2020
Biomarker-driven therapies for previously treated squamous non-small-cell lung cancer (Lung-MAP SWOG S1400): a biomarker-driven master protocol
Redman MW, Papadimitrakopoulou VA, Minichiello K, Hirsch FR, Mack PC, Schwartz LH, Vokes E, Ramalingam S, Leighl N, Bradley J, Miao J, Moon J, Highleyman L, Miwa C, LeBlanc ML, Malik S, Miller VA, Sigal EV, Adam S, Wholley D, Sigman C, Smolich B, Blanke CD, Kelly K, Gandara DR, Herbst RS. Biomarker-driven therapies for previously treated squamous non-small-cell lung cancer (Lung-MAP SWOG S1400): a biomarker-driven master protocol. The Lancet Oncology 2020, 21: 1589-1601. PMID: 33125909, PMCID: PMC8109255, DOI: 10.1016/s1470-2045(20)30475-7.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overBiomarkers, TumorCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellClinical Decision-MakingDisease ProgressionFemaleHigh-Throughput Nucleotide SequencingHumansLung NeoplasmsMaleMiddle AgedMolecular Targeted TherapyNeoplasm Recurrence, LocalNeoplasm StagingPrecision MedicinePredictive Value of TestsProgression-Free SurvivalTime FactorsYoung AdultConceptsCell lung cancerNational Cancer InstituteTargeted therapy groupLung cancerLung-MAPMaster protocolsDocetaxel groupTherapy groupEastern Cooperative Oncology Group performance statusUnmet needMedian progression-free survivalNational Clinical Trials NetworkMedian overall survivalAdvanced lung cancerProgression-free survivalPlatinum-based chemotherapyClinical Trials NetworkNational InstituteClinical trial componentUS National Cancer InstituteNew screening protocolBristol-Myers SquibbAdditional substudyEligible patientsImmunotherapy combinationsChemoradiotherapy efficacy is predicted by intra-tumour CD8+/FoxP3+ double positive T cell density in locally advanced N2 non–small-cell lung carcinoma
Boulle G, Velut Y, Mansuet-Lupo A, Gibault L, Blons H, Fournel L, Boni A, Cremer I, Wislez M, Duchatelle V, Trédaniel J, Hammond S, Herbst R, Alifano M, Giraud P, Damotte D. Chemoradiotherapy efficacy is predicted by intra-tumour CD8+/FoxP3+ double positive T cell density in locally advanced N2 non–small-cell lung carcinoma. European Journal Of Cancer 2020, 135: 221-229. PMID: 32610210, DOI: 10.1016/j.ejca.2020.04.040.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overB7-H1 AntigenCarcinoma, Non-Small-Cell LungCD8-Positive T-LymphocytesChemoradiotherapyChemoradiotherapy, AdjuvantFemaleForkhead Transcription FactorsHumansLung NeoplasmsLymphocytes, Tumor-InfiltratingMaleMiddle AgedNeoplasm StagingRetrospective StudiesTime FactorsTreatment OutcomeTumor MicroenvironmentConceptsT-cell densityCell lung carcinomaN2 NSCLCPatient survivalLung carcinomaClinical dataT cellsRadiotherapy efficacyIII-N2 NSCLCSurgery/chemotherapyPD-L1 expressionStandard of careImmunogenic cell deathDouble-positive cellsAction of radiotherapyIII-N2Immune environmentAbscopal effectChemoradiotherapy efficacyImmune infiltrationImmune cellsPositive cellsMultivariate analysisRadiotherapyTumor samples
2018
Early Assessment of Lung Cancer Immunotherapy Response via Circulating Tumor DNA
Goldberg SB, Narayan A, Kole AJ, Decker RH, Teysir J, Carriero NJ, Lee A, Nemati R, Nath SK, Mane SM, Deng Y, Sukumar N, Zelterman D, Boffa DJ, Politi K, Gettinger S, Wilson LD, Herbst RS, Patel AA. Early Assessment of Lung Cancer Immunotherapy Response via Circulating Tumor DNA. Clinical Cancer Research 2018, 24: 1872-1880. PMID: 29330207, PMCID: PMC5899677, DOI: 10.1158/1078-0432.ccr-17-1341.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerImmune checkpoint inhibitorsCtDNA responseCheckpoint inhibitorsCtDNA levelsMetastatic non-small cell lung cancerImmune checkpoint inhibitor therapySuperior progression-free survivalRadiographic tumor sizeCheckpoint inhibitor therapyProgression-free survivalSuperior overall survivalTumor DNA levelsCell lung cancerAllele fractionClin Cancer ResMultigene next-generation sequencingMutant allele fractionTumor cell deathInhibitor therapyOverall survivalRadiographic responseImmunotherapy efficacyImmunotherapy responseMedian time
2017
Cetuximab plus carboplatin and paclitaxel with or without bevacizumab versus carboplatin and paclitaxel with or without bevacizumab in advanced NSCLC (SWOG S0819): a randomised, phase 3 study
Herbst RS, Redman MW, Kim ES, Semrad TJ, Bazhenova L, Masters G, Oettel K, Guaglianone P, Reynolds C, Karnad A, Arnold SM, Varella-Garcia M, Moon J, Mack PC, Blanke CD, Hirsch FR, Kelly K, Gandara DR. Cetuximab plus carboplatin and paclitaxel with or without bevacizumab versus carboplatin and paclitaxel with or without bevacizumab in advanced NSCLC (SWOG S0819): a randomised, phase 3 study. The Lancet Oncology 2017, 19: 101-114. PMID: 29169877, PMCID: PMC5847342, DOI: 10.1016/s1470-2045(17)30694-0.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCarcinoma, Non-Small-Cell LungCetuximabDisease ProgressionDisease-Free SurvivalErbB ReceptorsFemaleHumansIn Situ Hybridization, FluorescenceLung NeoplasmsMaleMexicoMiddle AgedMutationPaclitaxelRisk FactorsTime FactorsTreatment OutcomeUnited StatesConceptsProgression-free survivalSquamous cell histologyCetuximab groupEntire study populationOverall survivalCell histologyControl groupTreatment groupsAdvanced NSCLCAdverse eventsStudy populationProgression-free survival eventsSquamous cell carcinoma cancerEGFR FISHActivity of cetuximabCommon grade 3Non-squamous histologyStage IV NSCLCSevere adverse eventsCell lung cancerCo-primary endpointsAnti-EGFR antibodiesNational Cancer InstituteEligible patientsEGFR FISH status
2014
Vandetanib and Indwelling Pleural Catheter for Non–Small-Cell Lung Cancer With Recurrent Malignant Pleural Effusion
Massarelli E, Onn A, Marom EM, Alden CM, Liu DD, Tran HT, Mino B, Wistuba II, Faiz SA, Bashoura L, Eapen GA, Morice RC, Lee J, Hong WK, Herbst RS, Jimenez CA. Vandetanib and Indwelling Pleural Catheter for Non–Small-Cell Lung Cancer With Recurrent Malignant Pleural Effusion. Clinical Lung Cancer 2014, 15: 379-386. PMID: 24913066, PMCID: PMC4160385, DOI: 10.1016/j.cllc.2014.04.002.Peer-Reviewed Original ResearchConceptsRecurrent malignant pleural effusionCell lung cancer patientsMalignant pleural effusionLung cancer patientsCell lung cancerPleural effusionCancer patientsMedian timeCatheter placementLung cancerEastern Cooperative Oncology Group performance statusPoor overall median survivalEnd pointSingle-arm phase II clinical trialPhase II clinical trialIndwelling pleural catheterOverall median survivalPrimary end pointSecondary end pointsDaily oral doseWeeks of treatmentPleural fluid cytologyVEGF receptor inhibitorPleural fluid cytokinesEligible patients
2011
Small-Cell Lung Cancer: Prognostic Factors and Changing Treatment Over 15 Years
Gaspar LE, McNamara EJ, Gay EG, Putnam JB, Crawford J, Herbst RS, Bonner JA. Small-Cell Lung Cancer: Prognostic Factors and Changing Treatment Over 15 Years. Clinical Lung Cancer 2011, 13: 115-122. PMID: 22000695, DOI: 10.1016/j.cllc.2011.05.008.Peer-Reviewed Original ResearchConceptsSmall cell lung cancerNational Cancer Data BaseExtensive SCLCHazard ratioLimited SCLCRadiation therapyExtensive small cell lung cancerLimited small cell lung cancerNon-Hispanic white patientsBenefit of chemotherapyReceipt of surgeryAmerican Joint CommitteeEarly-stage diseaseMedian survivalOnly chemotherapyStage diseasePrognostic factorsWhite patientsFemale patientsImproved survivalFemale sexLung cancerCancer stageBetter survivalPatients
2010
Pharmacokinetic study of the phase III, randomized, double-blind, multicenter trial (TRIBUTE) of paclitaxel and carboplatin combined with erlotinib or placebo in patients with advanced Non-small Cell Lung Cancer (NSCLC)
Tran HT, Zinner RG, Blumenschein GR, Oh YW, Papadimitrakopoulou VA, Kim ES, Lu C, Malik M, Lum BL, Herbst RS. Pharmacokinetic study of the phase III, randomized, double-blind, multicenter trial (TRIBUTE) of paclitaxel and carboplatin combined with erlotinib or placebo in patients with advanced Non-small Cell Lung Cancer (NSCLC). Investigational New Drugs 2010, 29: 499-505. PMID: 20094773, DOI: 10.1007/s10637-009-9380-z.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerAdvanced non-small cell lung cancerDrug-drug interactionsErlotinib groupPlacebo groupPotential drug-drug interactionsErlotinib treatment groupPlacebo-treated patientsPossible drug-drug interactionsStandard chemotherapy regimenPhase III trialsCell lung cancerAddition of erlotinibPharmacokinetics of erlotinibMetabolite OSI-420Non-compartmental modelingAUC 6Erlotinib 150Paclitaxel 200Resultant paclitaxelChemotherapy regimenIII trialsUntreated patientsConcomitant administrationMulticenter trial
2007
Efficacy and Safety of Single-Agent Pertuzumab, a Human Epidermal Receptor Dimerization Inhibitor, in Patients with Non–Small Cell Lung Cancer
Herbst RS, Davies AM, Natale RB, Dang TP, Schiller JH, Garland LL, Miller VA, Mendelson D, Van den Abbeele AD, Melenevsky Y, de Vries DJ, Eberhard DA, Lyons B, Lutzker SG, Johnson BE. Efficacy and Safety of Single-Agent Pertuzumab, a Human Epidermal Receptor Dimerization Inhibitor, in Patients with Non–Small Cell Lung Cancer. Clinical Cancer Research 2007, 13: 6175-6181. PMID: 17947484, DOI: 10.1158/1078-0432.ccr-07-0460.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBiopsyCarcinoma, Non-Small-Cell LungDimerizationErbB ReceptorsFemaleFluorodeoxyglucose F18HumansLung NeoplasmsMaleMiddle AgedMutationPositron-Emission TomographyProtein Structure, TertiaryReceptor, ErbB-2Time FactorsTreatment OutcomeConceptsNon-small cell lung cancerProgression-free survival ratesCell lung cancerPositron emission tomographyLung cancerRecurrent non-small cell lung cancerHumanized monoclonal anti-HER2 antibodyGrade 4 adverse eventsGrade 4 cardiac toxicityPrimary efficacy end pointEmission tomographyEfficacy end pointPhase II trialResponse Evaluation CriteriaMonoclonal anti-HER2 antibodyOverall response rateMetabolic responseTumor glucose metabolismAnti-HER2 antibodyStable diseaseII trialAdverse eventsCardiac toxicityPharmacodynamic markersCore biopsy
2006
Efficacy and safety of gefitinib in chemonaive patients with advanced non-small cell lung cancer treated in an Expanded Access Program
Govindan R, Natale R, Wade J, Herbst R, Krebs A, Reiling R, Hensing T, Wozniak A, Belani CP, Kelly K, Ochs J. Efficacy and safety of gefitinib in chemonaive patients with advanced non-small cell lung cancer treated in an Expanded Access Program. Lung Cancer 2006, 53: 331-337. PMID: 16797779, DOI: 10.1016/j.lungcan.2006.04.013.Peer-Reviewed Original ResearchConceptsAdvanced non-small cell lung cancerNon-small cell lung cancerExpanded Access ProgramCell lung cancerLung cancerRecurrent advanced non-small cell lung cancerEpidermal growth factor receptor tyrosine kinase inhibitor gefitinibNumerous clinical guidelinesSafety of gefitinibBest supportive careCommon adverse eventsPartial response ratePoor performance statusRetrospective chart reviewMajority of patientsTyrosine kinase inhibitor gefitinibFavorable toxicity profileAccess programKinase inhibitor gefitinibPrevious chemotherapyStable diseaseSubsequent chemotherapyChemonaive patientsAdverse eventsChart review
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 number
2004
A phase I surrogate endpoint study of SU6668 in patients with solid tumors
Xiong HQ, Herbst R, Faria SC, Scholz C, Davis D, Jackson EF, Madden T, McConkey D, Hicks M, Hess K, Charnsangavej C, Abbruzzese JL. A phase I surrogate endpoint study of SU6668 in patients with solid tumors. Investigational New Drugs 2004, 22: 459-466. PMID: 15292716, DOI: 10.1023/b:drug.0000036688.96453.8d.Peer-Reviewed Original ResearchConceptsCore needle biopsyBiologic effectsNeedle biopsyDay 1Solid tumorsMean apparent oral clearanceContrast-enhanced magnetic resonance imagingApparent oral clearanceDynamic contrast-enhanced magnetic resonance imagingCorrelative studiesHigh-performance liquid chromatography assayMagnetic resonance imagingDCE-MRI resultsEligible patientsOral clearanceLiquid chromatography assayEndpoint studiesAntiangiogenic agentsFunctional CTBlood flowTumor specimensPatientsTissue biopsiesDay 22PK studies
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 survivalInduction of p53-regulated genes and tumor regression in lung cancer patients after intratumoral delivery of adenoviral p53 (INGN 201) and radiation therapy.
Swisher SG, Roth JA, Komaki R, Gu J, Lee JJ, Hicks M, Ro JY, Hong WK, Merritt JA, Ahrar K, Atkinson NE, Correa AM, Dolormente M, Dreiling L, El-Naggar AK, Fossella F, Francisco R, Glisson B, Grammer S, Herbst R, Huaringa A, Kemp B, Khuri FR, Kurie JM, Liao Z, McDonnell TJ, Morice R, Morello F, Munden R, Papadimitrakopoulou V, Pisters KM, Putnam JB, Sarabia AJ, Shelton T, Stevens C, Shin DM, Smythe WR, Vaporciyan AA, Walsh GL, Yin M. Induction of p53-regulated genes and tumor regression in lung cancer patients after intratumoral delivery of adenoviral p53 (INGN 201) and radiation therapy. Clinical Cancer Research 2003, 9: 93-101. PMID: 12538456.Peer-Reviewed Original ResearchMeSH KeywordsAdenoviridaeAgedAged, 80 and overApoptosisCarcinoma, Non-Small-Cell LungCombined Modality TherapyFemaleGene Transfer TechniquesGenes, p53Genetic TherapyGenetic VectorsHumansLung NeoplasmsMaleMiddle AgedRadiotherapyReverse Transcriptase Polymerase Chain ReactionRNA, MessengerTime FactorsTumor Suppressor Protein p53ConceptsNon-small cell lung cancerAd-p53 gene transferCell lung cancerRadiation therapyViable tumorLung cancerTumor regressionNonmetastatic non-small cell lung cancerProspective single-arm phase II studyIntratumoral injectionSingle-arm phase II studyAd-p53 gene therapyArm phase II studyCommon adverse eventsPhase II studyCompletion of therapyLung cancer patientsCourse of treatmentStable diseaseAdverse eventsBronchoscopic findingsII studyPartial responseProgressive diseaseComplete responseA retrospective analysis of the outcome of patients who have received two prior chemotherapy regimens including platinum and docetaxel for recurrent non-small-cell lung cancer
Massarelli E, Andre F, Liu DD, Lee JJ, Wolf M, Fandi A, Ochs J, Le Chevalier T, Fossella F, Herbst RS. A retrospective analysis of the outcome of patients who have received two prior chemotherapy regimens including platinum and docetaxel for recurrent non-small-cell lung cancer. Lung Cancer 2003, 39: 55-61. PMID: 12499095, DOI: 10.1016/s0169-5002(02)00308-2.Peer-Reviewed Original ResearchConceptsMedian overall survival timePrior chemotherapy regimensSecond-line treatmentCell lung cancerOverall survival timeChemotherapy regimensLung cancerChemotherapy agentsRetrospective analysisSurvival timeDisease control rateFourth-line chemotherapyFourth-line treatmentOverall performance statusSecond-line therapyStage III diseaseStage IV diseaseOutcomes of patientsDays of chemotherapyFirst-line treatmentLine of treatmentEuropean cancer centersNovel therapy approachesRecurrent NSCLCAdvanced NSCLC
2002
Phase I study of recombinant human endostatin in patients with advanced solid tumors.
Herbst RS, Hess KR, Tran HT, Tseng JE, Mullani NA, Charnsangavej C, Madden T, Davis DW, McConkey DJ, O’Reilly M, Ellis LM, Pluda J, Hong WK, Abbruzzese JL. Phase I study of recombinant human endostatin in patients with advanced solid tumors. Journal Of Clinical Oncology 2002, 20: 3792-803. PMID: 12228199, DOI: 10.1200/jco.2002.11.061.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAdultAgedAngiogenesis InhibitorsCollagenCollagen Type XVIIIEndostatinsEndothelial Growth FactorsE-SelectinFemaleFibroblast Growth Factor 2Hematologic DiseasesHumansImmunoglobulinsInfusions, IntravenousLymphokinesMagnetic Resonance ImagingMaleMaximum Tolerated DoseMiddle AgedNeoplasmsPeptide FragmentsRecombinant ProteinsTime FactorsTissue DistributionVascular Cell Adhesion Molecule-1Vascular Endothelial Growth Factor AVascular Endothelial Growth FactorsConceptsRh-EndoConcentration-time curveRecombinant human endostatinSerum markersPreclinical modelsSolid tumorsHuman endostatinDose-limiting toxic effectAntitumor activityTwo-compartmental open modelAdvanced solid tumorsPhase I trialCentral line accessDose-finding trialMinor antitumor activityI trialIntravenous bolusSerum biomarkersSerum antibodiesPharmacokinetic dispositionAllergic reactionsPatientsPharmacokinetic profileDose levelsPhase I
1997
Reversal of in vivo drug resistance by the transforming growth factor‐β inhibitor decorin
Teicher B, Maehara Y, Kakeh Y, Ara G, Keyes S, Wong J, Herbst R. Reversal of in vivo drug resistance by the transforming growth factor‐β inhibitor decorin. International Journal Of Cancer 1997, 71: 49-58. PMID: 9096665, DOI: 10.1002/(sici)1097-0215(19970328)71:1<49::aid-ijc10>3.0.co;2-4.Peer-Reviewed Original ResearchConceptsEMT-6/CDDP tumorTumor cell survivalParent tumorResistant tumorsDrug resistanceAdministration of decorinCell survivalEMT-6/CTXPlasma TGF-beta levelsTGF-beta proteinGranulocyte-macrophage colony-stimulating factorSitu hybridizationTGF-beta levelsVivo drug resistanceHigher plasma levelsTGF-beta mRNATumor-bearing animalsMurine mammary tumorsGrowth factorColony-stimulating factorDrug responseDecorinCytotoxic therapyPlasma levelsTumor levels