2024
945TiP JADE: A phase (ph) III study to evaluate dostarlimab vs placebo (PBO) as sequential therapy after chemoradiation (CRT) in patients (pts) with locally advanced unresected head and neck squamous cell carcinoma (LA-HNSCC)
Machiels J, Burtness B, Harrington K, Saba N, Tahara M, Crossman T, Hua L, Perera A, Theti D, Zografos E, Siu L. 945TiP JADE: A phase (ph) III study to evaluate dostarlimab vs placebo (PBO) as sequential therapy after chemoradiation (CRT) in patients (pts) with locally advanced unresected head and neck squamous cell carcinoma (LA-HNSCC). Annals Of Oncology 2024, 35: s655. DOI: 10.1016/j.annonc.2024.08.2145.Peer-Reviewed Original ResearchSafety 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
Pembrolizumab versus methotrexate, docetaxel, or cetuximab in recurrent or metastatic head and neck squamous cell carcinoma (KEYNOTE-040): Subgroup analysis by pattern of disease recurrence
Harrington K, Cohen E, Soulières D, Dinis J, Licitra L, Ahn M, Soria A, Machiels J, Mach N, Mehra R, Burtness B, Swaby R, Lin J, Ge J, Lerman N, Tourneau C. Pembrolizumab versus methotrexate, docetaxel, or cetuximab in recurrent or metastatic head and neck squamous cell carcinoma (KEYNOTE-040): Subgroup analysis by pattern of disease recurrence. Oral Oncology 2023, 147: 106587. PMID: 37925894, DOI: 10.1016/j.oraloncology.2023.106587.Peer-Reviewed Original ResearchConceptsSubgroup analysisRecurrence patternsNeck squamous cell carcinomaDisease recurrence patternsPlatinum-containing treatmentSquamous cell carcinomaLonger OSProlonged OSAdvanced diseaseData cutoffDefinitive therapyMetastatic headDurable responsesHazard ratioDisease recurrenceMetastatic HNSCCTreatment armsCell carcinomaM diseaseInvestigator's choicePatientsPembrolizumabRecurrentOnly subgroupSubgroups
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 NetworkPET/CT radiomics potentially improves progression-free survival (PFS) and overall survival (OS) prognostication beyond UICC TNM staging in oropharyngeal squamous cell carcinoma (OPSCC) patients
Haider S, Sharaf K, Zeevi T, Mahajan A, Forghani R, Judson B, Kann B, Burtness B, Reichel C, Baumeister P, Payabvash S. PET/CT radiomics potentially improves progression-free survival (PFS) and overall survival (OS) prognostication beyond UICC TNM staging in oropharyngeal squamous cell carcinoma (OPSCC) patients. Laryngo-Rhino-Otologie 2022, 101: s184-s184. DOI: 10.1055/s-0042-1746471.Peer-Reviewed Original Research
2021
Epigenetic age acceleration, fatigue, and inflammation in patients undergoing radiation therapy for head and neck cancer: A longitudinal study
Xiao C, Beitler JJ, Peng G, Levine ME, Conneely KN, Zhao H, Felger JC, Wommack EC, Chico CE, Jeon S, Higgins KA, Shin DM, Saba NF, Burtness BA, Bruner DW, Miller AH. Epigenetic age acceleration, fatigue, and inflammation in patients undergoing radiation therapy for head and neck cancer: A longitudinal study. Cancer 2021, 127: 3361-3371. PMID: 34027995, DOI: 10.1002/cncr.33641.Peer-Reviewed Original ResearchConceptsC-reactive proteinIL-6 levelsEpigenetic age accelerationNeck cancerInterleukin-6Inflammatory markersHigher epigenetic age accelerationLower C-reactive proteinAge accelerationHigher C-reactive proteinMultidimensional Fatigue Inventory-20Poor functional outcomeBlood DNA methylationMonths postradiotherapyAdvanced diseaseConcurrent chemoradiationMost patientsDistant metastasisFunctional outcomeSevere fatigueTreatment completionRadiation therapyPatientsGreater fatigueInflammationAssociation of Epigenetic Age Acceleration With Risk Factors, Survival, and Quality of Life in Patients With Head and Neck Cancer
Xiao C, Miller AH, Peng G, Levine ME, Conneely KN, Zhao H, Eldridge RC, Wommack EC, Jeon S, Higgins KA, Shin DM, Saba NF, Smith AK, Burtness B, Park HS, Irwin ML, Ferrucci LM, Ulrich B, Qian DC, Beitler JJ, Bruner DW. Association of Epigenetic Age Acceleration With Risk Factors, Survival, and Quality of Life in Patients With Head and Neck Cancer. International Journal Of Radiation Oncology • Biology • Physics 2021, 111: 157-167. PMID: 33882281, PMCID: PMC8802868, DOI: 10.1016/j.ijrobp.2021.04.002.Peer-Reviewed Original ResearchConceptsProgression-free survivalBody mass indexQuality of lifeHigher epigenetic age accelerationTreatment-related symptomsOverall survivalEpigenetic age accelerationRadiation therapyRisk factorsClinical characteristicsNeck cancerAge accelerationWorse overall survivalHuman papilloma virusFaster biological agingAdverse eventsDistant metastasisLifestyle factorsMass indexCancer outcomesBlood biomarkersPapilloma virusFunctional assessmentHigher HRPatientsMeta-analysis of chemotherapy in head and neck cancer (MACH-NC): An update on 107 randomized trials and 19,805 patients, on behalf of MACH-NC Group
Lacas B, Carmel A, Landais C, Wong SJ, Licitra L, Tobias JS, Burtness B, Ghi MG, Cohen EEW, Grau C, Wolf G, Hitt R, Corvò R, Budach V, Kumar S, Laskar SG, Mazeron JJ, Zhong LP, Dobrowsky W, Ghadjar P, Fallai C, Zakotnik B, Sharma A, Bensadoun RJ, Redda M, Racadot S, Fountzilas G, Brizel D, Rovea P, Argiris A, Nagy ZT, Lee JW, Fortpied C, Harris J, Bourhis J, Aupérin A, Blanchard P, Pignon JP, Group M, Adelstein D, Alfonsi M, Belkacemi Y, Bar-Ad V, Bernier J, Bratland Å, Calais G, Campbell B, Caudell J, Chabaud S, Chamorey E, Chaukar D, Choi K, Choussy O, Collette L, Cruz J, Dani C, Dauzier E, Forastiere A, Garaud P, Gregoire V, Hackshaw A, Haddad E, Haffty B, Hansen A, Hayoz S, Horiot J, Jeremic B, Karrison T, Langendijk J, Lapeyre M, Lartigau E, Leong T, Le Q, Lee P, Lewin F, Lin A, Lopes A, Mehta S, Moon J, Moyal E, Occéan B, Olmi P, Orecchia R, O'Sullivan B, Overgaard J, Petit C, Quon H, Sanguineti G, Satar T, Simes J, Simon C, Sire C, Staar S, Stromberger C, Strojan P, Temam S, Thomson D, Timochenko A, Torri V, Tseroni V, Vermorken J, Vokes E, Waldron J, Wernecke K, Widder J, Zackrisson B. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): An update on 107 randomized trials and 19,805 patients, on behalf of MACH-NC Group. Radiotherapy And Oncology 2021, 156: 281-293. PMID: 33515668, PMCID: PMC8386522, DOI: 10.1016/j.radonc.2021.01.013.Peer-Reviewed Original ResearchConceptsLoco-regional treatmentConcomitant CTConcomitant chemotherapyOverall survivalNeck cancerNon-metastatic headPoor performance statusSquamous cell headIndividual patient dataNon-metastatic carcinomasAddition of inductionFixed-effects modelPerformance statusPatient ageDistant metastasisRandomized trialsMain endpointCell headStage IIIMeta-AnalysisPatientsChemotherapyPatient dataTrialsCancer
2020
ECOG-ACRIN 2399: analysis of patient related outcomes after Chemoradiation for locally advanced head and neck Cancer
Cmelak A, Dietrich MS, Li S, Ridner S, Forastiere A, Burtness BA, Cella D, Murphy BA. ECOG-ACRIN 2399: analysis of patient related outcomes after Chemoradiation for locally advanced head and neck Cancer. Cancers Of The Head & Neck 2020, 5: 12. PMID: 33353553, PMCID: PMC7756946, DOI: 10.1186/s41199-020-00059-1.Peer-Reviewed Original ResearchQuality of lifeFunctional communication measuresMajority of patientsVoice Handicap IndexFACT-HNSwallow assessmentEffects of chemoradiationLarge therapeutic trialsPatient related outcomesSevere dysphagiaAdvanced headOverall survivalBarium swallowTherapeutic trialsNeck cancerSwallow functionSurrogate markerDisability AssessmentLarynx cancerFunctional assessmentPatientsHandicap IndexVocal functionRelated outcomesMarked decrease71P A phase II study of ADU-S100 in combination with pembrolizumab in adult patients with PD-L1+ recurrent or metastatic HNSCC: Preliminary safety, efficacy and PK/PD results
Zandberg D, Ferris R, Laux D, Mehra R, Nabell L, Kaczmar J, Gibson M, Kim Y, Neupane P, Bauman J, Julian R, Adkins D, Cohen E, Burtness B, Bermingham C, Dupage A, Desbien A, Loi A, Nuyten D, Saba N. 71P A phase II study of ADU-S100 in combination with pembrolizumab in adult patients with PD-L1+ recurrent or metastatic HNSCC: Preliminary safety, efficacy and PK/PD results. Annals Of Oncology 2020, 31: s1446-s1447. DOI: 10.1016/j.annonc.2020.10.559.Peer-Reviewed Original ResearchComparing 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 indexHNSCCPatients354 A phase 1 trial of CUE-101 a novel HPV16 E7-pHLA-IL2-Fc fusion protein in patients with recurrent/metastatic HPV16+ head and neck cancer
Pai S, Adkins D, Wirth L, Chung C, Gibson M, Sukari A, Worden F, Colevas D, Saba N, Burtness B, Rodriguez C, Bauman J, Glisson B, Dunn L, Suri A, Haydock M, Quayle S, Cemerski S, Leader M, Brown J, Pienta K, Simcox M. 354 A phase 1 trial of CUE-101 a novel HPV16 E7-pHLA-IL2-Fc fusion protein in patients with recurrent/metastatic HPV16+ head and neck cancer. 2020, a216.1-a216. DOI: 10.1136/jitc-2020-sitc2020.0354.Peer-Reviewed Original ResearchPredictive classifier for intensive treatment of head and neck cancer
Zakeri K, Rotolo F, Lacas B, Vitzthum LK, Le Q, Gregoire V, Overgaard J, Hackshaw A, Zackrisson B, Parmar MKB, Burtness BA, Ghi MG, Sanguineti G, O’Sullivan B, Fortpied C, Bourhis J, Shen H, Harris J, Michiels S, Pignon J, Mell LK, Intergroup F. Predictive classifier for intensive treatment of head and neck cancer. Cancer 2020, 126: 5263-5273. PMID: 33017867, DOI: 10.1002/cncr.33212.Peer-Reviewed Original ResearchConceptsOverall survivalIntensive treatmentΩ scoreNeck cancerGood performance statusEffect of chemotherapyOral cavity sitesPerformance statusAdvanced headRandomized trialsControl armHigh riskN categoryPatientsRelative hazardYounger ageEvent riskEvent regressionCancerCancer progressionUnknown statusTreatment effectsChemotherapyScoresTreatmentLEAP-010: Phase III study of first-line pembrolizumab with or without lenvatinib in patients (pts) with 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, Okpara C, Pinheiro C, Swaby R, Machiels J, Tahara M. LEAP-010: Phase III study of first-line pembrolizumab with or without lenvatinib in patients (pts) with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Annals Of Oncology 2020, 31: s683-s684. DOI: 10.1016/j.annonc.2020.08.1088.Peer-Reviewed Original ResearchA 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 headPatientsSurgeryPembrolizumab given concomitantly with chemoradiation and as maintenance therapy for locally advanced head and neck squamous cell carcinoma: KEYNOTE-412
Machiels JP, Tao Y, Burtness B, Tahara M, Licitra L, Rischin D, Waldron J, Simon C, Gregoire V, Harrington K, Alves GV, Lima I, Pointreau Y, Hughes B, Aksoy S, Hetnal M, Ge JY, Brown H, Cheng J, Bidadi B, Siu LL. Pembrolizumab given concomitantly with chemoradiation and as maintenance therapy for locally advanced head and neck squamous cell carcinoma: KEYNOTE-412. Future Oncology 2020, 16: 1235-1243. PMID: 32490686, DOI: 10.2217/fon-2020-0184.Peer-Reviewed Original ResearchConceptsNeck squamous cell carcinomaPhase III trialsSquamous cell carcinomaChemoradiation therapyAdvanced headIII trialsCell carcinomaImmune checkpoint inhibitor pembrolizumabLarge phase III trialsCheckpoint inhibitor pembrolizumabUse of pembrolizumabCurrent treatment guidelinesAdvanced HNSCCAdvanced diseaseMaintenance therapyMetastatic HNSCCTreatment guidelinesMaintenance treatmentMultimodal treatmentPembrolizumabPatientsAntitumor activityIB dataChemoradiationHNSCCQuality of Life With Pembrolizumab for Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma: KEYNOTE-040
Harrington KJ, Soulières D, Le Tourneau C, Dinis J, Licitra LF, Ahn MJ, Soria A, Machiels JH, Mach N, Mehra R, Burtness B, Ellison MC, Cheng JD, Chirovsky DR, Swaby RF, Cohen EEW. Quality of Life With Pembrolizumab for Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma: KEYNOTE-040. Journal Of The National Cancer Institute 2020, 113: 171-181. PMID: 32407532, PMCID: PMC7850527, DOI: 10.1093/jnci/djaa063.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCetuximabDisease-Free SurvivalDocetaxelHumansMaleMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalPatient Reported Outcome MeasuresQuality of LifeSquamous Cell Carcinoma of Head and NeckConceptsGHS/QoL scoresStandard of careNeck squamous cell carcinomaGlobal health statusSquamous cell carcinomaQOL scoresWeek 15KEYNOTE-040Metastatic HNSCCCell carcinomaNeck cancer-specific modulePlatinum-containing regimenHealth-related qualityCancer-specific moduleQuality of lifeHRQoL benefitsHRQoL populationMetastatic headHRQoL analysisMedian timeLife HeadPembrolizumabPatientsHealth statusEuropean OrganizationAssessment of Lymph Node Evaluation in Patients with Clinically Node Negative Merkel Cell Carcinoma of the Head and Neck
Jacobs D, Park H, Young M, Olino K, Rahmati R, Mehra S, Burtness B, Judson B. Assessment of Lymph Node Evaluation in Patients with Clinically Node Negative Merkel Cell Carcinoma of the Head and Neck. International Journal Of Radiation Oncology • Biology • Physics 2020, 106: 1191-1192. DOI: 10.1016/j.ijrobp.2019.11.099.Peer-Reviewed Original ResearchAdjuvant external beam radiotherapy for surgically resected, nonmetastatic anaplastic thyroid cancer
Saeed NA, Kelly JR, Deshpande HA, Bhatia AK, Burtness BA, Judson BL, Mehra S, Edwards HA, Yarbrough WG, Peter PR, Holt EH, Decker RH, Husain ZA, Park HS. Adjuvant external beam radiotherapy for surgically resected, nonmetastatic anaplastic thyroid cancer. Head & Neck 2020, 42: 1031-1044. PMID: 32011055, DOI: 10.1002/hed.26086.Peer-Reviewed Original ResearchConceptsAnaplastic thyroid cancerLonger OSAdjuvant EBRTThyroid cancerAdjuvant external beam radiotherapyNational Cancer DatabaseExternal beam radiotherapyConcurrent chemoradiationConcurrent chemotherapyImproved survivalMedian ageCancer DatabaseRetrospective analysisBeam radiotherapyEBRTChemotherapyPatientsCancerUVAChemoradiationResectionRadiotherapy
2019
Randomized, Phase II Study Prospectively Evaluating Treatment of Metastatic Esophageal, Gastric, or Gastroesophageal Cancer by Gene Expression of ERCC1: SWOG S1201.
Iqbal S, McDonough S, Lenz HJ, Ilson D, Burtness B, Nangia CS, Barzi A, Schneider CJ, Liu JJ, Dotan E, Guthrie KA, Hochster HS. Randomized, Phase II Study Prospectively Evaluating Treatment of Metastatic Esophageal, Gastric, or Gastroesophageal Cancer by Gene Expression of ERCC1: SWOG S1201. Journal Of Clinical Oncology 2019, 38: 472-479. PMID: 31815582, PMCID: PMC7007287, DOI: 10.1200/jco.19.00925.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsDNA-Binding ProteinsEndonucleasesEsophageal NeoplasmsEsophagogastric JunctionFemaleFluorouracilGene ExpressionHumansLeucovorinMaleMiddle AgedNeoplasm MetastasisOrganoplatinum CompoundsOxaliplatinPrognosisProgression-Free SurvivalProportional Hazards ModelsProspective StudiesStomach NeoplasmsYoung AdultConceptsProgression-free survivalAdvanced esophagogastric cancerPhase II studyPlatinum-based therapyOverall survivalII studySuperior median progression-free survivalMedian progression-free survivalMRNA expressionRegimen of irinotecanUpper GI tumorsZubrod performance statusPercent of patientsOccurrence of gradeStandard of careMetastatic esophagealEsophagogastric cancerPerformance statusUntreated patientsGastroesophageal cancerGI tumorsTreatment armsFOLFOXPlatinum sensitivityPatients