2017
The HGF/c-MET Pathway Is a Driver and Biomarker of VEGFR-inhibitor Resistance and Vascular Remodeling in Non–Small Cell Lung Cancer
Cascone T, Xu L, Lin HY, Liu W, Tran HT, Liu Y, Howells K, Haddad V, Hanrahan E, Nilsson MB, Cortez MA, Giri U, Kadara H, Saigal B, Park YY, Peng W, Lee JS, Ryan AJ, Jüergensmeier JM, Herbst RS, Wang J, Langley RR, Wistuba II, Lee JJ, Heymach JV. The HGF/c-MET Pathway Is a Driver and Biomarker of VEGFR-inhibitor Resistance and Vascular Remodeling in Non–Small Cell Lung Cancer. Clinical Cancer Research 2017, 23: 5489-5501. PMID: 28559461, PMCID: PMC5600821, DOI: 10.1158/1078-0432.ccr-16-3216.Peer-Reviewed Original ResearchMeSH KeywordsAnimalsCarcinoma, Non-Small-Cell LungCell Line, TumorClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicDisease Models, AnimalDrug Resistance, NeoplasmGene Expression ProfilingHepatocyte Growth FactorHumansHypoxiaKaplan-Meier EstimateLung NeoplasmsMaleMiceMolecular Targeted TherapyMulticenter Studies as TopicNeovascularization, PathologicPrognosisProtein Kinase InhibitorsProto-Oncogene Proteins c-metReceptors, Vascular Endothelial Growth FactorSignal TransductionXenograft Model Antitumor AssaysConceptsNon-small cell lung cancerHepatocyte growth factorC-MetHGF/c-Met pathwayHuman non-small cell lung cancerResistance of NSCLCAngiogenic factor levelsHGF plasma levelsCancer cellsTumor microvascular densityCell lung cancerEffect of therapyTortuous blood vesselsTumor vascular bedC-Met pathwayTyrosine kinase inhibitorsTumor-associated stromaClin Cancer ResHuman lung adenocarcinomaMurine xenograft modelVEGFR-TKIClinical outcomesLung cancerPlasma levelsMicrovascular density
2015
Lung-MAP—framework, overview, and design principles
Ferrarotto R, Redman MW, Gandara DR, Herbst RS, Papadimitrakopoulou VA. Lung-MAP—framework, overview, and design principles. Chinese Clinical Oncology 2015, 4: 36-36. PMID: 26408303, DOI: 10.3978/j.issn.2304-3865.2015.09.02.Peer-Reviewed Original ResearchMeSH KeywordsCarcinoma, Squamous CellClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicHigh-Throughput Screening AssaysHumansLung NeoplasmsMolecular Targeted TherapyNeoplasm MetastasisResearch DesignConceptsSquamous cell carcinomaLung-MAPClinical trialsMetastatic lung squamous cell carcinomaLung squamous cell carcinomaLung SCC patientsLimited therapeutic optionsEvidence of efficacyPoor patient outcomesClinical trial designDriver genetic alterationsEligible patientsSCC patientsPatients' qualityTreatment armsTherapeutic optionsCell carcinomaTherapy clinical trialsPatient outcomesTrial designMaster protocolsPatientsFDA approvalGenomic profilingPromising agentInnovative Clinical Trials: The LUNG‐MAP Study
Steuer C, Papadimitrakopoulou V, Herbst R, Redman M, Hirsch F, Mack P, Ramalingam S, Gandara. Innovative Clinical Trials: The LUNG‐MAP Study. Clinical Pharmacology & Therapeutics 2015, 97: 488-491. PMID: 25676724, DOI: 10.1002/cpt.88.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic AgentsBiomarkers, TumorCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicGenetic Predisposition to DiseaseGenomicsHumansLung NeoplasmsMolecular Targeted TherapyPhenotypePrecision MedicineResearch DesignSignal TransductionConceptsCell lung cancerSquamous cell carcinomaSquamous cell lung cancerCell carcinomaLung cancerTrial designNon-small cell lung cancerMetastatic squamous cell carcinomaSecond-line therapyProportion of patientsNew active drugsNovel trial designsDrug developmentWide molecular heterogeneityAdenocarcinoma histologyLine therapyTherapeutic optionsLung-MAPClinical trialsGroup trialsActive drugPatientsMaster protocolsCarcinomaCancer
2014
American Society of Clinical Oncology Perspective: Raising the Bar for Clinical Trials by Defining Clinically Meaningful Outcomes
Ellis LM, Bernstein DS, Voest EE, Berlin JD, Sargent D, Cortazar P, Garrett-Mayer E, Herbst RS, Lilenbaum RC, Sima C, Venook AP, Gonen M, Schilsky RL, Meropol NJ, Schnipper LE. American Society of Clinical Oncology Perspective: Raising the Bar for Clinical Trials by Defining Clinically Meaningful Outcomes. Journal Of Clinical Oncology 2014, 32: 1277-1280. PMID: 24638016, DOI: 10.1200/jco.2013.53.8009.Peer-Reviewed Original Research
2012
Design of a Phase III Clinical Trial with Prospective Biomarker Validation: SWOG S0819
Redman MW, Crowley JJ, Herbst RS, Hirsch FR, Gandara DR. Design of a Phase III Clinical Trial with Prospective Biomarker Validation: SWOG S0819. Clinical Cancer Research 2012, 18: 4004-4012. PMID: 22592956, PMCID: PMC3409929, DOI: 10.1158/1078-0432.ccr-12-0167.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBiomarkers, TumorCarcinoma, Non-Small-Cell LungCetuximabClinical Trials, Phase III as TopicDisease-Free SurvivalErbB ReceptorsHumansIn Situ Hybridization, FluorescenceLung NeoplasmsPrognosisProspective StudiesResearch DesignTreatment OutcomeConceptsNon-small cell lung cancerEpidermal growth factor receptorPredictive biomarkersStudy populationAdvanced non-small cell lung cancerEGFR FISH-positive patientsPhase III clinical trialsRole of cetuximabOverall study populationPhase III trialsCell lung cancerEntire study populationFISH-positive patientsInterim monitoring planGrowth factor receptorCoprimary endpointsIII trialsCetuximab efficacyLung cancerClinical trialsPositive groupCetuximabEGFR FISHFactor receptorMolecular targets
2009
Patient selection criteria and the FLEX Study
Herbst RS, Hirsch FR. Patient selection criteria and the FLEX Study. The Lancet 2009, 373: 1497-1498. PMID: 19410696, DOI: 10.1016/s0140-6736(09)60834-5.Peer-Reviewed Original ResearchAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCarcinoma, Non-Small-Cell LungCetuximabClinical Trials, Phase III as TopicDisease-Free SurvivalErbB ReceptorsHumansLung NeoplasmsPatient SelectionRandomized Controlled Trials as TopicSurvival RateBeyond Doublet Chemotherapy for Advanced Non–Small-Cell Lung Cancer: Combination of Targeted Agents with First-Line Chemotherapy
Herbst RS, Lynch TJ, Sandler AB. Beyond Doublet Chemotherapy for Advanced Non–Small-Cell Lung Cancer: Combination of Targeted Agents with First-Line Chemotherapy. Clinical Lung Cancer 2009, 10: 20-27. PMID: 19289368, DOI: 10.3816/clc.2009.n.003.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungClinical Trials, Phase III as TopicDisease ProgressionDisease-Free SurvivalDrug Delivery SystemsHumansLung NeoplasmsSurvival RateConceptsBest supportive careOverall survivalMetastatic NSCLCLung cancerAdvanced non-small cell lung cancerNon-small cell lung cancerPhase III clinical trialsPlatinum-based doubletsAddition of bevacizumabFirst-line chemotherapyPlatinum-based regimensProgression-free survivalFirst-line treatmentCell lung cancerOverall patient survivalTyrosine kinase inhibitorsInhibition of componentsMatrix metalloproteinase inhibitorsDoublet chemotherapySystemic chemotherapyMedian survivalSupportive careMost patientsTargeted agentsChemotherapeutic regimens
2006
Angiogenesis inhibition in the treatment of lung cancer.
Vokes E, Herbst R, Sandler A. Angiogenesis inhibition in the treatment of lung cancer. Clinical Advances In Hematology And Oncology 2006, 4: 1-10; quiz 11-2. PMID: 17143257.Peer-Reviewed Original ResearchMeSH KeywordsAngiogenesis InhibitorsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarboplatinCarcinoma, Non-Small-Cell LungClinical Trials, Phase III as TopicDisease-Free SurvivalErlotinib HydrochlorideHemorrhageHumansLung NeoplasmsNeovascularization, PathologicPaclitaxelProtein Kinase InhibitorsQuinazolinesRandomized Controlled Trials as TopicRisk FactorsSurvival RateVascular Endothelial Growth Factor AConceptsNon-small cell lung cancerVascular endothelial growth factorLung cancerAntiangiogenic therapyNon-squamous cell non-small cell lung cancerAnti-VEGF monoclonal antibody bevacizumabSmall molecule tyrosine kinase inhibitorsRandomized phase II studyRandomized phase III trialEpidermal growth factor receptor inhibitor erlotinibPhase II studyAddition of bevacizumabPhase III trialsSignificant survival benefitCell lung cancerSignificant clinical benefitMonoclonal antibody bevacizumabComprehensive treatment approachTyrosine kinase inhibitorsEndothelial growth factorImportant therapeutic targetOngoing studiesNSCLC settingBevacizumab treatmentII studyEpidermal Growth Factor Receptor Inhibitors in Development for the Treatment of Non–Small Cell Lung Cancer
Heymach JV, Nilsson M, Blumenschein G, Papadimitrakopoulou V, Herbst R. Epidermal Growth Factor Receptor Inhibitors in Development for the Treatment of Non–Small Cell Lung Cancer. Clinical Cancer Research 2006, 12: 4441s-4445s. PMID: 16857825, DOI: 10.1158/1078-0432.ccr-06-0286.Peer-Reviewed Original ResearchMeSH KeywordsCarcinoma, Non-Small-Cell LungClinical Trials, Phase III as TopicErbB ReceptorsHumansLung NeoplasmsProtein Kinase InhibitorsConceptsNon-small cell lung cancerCell lung cancerExtensive clinical testingLung cancerClinical testingRandomized phase II clinical trialEpidermal growth factor receptor inhibitor erlotinibPhase III clinical testingEpidermal growth factor receptor inhibitorsPhase II clinical trialGrowth factor receptor inhibitorsVascular endothelial growth factor receptorEndothelial growth factor receptorAdvanced clinical testingMultiple EGFR family membersGrowth factor receptorReceptor inhibitionClinical trialsEGFR family membersClinical activityReceptor inhibitorsPreclinical studiesInhibitor erlotinibClinical developmentSolid tumors
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
ZD1839: 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