiologic effectsNeedle biopsyDay 1Solid tumorsMean apparent oral clearanceContrast-enhanced magnetic resonance imagingApparent oral clearanceDynamic contrast-enhanced magnetic resonance imagingCorrelative studiesHigh-performance liquid chromatography assayMagnetic resonance imagingDCE-MRI resultsEligible patientsOral clearanceLiquid chromatography assayEndpoint studiesAntiangiogenic agentsFunctional CTBlood flowTumor specimensPatientsTissue biopsiesDay 22PK studies
2002
Angiogenesis inhibitors in clinical development for lung cancer
Herbst RS, Hidalgo M, Pierson AS, Holden SN, Bergen M, Eckhardt SG. Angiogenesis inhibitors in clinical development for lung cancer. Seminars In Oncology 2002, 29: 66-77. PMID: 11894016, DOI: 10.1053/sonc.2002.31527.Peer-Reviewed Original ResearchMeSH KeywordsAngiogenesis InhibitorsAntineoplastic Combined Chemotherapy ProtocolsClinical Trials as TopicDisease ProgressionEndothelial Growth FactorsEndpoint DeterminationEnzyme InhibitorsHumansLung NeoplasmsLymphokinesMatrix Metalloproteinase InhibitorsMatrix MetalloproteinasesNeovascularization, PathologicTreatment OutcomeVascular Endothelial Growth Factor AVascular Endothelial Growth FactorsConceptsAngiogenesis inhibitorsLung cancerClinical trialsClinical developmentPhase II trialLong-term administrationPlatinum-based therapyEarly clinical trialsReceptor-targeted agentsPrimary endpointAdvanced diseaseII trialMetastatic diseaseAdjunctive therapyProcess of angiogenesisCancer patientsField of angiogenesisEfficacious dosesClinical evaluationTumor regressionNovel agentsAntiangiogenic agentsTherapeutic targetDependence of tumorsTumor angiogenesis
2001
Clinical studies of angiogenesis inhibitors: The university of texas md anderson center trial of human endostatin
Herbst R, Lee A, Tran H, Abbruzzese J. Clinical studies of angiogenesis inhibitors: The university of texas md anderson center trial of human endostatin. Current Oncology Reports 2001, 3: 131-140. PMID: 11177745, DOI: 10.1007/s11912-001-0013-8.Peer-Reviewed Original ResearchConceptsPhase I trialI trialClinical studiesHuman endostatinTumor vasculatureSolid tumor malignanciesAnti-angiogenic agentsAnti-angiogenic mechanismAnti-angiogenic compoundsToxic cancer treatmentsAdvanced diseaseBlood vessel supplyCenter trialMinimal diseaseTumor sizeNovel agentsSurrogate endpointsNew agentsSide effectsBiologic mechanismsSingle agentAngiogenesis inhibitorsGrowth-inhibiting moleculesNon-toxic agentsTumor growth