2024
Pragmaticism in Cancer Clinical Trials.
Sankar K, Redman M, Dragnev K, Henick B, Iams W, Blanke C, Herbst R, Gray J, Reckamp K. Pragmaticism in Cancer Clinical Trials. American Society Of Clinical Oncology Educational Book 2024, 44: e100040. PMID: 38771997, DOI: 10.1200/edbk_100040.Peer-Reviewed Original ResearchMeSH KeywordsClinical Trials as TopicHumansMedical OncologyNeoplasmsPragmatic Clinical Trials as TopicResearch DesignConceptsCancer clinical trialsTraditional explanatory trialsCancer mortality ratesPatient care scenariosGoal of improving patient outcomesPragmatic trial designTrial designRepresentative patient populationPragmatic trialIntervention effectsIntervention efficacyCare scenariosExplanatory trialsTrial generalizabilityPragmatic designPatient outcomesClinical trialsReal-world practiceOncologyEscalating costsCancer clinical trial designPatient populationMortality rateDuration of trialsOncology research
2019
Challenges and approaches to implementing master/basket trials in oncology
Burd A, Schilsky RL, Byrd JC, Levine RL, Papadimitrakopoulou VA, Herbst RS, Redman MW, Druker BJ, Gandara DR. Challenges and approaches to implementing master/basket trials in oncology. Blood Advances 2019, 3: 2237-2243. PMID: 31337605, PMCID: PMC6650731, DOI: 10.1182/bloodadvances.2019031229.Peer-Reviewed Original ResearchConceptsBasket trialsClinical trial designHealth care providersDifferent tumor typesTherapeutic optionsImmunologic reactionsCare providersDrug development effortsTrial designTumor typesPatientsMost cancersClinical researchNew therapeuticsCancer communityTherapy todayMedical institutionsCancerCancer researchTrialsRare mutationsEpigenetic changesHistologyOncologyAppetite
2018
ADAURA: Phase III, Double-blind, Randomized Study of Osimertinib Versus Placebo in EGFR Mutation-positive Early-stage NSCLC After Complete Surgical Resection
Wu YL, Herbst R, Mann H, Rukazenkov Y, Marotti M, Tsuboi M. ADAURA: Phase III, Double-blind, Randomized Study of Osimertinib Versus Placebo in EGFR Mutation-positive Early-stage NSCLC After Complete Surgical Resection. Clinical Lung Cancer 2018, 19: e533-e536. PMID: 29789220, DOI: 10.1016/j.cllc.2018.04.004.Peer-Reviewed Original ResearchConceptsCell lung cancerDisease recurrenceLung cancerMutation statusSurvival rateEpidermal growth factor receptor tyrosine kinase inhibitorsGrowth factor receptor tyrosine kinase inhibitorsComplete surgical tumor resectionDisease-free survival ratesT790M mutation statusReceptor tyrosine kinase inhibitorsMaximum treatment durationStage IB-IIIAPlacebo-controlled studyDisease-free survivalEarly-stage NSCLCComplete surgical resectionOverall survival rateHealth-related qualityHealth resource useSurgical tumor resectionEGFR mutation statusTyrosine kinase inhibitorsCentral confirmationVersus Placebo
2016
Clinician Perspectives on Current Issues in Lung Cancer Drug Development
Waqar SN, Bonomi PD, Govindan R, Hirsch FR, Riely GJ, Papadimitrakopoulou V, Kazandjian D, Khozin S, Larkins E, Dickson DJ, Malik S, Horn L, Ferris A, Shaw AT, Jänne PA, Mok TS, Herbst R, Keegan P, Pazdur R, Blumenthal GM. Clinician Perspectives on Current Issues in Lung Cancer Drug Development. Journal Of Thoracic Oncology 2016, 11: 1387-1396. PMID: 27401214, PMCID: PMC5131641, DOI: 10.1016/j.jtho.2016.05.009.Peer-Reviewed Original Research
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 ResearchConceptsSquamous 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 protocolsCarcinomaCancerLung Master Protocol (Lung-MAP)—A Biomarker-Driven Protocol for Accelerating Development of Therapies for Squamous Cell Lung Cancer: SWOG S1400
Herbst RS, Gandara DR, Hirsch FR, Redman MW, LeBlanc M, Mack PC, Schwartz LH, Vokes E, Ramalingam SS, Bradley JD, Sparks D, Zhou Y, Miwa C, Miller VA, Yelensky R, Li Y, Allen JD, Sigal EV, Wholley D, Sigman CC, Blumenthal GM, Malik S, Kelloff GJ, Abrams JS, Blanke CD, Papadimitrakopoulou VA. Lung Master Protocol (Lung-MAP)—A Biomarker-Driven Protocol for Accelerating Development of Therapies for Squamous Cell Lung Cancer: SWOG S1400. Clinical Cancer Research 2015, 21: 1514-1524. PMID: 25680375, PMCID: PMC4654466, DOI: 10.1158/1078-0432.ccr-13-3473.Peer-Reviewed Original ResearchConceptsSquamous cell carcinomaLung squamous cell carcinomaMaster protocolsClinical trialsAdvanced lung squamous cell carcinomaSquamous cell lung cancerCell lung cancerStandard of careMutation/amplificationTraditional clinical trialsDevelopment of therapiesInvestigational agentsCell carcinomaLung cancerCancer Genome Atlas (TCGA) projectMolecular abnormalitiesTherapyLungTrialsSignificant numberCarcinomaCancerAbnormalitiesProtocolCare
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 ResearchConceptsClinical 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
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 targetsReports from the 2010 Clinical and Translational Cancer Research Think Tank Meeting: Design Strategies for Personalized Therapy Trials
Berry DA, Herbst RS, Rubin EH. Reports from the 2010 Clinical and Translational Cancer Research Think Tank Meeting: Design Strategies for Personalized Therapy Trials. Clinical Cancer Research 2012, 18: 638-644. PMID: 22298897, PMCID: PMC4314693, DOI: 10.1158/1078-0432.ccr-11-2018.Peer-Reviewed Original ResearchConceptsClinical trialsMajority of patientsSingle-therapy approachesSame histologyTranslational cancer researchSingle therapyHeterogeneous diseaseCertain therapiesClinical strategiesPatientsTherapy trialsTherapyClinical researchTrialsTank meetingDiseaseClinical experimentsAdaptive trialsBiomarker subsetsCancer researchSubsetOvertreatmentClinicalHistologyTumors
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
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 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
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 tumorsTo kill a tumor cell: the potential of proapoptotic receptor agonists
Ashkenazi A, Herbst RS. To kill a tumor cell: the potential of proapoptotic receptor agonists. Journal Of Clinical Investigation 2008, 118: 1979-1990. PMID: 18523647, PMCID: PMC2396896, DOI: 10.1172/jci34359.Peer-Reviewed Original ResearchConceptsProapoptotic receptor agonistsApo2L/TRAILReceptor agonistRecombinant human Apo2L/TRAILExtrinsic apoptosis pathwayPotential therapeutic interventionsNovel molecular biomarkersApoptosis pathwayAgonistic mAbConventional therapyPreclinical dataTherapeutic interventionsTumor cellsMolecular biomarkersAbnormal cellsLogical targetTherapyAgonistsCellsExciting opportunitiesTumorigenesisPatientsApoptosisPathwaySummary Report 7th Annual Targeted Therapies of the Treatment of Lung Cancer
Einhorn LH, Bonomi P, Bunn PA, Camidge DR, Carbone DP, Choy H, Dubinett SM, Gandara DR, Gaspar LE, Govindan R, Johnson DH, Minna JD, Scagliotti G, West HJ, Herbst RS. Summary Report 7th Annual Targeted Therapies of the Treatment of Lung Cancer. Journal Of Thoracic Oncology 2008, 3: 545-555. PMID: 18449013, PMCID: PMC3374724, DOI: 10.1097/jto.0b013e318170627f.Peer-Reviewed Original Research
2004
Novel Agents in the Treatment of Lung CancerConference Summary Statement
Lynch TJ, Adjei AA, Bunn PA, DuBois RN, Gandara DR, Giaccone G, Govindan R, Herbst RS, Johnson BE, Khuri FR, Perez-Soler R, Rosell R, Rowinsky EK, Sandler AB, Scagliotti GV, Schiller JH, Shapiro GI, Socinski MA, Hart CS. Novel Agents in the Treatment of Lung CancerConference Summary Statement. Clinical Cancer Research 2004, 10: 4199s-4204s. PMID: 15217958, DOI: 10.1158/1078-0432.ccr-040021.Peer-Reviewed Original Research
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' understandingPatientsRespondents
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