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 carcinomaRandomized 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
2022
Phase II Study of Enzalutamide for Patients With Androgen Receptor–Positive Salivary Gland Cancers (Alliance A091404)
Ho AL, Foster NR, Zoroufy AJ, Campbell JD, Worden F, Price K, Adkins D, Bowles DW, Kang H, Burtness B, Sherman E, Morton R, Morris LGT, Nadeem Z, Katabi N, Munster P, Schwartz GK. Phase II Study of Enzalutamide for Patients With Androgen Receptor–Positive Salivary Gland Cancers (Alliance A091404). Journal Of Clinical Oncology 2022, 40: 4240-4249. PMID: 35867947, PMCID: PMC9916043, DOI: 10.1200/jco.22.00229.Peer-Reviewed Original ResearchConceptsSalivary gland cancerPrimary end pointProgression-free survivalAndrogen receptorStable diseaseEnd pointOverall survivalPartial responseGland cancerTumor regressionPartial response/stable diseaseBest overall response rateMedian progression-free survivalResponse/stable diseaseHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Common adverse eventsMedian overall survivalPhase II studySecondary end pointsPhase II trialFree testosterone levelsGrowth factor receptor 2Overall response rateProgression of diseasePhase 2 LEAP-009: Lenvatinib (Lenva) With or Without Pembrolizumab (Pembro) vs. Chemotherapy (Chemo) for Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) That has Progressed on Platinum and Immunotherapy
Harrington K, Cohen E, Siu L, Rischin D, Licitra L, Vermorken J, Le Q, Tahara M, Machiels J, Hawk N, Ge J, Bidadi B, Swaby R, Burtness B. Phase 2 LEAP-009: Lenvatinib (Lenva) With or Without Pembrolizumab (Pembro) vs. Chemotherapy (Chemo) for Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) That has Progressed on Platinum and Immunotherapy. International Journal Of Radiation Oncology • Biology • Physics 2022, 112: e43-e44. DOI: 10.1016/j.ijrobp.2021.12.101.Peer-Reviewed Original ResearchPD-1/PD-L1 inhibitorsECOG performance statusPD-L1 inhibitorsM HNSCCDisease progressionRECIST v1.1Monotherapy armPerformance statusPO QDPD-L1 tumor proportion scoreOptimal second-line regimenEnd pointNeck squamous cell carcinomaPrimary end pointSecond-line regimenSecondary end pointsFirst-line treatmentTumor proportion scoreKey eligibility criteriaSquamous cell carcinomaInterim futility analysisMeasurable diseaseSOC chemotherapyMetastatic headUnacceptable toxicity
2021
Efficacy and toxicity of weekly paclitaxel, carboplatin, and cetuximab as induction chemotherapy or in cases of metastases or relapse for head and neck cancer in elderly or frail patients.
Forman R, Bhatia A, Burtness B. Efficacy and toxicity of weekly paclitaxel, carboplatin, and cetuximab as induction chemotherapy or in cases of metastases or relapse for head and neck cancer in elderly or frail patients. Journal Of Clinical Oncology 2021, 39: 6042-6042. DOI: 10.1200/jco.2021.39.15_suppl.6042.Peer-Reviewed Original ResearchProgression-free survivalOverall survivalInduction chemotherapyFrail patientsAdverse effectsMean progression-free survivalNeck squamous cell carcinomaP16-positive diseasePrimary end pointRECIST response rateCommon adverse effectsMean overall survivalRetrospective observational studyCommon tumor siteCommon reason patientsSquamous cell carcinomaCases of metastasisDose interruptionWeekly paclitaxelAdvanced diseaseGastrointestinal symptomsMetastatic headPrior radiationChart reviewElderly patients
2020
Phase III LEAP-010 study: first-line pembrolizumab with or without lenvatinib in recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).
Siu L, Burtness B, Cohen E, Harrington K, Licitra L, Rischin D, Zhu Y, Lee C, Pinheiro C, Swaby R, Machiels J, Tahara M. Phase III LEAP-010 study: first-line pembrolizumab with or without lenvatinib in recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Journal Of Clinical Oncology 2020, 38: tps6589-tps6589. DOI: 10.1200/jco.2020.38.15_suppl.tps6589.Peer-Reviewed Original ResearchBlinded independent central reviewCombined positive scoreFirst-line pembrolizumabM HNSCCDisease progressionRECIST v1.1PD-L1PD-L1 combined positive scoreECOG performance status 0PD-1 inhibitor pembrolizumabRecurrent/metastatic headEnd pointNeck squamous cell carcinomaCycles of pembrolizumabFirst-line monotherapyPerformance status 0Phase 1b/2 trialManageable safety profileObjective response ratePrimary end pointSecondary end pointsHuman papillomavirus (HPV) statusPD-L1 statusPhase 3 studyProgression-free survival
2019
Afatinib vs Placebo as Adjuvant Therapy After Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck
Burtness B, Haddad R, Dinis J, Trigo J, Yokota T, de Souza Viana L, Romanov I, Vermorken J, Bourhis J, Tahara M, Segalla J, Psyrri A, Vasilevskaya I, Nangia CS, Chaves-Conde M, Kiyota N, Homma A, Holeckova P, Del Campo JM, Asarawala N, Nicolau UR, Rauch D, Even C, Wang B, Gibson N, Ehrnrooth E, Harrington K, Cohen EEW. Afatinib vs Placebo as Adjuvant Therapy After Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck. JAMA Oncology 2019, 5: 1170-1180. PMID: 31194247, PMCID: PMC6567846, DOI: 10.1001/jamaoncol.2019.1146.Peer-Reviewed Original ResearchDisease-free survivalAdverse eventsEastern Cooperative Oncology Group performance statusMedian disease-free survivalDrug-related adverse effectsEnd pointNeck squamous cell cancerIndependent data monitoring committeeErbB family blocker afatinibCommon grade 3More adverse eventsPrimary end pointSecondary end pointsUnacceptable adverse eventsDate of randomizationHealth-related qualitySquamous cell cancerRisk of recurrenceSquamous cell carcinomaSecondary primary tumorsInterim futility analysisData monitoring committeeAcneiform rashAfatinib groupDefinitive chemoradiotherapyPembrolizumab (pembro) for recurrent head and neck squamous cell carcinoma (HNSCC): Post hoc analyses of phase 3 KEYNOTE-040 prior radiation treatment (RT) and disease state.
Harrington K, Cohen E, Soulieres D, Dinis J, Licitra L, Ahn M, Soria A, Machiels J, Mach N, Mehra R, Burtness B, Lin J, Cheng J, Swaby R, Le Tourneau C. Pembrolizumab (pembro) for recurrent head and neck squamous cell carcinoma (HNSCC): Post hoc analyses of phase 3 KEYNOTE-040 prior radiation treatment (RT) and disease state. Journal Of Clinical Oncology 2019, 37: 6026-6026. DOI: 10.1200/jco.2019.37.15_suppl.6026.Peer-Reviewed Original ResearchPrior radiation treatmentSurvival benefitRadiation treatmentM diseaseEnd pointNeck squamous cell carcinomaDisease statesPrimary end pointSecondary end pointsPlatinum-based therapySquamous cell carcinomaITT populationCare chemotherapyMetastatic HNSCCRecurrent headCell carcinomaPembroInvestigator's choicePatientsDiseaseDefinitive conclusionsMetastaticPFSRecurrentTreatment
2016
E1308: Phase II Trial of Induction Chemotherapy Followed by Reduced-Dose Radiation and Weekly Cetuximab in Patients With HPV-Associated Resectable Squamous Cell Carcinoma of the Oropharynx— ECOG-ACRIN Cancer Research Group
Marur S, Li S, Cmelak AJ, Gillison ML, Zhao WJ, Ferris RL, Westra WH, Gilbert J, Bauman JE, Wagner LI, Trevarthen DR, Balkrishna J, Murphy BA, Agrawal N, Colevas AD, Chung CH, Burtness B. E1308: Phase II Trial of Induction Chemotherapy Followed by Reduced-Dose Radiation and Weekly Cetuximab in Patients With HPV-Associated Resectable Squamous Cell Carcinoma of the Oropharynx— ECOG-ACRIN Cancer Research Group. Journal Of Clinical Oncology 2016, 35: 490-497. PMID: 28029303, PMCID: PMC5455313, DOI: 10.1200/jco.2016.68.3300.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Squamous CellCetuximabChemoradiotherapyDisease-Free SurvivalDrug Administration ScheduleExanthemaFemaleHuman papillomavirus 16HumansInduction ChemotherapyMaleMiddle AgedNeutropeniaOropharyngeal NeoplasmsPapillomavirus InfectionsRadiotherapy DosageRemission InductionConceptsOropharyngeal squamous cell carcinomaComplete clinical responseCycle of ICPhase II trialProgression-free survivalSquamous cell carcinomaWeekly cetuximabII trialCell carcinomaPack-year smoking historyResectable squamous cell carcinomaFavorable-risk patientsPrimary end pointOverall survival rateHigh cure ratesCancer Research GroupGy of radiationRadiation doseLong-term toxicityRadiation dose reductionChemoradiation resultsICS respondersInduction chemotherapyLate sequelaeClinical responseAntitumor Activity of Pembrolizumab in Biomarker-Unselected Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma: Results From the Phase Ib KEYNOTE-012 Expansion Cohort
Chow LQM, Haddad R, Gupta S, Mahipal A, Mehra R, Tahara M, Berger R, Eder JP, Burtness B, Lee SH, Keam B, Kang H, Muro K, Weiss J, Geva R, Lin CC, Chung HC, Meister A, Dolled-Filhart M, Pathiraja K, Cheng JD, Seiwert TY. Antitumor Activity of Pembrolizumab in Biomarker-Unselected Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma: Results From the Phase Ib KEYNOTE-012 Expansion Cohort. Journal Of Clinical Oncology 2016, 34: 3838-3845. PMID: 27646946, PMCID: PMC6804896, DOI: 10.1200/jco.2016.68.1478.Peer-Reviewed Original ResearchConceptsOverall response rateNeck squamous cell carcinomaProgression-free survivalSquamous cell carcinomaMetastatic headExpansion cohortPD-L1Cell carcinomaAnti-programmed death-1 antibodySix-month progression-free survivalTreatment-related adverse eventsEnd pointDeath-1 antibodyDose of pembrolizumabAntitumor activityPrimary end pointSecondary end pointsHuman papillomavirus (HPV) statusPD-L1 expressionOverall survival rateDurable antitumor activityFrequent dosing scheduleAssociation of responseAdvanced HNSCCM HNSCCCALGB 80403 (Alliance)/E1206: A Randomized Phase II Study of Three Chemotherapy Regimens Plus Cetuximab in Metastatic Esophageal and Gastroesophageal Junction Cancers
Enzinger PC, Burtness BA, Niedzwiecki D, Ye X, Douglas K, Ilson DH, Villaflor VM, Cohen SJ, Mayer RJ, Venook A, Benson AB, Goldberg RM. CALGB 80403 (Alliance)/E1206: A Randomized Phase II Study of Three Chemotherapy Regimens Plus Cetuximab in Metastatic Esophageal and Gastroesophageal Junction Cancers. Journal Of Clinical Oncology 2016, 34: 2736-2742. PMID: 27382098, PMCID: PMC5019745, DOI: 10.1200/jco.2015.65.5092.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAdultAgedAged, 80 and overAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsCamptothecinCarcinoma, Squamous CellCetuximabCisplatinDisease ProgressionDisease-Free SurvivalEpirubicinEsophageal NeoplasmsEsophagogastric JunctionFemaleFluorouracilHumansIrinotecanLeucovorinMaleMiddle AgedOrganoplatinum CompoundsSurvival RateTime FactorsTreatment FailureConceptsGastroesophageal junction cancerProgression-free survivalMetastatic esophagealJunction cancerOverall survivalTreatment failureResponse rateMedian progression-free survivalRandomized phase II studyContinuous infusion fluorouracilOptimal chemotherapy backboneTreatment-related deathsMedian overall survivalPhase II studyPrimary end pointCooperative group studiesPromising preclinical dataChemotherapy backboneChemotherapy regimensAdverse eventsII studySecondary outcomesMedian timeTreatment armsPreclinical data
2015
Antitumor activity and safety of pembrolizumab in patients (pts) with advanced squamous cell carcinoma of the head and neck (SCCHN): Preliminary results from KEYNOTE-012 expansion cohort.
Seiwert T, Haddad R, Gupta S, Mehra R, Tahara M, Berger R, Lee S, Burtness B, Le D, Heath K, Blum A, Dolled-Filhart M, Emancipator K, Pathiraja K, Cheng J, Chow L. Antitumor activity and safety of pembrolizumab in patients (pts) with advanced squamous cell carcinoma of the head and neck (SCCHN): Preliminary results from KEYNOTE-012 expansion cohort. Journal Of Clinical Oncology 2015, 33: lba6008-lba6008. DOI: 10.1200/jco.2015.33.18_suppl.lba6008.Peer-Reviewed Original ResearchRecurrent/metastatic SCCHNOverall response rateDrug-related adverse eventsProgression-free survivalAdverse eventsMetastatic SCCHNPD-L1KEYNOTE-012Expansion cohortOverall survivalCommon drug-related adverse eventsTumor-specific effector T cellsResponse rateAdvanced squamous cell carcinomaDrug-related gradePost-baseline scanSafety of pembrolizumabPrimary end pointLines of therapyPD-L1 expressionEffector T cellsSquamous cell carcinomaHumanized monoclonal antibodyPreliminary efficacy analysisAdvanced SCCHN
2014
LBA31 A Phase Ib Study of Pembrolizumab (Pembro; Mk-3475) in Patients (Pts) with Human Papiilloma Virus (Hpv)-Positive and Negative Head and Neck Cancer (Hnc)
Chow L, Burtness B, Weiss J, Berger R, Eder J, Gonzalez E, Pulini J, Johnson J, Dolled-Filhart M, Emancipator K, Lunceford J, Pathiraja K, Gause C, Cheng J, Seiwert T. LBA31 A Phase Ib Study of Pembrolizumab (Pembro; Mk-3475) in Patients (Pts) with Human Papiilloma Virus (Hpv)-Positive and Negative Head and Neck Cancer (Hnc). Annals Of Oncology 2014, 25: v1. DOI: 10.1093/annonc/mdu438.32.Peer-Reviewed Original ResearchOverall response ratePD-L1 expressionDrug-related adverse eventsAdverse eventsRECIST v1.1Subsidiary of MerckBristol-Myers SquibbInvestigator reviewAntitumor activityCommon drug-related adverse eventsAdvisory board membershipHigh PD-L1 expressionBoehringer IngelheimMerck SharpGenentech/RochePhase Ib studyPrimary end pointDrug-related deathsMeasurable diseaseMedian OSMedian PFSMetastatic HNCAdvanced HNCUnacceptable toxicityComplete response
2008
A randomized phase II study of ixabepilone (BMS-247550) given daily × 5 days every 3 weeks or weekly in patients with metastatic or recurrent squamous cell cancer of the head and neck: an Eastern Cooperative Oncology Group study
Burtness BA, Manola J, Axelrod R, Argiris A, Forastiere AA. A randomized phase II study of ixabepilone (BMS-247550) given daily × 5 days every 3 weeks or weekly in patients with metastatic or recurrent squamous cell cancer of the head and neck: an Eastern Cooperative Oncology Group study. Annals Of Oncology 2008, 19: 977-983. PMID: 18296423, DOI: 10.1093/annonc/mdm591.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibiotics, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Squamous CellCombined Modality TherapyDisease-Free SurvivalDocetaxelDrug Administration ScheduleDrug Resistance, NeoplasmEpothilonesFemaleHead and Neck NeoplasmsHematologic DiseasesHumansInfusions, IntravenousMaleMiddle AgedPaclitaxelPeripheral Nervous System DiseasesRecurrenceSalvage TherapySurvival AnalysisTaxoidsConceptsTaxane-naive patientsArm BEastern Cooperative Oncology Group performance statusEastern Cooperative Oncology Group StudyRecurrent squamous cell cancerSensory/motor neuropathyRandomized phase II studyMetastatic/recurrent diseaseCommon grade 3Grade 3 neuropathyPhase II studyPrimary end pointSquamous cell cancerSquamous cell carcinomaEligible patientsPrior regimensWeekly ixabepiloneRecurrent diseaseII studyMedian survivalPartial responsePerformance statusMotor neuropathyCell cancerCell carcinoma
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 rash