2024
Safety profile of pembrolizumab monotherapy based on an aggregate safety evaluation of 8937 patients
Brahmer J, Long G, Hamid O, Garon E, Herbst R, Andre T, Armand P, Bajorin D, Bellmunt J, Burtness B, Choueiri T, Cohen E, Diaz L, Shitara K, Kulkarni G, McDermott D, Shah M, Tabernero J, Vogel A, Zinzani P, Jafari N, Bird S, Snyder E, Gause C, Bracco O, Pietanza M, Gruber T, Ribas A. Safety profile of pembrolizumab monotherapy based on an aggregate safety evaluation of 8937 patients. European Journal Of Cancer 2024, 199: 113530. PMID: 38295556, PMCID: PMC11227881, DOI: 10.1016/j.ejca.2024.113530.Peer-Reviewed Original ResearchConceptsImmune-mediated adverse eventsAdverse eventsInfusion reactionsSafety profileClinical trialsPembrolizumab discontinuationPembrolizumab monotherapyNon-small cell lung cancerSafety of pembrolizumabDose of pembrolizumabTreated with prednisoneCell lung cancerLow steroid dosesPopulation of patientsSteroid doseMedian durationPembrolizumabAE onsetPooled analysisLung cancerCancer clinical trialsSafety dataPatientsCancer typesInfusion
2023
Radiotherapy Plus Cisplatin With or Without Lapatinib for Non–Human Papillomavirus Head and Neck Carcinoma
Wong S, Torres-Saavedra P, Saba N, Shenouda G, Bumpous J, Wallace R, Chung C, El-Naggar A, Gwede C, Burtness B, Tennant P, Dunlap N, Redman R, Stokes W, Rudra S, Mell L, Sacco A, Spencer S, Nabell L, Yao M, Cury F, Mitchell D, Jones C, Firat S, Contessa J, Galloway T, Currey A, Harris J, Curran W, Le Q. Radiotherapy Plus Cisplatin With or Without Lapatinib for Non–Human Papillomavirus Head and Neck Carcinoma. JAMA Oncology 2023, 9: 1565-1573. PMID: 37768670, PMCID: PMC10540060, DOI: 10.1001/jamaoncol.2023.3809.Peer-Reviewed Original ResearchConceptsProgression-free survivalAdverse event ratesOverall survivalStage IIIClinical trialsAcute adverse event ratesProgression-free survival ratesEnd pointEvent ratesAnti-epidermal growth factor receptor (EGFR) antibodiesBenefit of chemoradiotherapyZubrod performance statusPrimary end pointSecondary end pointsCycles of cisplatinAddition of lapatinibEGFR antibody therapyGrowth factor receptor antibodyLog-rank testDual EGFRPlus CisplatinFrontline therapyPerformance statusAntibody therapyNeck carcinomaThe room where it happens: addressing diversity, equity, and inclusion in National Clinical Trials Network clinical trial leadership
Snyder R, Burtness B, Cho M, Del Rivero J, Doroshow D, Hitchcock K, Kalyan A, Kim C, Lukovic J, Parikh A, Sanford N, Singh B, Shen C, Shroff R, Vijayvergia N, Goodman K, Kunz P. The room where it happens: addressing diversity, equity, and inclusion in National Clinical Trials Network clinical trial leadership. Journal Of The National Cancer Institute 2023, 115: 1132-1138. PMID: 37364007, PMCID: PMC11009492, DOI: 10.1093/jnci/djad121.Peer-Reviewed Original ResearchConceptsNational Clinical Trials NetworkTrial leadershipClinical Trials NetworkDesign of trialsNational Cancer InstituteTask ForceCancer careClinical trialsNovel therapiesGastrointestinal oncologyCancer InstituteTrials NetworkMultidisciplinary investigatorsTrialsCooperative groupsBroader populationCancer researchOncology
2022
Clinical Trial Development in TP53-Mutated Locally Advanced and Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma
Rodriguez CP, Kang H, Geiger JL, Burtness B, Chung CH, Pickering CR, Fakhry C, Le QT, Yom SS, Galloway TJ, Golemis E, Li A, Shoop J, Wong S, Mehra R, Skinner H, Saba NF, Flores ER, Myers JN, Ford JM, Karchin R, Ferris RL, Kunos C, Lynn JM, Malik S. Clinical Trial Development in TP53-Mutated Locally Advanced and Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma. Journal Of The National Cancer Institute 2022, 114: 1619-1627. PMID: 36053203, PMCID: PMC9745425, DOI: 10.1093/jnci/djac163.Peer-Reviewed Original ResearchConceptsNeck squamous cell carcinomaSquamous cell carcinomaClinical trialsCell carcinomaTrial designTP53 mutationsNational Clinical Trials NetworkMetastatic disease settingsClinical trial developmentClinical Trials NetworkNovel therapeutic approachesNational Cancer InstituteMetastatic headTP53-mutated tumorsWorse outcomesClinical studiesFrequent genetic eventTherapeutic approachesCancer InstituteTrial developmentBreakout groupsPatientsDisease settingsBiomarker integrationTrials Network
2020
Comparing programmed death ligand 1 scores for predicting pembrolizumab efficacy in head and neck cancer
Emancipator K, Huang L, Aurora-Garg D, Bal T, Cohen EEW, Harrington K, Soulières D, Le Tourneau C, Licitra L, Burtness B, Swaby R. Comparing programmed death ligand 1 scores for predicting pembrolizumab efficacy in head and neck cancer. Modern Pathology 2020, 34: 532-541. PMID: 33239737, DOI: 10.1038/s41379-020-00710-9.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalB7-H1 AntigenBiomarkers, TumorBiopsyClinical Decision-MakingClinical Trials, Phase III as TopicDecision Support TechniquesDisease ProgressionHead and Neck NeoplasmsHumansImmunohistochemistryPredictive Value of TestsProgression-Free SurvivalRandomized Controlled Trials as TopicRetrospective StudiesSquamous Cell Carcinoma of Head and NeckTime FactorsConceptsTumor proportion scoreObjective response ratePD-L1 expression statusDeath ligand 1 (PD-L1) expressionNeck squamous cell carcinomaImmune checkpoint inhibitorsLigand 1 expressionPD-L1 statusProgression-free survivalSquamous cell carcinomaKEYNOTE-040Pembrolizumab efficacyCheckpoint inhibitorsOverall survivalMetastatic HNSCCCell carcinomaNeck cancerClinical trialsProportion scoreInvestigator's choiceResponse rateExpression statusYouden indexHNSCCPatientsA novel surgeon credentialing and quality assurance process using transoral surgery for oropharyngeal cancer in ECOG-ACRIN Cancer Research Group Trial E3311
Ferris RL, Flamand Y, Holsinger FC, Weinstein GS, Quon H, Mehra R, Garcia JJ, Hinni ML, Gross ND, Sturgis EM, Duvvuri U, Méndez E, Ridge JA, Magnuson JS, Higgins KA, Patel MR, Smith RB, Karakla DW, Kupferman ME, Malone JP, Judson BL, Richmon J, Boyle JO, Bayon R, O'Malley BW, Ozer E, Thomas GR, Koch WM, Bell RB, Saba NF, Li S, Sigurdson ER, Burtness B. A novel surgeon credentialing and quality assurance process using transoral surgery for oropharyngeal cancer in ECOG-ACRIN Cancer Research Group Trial E3311. Oral Oncology 2020, 110: 104797. PMID: 32679405, PMCID: PMC7771718, DOI: 10.1016/j.oraloncology.2020.104797.Peer-Reviewed Original ResearchConceptsOropharyngeal cancerTransoral surgeryOropharyngeal bleedingPositive marginsTransoral resectionGrade III/IVSurgical oncology trialsPost-operative therapySurgical quality assuranceSurgical pathology reportsFinal pathologic marginsMulti-institutional dataPathologic marginsBleeding rateClinical trialsPathology reportsLower incidenceOngoing quality assuranceOncology trialsSurgical expertiseMeticulous evaluationSurgeon expertiseTransoral headPatientsSurgeryApplications of radiomics in precision diagnosis, prognostication and treatment planning of head and neck squamous cell carcinomas
Haider SP, Burtness B, Yarbrough WG, Payabvash S. Applications of radiomics in precision diagnosis, prognostication and treatment planning of head and neck squamous cell carcinomas. Cancers Of The Head & Neck 2020, 5: 6. PMID: 32391171, PMCID: PMC7197186, DOI: 10.1186/s41199-020-00053-7.Peer-Reviewed Original ResearchNeck squamous cell carcinomaSquamous cell carcinomaCell carcinomaPatient selectionNeck cancerClinical trialsObjective biomarkersRoutine clinical applicationPrognostic biomarkerTreatment guidancePersonalized treatmentRadiomics analysisTreatment planningPrecision medicineClinical applicationCarcinomaPrecision diagnosisApplication of radiomicsPrognosticationBiomarkersRadiomicsHeadCancerDiagnosisTrialsChapter 11 Trials and tribulations: Clinical trials and the future
Khanna S, Burtness B. Chapter 11 Trials and tribulations: Clinical trials and the future. 2020, 197-215. DOI: 10.1016/b978-0-12-820679-9.00011-6.Peer-Reviewed Original ResearchClinical trialsNeck cancerRecent landmark trialsRole of immunotherapyRisk stratification toolPromising clinical trialsMetastatic headPoor accrualSystemic treatmentLandmark trialsNeck specialistsStratification toolDedicated headTrialsCurrent standardCancerExciting advancesLack of fundingHeadImmunotherapyHPVHNSCCTherapyDiseasePathobiology
2019
Immunotherapy for head and neck cancer: Recent advances and future directions
Cramer JD, Burtness B, Ferris RL. Immunotherapy for head and neck cancer: Recent advances and future directions. Oral Oncology 2019, 99: 104460. PMID: 31683169, PMCID: PMC7749717, DOI: 10.1016/j.oraloncology.2019.104460.Peer-Reviewed Original ResearchConceptsM HNSCCPembrolizumab monotherapyPD-L1Clinical trialsAnti-PD1 antibody nivolumabPhase III randomized trialsRandomized phase III trialCo-stimulatory agonistsImmune cell stainingInvestigator-choice chemotherapyPD-L1 CPSPhase III trialsRecurrent/metastaticDetailed clinical dataEXTREME regimenKEYNOTE-048Advanced diseaseCheckpoint inhibitorsIII trialsProlong survivalAntibody nivolumabRandomized trialsTherapeutic vaccinesNeck cancerTherapeutic advancesThe changing therapeutic landscape of head and neck cancer
Cramer JD, Burtness B, Le QT, Ferris RL. The changing therapeutic landscape of head and neck cancer. Nature Reviews Clinical Oncology 2019, 16: 669-683. PMID: 31189965, DOI: 10.1038/s41571-019-0227-z.Peer-Reviewed Original ResearchConceptsNeck cancerTherapeutic landscapeNeck squamous cell carcinomaFirst immunotherapeutic agentHuman papillomavirus infectionNon-surgical therapyUpper aerodigestive tractSquamous cell carcinomaDifferent treatment modalitiesPapillomavirus infectionAerodigestive tractImmunotherapeutic agentsCell carcinomaTreatment modalitiesClinical trialsOral cavitySalivary glandsWidespread testingHNSCCDevelopment of strategiesCancerCurrent eraHeadOropharynxPatientsGender disparities in head and neck cancer chemotherapy clinical trials participation and treatment
Benchetrit L, Torabi SJ, Tate JP, Mehra S, Osborn HA, Young MR, Burtness B, Judson BL. Gender disparities in head and neck cancer chemotherapy clinical trials participation and treatment. Oral Oncology 2019, 94: 32-40. PMID: 31178210, DOI: 10.1016/j.oraloncology.2019.05.009.Peer-Reviewed Original ResearchConceptsChemotherapy clinical trialsNational Cancer DatabaseClinical trialsDefinitive radiotherapyChemotherapy administrationNational Comprehensive Cancer Network guidelinesMultivariable logistic regression analysisNeck squamous cell carcinomaEnd Results ProgramSquamous cell carcinomaClinical trial participationLogistic regression analysisGeneral U.S. populationChemotherapy useDefinitive chemoradiotherapyNCCN guidelinesAdult patientsDefinitive treatmentMultivariable analysisNetwork guidelinesResults ProgramCell carcinomaTrial participationCancer DatabaseU.S. patientsRole of Treatment Deintensification in the Management of p16+ Oropharyngeal Cancer: ASCO Provisional Clinical Opinion
Adelstein DJ, Ismaila N, Ku JA, Burtness B, Swiecicki PL, Mell L, Beitler JJ, Gross N, Jones CU, Kaufman M, Le QT, Semrad TJ, Siu LL, Ridge JA. Role of Treatment Deintensification in the Management of p16+ Oropharyngeal Cancer: ASCO Provisional Clinical Opinion. Journal Of Clinical Oncology 2019, 37: jco.19.00441. PMID: 31021656, DOI: 10.1200/jco.19.00441.Peer-Reviewed Original ResearchConceptsProvisional clinical opinionASCO's provisional clinical opinionsTreatment deintensificationOropharyngeal cancerClinical opinionClinical trialsGood prognosis subsetPractice-changing dataTransoral surgical techniquesAmerican Joint CommitteeCancer (AJCC) staging systemEarly-stage diseaseCurrent treatment standardsCurrent treatment approachesCurrent eighth editionLong-term toxicityBetter treatment resultsLate toxicitySystemic treatmentStaging systemIntensity-modulated radiation therapy (IMRT) planningSurgical techniqueTherapeutic decisionsAmeliorate toxicityASCO's membership
2017
Demethylation Therapy as a Targeted Treatment for Human Papillomavirus–Associated Head and Neck Cancer
Biktasova A, Hajek M, Sewell A, Gary C, Bellinger G, Deshpande HA, Bhatia A, Burtness B, Judson B, Mehra S, Yarbrough WG, Issaeva N. Demethylation Therapy as a Targeted Treatment for Human Papillomavirus–Associated Head and Neck Cancer. Clinical Cancer Research 2017, 23: 7276-7287. PMID: 28916527, DOI: 10.1158/1078-0432.ccr-17-1438.Peer-Reviewed Original ResearchConceptsClinical trialsHNSCC cellsMatrix metalloproteinasesHuman papillomavirus-associated headNeck squamous cell carcinomaSquamous cell carcinomaAbility of HPVClin Cancer ResTumor cell proliferationNeck cancer cellsWindow trialsCell carcinomaEffective therapyPreclinical modelsHPVHPV oncogenesMouse modelMouse blood vesselsDNA demethylating agentHNSCCXenografted tumorsHPV genesIFN responseTherapyTumor samplesNovel Molecular Targets for Chemoprevention in Malignancies of the Head and Neck
Bhatia A, Burtness B. Novel Molecular Targets for Chemoprevention in Malignancies of the Head and Neck. Cancers 2017, 9: 113. PMID: 28858212, PMCID: PMC5615328, DOI: 10.3390/cancers9090113.Peer-Reviewed Original ResearchNeck cancerSecond primary tumorsExtensive clinical researchCancer-related mortalityNovel molecular targetsWhole-exome sequencingBiologic agentsOral leukoplakiaInvasive cancerPrimary tumorClinical trialsPrecursor lesionsNovel molecular pathwaysPrimary headMucosal fieldTumor specimensNeck regionCare optionsClinical researchCancerDriver mutationsExome sequencingMolecular targetsGenetic mutationsMolecular pathwaysTRAF3/CYLD mutations identify a distinct subset of human papillomavirus‐associated head and neck squamous cell carcinoma
Hajek M, Sewell A, Kaech S, Burtness B, Yarbrough WG, Issaeva N. TRAF3/CYLD mutations identify a distinct subset of human papillomavirus‐associated head and neck squamous cell carcinoma. Cancer 2017, 123: 1778-1790. PMID: 28295222, PMCID: PMC5419871, DOI: 10.1002/cncr.30570.Peer-Reviewed Original ResearchConceptsHPV-positive HNSCCNeck squamous cell carcinomaDe-escalation therapyHPV-positive HNSCCsMechanisms of HPVRecurrent metastatic diseaseBetter overall survivalSquamous cell carcinomaNuclear factor-κB signalingFactor-κB signalingNew therapeutic strategiesNuclear factor κBHPV vaccineCancer Genome AtlasCurative optionHPV statusMetastatic diseaseOverall survivalCervical cancerPatient survivalSmoking characteristicsCell carcinomaHuman papillomavirusLifelong morbidityClinical trials
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
2015
National treatment patterns in patients presenting with Stage IVC head and neck cancer: analysis of the National Cancer Database
Schwam ZG, Burtness B, Yarbrough WG, Mehra S, Husain Z, Judson BL. National treatment patterns in patients presenting with Stage IVC head and neck cancer: analysis of the National Cancer Database. Cancer Medicine 2015, 4: 1828-1835. PMID: 26471244, PMCID: PMC5123708, DOI: 10.1002/cam4.546.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAged, 80 and overCombined Modality TherapyComorbidityDatabases, FactualFemaleHead and Neck NeoplasmsHumansKaplan-Meier EstimateMaleMiddle AgedNeoplasm MetastasisNeoplasm StagingPopulation SurveillanceRetrospective StudiesRisk FactorsTreatment OutcomeUnited StatesYoung AdultConceptsNational Cancer DatabaseSystemic therapyPalliative therapyTreatment patternsNeck cancerCancer DatabaseClinical trialsMedicaid/uninsured statusCox proportional hazards analysisCommon treatment regimenNational treatment patternsCharlson comorbidity scorePrimary disease siteRetrospective cohort analysisProportional hazards analysisRisk of deathNeck cancer patientsMedicare/Comorbidity scoreMetastatic headOverall survivalSystemic treatmentTreatment regimenDistant metastasisKaplan-MeierHuman Papillomavirus–Associated Oropharyngeal Cancer: Defining Risk Groups and Clinical Trials
Bhatia A, Burtness B. Human Papillomavirus–Associated Oropharyngeal Cancer: Defining Risk Groups and Clinical Trials. Journal Of Clinical Oncology 2015, 33: 3243-3250. PMID: 26351343, PMCID: PMC5814107, DOI: 10.1200/jco.2015.61.2358.Peer-Reviewed Original ResearchConceptsClinical trialsRisk groupsHuman papillomavirus-associated oropharynx cancerHPV-negative OPCPoor-risk subsetTreatment-related morbidityDe-escalation trialsPrognostic risk groupsClinical trial optionsYounger median ageNew treatment strategiesIdeal patient groupNovel therapeutic targetInvasive surgical techniquesDeintensification trialsTreatment deintensificationOropharynx cancerSmoking exposureMetastatic diseaseModality therapyFavorable prognosisMedian ageBetter prognosisSuperior prognosisIntense therapy
2014
A 3′-UTR KRAS-variant is associated with cisplatin resistance in patients with recurrent and/or metastatic head and neck squamous cell carcinoma
Chung CH, Lee JW, Slebos RJ, Howard JD, Perez J, Kang H, Fertig EJ, Considine M, Gilbert J, Murphy BA, Nallur S, Paranjape T, Jordan RC, Garcia J, Burtness B, Forastiere AA, Weidhaas JB. A 3′-UTR KRAS-variant is associated with cisplatin resistance in patients with recurrent and/or metastatic head and neck squamous cell carcinoma. Annals Of Oncology 2014, 25: 2230-2236. PMID: 25081901, PMCID: PMC4207729, DOI: 10.1093/annonc/mdu367.Peer-Reviewed Original ResearchMeSH Keywords3' Untranslated RegionsAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedCarcinoma, Squamous CellCetuximabCisplatinCyclin-Dependent Kinase Inhibitor p16Disease-Free SurvivalDrug Resistance, NeoplasmFemaleGene Expression Regulation, NeoplasticGenotypeHead and Neck NeoplasmsHumansMaleMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalPrognosisProto-Oncogene ProteinsProto-Oncogene Proteins p21(ras)Ras ProteinsSquamous Cell Carcinoma of Head and NeckConceptsNeck squamous cell carcinomaSquamous cell carcinomaKRAS-variantMetastatic headCell carcinomaPatient outcomesP16 expressionRecurrent/metastatic headPoor progression-free survivalCell linesM HNSCC patientsPlatinum-based regimenProgression-free survivalPotential predictive biomarkersHNSCC tumor samplesHNSCC cell linesTG/GGDrug resistance/sensitivityHNSCC patientsOropharynx tumorsClinical findingsRetrospective studyPredictive biomarkersClinical trialsPlatinum responsePrognostic significance of human papillomavirus in recurrent or metastatic head and neck cancer: an analysis of Eastern Cooperative Oncology Group trials
Argiris A, Li S, Ghebremichael M, Egloff AM, Wang L, Forastiere AA, Burtness B, Mehra R. Prognostic significance of human papillomavirus in recurrent or metastatic head and neck cancer: an analysis of Eastern Cooperative Oncology Group trials. Annals Of Oncology 2014, 25: 1410-1416. PMID: 24799460, PMCID: PMC4071756, DOI: 10.1093/annonc/mdu167.Peer-Reviewed Original ResearchConceptsProgression-free survivalHuman papillomavirusOverall survivalMetastatic SCCHNClinical outcomesClinical trialsEastern Cooperative Oncology Group trialMetastatic squamous cell carcinomaP16-negative patientsP16-positive patientsHPV-negative patientsObjective response ratePhase II trialPhase III trialsFavorable prognostic factorSquamous cell carcinomaUnfavorable risk factorsWide spectrum probeII trialMetastatic headHazard ratioIII trialsMedian survivalObjective responseHPV DNA