2020
Randomized Trial of Afatinib Plus Cetuximab Versus Afatinib Alone for First-Line Treatment of EGFR-Mutant Non-Small-Cell Lung Cancer: Final Results From SWOG S1403.
Goldberg SB, Redman MW, Lilenbaum R, Politi K, Stinchcombe TE, Horn L, Chen EH, Mashru SH, Gettinger SN, Melnick MA, Herbst RS, Baumgart MA, Miao J, Moon J, Kelly K, Gandara DR. Randomized Trial of Afatinib Plus Cetuximab Versus Afatinib Alone for First-Line Treatment of EGFR-Mutant Non-Small-Cell Lung Cancer: Final Results From SWOG S1403. Journal Of Clinical Oncology 2020, 38: 4076-4085. PMID: 33021871, PMCID: PMC7768342, DOI: 10.1200/jco.20.01149.Peer-Reviewed Original ResearchConceptsProgression-free survivalLung cancerMutant NSCLCEGFR monoclonal antibody cetuximabSmall cell lung cancerAddition of cetuximabPrimary end pointTyrosine kinase inhibitor afatinibCell lung cancerEGFR-Mutant NonCombination of afatinibMonoclonal antibody cetuximabAdvanced diseaseAdverse eventsOverall survivalMulticenter trialLine treatmentEGFR-TKIAntibody cetuximabDose reductionInhibitor afatinibInterim analysisCetuximabInsufficient evidencePatients
2016
Outcomes for patients treated with or without bevacizumab on SWOG S0819: A randomized, phase III study comparing carboplatin/Paclitaxel or carboplatin/Paclitaxel/bevacizumab with or without concurrent cetuximab in patients with advanced non-small cell lung cancer (NSCLC).
Semrad T, Redman M, Herbst R, Kim E, Bazhenova L, Masters G, Oettel K, Guaglianone P, Reynolds C, Karnad A, Arnold S, Varella-Garcia M, Moon J, Mack P, Blanke C, Hirsch F, Kelly K, Gandara D. Outcomes for patients treated with or without bevacizumab on SWOG S0819: A randomized, phase III study comparing carboplatin/Paclitaxel or carboplatin/Paclitaxel/bevacizumab with or without concurrent cetuximab in patients with advanced non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2016, 34: 9082-9082. DOI: 10.1200/jco.2016.34.15_suppl.9082.Peer-Reviewed Original ResearchBiomarker-enriched efficacy of cetuximab-based therapy: Squamous subset analysis from S0819, a phase III trial of chemotherapy with or without cetuximab in advanced NSCLC.
Hirsch F, Redman M, Herbst R, Kim E, Semrad T, Bazhenova L, Masters G, Oettel K, Guaglianone P, Reynolds C, Karnad A, Arnold S, Varella-Garcia M, Moon J, Mack P, Blanke C, Kelly K, Gandara D. Biomarker-enriched efficacy of cetuximab-based therapy: Squamous subset analysis from S0819, a phase III trial of chemotherapy with or without cetuximab in advanced NSCLC. Journal Of Clinical Oncology 2016, 34: 9090-9090. DOI: 10.1200/jco.2016.34.15_suppl.9090.Peer-Reviewed Original Research
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
Cetuximab therapy for patients with advanced squamous cell carcinomas of the head and neck
William WN, Kim ES, Herbst RS. Cetuximab therapy for patients with advanced squamous cell carcinomas of the head and neck. Nature Reviews Clinical Oncology 2009, 6: 132-133. PMID: 19190590, DOI: 10.1038/ncponc1321.Peer-Reviewed Original ResearchAdvanced squamous cell carcinomaSquamous cell carcinomaCell carcinomaFirst phase III trialChemotherapy-alone armMedian overall survivalPrimary end pointPhase III trialsCetuximab armCetuximab therapyUntreated patientsIII trialsOverall survivalCurative treatmentCurable diseasePredictive markerSurvival advantageClinical practiceCetuximabPatientsEnd pointEXTREME trialTrialsChemotherapyCarcinoma
2007
EGFR expression by immunohistochemistry (IHC) and response to chemotherapy and cetuximab in squamous cell carcinoma of the head and neck (SCCHN)
Kies M, Ghebremichael M, Katz T, Herbst R, Youssoufian H, Burtness B. EGFR expression by immunohistochemistry (IHC) and response to chemotherapy and cetuximab in squamous cell carcinoma of the head and neck (SCCHN). Journal Of Clinical Oncology 2007, 25: 6024-6024. DOI: 10.1200/jco.2007.25.18_suppl.6024.Peer-Reviewed Original ResearchHigh EGFR expressionEGFR expressionRecurrent SCCHNTumor samplesCisplatin-based chemotherapySquamous cell carcinomaAssociation of responsePercentage of cellsHazard ratioProgressive diseaseCisplatin therapyPatient selectionCell carcinomaHigher eGFREGFR immunoreactivityInitial cohortCetuximabChemotherapyIndependent cohortFurther enrollmentPatientsSurvival analysisTumor resistanceDako kitSCCHN