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
2019
Neuregulin Signaling Is a Mechanism of Therapeutic Resistance in Head and Neck Squamous Cell Carcinoma
Baro M, Lopez Sambrooks C, Burtness BA, Lemmon MA, Contessa JN. Neuregulin Signaling Is a Mechanism of Therapeutic Resistance in Head and Neck Squamous Cell Carcinoma. Molecular Cancer Therapeutics 2019, 18: 2124-2134. PMID: 31387891, PMCID: PMC6825559, DOI: 10.1158/1535-7163.mct-19-0163.Peer-Reviewed Original ResearchMeSH KeywordsAnimalsAntibodies, MonoclonalCell Line, TumorCell ProliferationCell SurvivalCetuximabDrug Resistance, NeoplasmFemaleHead and Neck NeoplasmsHumansMiceNeuregulinsProto-Oncogene Proteins c-aktReceptor, ErbB-3Signal TransductionSquamous Cell Carcinoma of Head and NeckUp-RegulationXenograft Model Antitumor AssaysConceptsNeck squamous cell carcinomaSquamous cell carcinomaTherapeutic resistanceCell carcinomaResistant cellsConcentrations of cetuximabEFM-19 cellsCetuximab-resistant cellsActionable therapeutic targetsHNSCC cell linesTumor growth experimentsInhibition of EGFRErbB3 antibodyNeuregulin expressionOverall survivalTreatment regimensCetuximab resistanceTherapeutic targetAutocrine loopLocal controlTumor growthRadiotherapyEGFR inhibitionCetuximabNeuregulin Signaling
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
EGFR-directed antibodies increase the risk of severe infection in cancer patients
Altan M, Burtness B. EGFR-directed antibodies increase the risk of severe infection in cancer patients. BMC Medicine 2015, 13: 37. PMID: 25857245, PMCID: PMC4336483, DOI: 10.1186/s12916-015-0276-9.Peer-Reviewed Original ResearchConceptsEpidermal growth factor receptorSevere infectionsMonoclonal antibodiesRole of EGFRDose modification strategiesMonoclonal antibody treatmentClinical trial designRisk of infectionPractice of oncologyGrowth factor receptorConstitutional symptomsAntibody treatmentHypersensitivity reactionsCancer patientsRadiation therapyTrial designSolid tumorsInfection riskInfectionFactor receptorAntibodiesFurther studiesPatientsRiskRelated articles
2011
Phase II and Coagulation Cascade Biomarker Study of Bevacizumab With or Without Docetaxel in Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma
Astsaturov IA, Meropol NJ, Alpaugh RK, Burtness BA, Cheng JD, McLaughlin S, Rogatko A, Xu Z, Watson JC, Weiner LM, Cohen SJ. Phase II and Coagulation Cascade Biomarker Study of Bevacizumab With or Without Docetaxel in Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma. American Journal Of Clinical Oncology 2011, 34: 70-75. PMID: 20458210, PMCID: PMC3030655, DOI: 10.1097/coc.0b013e3181d2734a.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBiomarkersBlood Coagulation FactorsDeoxycytidineFemaleGemcitabineHumansLiver NeoplasmsLymphatic MetastasisMaleMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingPancreatic NeoplasmsPeritoneal NeoplasmsSurvival RateTreatment OutcomeConceptsMetastatic pancreatic cancerPancreatic cancerArm BArm AAnti-vascular endothelial growth factor antibody bevacizumabCommon grade 3/4 nonhematologic toxicitiesGemcitabine-refractory metastatic pancreatic cancerElevated D-dimer levelsGrade 3/4 nonhematologic toxicitiesMedian progression-free survivalThrombin-antithrombin complex levelsVascular endothelial growth factor (VEGF) pathwayEndothelial growth factor pathwayConfirmed objective responsesGemcitabine-containing regimenAntitumor activityModest antitumor activitySecond-line treatmentD-dimer levelsMetastatic pancreatic adenocarcinomaProgression-free survivalThrombin-antithrombin complexGrowth factor pathwaysNonhematologic toxicityObjective response
2010
Initial Results of a Phase I Dose-Escalation Trial of Concurrent and Maintenance Erlotinib and Reirradiation for Recurrent and New Primary Head-and-Neck Cancer
Rusthoven KE, Feigenberg SJ, Raben D, Kane M, Song JI, Nicolaou N, Mehra R, Burtness B, Ridge J, Swing R, Lango M, Cohen R, Jimeno A, Chen C. Initial Results of a Phase I Dose-Escalation Trial of Concurrent and Maintenance Erlotinib and Reirradiation for Recurrent and New Primary Head-and-Neck Cancer. International Journal Of Radiation Oncology • Biology • Physics 2010, 78: 1020-1025. PMID: 20231078, DOI: 10.1016/j.ijrobp.2009.09.003.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsCarcinoma, Squamous CellCetuximabCombined Modality TherapyDrug Administration ScheduleErlotinib HydrochlorideFeasibility StudiesFemaleFollow-Up StudiesGastrostomyHead and Neck NeoplasmsHumansMaleMiddle AgedNeoplasm Recurrence, LocalProtein Kinase InhibitorsQuinazolinesRadiotherapy DosageRetreatmentTreatment OutcomeConceptsDose-limiting toxicityMaintenance erlotinibPrimary HNCCohort IIICohort IINeck cancerCohort IPrimary headRadiation therapyPhase I dose-escalation trialPercutaneous endoscopic gastrostomy (PEG) tube placementAcute grade 3 toxicityGrade 4 acute toxicityI dose-escalation trialEndoscopic gastrostomy tube placementGrade 3 dysphagiaGrade 3 osteoradionecrosisNew primary headGrade 3 toxicityDose-escalation trialPhase I trialGastrostomy tube placementErlotinib dailyMaintenance therapyPrior radiationDetection of Tumor Epidermal Growth Factor Receptor Pathway Dependence by Serum Mass Spectrometry in Cancer Patients
Chung CH, Seeley EH, Roder H, Grigorieva J, Tsypin M, Roder J, Burtness BA, Argiris A, Forastiere AA, Gilbert J, Murphy B, Caprioli RM, Carbone DP, Cohen EE. Detection of Tumor Epidermal Growth Factor Receptor Pathway Dependence by Serum Mass Spectrometry in Cancer Patients. Cancer Epidemiology Biomarkers & Prevention 2010, 19: 358-365. PMID: 20086114, PMCID: PMC2846615, DOI: 10.1158/1055-9965.epi-09-0937.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBevacizumabBiomarkers, TumorCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellCetuximabColorectal NeoplasmsErbB ReceptorsErlotinib HydrochlorideGefitinibHead and Neck NeoplasmsHumansKaplan-Meier EstimateLung NeoplasmsMass SpectrometryMutationProtein Kinase InhibitorsProteomicsProto-Oncogene ProteinsProto-Oncogene Proteins p21(ras)QuinazolinesRas ProteinsSignal TransductionSpectrometry, Mass, Matrix-Assisted Laser Desorption-IonizationConceptsCRC patientsColorectal cancerCancer patientsNon-small cell lung cancer patientsEpidermal growth factor receptor tyrosine kinase inhibitorsGrowth factor receptor tyrosine kinase inhibitorsNon-small cell lung cancerRecurrent/metastatic headCell lung cancer patientsNeck squamous cell carcinomaLigand levelsReceptor tyrosine kinase inhibitorsCell lung cancerSquamous cell carcinomaLung cancer patientsKRAS mutation statusTyrosine kinase inhibitorsProteomic classificationSerum proteomic profilesDiverse cancer typesSite of originChemotherapy cohortMetastatic headPretreatment serumSurvival benefit
2009
Targeting EGFR resistance networks in head and neck cancer
Ratushny V, Astsaturov I, Burtness BA, Golemis EA, Silverman JS. Targeting EGFR resistance networks in head and neck cancer. Cellular Signalling 2009, 21: 1255-1268. PMID: 19258037, PMCID: PMC2770888, DOI: 10.1016/j.cellsig.2009.02.021.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalApoptosisCarcinoma, Squamous CellCell CycleDrug Resistance, NeoplasmErbB ReceptorsHead and Neck NeoplasmsHumansProtein Kinase InhibitorsConceptsSquamous cell carcinomaResponse of patientsPersonalized treatment approachesTumor progenitor cellsTypes of cancerAntibody agentsClinical outcomesCell carcinomaNeck cancerTreatment modalitiesInflammatory agentsTherapeutic strategiesTreatment approachesViral infectionEGFR/ErbB1Individual tumorsCancer typesProgenitor cellsCancerEGFREpigenetic modulationSurvival responseBiological featuresDevelopmental lineageOncoprotein
2008
The role of cetuximab for the treatment of squamous cell carcinoma of the head and neck.
Mehra R, Cohen RB, Burtness BA. The role of cetuximab for the treatment of squamous cell carcinoma of the head and neck. Clinical Advances In Hematology And Oncology 2008, 6: 742-50. PMID: 18997665, PMCID: PMC2745918.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsCarcinoma, Squamous CellCetuximabErbB ReceptorsHead and Neck NeoplasmsHumansConceptsRecurrent/metastatic diseaseRole of cetuximabSquamous cell carcinomaTreatment of HNSCCEpidermal growth factor receptorMetastatic diseaseCell carcinomaFirst-line regimenStandard of careGrowth factor receptorSurvival benefitSignificant morbidityCurable diseaseClinical trialsSingle agentDrug AdministrationCetuximabEGFR inhibitorsHNSCCBeneficial effectsDiseaseMonoclonal antibodiesFactor receptorCarcinomaFollowing review
2007
Clinical use of monoclonal antibodies to the epidermal growth factor receptor in colorectal cancer.
Burtness B. Clinical use of monoclonal antibodies to the epidermal growth factor receptor in colorectal cancer. Oncology 2007, 21: 964-70; discussion 970, 974, 976-7. PMID: 17715697.Peer-Reviewed Original ResearchConceptsEpidermal growth factor receptorColorectal cancerGrowth factor receptorChemotherapy-refractory colorectal cancerMonoclonal antibodiesFront-line therapyUse of cetuximabFactor receptorPredictors of responseClinical useCancerPromising novelPanitumumabSuch agentsTherapyAntibodiesReceptorsCetuximabAgentsDiseaseHer signaling in pancreatic cancer
Burtness B. Her signaling in pancreatic cancer. Expert Opinion On Biological Therapy 2007, 7: 823-829. PMID: 17555368, DOI: 10.1517/14712598.7.6.823.Peer-Reviewed Original ResearchMeSH KeywordsAnimalsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntimetabolites, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsCetuximabDeoxycytidineEpidermal Growth FactorErlotinib HydrochlorideGemcitabineHumansLapatinibOrganoplatinum CompoundsOxaliplatinPancreatic NeoplasmsProtein Kinase InhibitorsQuinazolinesReceptor, ErbB-2Signal TransductionTreatment OutcomeConceptsPhase II trialPhase III trialsPancreatic cancerEpidermal growth factor receptorII trialIII trialsRandomized phase II trialTreatment-refractory cancerManagement of patientsPhase I trialEGFR antibody cetuximabAddition of erlotinibGrowth factor receptorGemcitabine chemotherapyMedian survivalStandard therapyI trialPatient selectionSignificant prolongationMetastatic cancerAntibody cetuximabTherapeutic targetGemcitabineEGFR/CancerEpidermal Growth Factor Receptor Inhibition in Head and Neck Cancer—More Insights, but More Questions
Forastiere AA, Burtness BA. Epidermal Growth Factor Receptor Inhibition in Head and Neck Cancer—More Insights, but More Questions. Journal Of Clinical Oncology 2007, 25: 2152-2155. PMID: 17538157, DOI: 10.1200/jco.2007.10.9017.Peer-Reviewed Original Research
2006
Antibody therapy for early-stage breast cancer: trastuzumab adjuvant and neoadjuvant trials
Mehra R, Burtness B. Antibody therapy for early-stage breast cancer: trastuzumab adjuvant and neoadjuvant trials. Expert Opinion On Biological Therapy 2006, 6: 951-962. PMID: 16918262, DOI: 10.1517/14712598.6.9.951.Peer-Reviewed Original ResearchConceptsBreast cancerVascular endothelial growth factor levelsEarly-stage breast cancerYear of trastuzumabHER2/neu geneGrowth factor levelsBreast cancer cellsAdjuvant settingNeoadjuvant trialsOverall survivalRandomised trialsAggressive courseImproved outcomesImmune responseTrastuzumabActivation initiatesFactor levelsHER2 phosphorylationMonoclonal antibodiesNeu geneCancerCancer cellsHER2TrialsAntibodies
2005
Phase III Randomized Trial of Cisplatin Plus Placebo Compared With Cisplatin Plus Cetuximab in Metastatic/Recurrent Head and Neck Cancer: An Eastern Cooperative Oncology Group Study
Burtness B, Goldwasser MA, Flood W, Mattar B, Forastiere AA. Phase III Randomized Trial of Cisplatin Plus Placebo Compared With Cisplatin Plus Cetuximab in Metastatic/Recurrent Head and Neck Cancer: An Eastern Cooperative Oncology Group Study. Journal Of Clinical Oncology 2005, 23: 8646-8654. PMID: 16314626, DOI: 10.1200/jco.2005.02.4646.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Squamous CellCetuximabCisplatinCross-Over StudiesDose-Response Relationship, DrugDrug HypersensitivityErbB ReceptorsFemaleFollow-Up StudiesHead and Neck NeoplasmsHematologic DiseasesHumansImmunohistochemistryMaleMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalSeverity of Illness IndexSkin DiseasesSurvival AnalysisTime FactorsTreatment OutcomeConceptsProgression-free survivalAddition of cetuximabRecurrent/metastatic squamous cell carcinomaMedian progression-free survivalMetastatic squamous cell carcinomaEpidermal growth factor receptorSquamous cell carcinomaOverall survivalArm BArm AResponse rateEnd pointHazard ratioCell carcinomaCorrelation of EGFREastern Cooperative Oncology Group StudyMetastatic/recurrent headPhase III randomized trialsCetuximab-treated patientsMedian overall survivalObjective response ratePrimary end pointSecondary end pointsClinical end pointsDevelopment of rashCetuximab-Associated Acneiform Eruption
Moss JE, Burtness B. Cetuximab-Associated Acneiform Eruption. New England Journal Of Medicine 2005, 353: e17. PMID: 16282170, DOI: 10.1056/nejmicm050560.Peer-Reviewed Original ResearchOxaliplatin Induces a Delayed Immune-Mediated Hemolytic Anemia: A Case Report and Review of the Literature
Noronha V, Burtness B, Murren J, Duffy TP. Oxaliplatin Induces a Delayed Immune-Mediated Hemolytic Anemia: A Case Report and Review of the Literature. Clinical Colorectal Cancer 2005, 5: 283-286. PMID: 16356307, DOI: 10.3816/ccc.2005.n.041.Peer-Reviewed Original ResearchMeSH KeywordsAnemia, HemolyticAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCecal NeoplasmsDrug HypersensitivityFemaleFluorouracilHumansHypersensitivity, DelayedIleal NeoplasmsIntestinal NeoplasmsLeucovorinMiddle AgedOrganoplatinum CompoundsOxaliplatinTreatment OutcomeConceptsHemolytic anemiaMild self-limited episodesCycles of chemotherapySelf-limited episodesImmune-mediated hemolysisMinimal side effectsBevacizumab therapyPartial remissionLaboratory featuresIleocecal regionMetastatic carcinomaCase reportFuture therapiesSide effectsAnemiaOxaliplatinTherapyRemissionChemotherapyCarcinomaSymptomsImmuneWomenThe role of cetuximab in the treatment of squamous cell cancer of the head and neck
Burtness B. The role of cetuximab in the treatment of squamous cell cancer of the head and neck. Expert Opinion On Biological Therapy 2005, 5: 1085-1093. PMID: 16050785, DOI: 10.1517/14712598.5.8.1085.Peer-Reviewed Original ResearchConceptsEpidermal growth factor receptorEpidermal growth factorGrowth factor receptorImportant clinical prognostic markerTyrosine kinase growth factor receptorsSignal transduction moleculesFactor receptorCell cycle progressionIntracellular tyrosine kinaseSmall molecular inhibitorsTyrosine kinase domainNormal human cellsGrowth factorKinase domainTransduction moleculesCycle progressionEGFR expression correlatesTyrosine kinaseEGFR moleculesHuman cellsMetastatic phenotypeConformational changesPrevents activationMolecular inhibitorsImportant therapeutic targetCetuximab and Cisplatin for Chemotherapy-Refractory Squamous Cell Cancer of the Head and Neck
Burtness B. Cetuximab and Cisplatin for Chemotherapy-Refractory Squamous Cell Cancer of the Head and Neck. Journal Of Clinical Oncology 2005, 23: 5440-5442. PMID: 16009959, DOI: 10.1200/jco.2005.02.002.Peer-Reviewed Original ResearchCetuximab: an epidermal growth factor receptor chemeric human-murine monoclonal antibody.
Harding J, Burtness B. Cetuximab: an epidermal growth factor receptor chemeric human-murine monoclonal antibody. Drugs Of Today 2005, 41: 107-27. PMID: 15821783, DOI: 10.1358/dot.2005.41.2.882662.Peer-Reviewed Original ResearchMeSH KeywordsAnimalsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntibody SpecificityAntineoplastic AgentsApoptosisArea Under CurveCell ProliferationCetuximabChemotherapy, AdjuvantClinical Trials as TopicDrug Resistance, NeoplasmErbB ReceptorsHalf-LifeHumansNeoplasmsNeovascularization, PathologicRadiation ToleranceConceptsEpidermal growth factor receptorImportant clinical prognostic markerHydrophobic transmembrane regionCell cycle progressionIntracellular tyrosine kinaseLigand-binding domainNormal human cellsProtein phosphorylationTransmembrane regionCytoplasmic regionGene transcriptionGrowth factor receptorEndogenous ligandCycle progressionExtracellular domainTyrosine kinaseOverall downregulationHuman cellsConformational changesNew anticancer therapiesHuman tumor cell linesErbB familyTumor cell linesVariety of cancersFactor receptor
2000
Phase I studies of anti-epidermal growth factor receptor chimeric antibody C225 alone and in combination with cisplatin.
Baselga J, Pfister D, Cooper MR, Cohen R, Burtness B, Bos M, D’Andrea G, Seidman A, Norton L, Gunnett K, Falcey J, Anderson V, Waksal H, Mendelsohn J. Phase I studies of anti-epidermal growth factor receptor chimeric antibody C225 alone and in combination with cisplatin. Journal Of Clinical Oncology 2000, 18: 904-14. PMID: 10673534, DOI: 10.1200/jco.2000.18.4.904.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsArea Under CurveCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellCetuximabCisplatinDose-Response Relationship, DrugDrug Administration ScheduleErbB ReceptorsFemaleGene Expression Regulation, NeoplasticHead and Neck NeoplasmsHumansInfusions, IntravenousLung NeoplasmsMaleNeoplasms, Glandular and EpithelialRecombinant Fusion ProteinsRemission InductionSafetyConceptsAntibody dosesMultiple doseSystemic clearancePhase I clinical trialWeeks of therapyDose-dependent pharmacokineticsCell lung cancerChimeric monoclonal antibodyCoadministration of cisplatinEpidermal growth factor receptorMurine chimeric monoclonal antibodyGrowth factor receptorDisease stabilizationPartial responseAdvanced tumorsSingle doseLung cancerClinical trialsDisease progressionEpithelial tumorsNonlinear pharmacokineticsPatientsDose levelsAntibody C225Relevant doses