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 research
2021
Clinical characteristics and outcomes for 7,995 patients with SARS-CoV-2 infection
McPadden J, Warner F, Young HP, Hurley NC, Pulk RA, Singh A, Durant TJS, Gong G, Desai N, Haimovich A, Taylor RA, Gunel M, Dela Cruz CS, Farhadian SF, Siner J, Villanueva M, Churchwell K, Hsiao A, Torre CJ, Velazquez EJ, Herbst RS, Iwasaki A, Ko AI, Mortazavi BJ, Krumholz HM, Schulz WL. Clinical characteristics and outcomes for 7,995 patients with SARS-CoV-2 infection. PLOS ONE 2021, 16: e0243291. PMID: 33788846, PMCID: PMC8011821, DOI: 10.1371/journal.pone.0243291.Peer-Reviewed Original ResearchConceptsSARS-CoV-2 infectionYale New Haven HealthSARS-CoV-2Hospital mortalityRisk of admissionMale sexRisk factorsSARS-CoV-2 testingInvasive mechanical ventilationSevere acute respiratory syndrome virusBurden of diseaseRT-PCR testingAcademic health systemDiverse patient populationsRespiratory syndrome virusEthnic groupsAdult patientsClinical characteristicsDischarge dispositionRespiratory supportPrimary outcomeTreatment guidelinesMechanical ventilationRetrospective studyPatient population
2019
Health-Related Quality of Life in KEYNOTE-010: a Phase II/III Study of Pembrolizumab Versus Docetaxel in Patients With Previously Treated Advanced, Programmed Death Ligand 1–Expressing NSCLC
Barlesi F, Garon E, Kim D, Felip E, Han J, Kim J, Ahn M, Fidler M, Gubens M, de Castro G, Surmont V, Li Q, Deitz A, Lubiniecki G, Herbst R. Health-Related Quality of Life in KEYNOTE-010: a Phase II/III Study of Pembrolizumab Versus Docetaxel in Patients With Previously Treated Advanced, Programmed Death Ligand 1–Expressing NSCLC. Journal Of Thoracic Oncology 2019, 14: 793-801. PMID: 30711649, DOI: 10.1016/j.jtho.2019.01.016.Peer-Reviewed Original ResearchConceptsGlobal health statusDeath ligand 1Composite endpointPhase II/III studyGHS/QoL scoresLife Questionnaire Core 30Programmed Death Ligand 1Symptom domainsNSCLC patient populationPembrolizumab-treated patientsWeek 12 changesHealth-related qualityLigand 1Quality of lifeGHS/KEYNOTE-010Advanced NSCLCChest painIII studyOverall survivalCancer QualityEuroQol-5D.Life scoresMean baselinePatient population
2018
The biology and management of non-small cell lung cancer
Herbst RS, Morgensztern D, Boshoff C. The biology and management of non-small cell lung cancer. Nature 2018, 553: 446-454. PMID: 29364287, DOI: 10.1038/nature25183.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerCell lung cancerLung cancerSmall molecule tyrosine kinase inhibitorsMolecule tyrosine kinase inhibitorsBroader patient populationTyrosine kinase inhibitorsUnprecedented survival benefitsMetastatic diseaseMultimodal careSurvival benefitClinical benefitCombination therapyOverall curePatient populationSurvival rateTumor progressionEarly detectionKinase inhibitorsNew drugsDisease biologyCancerImmunotherapyPatientsTherapy
2017
Enhancing Insights into Pulmonary Vascular Disease through a Precision Medicine Approach. A Joint NHLBI–Cardiovascular Medical Research and Education Fund Workshop Report
Newman JH, Rich S, Abman SH, Alexander JH, Barnard J, Beck GJ, Benza RL, Bull TM, Chan SY, Chun HJ, Doogan D, Dupuis J, Erzurum SC, Frantz RP, Geraci M, Gillies H, Gladwin M, Gray MP, Hemnes AR, Herbst RS, Hernandez AF, Hill NS, Horn EM, Hunter K, Jing ZC, Johns R, Kaul S, Kawut SM, Lahm T, Leopold JA, Lewis GD, Mathai SC, McLaughlin VV, Michelakis ED, Nathan SD, Nichols W, Page G, Rabinovitch M, Rich J, Rischard F, Rounds S, Shah SJ, Tapson VF, Lowy N, Stockbridge N, Weinmann G, Xiao L. Enhancing Insights into Pulmonary Vascular Disease through a Precision Medicine Approach. A Joint NHLBI–Cardiovascular Medical Research and Education Fund Workshop Report. American Journal Of Respiratory And Critical Care Medicine 2017, 195: 1661-1670. PMID: 28430547, PMCID: PMC5476915, DOI: 10.1164/rccm.201701-0150ws.Peer-Reviewed Original ResearchConceptsPulmonary vascular diseaseClinical trialsPulmonary hypertensionVascular diseaseNational Biological SamplePrecision medicine principlesVascular disease phenotypesNational Precision Medicine InitiativeSmall clinical trialsFuture clinical trialsPrecision medicine approachInnovative statistical designLung diseasePatient populationPatient advocacy organizationsPrecision Medicine InitiativeTherapeutic interventionsClinical investigatorsMedicine approachMedicine principlesMetabolic testsTrialsDiseaseBreakthrough InitiativePharmaceutical industry experts
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 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
Prognostic significance of the AJCC staging in patients with squamous cell carcinoma of the oropharynx.
Acevedo-Gadea C, Baumgart M, Wang Z, Deshpande H, Davies M, Decker R, Sasaki C, Judson B, Herbst R, Morgensztern D. Prognostic significance of the AJCC staging in patients with squamous cell carcinoma of the oropharynx. Journal Of Clinical Oncology 2012, 30: 5529-5529. DOI: 10.1200/jco.2012.30.15_suppl.5529.Peer-Reviewed Original ResearchSquamous cell carcinomaOP cancerOverall survivalHuman papillomavirusOral cavityAJCC stagePrognostic significanceCell carcinomaStage IFrequency of HPVNeck squamous cell carcinomaCurrent AJCC systemEnd Results registryKaplan-Meier methodEpidemiology of headL. PatientsPrognostic impactAJCC stagingOropharyngeal cancerPrognostic factorsStage IVBSurveillance EpidemiologyAJCC systemPatient populationClinical behavior
2011
The BATTLE Trial: Personalizing Therapy for Lung Cancer
Kim ES, Herbst RS, Wistuba II, Lee JJ, Blumenschein GR, Tsao A, Stewart DJ, Hicks ME, Erasmus J, Gupta S, Alden CM, Liu S, Tang X, Khuri FR, Tran HT, Johnson BE, Heymach JV, Mao L, Fossella F, Kies MS, Papadimitrakopoulou V, Davis SE, Lippman SM, Hong WK. The BATTLE Trial: Personalizing Therapy for Lung Cancer. Cancer Discovery 2011, 1: 44-53. PMID: 22586319, PMCID: PMC4211116, DOI: 10.1158/2159-8274.cd-10-0010.Peer-Reviewed Original ResearchConceptsLung cancer patientsCancer patientsNon-small cell lung cancer patientsLung Cancer Elimination (BATTLE) trialCell lung cancer patientsDisease control rateCore needle biopsy specimensLung cancer clinical trialsSpecific patient populationsLung cancer therapyNeedle biopsy specimensCancer clinical trialsRelevant molecular biomarkersKRAS patientsNSCLC patientsPatient populationRandomization periodControl rateLaboratory findingsLung cancerBiopsy specimensClinical trialsTargeted therapyBATTLE TrialIndividualized treatment
2003
Mode of action of docetaxel – a basis for combination with novel anticancer agents
Herbst RS, Khuri FR. Mode of action of docetaxel – a basis for combination with novel anticancer agents. Cancer Treatment Reviews 2003, 29: 407-415. PMID: 12972359, DOI: 10.1016/s0305-7372(03)00097-5.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Agents, PhytogenicAntineoplastic Combined Chemotherapy ProtocolsApoptosisDocetaxelDrug Resistance, NeoplasmDrug SynergismErbB ReceptorsFemaleFollow-Up StudiesHumansMaleNeoplasmsNeovascularization, PathologicPaclitaxelPharmacogeneticsSurvival AnalysisTaxoidsTreatment OutcomeConceptsPatient populationOptimal treatment strategySpecific patient populationsCertain chemotherapeutic drugsAnticancer agentsOptimal therapySpecific therapyTreatment strategiesNovel agentsClinical investigationNew anticancer agentsNovel anticancer agentsCancer growthDifferent tumorsStimulation pathwayChemotherapeutic drugsInhibitor of mitosisAntitumor activityTumorigenic mechanismsMode of actionAgent combinationsDocetaxelTherapyAgentsDifferent aberrationsErlotinib (Tarceva): An update on the clinical trial program
Herbst RS. Erlotinib (Tarceva): An update on the clinical trial program. Seminars In Oncology 2003, 30: 34-46. PMID: 12840799, DOI: 10.1016/s0093-7754(03)70013-x.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerCell lung cancerLung cancerAdvanced non-small cell lung cancerPhase II monotherapy trialsNeck squamous cell cancerUse of erlotinibAntitumor activitySingle-agent chemotherapyPhase III trialsClinical trial programSquamous cell cancerSimilar patient populationsSubstantial antitumor activityHuman tumor xenograftsMonotherapy trialsEpidermal growth factor receptor tyrosine kinaseIII trialsCell cancerPatient populationPancreatic cancerOvarian cancerPreclinical studiesGrowth factor receptor tyrosine kinaseTumor xenografts
2002
ZD1839 (Iressa™) in Non-Small Cell Lung Cancer
Herbst RS, Kies MS. ZD1839 (Iressa™) in Non-Small Cell Lung Cancer. The Oncologist 2002, 7: 9-15. PMID: 12202783, DOI: 10.1634/theoncologist.7-suppl_4-9.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerCell lung cancerEpidermal growth factor receptorLung cancerAdvanced non-small cell lung cancerEGFR tyrosine kinase inhibitor ZD1839Treatment of NSCLCCisplatin-based combination chemotherapyAnti-EGFR agentsConventional cytotoxic chemotherapyAvailable clinical dataGrowth factor receptorCombination chemotherapyCytotoxic chemotherapyPatient populationClinical dataClinical developmentGreater efficacyFactor receptorZD1839Less toxicityUseful targetChemotherapyCancerPrognosis