2020
Atezolizumab for First-Line Treatment of PD-L1–Selected Patients with NSCLC
Herbst RS, Giaccone G, de Marinis F, Reinmuth N, Vergnenegre A, Barrios CH, Morise M, Felip E, Andric Z, Geater S, Özgüroğlu M, Zou W, Sandler A, Enquist I, Komatsubara K, Deng Y, Kuriki H, Wen X, McCleland M, Mocci S, Jassem J, Spigel DR. Atezolizumab for First-Line Treatment of PD-L1–Selected Patients with NSCLC. New England Journal Of Medicine 2020, 383: 1328-1339. PMID: 32997907, DOI: 10.1056/nejmoa1917346.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsB7-H1 AntigenCarboplatinCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellCisplatinDeoxycytidineFemaleGemcitabineHumansLung NeoplasmsMaleMiddle AgedMutationSurvival AnalysisConceptsPD-L1 expressionBlood-based tumor mutational burdenProgression-free survivalPlatinum-based chemotherapyTumor mutational burdenOverall survivalWild-type tumorsAtezolizumab groupChemotherapy groupAdverse eventsPD-L1Mutational burdenHigh PD-L1 expressionPD-L1 expression statusTumor-infiltrating immune cellsMedian overall survivalFirst-line treatmentPD-L1 assaysPhase 3 trialLonger overall survivalSubgroup of patientsCell lung cancerAtezolizumab treatmentSquamous NSCLCTreat population
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
2013
Phase II Trial of Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab Followed by Cetuximab and Bevacizumab in Advanced Nonsquamous Non–Small-Cell Lung Cancer: SWOG S0536
Kim ES, Moon J, Herbst RS, Redman MW, Dakhil SR, Velasco MR, Hirsch FR, Mack PC, Kelly K, Heymach JV, Gandara DR. Phase II Trial of Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab Followed by Cetuximab and Bevacizumab in Advanced Nonsquamous Non–Small-Cell Lung Cancer: SWOG S0536. Journal Of Thoracic Oncology 2013, 8: 1519-1528. PMID: 24189513, PMCID: PMC4072123, DOI: 10.1097/jto.0000000000000009.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarboplatinCarcinoma, Non-Small-Cell LungCetuximabFeasibility StudiesFemaleFollow-Up StudiesHumansLung NeoplasmsMaleMiddle AgedNeoplasm StagingPaclitaxelPrognosisSurvival RateConceptsPhase II trialProgression-free survivalII trialPrimary endpointOverall survivalLung cancerAdvanced nonsquamous non-small cell lung cancerNonsquamous non-small cell lung cancerResponse rateNon-small cell lung cancerMedian progression-free survivalOverall disease control rateCycles of carboplatinPlatinum-based doubletsTreatment-related deathsChemotherapy-naive patientsDisease control rateMedian overall survivalCombination of carboplatinCell lung cancerHigher hemorrhageMaintenance cetuximabStable diseaseAdvanced NSCLCNonsquamous NSCLC
2012
Phase I trial of axitinib combined with platinum doublets in patients with advanced non-small cell lung cancer and other solid tumours
Kozloff MF, Martin LP, Krzakowski M, Samuel TA, Rado TA, Arriola E, De Castro Carpeño J, Herbst RS, Tarazi J, Kim S, Rosbrook B, Tortorici M, Olszanski AJ, Cohen RB. Phase I trial of axitinib combined with platinum doublets in patients with advanced non-small cell lung cancer and other solid tumours. British Journal Of Cancer 2012, 107: 1277-1285. PMID: 22990652, PMCID: PMC3494447, DOI: 10.1038/bjc.2012.406.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerPaclitaxel/carboplatinAdvanced non-small cell lung cancerPharmacokinetics of axitinibGemcitabine/cisplatinCell lung cancerAxitinib 5Platinum doubletsLung cancerSolid tumorsSquamous cell non-small cell lung cancerTreatment-related adverse eventsSelective second-generation inhibitorVascular endothelial growth factor receptorObjective response rateDose-limiting toxicityPhase I trialEndothelial growth factor receptorDose-finding trialDrug-drug interactionsPhase I dose-finding trialsCisplatin regimensFebrile neutropeniaGrowth factor receptorExpansion cohort
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 therapyComparison of Patient Outcomes According to Histology Among Pemetrexed-Treated Patients With Stage IIIB/IV Non–Small-Cell Lung Cancer in Two Phase II Trials
Zinner RG, Novello S, Peng G, Herbst R, Obasaju C, Scagliotti G. Comparison of Patient Outcomes According to Histology Among Pemetrexed-Treated Patients With Stage IIIB/IV Non–Small-Cell Lung Cancer in Two Phase II Trials. Clinical Lung Cancer 2010, 11: 126-131. PMID: 20199979, DOI: 10.3816/clc.2010.n.017.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellFemaleGlutamatesGuanineHumansLung NeoplasmsMaleMiddle AgedMulticenter Studies as TopicNeoplasm StagingOrganoplatinum CompoundsOxaliplatinPemetrexedRetrospective StudiesSurvival RateTreatment OutcomeConceptsNonsquamous histologyProgression-free survivalSquamous histologyOverall survivalLung cancerStage IIIB/IV non-small cell lung cancerResponse rateStage IIIB/IV NSCLCNon-small cell lung cancerRecent phase III studyPemetrexed-treated patientsChemotherapy-naive patientsPhase II studyPhase II trialPhase III studyCell lung cancerCarboplatin areaNSCLC histologyPlatinum doubletsII trialPrimary endpointII studyIII studyPerformance statusTreatment armsPharmacokinetic 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
2008
Randomized Phase II Study of Vandetanib Alone or With Paclitaxel and Carboplatin as First-Line Treatment for Advanced Non–Small-Cell Lung Cancer
Heymach JV, Paz-Ares L, De Braud F, Sebastian M, Stewart DJ, Eberhardt WE, Ranade AA, Cohen G, Trigo JM, Sandler AB, Bonomi PD, Herbst RS, Krebs AD, Vasselli J, Johnson BE. Randomized Phase II Study of Vandetanib Alone or With Paclitaxel and Carboplatin as First-Line Treatment for Advanced Non–Small-Cell Lung Cancer. Journal Of Clinical Oncology 2008, 26: 5407-5415. PMID: 18936474, DOI: 10.1200/jco.2008.17.3138.Peer-Reviewed Original ResearchConceptsProgression-free survivalPhase II studyRisk of progressionVandetanib monotherapyII studyOverall survivalLung cancerAdvanced non-small cell lung cancerNon-small cell lung cancerMedian progression-free survivalLonger progression-free survivalRandomized phase II studyShorter progression-free survivalEnd pointVascular endothelial growth factor receptorCommon adverse eventsPrimary end pointStudy end pointSquamous cell histologyEndothelial growth factor receptorCell lung cancerCNS metastasesGrowth factor receptorMonotherapy armNSCLC histologyOverview of the efficacy of cetuximab in recurrent and/or metastatic squamous cell carcinoma of the head and neck in patients who previously failed platinum‐based therapies
Vermorken JB, Herbst RS, Leon X, Amellal N, Baselga J. Overview of the efficacy of cetuximab in recurrent and/or metastatic squamous cell carcinoma of the head and neck in patients who previously failed platinum‐based therapies. Cancer 2008, 112: 2710-2719. PMID: 18481809, DOI: 10.1002/cncr.23442.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCarcinoma, Squamous CellCetuximabCisplatinClinical Trials as TopicDrug Resistance, NeoplasmHead and Neck NeoplasmsHumansMiddle AgedNeoplasm Recurrence, LocalProspective StudiesRetrospective StudiesSurvival AnalysisTreatment OutcomeConceptsMetastatic squamous cell carcinomaSquamous cell carcinomaMetastatic SCCHNPlatinum therapyRetrospective studyCell carcinomaEpidermal growth factor receptor (EGFR) inhibitor cetuximabActivity of cetuximabCarboplatin-based chemotherapyCetuximab-based treatmentCisplatin/carboplatinDisease control rateMedian overall survivalSecond-line therapySecond-line treatmentEfficacy of cetuximabPlatinum-based therapyOverall response ratePlatinum failureOverall survivalMedian timeProlong survivalProspective studyControl rateEfficacy data
2006
Angiogenesis inhibition in the treatment of lung cancer.
Vokes E, Herbst R, Sandler A. Angiogenesis inhibition in the treatment of lung cancer. Clinical Advances In Hematology And Oncology 2006, 4: 1-10; quiz 11-2. PMID: 17143257.Peer-Reviewed Original ResearchMeSH KeywordsAngiogenesis InhibitorsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarboplatinCarcinoma, Non-Small-Cell LungClinical Trials, Phase III as TopicDisease-Free SurvivalErlotinib HydrochlorideHemorrhageHumansLung NeoplasmsNeovascularization, PathologicPaclitaxelProtein Kinase InhibitorsQuinazolinesRandomized Controlled Trials as TopicRisk FactorsSurvival RateVascular Endothelial Growth Factor AConceptsNon-small cell lung cancerVascular endothelial growth factorLung cancerAntiangiogenic therapyNon-squamous cell non-small cell lung cancerAnti-VEGF monoclonal antibody bevacizumabSmall molecule tyrosine kinase inhibitorsRandomized phase II studyRandomized phase III trialEpidermal growth factor receptor inhibitor erlotinibPhase II studyAddition of bevacizumabPhase III trialsSignificant survival benefitCell lung cancerSignificant clinical benefitMonoclonal antibody bevacizumabComprehensive treatment approachTyrosine kinase inhibitorsEndothelial growth factorImportant therapeutic targetOngoing studiesNSCLC settingBevacizumab treatmentII study
2005
Phase I/IIa Study of Cetuximab With Gemcitabine Plus Carboplatin in Patients With Chemotherapy-Naïve Advanced Non–Small-Cell Lung Cancer
Robert F, Blumenschein G, Herbst RS, Fossella FV, Tseng J, Saleh MN, Needle M. Phase I/IIa Study of Cetuximab With Gemcitabine Plus Carboplatin in Patients With Chemotherapy-Naïve Advanced Non–Small-Cell Lung Cancer. Journal Of Clinical Oncology 2005, 23: 9089-9096. PMID: 16301597, DOI: 10.1200/jco.2004.00.1438.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCarcinoma, Non-Small-Cell LungCetuximabDeoxycytidineDisease ProgressionDrug Administration ScheduleDrug EruptionsFemaleGemcitabineHumansInfusions, IntravenousLung NeoplasmsMaleMiddle AgedSurvival AnalysisTreatment OutcomeConceptsPhase I/IIa studyAdverse eventsIIa studyOverall survivalLung cancerToxicity profileResponse rateGrade 3 adverse eventsGrade 3 allergic reactionSmall cell lung cancerAcne-like rashMucositis/stomatitisCycles of therapyMedian overall survivalNausea/vomitingSafety/toxicity profileTumor response rateAcceptable toxicity profileFever/chillsCombination of cetuximabCell lung cancerAssessable patientsChemotherapy-naïveStable diseaseMedian survivalPhase 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 numberMutations in the Epidermal Growth Factor Receptor and in KRAS Are Predictive and Prognostic Indicators in Patients With Non–Small-Cell Lung Cancer Treated With Chemotherapy Alone and in Combination With Erlotinib
Eberhard DA, Johnson BE, Amler LC, Goddard AD, Heldens SL, Herbst RS, Ince WL, Jänne PA, Januario T, Johnson DH, Klein P, Miller VA, Ostland MA, Ramies DA, Sebisanovic D, Stinson JA, Zhang YR, Seshagiri S, Hillan KJ. Mutations in the Epidermal Growth Factor Receptor and in KRAS Are Predictive and Prognostic Indicators in Patients With Non–Small-Cell Lung Cancer Treated With Chemotherapy Alone and in Combination With Erlotinib. Journal Of Clinical Oncology 2005, 23: 5900-5909. PMID: 16043828, DOI: 10.1200/jco.2005.02.857.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCarcinoma, Non-Small-Cell LungCombined Modality TherapyDNA Mutational AnalysisErbB ReceptorsErlotinib HydrochlorideFemaleGenes, rasHumansLung NeoplasmsMaleMiddle AgedPaclitaxelPlacebosPredictive Value of TestsPrognosisQuinazolinesSurvival AnalysisTreatment OutcomeConceptsRetrospective subset analysisCell lung cancerEGFR mutationsKRAS mutationsLung cancerSubset analysisSingle-agent EGFR inhibitorsEpidermal growth factor receptor (EGFR) mutationsEGFR inhibitorsErlotinib-treated patientsFirst-line chemotherapyAdvanced NSCLC patientsChemotherapy-treated patientsPositive prognostic factorPoor clinical outcomeEGFR inhibitor treatmentImproved response ratesKRAS-mutant NSCLCKRAS exon 2Epidermal growth factor receptorGrowth factor receptorAdvanced NSCLCUntreated patientsNSCLC patientsPrognostic factorsTRIBUTE: A Phase III Trial of Erlotinib Hydrochloride (OSI-774) Combined With Carboplatin and Paclitaxel Chemotherapy in Advanced Non–Small-Cell Lung Cancer
Herbst RS, Prager D, Hermann R, Fehrenbacher L, Johnson BE, Sandler A, Kris MG, Tran HT, Klein P, Li X, Ramies D, Johnson DH, Miller VA. TRIBUTE: A Phase III Trial of Erlotinib Hydrochloride (OSI-774) Combined With Carboplatin and Paclitaxel Chemotherapy in Advanced Non–Small-Cell Lung Cancer. Journal Of Clinical Oncology 2005, 23: 5892-5899. PMID: 16043829, DOI: 10.1200/jco.2005.02.840.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCarcinoma, Non-Small-Cell LungDisease ProgressionErbB ReceptorsErlotinib HydrochlorideFemaleHumansLung NeoplasmsMaleMiddle AgedPaclitaxelPlacebosProtein Kinase InhibitorsQuinazolinesSurvival AnalysisConceptsUntreated advanced NSCLCOverall survivalAdvanced NSCLCObjective responseLung cancerAdvanced non-small cell lung cancerEpidermal growth factor receptor tyrosine kinase inhibitorsGrowth factor receptor tyrosine kinase inhibitorsNon-small cell lung cancerEnd pointReceptor tyrosine kinase inhibitorsCycles of carboplatinGood performance statusImproved overall survivalOutcomes of patientsPrimary end pointSecondary end pointsPhase III trialsSingle-agent activityCell lung cancerDuration of responseTyrosine kinase inhibitorsAssessable patientsConcurrent carboplatinErlotinib arm
2004
Clinical and pharmacokinetic study of TNP-470, an angiogenesis inhibitor, in combination with paclitaxel and carboplatin in patients with solid tumors
Tran HT, Blumenschein GR, Lu C, Meyers CA, Papadimitrakopoulou V, Fossella FV, Zinner R, Madden T, Smythe LG, Puduvalli VK, Munden R, Truong M, Herbst RS. Clinical and pharmacokinetic study of TNP-470, an angiogenesis inhibitor, in combination with paclitaxel and carboplatin in patients with solid tumors. Cancer Chemotherapy And Pharmacology 2004, 54: 308-314. PMID: 15184994, DOI: 10.1007/s00280-004-0816-z.Peer-Reviewed Original ResearchConceptsPharmacokinetics of carboplatinTNP-470Solid tumorsDoublet regimenAngiogenesis inhibitor TNP-470Hematological toxic effectsRegimen of paclitaxelCycles of therapyMedian survival durationCombination of paclitaxelPatient survival ratesRecent clinical trialsHead/neckCell lung carcinomaTNP-470 administrationToxic effectsAUC 5AUC 6Chemotherapy doubletsIntravenous paclitaxelPurposePreclinical studiesStable diseasePartial responseRandomized studySurvival durationRandomized Phase II Trial Comparing Bevacizumab Plus Carboplatin and Paclitaxel With Carboplatin and Paclitaxel Alone in Previously Untreated Locally Advanced or Metastatic Non-Small-Cell Lung Cancer
Johnson DH, Fehrenbacher L, Novotny WF, Herbst RS, Nemunaitis JJ, Jablons DM, Langer CJ, DeVore RF, Gaudreault J, Damico LA, Holmgren E, Kabbinavar F. Randomized Phase II Trial Comparing Bevacizumab Plus Carboplatin and Paclitaxel With Carboplatin and Paclitaxel Alone in Previously Untreated Locally Advanced or Metastatic Non-Small-Cell Lung Cancer. Journal Of Clinical Oncology 2004, 22: 2184-2191. PMID: 15169807, DOI: 10.1200/jco.2004.11.022.Peer-Reviewed Original ResearchConceptsCell lung cancerSingle-agent bevacizumabLung cancerMajor hemoptysisCell histologyControl armResponse ratePrimary efficacy end pointNonsquamous cell histologyProminent adverse eventSafety of bevacizumabEfficacy end pointDistinct clinical patternsPhase II trialSquamous cell histologyLonger median timeHigh response rateMajor blood vesselsPreviously UntreatedStable diseaseII trialAdverse eventsControl patientsClinical patternMedian timePemetrexed in the Treatment of Advanced Non–Small-Cell Lung Cancer: A Review of the Clinical Data
Zinner RG, Herbst RS. Pemetrexed in the Treatment of Advanced Non–Small-Cell Lung Cancer: A Review of the Clinical Data. Clinical Lung Cancer 2004, 5: s67-s74. PMID: 15117428, DOI: 10.3816/clc.2004.s.006.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerSecond-line activityPhase III trialsIII trialsLung cancerAdvanced non-small cell lung cancerPhase II studyFirst-line therapyCell lung cancerFavorable toxicity profileChest radiationII studyThoracic malignanciesClinical dataSignificant efficacyToxicity profileSide effectsUseful agentFDA approvalPemetrexedPhase ICisplatinTrialsFurther studiesMesotheliomaGefitinib in Combination With Paclitaxel and Carboplatin in Advanced Non–Small-Cell Lung Cancer: A Phase III Trial—INTACT 2
Herbst RS, Giaccone G, Schiller JH, Natale RB, Miller V, Manegold C, Scagliotti G, Rosell R, Oliff I, Reeves JA, Wolf MK, Krebs AD, Averbuch SD, Ochs JS, Grous J, Fandi A, Johnson DH. Gefitinib in Combination With Paclitaxel and Carboplatin in Advanced Non–Small-Cell Lung Cancer: A Phase III Trial—INTACT 2. Journal Of Clinical Oncology 2004, 22: 785-794. PMID: 14990633, DOI: 10.1200/jco.2004.07.215.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCarcinoma, Non-Small-Cell LungDose-Response Relationship, DrugDrug Administration ScheduleFemaleGefitinibHumansInfusions, IntravenousLung NeoplasmsMaleMaximum Tolerated DoseMiddle AgedMultivariate AnalysisNeoplasm StagingPaclitaxelPredictive Value of TestsPrognosisQuinazolinesReference ValuesRisk AssessmentSurvival AnalysisTreatment OutcomeConceptsResponse rateOverall survivalLung cancerActive epidermal growth factor receptor tyrosine kinase inhibitorAdvanced non-small cell lung cancerEpidermal growth factor receptor tyrosine kinase inhibitorsGrowth factor receptor tyrosine kinase inhibitorsNon-small cell lung cancerReceptor tyrosine kinase inhibitorsDose-related diarrheaSignificant prolonged survivalUnexpected safety findingsChemotherapy-naive patientsDouble-blind trialPlacebo-controlled trialPhase II trialBaseline demographic characteristicsPhase I trialCell lung cancerConcentration/time curveTyrosine kinase inhibitorsCarboplatin areaDaily gefitinibGefitinib monotherapyMonotherapy trials
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 docetaxel and carboplatin followed by weekly docetaxel and carboplatin with concurrent radiotherapy, then surgery in stage III non-small cell lung cancer: a Phase I study.
Wirth LJ, Lucca J, Ostler P, Fidias P, Lynch C, Jänne PA, Herbst RS, Johnson BE, Sugarbaker DJ, Mathisen DJ, Lukanich JM, Choi NC, Berman SM, Skarin AT. Induction docetaxel and carboplatin followed by weekly docetaxel and carboplatin with concurrent radiotherapy, then surgery in stage III non-small cell lung cancer: a Phase I study. Clinical Cancer Research 2003, 9: 1698-704. PMID: 12738723.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerStage III non-small cell lung cancerCT/RTMaximum-tolerated doseCell lung cancerConcurrent radiotherapyLung cancerDose levelsConcurrent weekly carboplatinGrade 3 toxicityPathologic complete responsePhase II studyInduction docetaxelTrimodality treatmentWeekly carboplatinWeekly docetaxelII studyOverall survivalStage IIIAComplete responseSurgical patientsSubsequent radiotherapyNew regimenInduction CTGrade 3