2015
Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial
Herbst RS, Baas P, Kim DW, Felip E, Pérez-Gracia JL, Han JY, Molina J, Kim JH, Arvis CD, Ahn MJ, Majem M, Fidler MJ, de Castro G, Garrido M, Lubiniecki GM, Shentu Y, Im E, Dolled-Filhart M, Garon EB. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. The Lancet 2015, 387: 1540-1550. PMID: 26712084, DOI: 10.1016/s0140-6736(15)01281-7.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic AgentsB7-H1 AntigenCarcinoma, Non-Small-Cell LungDisease-Free SurvivalDocetaxelDrug Administration ScheduleFemaleGene Expression Regulation, NeoplasticHumansKaplan-Meier EstimateLung NeoplasmsMaleMiddle AgedMolecular Targeted TherapyPatient SelectionTaxoidsTreatment OutcomeConceptsCell lung cancerProgression-free survivalPD-L1 expressionOverall survivalLung cancerPD-L1Tumor cellsMedian progression-free survivalTreatment-related adverse eventsEfficacy of pembrolizumabMedian overall survivalProlongs overall survivalNew treatment optionsAcademic medical centerPrimary endpointAdverse eventsProgressive diseasePatient populationTotal populationTreatment optionsPembrolizumabGrade 3Medical CenterEffective treatmentInteractive voice response system
2014
New Strategies in Personalized Medicine for Solid Tumors: Molecular Markers and Clinical Trial Designs
Jürgensmeier JM, Eder JP, Herbst RS. New Strategies in Personalized Medicine for Solid Tumors: Molecular Markers and Clinical Trial Designs. Clinical Cancer Research 2014, 20: 4425-4435. PMID: 25183480, PMCID: PMC5369358, DOI: 10.1158/1078-0432.ccr-13-0753.Peer-Reviewed Original ResearchMeSH KeywordsBiomarkers, TumorClinical Trials as TopicGene Expression ProfilingHumansNeoplasmsPatient SelectionPrecision MedicineResearch DesignConceptsClinical trialsTumor biologyFuture patient selectionTherapy of patientsOngoing clinical evaluationBroad molecular profilingPromising tumor targetPersonalized medicinePatient selectionPatient populationTreatment recommendationsClinical evaluationTumor boardClinical studiesImmune parametersNovel agentsTumor targetsTreatment approachesSolid tumorsClinical researchPatientsMolecular profilingSpecific markersTumorsTrials
2010
Phase II Selection Design Trial of Concurrent Chemotherapy and Cetuximab Versus Chemotherapy Followed by Cetuximab in Advanced-Stage Non–Small-Cell Lung Cancer: Southwest Oncology Group Study S0342
Herbst RS, Kelly K, Chansky K, Mack PC, Franklin WA, Hirsch FR, Atkins JN, Dakhil SR, Albain KS, Kim ES, Redman M, Crowley JJ, Gandara DR. Phase II Selection Design Trial of Concurrent Chemotherapy and Cetuximab Versus Chemotherapy Followed by Cetuximab in Advanced-Stage Non–Small-Cell Lung Cancer: Southwest Oncology Group Study S0342. Journal Of Clinical Oncology 2010, 28: 4747-4754. PMID: 20921467, PMCID: PMC3020704, DOI: 10.1200/jco.2009.27.9356.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCarboplatinCarcinoma, Non-Small-Cell LungCetuximabDisease-Free SurvivalDrug Administration ScheduleErbB ReceptorsErlotinib HydrochlorideFemaleHumansKaplan-Meier EstimateLung NeoplasmsMaleMiddle AgedMutationNeoplasm StagingPaclitaxelPatient SelectionProto-Oncogene ProteinsProto-Oncogene Proteins p21(ras)QuinazolinesRas ProteinsResearch DesignSouthwestern United StatesTreatment OutcomeConceptsCell lung cancerConcurrent chemotherapyLung cancerEpidermal growth factor receptor tyrosine kinase inhibitorsGrowth factor receptor tyrosine kinase inhibitorsProgression-free survival timeRandomized phase II trialReceptor tyrosine kinase inhibitorsMedian overall survivalPaclitaxel/carboplatinTreatment-naive patientsGrade 3 rashPhase II trialAdvanced-stage NSCLCPhase III evaluationTyrosine kinase inhibitorsEnhanced antitumor activityConcurrent regimenMaintenance cetuximabMedian followVersus ChemotherapyChemotherapy regimenII trialSequential therapyConcurrent therapy
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 RateThe 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 ResearchConceptsPhase 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
2008
Increased EGFR Gene Copy Number Detected by Fluorescent In Situ Hybridization Predicts Outcome in Non–Small-Cell Lung Cancer Patients Treated With Cetuximab and Chemotherapy
Hirsch FR, Herbst RS, Olsen C, Chansky K, Crowley J, Kelly K, Franklin WA, Bunn PA, Varella-Garcia M, Gandara DR. Increased EGFR Gene Copy Number Detected by Fluorescent In Situ Hybridization Predicts Outcome in Non–Small-Cell Lung Cancer Patients Treated With Cetuximab and Chemotherapy. Journal Of Clinical Oncology 2008, 26: 3351-3357. PMID: 18612151, PMCID: PMC3368372, DOI: 10.1200/jco.2007.14.0111.Peer-Reviewed Original ResearchMeSH KeywordsAgedAnalysis of VarianceAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCarcinoma, Non-Small-Cell LungCetuximabFemaleGene Expression Regulation, NeoplasticGenes, erbB-1HumansIn Situ HybridizationIn Situ Hybridization, FluorescenceLung NeoplasmsMaleMiddle AgedMultivariate AnalysisNeoplasm StagingPatient SelectionPredictive Value of TestsPrognosisProportional Hazards ModelsReference ValuesRisk AssessmentSurvival AnalysisTreatment OutcomeConceptsCell lung cancer patientsLung cancer patientsFISH-negative patientsEGFR FISHNSCLC patientsCancer patientsSurvival timeMedian progression-free survival timeProgression-free survival timeEGFR tyrosine kinase inhibitorsDisease control rateChemotherapy-naive patientsAdvanced-stage NSCLCMedian survival timeEpidermal growth factor receptor (EGFR) gene copy numberFISH-positive patientsAvailable tumor tissueEGFR gene copy numberTyrosine kinase inhibitorsFISH-positive tumorsPhase II selection trialFISH-positive groupConcurrent chemotherapyConcurrent therapyPredictive factors
2005
Phase II study of pemetrexed in combination with carboplatin in the first‐line treatment of advanced nonsmall cell lung cancer
Zinner RG, Fossella FV, Gladish GW, Glisson BS, Blumenschein GR, Papadimitrakopoulou VA, Pisters KM, Kim ES, Oh YW, Peeples BO, Ye Z, Curiel RE, Obasaju CK, Hong WK, Herbst RS. Phase II study of pemetrexed in combination with carboplatin in the first‐line treatment of advanced nonsmall cell lung cancer. Cancer 2005, 104: 2449-2456. PMID: 16258975, DOI: 10.1002/cncr.21480.Peer-Reviewed Original ResearchConceptsAdvanced nonsmall cell lung cancerNonsmall cell lung cancerCell lung cancerPerformance statusLung cancerSerum concentration-time curveGrade 3/4 thrombocytopeniaNonhematologic side effectsZubrod performance statusGrade 3/4 neutropeniaPartial response ratePercent of patientsPhase II studyStage IV diseaseFirst-line therapyFirst-line treatmentConcentration-time curveCarboplatin areaPrior chemotherapyStage IIIBII studyMedian ageMedian timeSensory neuropathyMedian numberRole of novel targeted therapies in the clinic
Herbst RS. Role of novel targeted therapies in the clinic. British Journal Of Cancer 2005, 92: s21-s27. PMID: 15928655, PMCID: PMC2362061, DOI: 10.1038/sj.bjc.6602605.Peer-Reviewed Original Research
2003
A phase I/IIA trial of continuous five-day infusion of squalamine lactate (MSI-1256F) plus carboplatin and paclitaxel in patients with advanced non-small cell lung cancer.
Herbst RS, Hammond LA, Carbone DP, Tran HT, Holroyd KJ, Desai A, Williams JI, Bekele BN, Hait H, Allgood V, Solomon S, Schiller JH. A phase I/IIA trial of continuous five-day infusion of squalamine lactate (MSI-1256F) plus carboplatin and paclitaxel in patients with advanced non-small cell lung cancer. Clinical Cancer Research 2003, 9: 4108-15. PMID: 14519633.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAngiogenesis InhibitorsAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCarcinoma, Non-Small-Cell LungCholestanolsDisease-Free SurvivalFemaleHumansInfusions, IntravenousLactatesLung NeoplasmsMaleMiddle AgedNeoplasm StagingPaclitaxelPatient SelectionPleural EffusionSurvival AnalysisTime FactorsConceptsNon-small cell lung cancerCell lung cancerLung cancerDay 1Continuous infusionChemotherapy-naive non-small cell lung cancerAdvanced non-small cell lung cancerPhase I/IIa studyPhase I/IIa trialPhase II doseDose-limiting toxicityPartial tumor responseFive-day infusionEffective therapeutic strategyPatient survival dataEvaluable patientsStable diseaseStage IIIBStarting doseClinical responseCombination regimenCytotoxic chemotherapyIIa studyIIa trialMedian survival