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
2022
Maximizing the value of phase III trials in immuno-oncology: A checklist from the Society for Immunotherapy of Cancer (SITC)
Atkins MB, Abu-Sbeih H, Ascierto PA, Bishop MR, Chen DS, Dhodapkar M, Emens LA, Ernstoff MS, Ferris RL, Greten TF, Gulley JL, Herbst RS, Humphrey RW, Larkin J, Margolin KA, Mazzarella L, Ramalingam SS, Regan MM, Rini BI, Sznol M. Maximizing the value of phase III trials in immuno-oncology: A checklist from the Society for Immunotherapy of Cancer (SITC). Journal For ImmunoTherapy Of Cancer 2022, 10: e005413. PMID: 36175037, PMCID: PMC9528604, DOI: 10.1136/jitc-2022-005413.Peer-Reviewed Original ResearchMeSH KeywordsAnimalsChecklistClinical Trials as TopicImmune Checkpoint InhibitorsImmunologic FactorsImmunotherapyLigandsNeoplasmsProgrammed Cell Death 1 ReceptorConceptsPhase III trialsImmunotherapy of cancerIII trialsCurative responseImmune checkpoint inhibitor monotherapyCell death protein 1Checkpoint inhibitor monotherapyDefinitive predictive biomarkersDurable clinical benefitProgression-free survivalMinority of patientsDeath protein 1Variety of indicationsClinical trial designAnimal tumor modelsLimited Phase IDrug development programsImmunotherapy combinationsInvestigational chemotherapyImmunotherapy fieldInhibitor monotherapyOverall survivalDismal prognosisClinical benefitSurvival outcomes
2020
The value of interventional radiology in clinical trial teams: experience from the BATTLE lung cancer trials
Tam AL, Papadimitrakopoulou V, Wistuba II, Lee JJ, Ensor JE, Kim ES, Kalhor N, Blumenschein GR, Tsao AS, Heymach JV, Herbst RS, Hicks ME, Hong WK, Gupta S. The value of interventional radiology in clinical trial teams: experience from the BATTLE lung cancer trials. Clinical Radiology 2020, 76: 155.e25-155.e34. PMID: 33268083, DOI: 10.1016/j.crad.2020.09.024.Peer-Reviewed Original ResearchConceptsInterventional radiologistsClinical trial teamsTrial teamPercutaneous image-guided biopsyLung Cancer EliminationLung cancer trialsEvidence of viabilityImage-guided biopsyLesion scoring systemBiomarker analysisCancer trialsTargeted therapyCancer eliminationScore's abilityInterventional radiologyMultivariate analysisLesionsBiopsySolid massFollowing criteriaModerate agreementMultidisciplinary approachTrialsScoresBiomarkers
2019
Immunotherapy in Non–Small Cell Lung Cancer: Facts and Hopes
Doroshow DB, Sanmamed MF, Hastings K, Politi K, Rimm DL, Chen L, Melero I, Schalper KA, Herbst RS. Immunotherapy in Non–Small Cell Lung Cancer: Facts and Hopes. Clinical Cancer Research 2019, 25: 4592-4602. PMID: 30824587, PMCID: PMC6679805, DOI: 10.1158/1078-0432.ccr-18-1538.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsMeSH KeywordsAntineoplastic Agents, ImmunologicalB7-H1 AntigenCarcinoma, Non-Small-Cell LungClinical Trials as TopicHumansImmunologic FactorsImmunotherapyLung NeoplasmsConceptsNon-small cell lung cancerImmune checkpoint inhibitorsCell lung cancerPD-L1Lung cancerNonsquamous non-small cell lung cancerOngoing translational workPD-1 axisFirst-line therapyPD-L1 expressionProportion of patientsTumor mutational burdenAdvanced diseaseOverall survivalTumor inflammationMutational burdenPatientsNovel markerChemotherapyTherapyIndicative biomarkersCancerTranslational workBiomarkersSurvivalChallenges 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 ResearchMeSH KeywordsClinical Decision-MakingClinical Trials as TopicDisease ManagementHumansMedical OncologyNeoplasmsPrecision MedicineResearch DesignConceptsBasket trialsClinical trial designHealth care providersDifferent tumor typesTherapeutic optionsImmunologic reactionsCare providersDrug development effortsTrial designTumor typesPatientsMost cancersClinical researchNew therapeuticsCancer communityTherapy todayMedical institutionsCancerCancer researchTrialsRare mutationsEpigenetic changesHistologyOncologyAppetite
2018
Should chemotherapy plus immune checkpoint inhibition be the standard front‐line therapy for patients with metastatic non–small cell lung cancer?
Goldberg SB, Herbst RS. Should chemotherapy plus immune checkpoint inhibition be the standard front‐line therapy for patients with metastatic non–small cell lung cancer? Cancer 2018, 124: 4592-4596. PMID: 30383887, PMCID: PMC6443243, DOI: 10.1002/cncr.31681.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerCell lung cancerLung cancerNonsquamous non-small cell lung cancerAdvanced non-small cell lung cancerMetastatic non-small cell lung cancerCell death protein 1 (PD-1) inhibitorsStandard front-line therapyFirst-line settingImmune checkpoint inhibitionFront-line therapyNew treatment optionsProtein 1 inhibitorCheckpoint inhibitionTumor histologyTreatment optionsRecent trialsPatientsCancerChemotherapyTherapyHistologyMajor advancementsTrialsTreatment of Advanced Non–Small Cell Lung Cancer in 2018
Doroshow DB, Herbst RS. Treatment of Advanced Non–Small Cell Lung Cancer in 2018. JAMA Oncology 2018, 4: 569-570. PMID: 29494728, DOI: 10.1001/jamaoncol.2017.5190.Peer-Reviewed Original ResearchThe 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 ResearchMeSH KeywordsCarcinoma, Non-Small-Cell LungClinical Trials as TopicHumansImmunotherapyLung NeoplasmsMolecular Targeted TherapyPrecision MedicineSurvival RateTumor MicroenvironmentConceptsNon-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
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 ResearchMeSH KeywordsB7-H1 AntigenClinical Trials as TopicDisease-Free SurvivalDrug DiscoveryErbB ReceptorsHumansImmunotherapyLung NeoplasmsMolecular Targeted TherapyMutationResearch DesignImmune checkpoint therapy for non-small-cell lung cancer: an update
Xia B, Herbst RS. Immune checkpoint therapy for non-small-cell lung cancer: an update. Immunotherapy 2016, 8: 279-298. PMID: 26860624, DOI: 10.2217/imt.15.123.Peer-Reviewed Original ResearchConceptsCell lung cancerImmune checkpointsLung cancerCo-inhibitory immune checkpointsRole of immunotherapyImmune checkpoint therapyImmune checkpoint pathwaysSynergistic antitumor activityCheckpoint inhibitorsInhibitory checkpointsCheckpoint therapyL1 antibodyImmune cellsNovel therapiesImmune activityAntagonist antibodyTumor growthTumor microenvironmentTumor cellsTherapyAntitumor activityAntibodiesCancerImmunotherapyCells
2015
Lung Cancer in the Era of Precision Medicine
Politi K, Herbst RS. Lung Cancer in the Era of Precision Medicine. Clinical Cancer Research 2015, 21: 2213-2220. PMID: 25979927, PMCID: PMC4505624, DOI: 10.1158/1078-0432.ccr-14-2748.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsLung cancerClinical trialsBiomarker-driven clinical trialsLung cancer clinicEfficacy of immunotherapyLung cancer patientsLung cancer subtypesNovel therapeutic targetPrecision medicineFirst-generation drugsMetastatic diseaseCancer patientsEGFR mutationsCancer clinicActionable mutationsTherapeutic targetPatientsMolecular testingCancer subtypesImmune systemNew treatmentsMolecular subgroupsDrug resistanceMechanisms of sensitivityCancer
2014
The PD-1 pathway as a therapeutic target to overcome immune escape mechanisms in cancer
Henick BS, Herbst RS, Goldberg SB. The PD-1 pathway as a therapeutic target to overcome immune escape mechanisms in cancer. Expert Opinion On Therapeutic Targets 2014, 18: 1407-1420. PMID: 25331677, DOI: 10.1517/14728222.2014.955794.Peer-Reviewed Original ResearchMeSH KeywordsAnimalsAntibodies, MonoclonalAntineoplastic AgentsClinical Trials as TopicHumansImmunotherapyNeoplasmsProgrammed Cell Death 1 ReceptorTumor EscapeConceptsPD-1 pathwayEarly clinical trialsClinical trialsTumor typesDeath-1 pathway inhibitorsPD-1 pathway inhibitionImmune escape mechanismsOngoing clinical trialsEarly-stage cancerTreatment of cancerCure rateLikely respondersCancer immunotherapyPreclinical dataAntineoplastic effectsTherapeutic targetPathway inhibitionPathway inhibitorCancer typesBiological rationaleCancer treatmentMonoclonal antibodiesEscape mechanismsUpcoming trialsTrialsNew 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 markersTumorsTrialsB7-H1/PD-1 Blockade Therapy in Non–Small Cell Lung Cancer
Gettinger S, Herbst RS. B7-H1/PD-1 Blockade Therapy in Non–Small Cell Lung Cancer. The Cancer Journal 2014, 20: 281-289. PMID: 25098289, DOI: 10.1097/ppo.0000000000000063.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerAdvanced non-small cell lung cancerPhase III trialsCell lung cancerIII trialsPD-1Lung cancerClinical trialsPD-1/PD-L1 inhibitorsB7-H1/PDTumor PD-L1 expressionSevere autoimmune toxicityChemotherapy-naive patientsPD-L1 expressionPotential of immunotherapyPD-L1 inhibitorsDeath ligand 1Future clinical trialsNumber of antibodiesAutoimmune toxicityExpansion cohortBlockade therapyDurable responsesNSCLC patientsStandard therapyAmerican 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
Personalized Therapy
Ujhazy P, Herbst R. Personalized Therapy. Journal Of Thoracic Oncology 2012, 7: s401-s403. PMID: 23160334, DOI: 10.1097/jto.0b013e31826df27c.Peer-Reviewed Original ResearchAntineoplastic AgentsClinical Trials as TopicHumansLung NeoplasmsMutationNeoplasm ProteinsPrecision MedicineMiscellaneous Agents
Morgensztern D, Herbst RS. Miscellaneous Agents. Journal Of Thoracic Oncology 2012, 7: s390-s391. PMID: 23160329, DOI: 10.1097/jto.0b013e31826df1d2.Peer-Reviewed Original ResearchTobacco Assessment in Actively Accruing National Cancer Institute Cooperative Group Program Clinical Trials
Peters EN, Torres E, Toll BA, Cummings KM, Gritz ER, Hyland A, Herbst RS, Marshall JR, Warren GW. Tobacco Assessment in Actively Accruing National Cancer Institute Cooperative Group Program Clinical Trials. Journal Of Clinical Oncology 2012, 30: 2869-2875. PMID: 22689794, PMCID: PMC3410402, DOI: 10.1200/jco.2011.40.8815.Peer-Reviewed Original ResearchConceptsCooperative group clinical trialsGroup clinical trialTobacco use assessmentClinical trialsTobacco useCancer treatment outcomesTreatment outcomesTobacco assessmentEvidence-based cessation supportPhase III trialsSecondhand smoke exposureClinical oncology practiceCooperative Group ProgramCancer clinical trialsCurrent cigarette useIII trialsSmoke exposureCessation supportNeck trialsOncology practiceNicotine dependenceRoutine assessmentCigarette useTrialsGroup programReports 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 ResearchMeSH KeywordsBiomarkers, TumorClinical Trials as TopicHumansMolecular Targeted TherapyNeoplasmsPrecision MedicineResearch DesignTranslational Research, BiomedicalConceptsClinical trialsMajority of patientsSingle-therapy approachesSame histologyTranslational cancer researchSingle therapyHeterogeneous diseaseCertain therapiesClinical strategiesPatientsTherapy trialsTherapyClinical researchTrialsTank meetingDiseaseClinical experimentsAdaptive trialsBiomarker subsetsCancer researchSubsetOvertreatmentClinicalHistologyTumors
2011
Methodological and practical challenges for personalized cancer therapies
Wistuba II, Gelovani JG, Jacoby JJ, Davis SE, Herbst RS. Methodological and practical challenges for personalized cancer therapies. Nature Reviews Clinical Oncology 2011, 8: 135-141. PMID: 21364686, DOI: 10.1038/nrclinonc.2011.2.Peer-Reviewed Original Research