2025
Phase 2 trial of dual EGFR inhibition with cetuximab and afatinib in patients with recurrent/metastatic head and neck squamous cell cancers (HNSCC).
Bhatia A, Wei W, Chiorazzi M, Deshpande H, Reynolds J, Gehan D, Tara H, Newton B, Verma A, Sayed Z, Roche A, Mehra S, Judson B, Yarbrough W, Burtness B. Phase 2 trial of dual EGFR inhibition with cetuximab and afatinib in patients with recurrent/metastatic head and neck squamous cell cancers (HNSCC). Journal Of Clinical Oncology 2025, 43: 6023-6023. DOI: 10.1200/jco.2025.43.16_suppl.6023.Peer-Reviewed Original ResearchHead and neck squamous cell cancerEpidermal growth factor receptorMedian overall survivalCombination of cetuximabAdverse eventsHuman epidermal growth factor receptor (HER)-2Recurrent/metastatic head and neck squamous cell cancerRefractory to platinum-based chemotherapyEpidermal growth factor receptor targetEpidermal growth factor receptor inhibitionSingle-arm phase II trialPhosphorylated epidermal growth factor receptorCommonest adverse eventsP16+ diseaseProgression-free survivalImmune checkpoint therapyP16-positive tumorsPlatinum-based chemotherapyPrimary tumor locationPhase 2 trialPhase II trialSquamous cell cancerPost-treatment biopsiesTrials of chemotherapyEGFR inhibitor treatmentPhase II Trial of Chemotherapy, Cetuximab, and Erlotinib in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck
Bhatia A, Mehra R, Bauman J, Khan S, Wei W, Neumeister V, Sandoval‐Schaefer T, Alpaugh R, Lango M, Rimm D, Ridge J, Burtness B. Phase II Trial of Chemotherapy, Cetuximab, and Erlotinib in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck. Head & Neck 2025 PMID: 40166973, DOI: 10.1002/hed.28152.Peer-Reviewed Original ResearchHead and neck squamous cell cancerProgression-free survivalEpidermal growth factor receptorTyrosine kinase inhibitorsOverall survivalPhase II trial of chemotherapyMedian progression-free survivalRecurrent squamous cell carcinomaTreatment-related adverse eventsDual epidermal growth factor receptorTreated with carboplatinPhase 2 trialPhase II trialSecondary end pointsSquamous cell cancerNuclear translocation of epidermal growth factor receptorSquamous cell carcinomaTrials of chemotherapyHead and neckSmall patient sampleTranslocation of epidermal growth factor receptorGrowth factor receptorInhibited nuclear translocationEGFR blockadeChemotherapy backbone
2023
Randomized Phase II Trial of Ficlatuzumab With or Without Cetuximab in Pan-Refractory, Recurrent/Metastatic Head and Neck Cancer
Bauman J, Saba N, Roe D, Bauman J, Kaczmar J, Bhatia A, Muzaffar J, Julian R, Wang S, Bearelly S, Baker A, Steuer C, Giri A, Burtness B, Centuori S, Caulin C, Klein R, Saboda K, Obara S, Chung C. Randomized Phase II Trial of Ficlatuzumab With or Without Cetuximab in Pan-Refractory, Recurrent/Metastatic Head and Neck Cancer. Journal Of Clinical Oncology 2023, 41: 3851-3862. PMID: 36977289, DOI: 10.1200/jco.22.01994.Peer-Reviewed Original ResearchConceptsMedian progression-free survivalProgression-free survivalObjective response rateRecurrent/metastatic headCMET overexpressionMetastatic headCombination armAntiepidermal growth factor receptor monoclonal antibodyNoncomparative phase II studyRecurrent/metastatic HNSCCRandomized phase II trialEnd pointNeck squamous cell carcinomaHPV negative subgroupPhase II studyPrimary end pointSecondary end pointsHPV-positive diseaseHuman papillomavirus (HPV) statusMajor prognostic factorPhase II trialKey eligibility criteriaSquamous cell carcinomaReceptor monoclonal antibodyHPV-negative HNSCC
2021
Randomized phase II trial of ficlatuzumab with or without cetuximab in pan-refractory, advanced head and neck squamous cell carcinoma (HNSCC).
Bauman J, Saba N, Roe D, Bauman J, Kaczmar J, Bhatia A, Muzaffar J, Julian R, Wang S, Bearelly S, Baker A, Steuer C, Giri A, Burtness B, Centuori S, Caulin C, Saboda K, Obara S, Chung C. Randomized phase II trial of ficlatuzumab with or without cetuximab in pan-refractory, advanced head and neck squamous cell carcinoma (HNSCC). Journal Of Clinical Oncology 2021, 39: 6015-6015. DOI: 10.1200/jco.2021.39.15_suppl.6015.Peer-Reviewed Original ResearchMedian progression-free survivalOverall response rateHepatocyte growth factorAdvanced HNSCCPartial responsePrimary endpointEvaluable subjectsHPV statusRecurrent/metastatic HNSCCAnti-EGFR monoclonal antibodiesNeck squamous cell carcinomaMajor prognostic variablesPerformance status 0Phase II trialProgression-free survivalNon-comparative trialsSquamous cell carcinomaConfidence intervalsPhase III investigationFC combinationDual pathway inhibitionLFT elevationsPFS endpointPrior cetuximabStatus 0
2020
Randomized, phase II study of ficlatuzumab with or without cetuximab in patients with pan-refractory, recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).
Bauman J, Roe D, Saba N, Bauman J, Kaczmar J, Burtness B, Muzaffar J, Julian R, Wang S, Bearelly S, Baker A, Steuer C, Bhatia A, Giri A, Caulin C, Stabile L, Centuori S, Chung C. Randomized, phase II study of ficlatuzumab with or without cetuximab in patients with pan-refractory, recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Journal Of Clinical Oncology 2020, 38: tps6594-tps6594. DOI: 10.1200/jco.2020.38.15_suppl.tps6594.Peer-Reviewed Original ResearchProgression-free survivalOverall response rateM HNSCCPhase II trialHepatocyte growth factorII trialCetuximab resistanceMulticenter phase II trialRecurrent/metastatic headTotal peripheral T cellsRandomized phase II trialExpression of HGFPoor progression-free survivalNeck squamous cell carcinomaPeripheral immune profileKey secondary endpointPhase II studyKey eligibility criteriaSquamous cell carcinomaPeripheral T cellsPI3K/AktIgG1 monoclonal antibodyTwo-arm designECOG 0EGFR monotherapy
2016
Phase II trial of carboplatin/paclitaxel and cetuximab, followed by carboplatin/paclitaxel/cetuximab and erlotinib, in metastatic or recurrent squamous cell carcinoma of the head and neck.
Bhatia A, Mehra R, Khan S, Egleston B, Alpaugh R, Lango M, Ridge J, Burtness B. Phase II trial of carboplatin/paclitaxel and cetuximab, followed by carboplatin/paclitaxel/cetuximab and erlotinib, in metastatic or recurrent squamous cell carcinoma of the head and neck. Journal Of Clinical Oncology 2016, 34: 6027-6027. DOI: 10.1200/jco.2016.34.15_suppl.6027.Peer-Reviewed Original Research
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