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
2008
Epidermal growth factor receptor expression analysis in chemotherapy-naive patients with advanced non-small-cell lung cancer treated with gefitinib or placebo in combination with platinum-based chemotherapy
Giaccone G, Iacona RB, Fandi A, Janas M, Ochs JS, Herbst RS, Johnson DH. Epidermal growth factor receptor expression analysis in chemotherapy-naive patients with advanced non-small-cell lung cancer treated with gefitinib or placebo in combination with platinum-based chemotherapy. Journal Of Cancer Research And Clinical Oncology 2008, 135: 467-476. PMID: 18787840, DOI: 10.1007/s00432-008-0466-3.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBiopsyCarcinoma, Non-Small-Cell LungCell DivisionErbB ReceptorsGefitinibGene Expression Regulation, NeoplasticHumansImmunohistochemistryLung NeoplasmsNeoplasm StagingPlacebosPlatinum CompoundsPrognosisQuinazolinesSurvival AnalysisConceptsPlatinum-based chemotherapyCell lung cancerPrognostic factorsLung cancerFirst-line platinum-based chemotherapyEpidermal growth factor receptor stainingChemotherapy-naive patientsPlacebo-controlled trialCox regression analysisReceptor expression analysisStrong prognostic indicatorMembrane stainingEGFR expression correlatesSurvival benefitImproved survivalPrognostic effectGrowth patternPredictive factorsPrognostic indicatorReceptor stainingPoor survivalTreatment groupsEGFR PharmDxEGFR expressionGefitinib
2007
Randomized, Placebo-Controlled Phase II Study of Vandetanib Plus Docetaxel in Previously Treated Non–Small-Cell Lung Cancer
Heymach JV, Johnson BE, Prager D, Csada E, Roubec J, Pešek M, Špásová I, Belani CP, Bodrogi I, Gadgeel S, Kennedy SJ, Hou J, Herbst RS. Randomized, Placebo-Controlled Phase II Study of Vandetanib Plus Docetaxel in Previously Treated Non–Small-Cell Lung Cancer. Journal Of Clinical Oncology 2007, 25: 4270-4277. PMID: 17878479, DOI: 10.1200/jco.2006.10.5122.Peer-Reviewed Original ResearchConceptsProgression-free survivalRandomized phaseOverall survivalLung cancerFirst-line platinum-based chemotherapyNon-small cell lung cancerMedian progression-free survivalActivity of vandetanibCommon adverse eventsDaily oral inhibitorObjective response rateOpen-label runPhase II studyGrowth factor receptor 2Platinum-based chemotherapyCell lung cancerOne-sided significance levelEndothelial growth factor receptor 2Second-line NSCLCVascular endothelial growth factor receptor 2Factor receptor 2Asymptomatic prolongationEligible patientsMetastatic NSCLCII study
2005
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
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