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 ResearchConceptsCancer 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 researchMulti-stakeholder, intentional outreach for improving representative recruitment in Pragmatica–Lung (SWOG S2302).
Carrizosa D, Miao J, Reckamp K, Dragnev K, Hesketh P, Iams W, Henick B, Czerlanis C, DeSanto F, Sundstrom J, Johnson J, Gansauer L, Groller T, Redman M, Herbst R, Gray J. Multi-stakeholder, intentional outreach for improving representative recruitment in Pragmatica–Lung (SWOG S2302). Journal Of Clinical Oncology 2024, 42: 11019-11019. DOI: 10.1200/jco.2024.42.16_suppl.11019.Peer-Reviewed Original ResearchRecruitment planTrial designClinical trial enrollmentAdvanced/metastatic NSCLCAccrual rateStandard therapyPatient education materialsImprove community awarenessPatient accrual rateSWOGClinical trialsTrial enrollmentVA sitesApproaches to trial designPatient advocatesPatientsDecrease barriersMinority accrualRecruitment strategiesAdvocacy partnersLatinx patientsCommunity awarenessTrialsEducational materialsEnrollment information
2022
ESMO expert consensus statements on the management of EGFR mutant non-small-cell lung cancer
Passaro A, Leighl N, Blackhall F, Popat S, Kerr K, Ahn M, Arcila M, Arrieta O, Planchard D, de Marinis F, Dingemans A, Dziadziuszko R, Faivre-Finn C, Feldman J, Felip E, Curigliano G, Herbst R, Jänne P, John T, Mitsudomi T, Mok T, Normanno N, Paz-Ares L, Ramalingam S, Sequist L, Vansteenkiste J, Wistuba I, Wolf J, Wu Y, Yang S, Yang J, Yatabe Y, Pentheroudakis G, Peters S. ESMO expert consensus statements on the management of EGFR mutant non-small-cell lung cancer. Annals Of Oncology 2022, 33: 466-487. PMID: 35176458, DOI: 10.1016/j.annonc.2022.02.003.Peer-Reviewed Original ResearchConceptsCell lung cancerLung cancerESMO Clinical Practice GuidelinesManagement of EGFRClinical practice guidelinesExpert consensus statementClinical trial designSummary of evidenceEpidermal growth factor receptorGrowth factor receptorAdvanced diseaseMetastatic diseaseMedical oncologyConsensus statementMultidisciplinary panelPractice guidelinesConsensus recommendationsTrial designExpert panel discussionAvailable evidenceEuropean SocietyFactor receptorCancerExpert panelBiomarker analysis
2019
SY6-1 Cancer immunotherapy; A paradigm shift in the first-line treatment of lung cancer
Herbst R. SY6-1 Cancer immunotherapy; A paradigm shift in the first-line treatment of lung cancer. Annals Of Oncology 2019, 30: vi32. DOI: 10.1093/annonc/mdz325.Peer-Reviewed Original ResearchLung cancerImmune checkpoint inhibitorsFirst-line treatmentMinority of patientsTumor mutational burdenPresence of tumorEfficient trial designMarker of resistanceCheckpoint inhibitorsTreatment of cancerCancer deathCancer immunotherapyPredictive markerSmoking ratesMutational burdenNew therapiesTrial designImmune systemCancerTherapyImmunotherapyChemotherapyPatientsTreatmentMarkersChallenges 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
60 How to Promote and Organize Clinical Research in Lung Cancer
Barlesi F, Mazieres J, Zhou Y, Herbst R, Zalcman G. 60 How to Promote and Organize Clinical Research in Lung Cancer. 2018, 628-634.e2. DOI: 10.1016/b978-0-323-52357-8.00060-3.Peer-Reviewed Original ResearchLung cancerClinical trialsNew clinical trial designsClinical trial designPotential therapeutic drugBasic science dataClinical researchersAppropriate trialsPreclinical dataPreventative optionsCertain therapiesTrial designNew treatmentsClinical researchPreclinical conceptsTherapeutic drugsCancerTrialsPatientsPersonalized medicineTherapyBiomarkers
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, 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
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
2007
A clinical trial design applying Bayesian adaptive randomization for targeted therapy development in lung cancer: A step toward personalized medicine
Zhou X, Kim E, Herbst R, Liu S, Wistuba I, Mao L, Lewis J, Lippman S, Hong W, Lee J. A clinical trial design applying Bayesian adaptive randomization for targeted therapy development in lung cancer: A step toward personalized medicine. Journal Of Clinical Oncology 2007, 25: 7697-7697. DOI: 10.1200/jco.2007.25.18_suppl.7697.Peer-Reviewed Original ResearchBiomarker profilesEffective agentResponse rateRandomization ratesLung Cancer EliminationTumor biomarker profilesClinical trial designBayesian adaptive randomizationCancer ptsPrior chemotherapyTreatment armsClinical efficacyLung cancerCancer eliminationEffective therapyLung carcinogenesisTargeted therapyDifferent biomarker profilesTrial designTreatment efficacyBiopsy samplesTherapy trialsPatient entryBiomarker expressionTherapy
2004
Report from the Society for Biological Therapy and Vascular Biology Faculty of the NCI Workshop on Angiogenesis Monitoring
McDonald DM, Teicher BA, Stetler-Stevenson W, Ng SS, Figg WD, Folkman J, Hanahan D, Auerbach R, O’Reilly M, Herbst R, Cheresh D, Gordon M, Eggermont A, Libutti SK. Report from the Society for Biological Therapy and Vascular Biology Faculty of the NCI Workshop on Angiogenesis Monitoring. Journal Of Immunotherapy 2004, 27: 161-175. PMID: 14770088, DOI: 10.1097/00002371-200403000-00010.Peer-Reviewed Original Research