2016
Nivolumab and Pembrolizumab for Non–Small Cell Lung Cancer
Morgensztern D, Herbst RS. Nivolumab and Pembrolizumab for Non–Small Cell Lung Cancer. Clinical Cancer Research 2016, 22: 3713-3717. PMID: 27252413, DOI: 10.1158/1078-0432.ccr-15-2998.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungClinical Trials, Phase I as TopicHumansLung NeoplasmsNivolumabPrognosisProgrammed Cell Death 1 ReceptorRandomized Controlled Trials as TopicTreatment OutcomeConceptsCheckpoint inhibitorsClinical trialsAdvanced stage non-small lung cancerDeath-1 checkpoint inhibitorsLarge randomized clinical trialsNon-small lung cancerSecond-line docetaxelSurvivors 3 yearsBest supportive careSubset of patientsRandomized clinical trialsOverall survivalSupportive careCombination therapyLung cancerModest benefitPatientsPhase IImmunotherapyReliable predictorTherapyInhibitorsTrialsTreatmentNivolumab
2009
The changing face of Phase 1 cancer clinical trials
Craft BS, Kurzrock R, Lei X, Herbst R, Lippman S, Fu S, Karp DD. The changing face of Phase 1 cancer clinical trials. Cancer 2009, 115: 1592-1597. PMID: 19165808, PMCID: PMC2668727, DOI: 10.1002/cncr.24171.Peer-Reviewed Original ResearchMeSH KeywordsBiomedical ResearchClinical ProtocolsClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicNeoplasmsPatient SelectionPhysical ExaminationResearch DesignUnited StatesConceptsPhase 2 trialEarly phase clinical trialsPhase 1 studyPhase 1 trialClinical trialsVital sign determinationsCancer clinical trialsPhysical examinationEarly phase cancer clinical trialsWeeks of protocolPhase 2 studyPhase 1 cancer clinical trialsNew drug studyStudy requirementsPhase 1Pharmacokinetic samplingMore patientsMedical oncologyOncology communityLaboratory testsSuch trialsDrug studiesTrialsPhase 1 programElectrocardiogram
2007
Phase I participants’ views of quality of life and trial participation burdens
Cohen MZ, Slomka J, Pentz RD, Flamm AL, Gold D, Herbst RS, Abbruzzese JL. Phase I participants’ views of quality of life and trial participation burdens. Supportive Care In Cancer 2007, 15: 885-890. PMID: 17252219, DOI: 10.1007/s00520-007-0216-0.Peer-Reviewed Original ResearchConceptsTrial participationCurrent QoLPrevious cancer treatmentPhase I trialPhase I cancer trialsI cancer trialsSymptoms of diseaseStudy drugI trialCancer trialsPhysical complicationsTrial participantsSide effectsQoLCancer treatmentPhase ITrialsPotential participantsBurdenPerception of qualityProcedural burdenRespondent burdenParticipantsTreatmentBaseline ability
2006
Combining Targeted Agents: Blocking the Epidermal Growth Factor and Vascular Endothelial Growth Factor Pathways
Sandler A, Herbst R. Combining Targeted Agents: Blocking the Epidermal Growth Factor and Vascular Endothelial Growth Factor Pathways. Clinical Cancer Research 2006, 12: 4421s-4425s. PMID: 16857821, DOI: 10.1158/1078-0432.ccr-06-0796.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarcinoma, Non-Small-Cell LungClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicDrug SynergismEpidermal Growth FactorErlotinib HydrochlorideFemaleHumansLung NeoplasmsMaleQuinazolinesVascular Endothelial Growth Factor AConceptsNon-small cell lung cancerPhase II doseStage IIIB/IV non-small cell lung cancerAdvanced non-small cell lung cancerPhase I/II studyEpidermal growth factor receptor tyrosine kinase inhibitorsGrowth factor receptor tyrosine kinase inhibitorsRandomized phase II trialVascular endothelial growth factor (VEGF) pathwaySelective epidermal growth factor receptor tyrosine kinase inhibitorEndothelial growth factor pathwayReceptor tyrosine kinase inhibitorsGrowth factorCommon adverse eventsMedian overall survivalPhase II trialPhase III trialsProgression-free survivalSafety of erlotinibCell lung cancerHumanized monoclonal antibodyVascular endothelial growth factorTyrosine kinase inhibitorsEndothelial growth factorGrowth factor pathwaysDevelopment and Validation of a Drug Activity Biomarker that Shows Target Inhibition in Cancer Patients Receiving Enzastaurin, a Novel Protein Kinase C-β Inhibitor
Green LJ, Marder P, Ray C, Cook CA, Jaken S, Musib LC, Herbst RS, Carducci M, Britten CD, Basche M, Eckhardt SG, Thornton D. Development and Validation of a Drug Activity Biomarker that Shows Target Inhibition in Cancer Patients Receiving Enzastaurin, a Novel Protein Kinase C-β Inhibitor. Clinical Cancer Research 2006, 12: 3408-3415. PMID: 16740765, DOI: 10.1158/1078-0432.ccr-05-2231.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Combined Chemotherapy ProtocolsBiomarkersCapecitabineCell Line, TumorClinical Trials, Phase I as TopicDeoxycytidineEnzyme ActivatorsEnzyme InhibitorsFlow CytometryFluorouracilFollow-Up StudiesHumansIndolesLeukocytes, MononuclearMonocytesNeoplasmsProtein Kinase CProtein Kinase C betaReproducibility of ResultsSensitivity and SpecificitySignal TransductionStructure-Activity RelationshipTreatment OutcomeConceptsPeripheral blood mononuclear cellsDaily oral dosesBlood mononuclear cellsCancer patientsOral dosesMononuclear cellsFlow cytometryDrug activity biomarkerPKC activityTarget cellsActivity biomarkersPhorbol esterNormal donorsPatientsActivity of PKCU937 cell lineTarget inhibitionEnzastaurinKinase inhibitorsΒ inhibitorSignificant decreaseCell linesU937 cellsIntracellular phosphoproteinsProtein kinase C
2003
Gefitinib: current and future status in cancer therapy.
Herbst RS, Kies MS. Gefitinib: current and future status in cancer therapy. Clinical Advances In Hematology And Oncology 2003, 1: 466-72. PMID: 16258434.Peer-Reviewed Original ResearchMeSH KeywordsClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicDrug EvaluationErbB ReceptorsGefitinibHumansNeoplasmsQuinazolinesSignal TransductionConceptsEpidermal growth factor receptorTumor growthEGFR tyrosine kinase inhibitorsCurrent clinical development statusOngoing clinical trialsCombination of gefitinibClinical development statusCancer cell growthHost-dependent processesGrowth factor receptorHormonal therapyStandard chemotherapyBiologic agentsDisease recurrenceCell lungSolid malignanciesClinical trialsTumor cell functionsViable drug targetNovel agentsPreclinical studiesClinical developmentTumor typesGefitinibKinase inhibitors
2002
Study of the media's potential influence on prospective research participants' understanding of and motivations for participation in a high-profile phase I trial.
Pentz RD, Flamm AL, Sugarman J, Cohen MZ, Daniel Ayers G, Herbst RS, Abbruzzese JL. Study of the media's potential influence on prospective research participants' understanding of and motivations for participation in a high-profile phase I trial. Journal Of Clinical Oncology 2002, 20: 3785-91. PMID: 12228198, DOI: 10.1200/jco.2002.04.084.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic AgentsAttitude to HealthClinical Trials, Phase I as TopicCollagenData CollectionDecision MakingEndostatinsFemaleHumansInformed ConsentMaleMass MediaMiddle AgedMotivationNeoplasmsPatient ParticipationPeptide FragmentsPhysiciansProspective StudiesResearch DesignSurveys and QuestionnairesConceptsPercent of respondentsPhase I clinical trialPhase I trialHuman recombinant endostatinI trialClinical trialsTrial investigatorsResearch participants' understandingTrialsEndostatinPhysiciansRecombinant endostatinPotential influencePercentProspective participantsTrial purposesSurvey respondentsPersonal benefitsParticipants' understandingPatientsRespondentsZD1839: targeting the epidermal growth factor receptor in cancer therapy
Herbst RS. ZD1839: targeting the epidermal growth factor receptor in cancer therapy. Expert Opinion On Investigational Drugs 2002, 11: 837-849. PMID: 12036427, DOI: 10.1517/13543784.11.6.837.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerEpidermal growth factor receptorCell lung cancerGrowth factor receptorFactor receptorLung cancerSmall-molecule epidermal growth factor receptor (EGFR) tyrosine kinase inhibitorTumor typesEpidermal growth factor receptor tyrosine kinase inhibitorsGrowth factor receptor tyrosine kinase inhibitorsAntitumour activityReceptor tyrosine kinase inhibitorsMeaningful antitumour activityAcceptable tolerability profilePaclitaxel/carboplatinPhase II studyThird-line treatmentFirst-line treatmentPhase III trialsGemcitabine/cisplatinClinical trial programPromising clinical activityCancer cell growthHost-dependent processesAdvanced disease
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 ResearchMeSH KeywordsAngiogenesis InhibitorsAntineoplastic AgentsBiopsyClinical Trials, Phase I as TopicCollagenCombined Modality TherapyEndostatinsEndpoint DeterminationHumansNeoplasmsPeptide FragmentsRecombinant ProteinsResearch DesignConceptsPhase 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