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
2018
Efficacy and safety of pembrolizumab in recurrent/metastatic head and neck squamous cell carcinoma: pooled analyses after long-term follow-up in KEYNOTE-012
Mehra R, Seiwert TY, Gupta S, Weiss J, Gluck I, Eder JP, Burtness B, Tahara M, Keam B, Kang H, Muro K, Geva R, Chung HC, Lin CC, Aurora-Garg D, Ray A, Pathiraja K, Cheng J, Chow LQM, Haddad R. Efficacy and safety of pembrolizumab in recurrent/metastatic head and neck squamous cell carcinoma: pooled analyses after long-term follow-up in KEYNOTE-012. British Journal Of Cancer 2018, 119: 153-159. PMID: 29955135, PMCID: PMC6048158, DOI: 10.1038/s41416-018-0131-9.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedB7-H1 AntigenDrug-Related Side Effects and Adverse ReactionsFemaleFollow-Up StudiesGene Expression Regulation, NeoplasticHumansKaplan-Meier EstimateMaleMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalProgression-Free SurvivalSquamous Cell Carcinoma of Head and NeckConceptsTreatment-related adverse eventsNeck squamous cell carcinomaSquamous cell carcinomaAdverse eventsCell carcinomaDurable anti-tumor activityRecurrent/metastatic headRecurrent/metastatic HNSCCEfficacy of pembrolizumabSafety of pembrolizumabTolerable safety profileUse of pembrolizumabMedian response durationNon-randomised trialsOverall response rateCo-primary endpointsTreatment of HNSCCYears of treatmentAnti-tumor activityConclusionsSome patientsKEYNOTE-012MethodsMulti-centreGrade 3/4Metastatic headAdvanced head
2017
KEYNOTE-412: Pembrolizumab (pembro) in combination with chemoradiation versus chemoradiation alone in locally advanced head and neck squamous cell carcinoma (LA-HNSCC).
Machiels J, Licitra L, Rischin D, Waldron J, Burtness B, Gregoire V, Shekar T, Brown H, Cheng J, Siu L. KEYNOTE-412: Pembrolizumab (pembro) in combination with chemoradiation versus chemoradiation alone in locally advanced head and neck squamous cell carcinoma (LA-HNSCC). Journal Of Clinical Oncology 2017, 35: tps6090-tps6090. DOI: 10.1200/jco.2017.35.15_suppl.tps6090.Peer-Reviewed Original ResearchBlinded independent central reviewConcomitant chemoradiotherapyRECIST v1.1LA-HNSCCP16-positive oropharyngeal cancerPrimary efficacy end pointRecurrent/metastatic HNSCCNeck squamous cell carcinomaDefinitive concomitant chemoradiotherapyECOG PS 0Efficacy end pointOutcome of ptsP16 negative HNSCCEvent-free survivalHalf of patientsSquamous cell carcinomaEnd of treatmentIndependent central reviewQuality of lifeMeasurable diseaseAdvanced diseaseCTCAE v4.0Primary surgeryAdvanced headNeck dissection
2016
Immunotherapy of head and neck cancer: Emerging clinical trials from a National Cancer Institute Head and Neck Cancer Steering Committee Planning Meeting
Bauman JE, Cohen E, Ferris RL, Adelstein DJ, Brizel DM, Ridge JA, O'Sullivan B, Burtness BA, Butterfield LH, Carson WE, Disis ML, Fox BA, Gajewski TF, Gillison ML, Hodge JW, Le Q, Raben D, Strome SE, Lynn J, Malik S. Immunotherapy of head and neck cancer: Emerging clinical trials from a National Cancer Institute Head and Neck Cancer Steering Committee Planning Meeting. Cancer 2016, 123: 1259-1271. PMID: 27906454, PMCID: PMC5705038, DOI: 10.1002/cncr.30449.Peer-Reviewed Original ResearchConceptsNational Cancer InstituteClinical trialsCancer InstituteRecurrent/metastatic HNSCCNational Clinical Trials NetworkNeck squamous cell carcinomaClinical trial conceptsRandomized phase 2Use of immunotherapySquamous cell carcinomaStandard of careDifferent patient populationsClinical Trials NetworkClinical trial designNew immunotherapeutic targetsPhase 2Key immune componentsDifferent immunotherapiesOncologic communityImmunotherapeutic trialsMetastatic HNSCCOropharyngeal cancerImmunotherapeutic targetCell carcinomaPatient population