2021
EGFR High Copy Number Together With High EGFR Protein Expression Predicts Improved Outcome for Cetuximab-based Therapy in Squamous Cell Lung Cancer: Analysis From SWOG S0819, a Phase III Trial of Chemotherapy With or Without Cetuximab in Advanced NSCLC
Hirsch FR, Redman MW, Moon J, Agustoni F, Herbst RS, Semrad TJ, Varella-Garcia M, Rivard CJ, Kelly K, Gandara DR, Mack PC. EGFR High Copy Number Together With High EGFR Protein Expression Predicts Improved Outcome for Cetuximab-based Therapy in Squamous Cell Lung Cancer: Analysis From SWOG S0819, a Phase III Trial of Chemotherapy With or Without Cetuximab in Advanced NSCLC. Clinical Lung Cancer 2021, 23: 60-71. PMID: 34753703, PMCID: PMC8766941, DOI: 10.1016/j.cllc.2021.10.002.Peer-Reviewed Original ResearchConceptsSquamous cell carcinomaKRAS mutation statusAddition of cetuximabEGFR IHCMutation statusEGFR FISHAdvanced NSCLCSquamous cell lung cancerCetuximab-based therapyFirst-line chemotherapyPhase III trialsEGFR antibody therapyCell lung cancerImproved OSNon-SCCEGFR FISH statusEligible patientsOS benefitSCC patientsIII trialsKRAS statusCell carcinomaLung cancerSubgroup analysisExpression predicts
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
2012
Design of a Phase III Clinical Trial with Prospective Biomarker Validation: SWOG S0819
Redman MW, Crowley JJ, Herbst RS, Hirsch FR, Gandara DR. Design of a Phase III Clinical Trial with Prospective Biomarker Validation: SWOG S0819. Clinical Cancer Research 2012, 18: 4004-4012. PMID: 22592956, PMCID: PMC3409929, DOI: 10.1158/1078-0432.ccr-12-0167.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBiomarkers, TumorCarcinoma, Non-Small-Cell LungCetuximabClinical Trials, Phase III as TopicDisease-Free SurvivalErbB ReceptorsHumansIn Situ Hybridization, FluorescenceLung NeoplasmsPrognosisProspective StudiesResearch DesignTreatment OutcomeConceptsNon-small cell lung cancerEpidermal growth factor receptorPredictive biomarkersStudy populationAdvanced non-small cell lung cancerEGFR FISH-positive patientsPhase III clinical trialsRole of cetuximabOverall study populationPhase III trialsCell lung cancerEntire study populationFISH-positive patientsInterim monitoring planGrowth factor receptorCoprimary endpointsIII trialsCetuximab efficacyLung cancerClinical trialsPositive groupCetuximabEGFR FISHFactor receptorMolecular targets
2009
S0536: Carboplatin, paclitaxel, cetuximab, and bevacizumab followed by cetuximab and bevacizumab maintenance in advanced non-small cell lung cancer (NSCLC): A SWOG phase II study
Gandara D, Kim E, Herbst R, Moon J, Redman M, Dakhil S, Hirsch F, Mack P, Franklin W, Kelly K. S0536: Carboplatin, paclitaxel, cetuximab, and bevacizumab followed by cetuximab and bevacizumab maintenance in advanced non-small cell lung cancer (NSCLC): A SWOG phase II study. Journal Of Clinical Oncology 2009, 27: 8015-8015. DOI: 10.1200/jco.2009.27.15_suppl.8015.Peer-Reviewed Original ResearchNon-small cell lung cancerAdvanced non-small cell lung cancerProgression-free survivalOverall survivalEGFR FISHStable diseasePartial responseNon-squamous cell non-small cell lung cancerDay 1Median age 64 yearsTreatment-related deathsDisease control ratePhase II studyPhase III trialsPlatinum-based chemotherapyAge 64 yearsCell lung cancerEfficacy of carboplatinActive regimenAUC 6Bevacizumab maintenanceEligible ptsMedian followBrain metastasesEfficacy outcomes
2008
Increased EGFR Gene Copy Number Detected by Fluorescent In Situ Hybridization Predicts Outcome in Non–Small-Cell Lung Cancer Patients Treated With Cetuximab and Chemotherapy
Hirsch FR, Herbst RS, Olsen C, Chansky K, Crowley J, Kelly K, Franklin WA, Bunn PA, Varella-Garcia M, Gandara DR. Increased EGFR Gene Copy Number Detected by Fluorescent In Situ Hybridization Predicts Outcome in Non–Small-Cell Lung Cancer Patients Treated With Cetuximab and Chemotherapy. Journal Of Clinical Oncology 2008, 26: 3351-3357. PMID: 18612151, PMCID: PMC3368372, DOI: 10.1200/jco.2007.14.0111.Peer-Reviewed Original ResearchMeSH KeywordsAgedAnalysis of VarianceAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCarcinoma, Non-Small-Cell LungCetuximabFemaleGene Expression Regulation, NeoplasticGenes, erbB-1HumansIn Situ HybridizationIn Situ Hybridization, FluorescenceLung NeoplasmsMaleMiddle AgedMultivariate AnalysisNeoplasm StagingPatient SelectionPredictive Value of TestsPrognosisProportional Hazards ModelsReference ValuesRisk AssessmentSurvival AnalysisTreatment OutcomeConceptsCell lung cancer patientsLung cancer patientsFISH-negative patientsEGFR FISHNSCLC patientsCancer patientsSurvival timeMedian progression-free survival timeProgression-free survival timeEGFR tyrosine kinase inhibitorsDisease control rateChemotherapy-naive patientsAdvanced-stage NSCLCMedian survival timeEpidermal growth factor receptor (EGFR) gene copy numberFISH-positive patientsAvailable tumor tissueEGFR gene copy numberTyrosine kinase inhibitorsFISH-positive tumorsPhase II selection trialFISH-positive groupConcurrent chemotherapyConcurrent therapyPredictive factors