2024
907P Biomarker analysis of the phase III KEYNOTE-040 study of pembrolizumab (pembro) versus methotrexate, docetaxel, or cetuximab (SOC) for recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC)
Soulieres D, Le Tourneau C, Machiels J, Burtness B, Harrington K, Shen J, Tao J, Webber A, Vajdi A, Loboda A, Lerman N, Gumuscu B, Licitra L. 907P Biomarker analysis of the phase III KEYNOTE-040 study of pembrolizumab (pembro) versus methotrexate, docetaxel, or cetuximab (SOC) for recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Annals Of Oncology 2024, 35: s639-s640. DOI: 10.1016/j.annonc.2024.08.968.Peer-Reviewed Original ResearchPembrolizumab Plus Carboplatin and Paclitaxel as First-Line Therapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-B10): A Single-Arm Phase IV Trial
Dzienis M, Cundom J, Fuentes C, Spreafico A, Nordlinger M, Pastor A, Alesi E, Neki A, Fung A, Lima I, Oppelt P, da Cunha G, Burtness B, Franke F, Tseng J, Joshi A, McCarthy J, Swaby R, Sidi Y, Gumuscu B, Naicker N, de Castro G. Pembrolizumab Plus Carboplatin and Paclitaxel as First-Line Therapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-B10): A Single-Arm Phase IV Trial. Journal Of Clinical Oncology 2024, 42: 2989-2999. PMID: 39038265, PMCID: PMC11361359, DOI: 10.1200/jco.23.02625.Peer-Reviewed Original ResearchBlinded independent central reviewRecurrent/metastatic head and neck squamous cell carcinomaHead and neck squamous cell carcinomaNeck squamous cell carcinomaR/M HNSCCSquamous cell carcinomaRECIST v1.1Cell carcinomaSingle-armStandard-of-care first-line treatmentSafety of first-line pembrolizumabEastern Cooperative Oncology Group performance statusDay 1Treatment-related adverse eventsAlternative chemotherapy combinationsFirst-line pembrolizumabPD-L1 statusMedian follow-upFirst-line therapyIndependent central reviewFirst-line treatmentPhase IV trialChemotherapy combinationsComplete responsePD-L1Health-Related Quality of Life (HRQoL) Data From KEYNOTE-412: Chemoradiotherapy (CRT) with or Without Pembrolizumab (pembro) in Patients (pts) with Locally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC)
Machiels J, TAO Y, Burtness B, Tahara M, Rischin D, Alves G, Lima I, Hughes B, Pointreau Y, Aksoy S, Laban S, Greil R, Burian M, Hetnal M, Licitra L, Black C, Norquist J, Gumuscu B, Bidadi B, Siu L. Health-Related Quality of Life (HRQoL) Data From KEYNOTE-412: Chemoradiotherapy (CRT) with or Without Pembrolizumab (pembro) in Patients (pts) with Locally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC). International Journal Of Radiation Oncology • Biology • Physics 2024, 118: e39-e40. DOI: 10.1016/j.ijrobp.2024.01.091.Peer-Reviewed Original ResearchBL to weekLA-HNSCCEQ-5D VASLSM changeLocally advanced head and neck squamous cell carcinomaAdvanced head and neck squamous cell carcinomaQLQ-H&N35Head and neck squamous cell carcinomaNeck squamous cell carcinomaEnd pointsPrespecified secondary end pointsSecondary end pointsSquamous cell carcinomaExploratory end pointsCompliance rateQLQ-C30Disease symptom scoreDose of treatmentPatient-reported outcomesPhysical function scoresCell carcinomaPembroHealth-related quality of lifeChemoradiotherapyAnalysis populationImpact of 18F-FDG PET Intensity Normalization on Radiomic Features of Oropharyngeal Squamous Cell Carcinomas and Machine Learning–Generated Biomarkers
Haider S, Zeevi T, Sharaf K, Gross M, Mahajan A, Kann B, Judson B, Prasad M, Burtness B, Aboian M, Canis M, Reichel C, Baumeister P, Payabvash S. Impact of 18F-FDG PET Intensity Normalization on Radiomic Features of Oropharyngeal Squamous Cell Carcinomas and Machine Learning–Generated Biomarkers. Journal Of Nuclear Medicine 2024, 65: jnumed.123.266637. PMID: 38514087, DOI: 10.2967/jnumed.123.266637.Peer-Reviewed Original ResearchOropharyngeal squamous cell carcinomaSquamous cell carcinomaHuman papillomavirusRadiomic featuresIntraclass correlation coefficientCell carcinomaLentiform nucleusHuman papillomavirus statusReceiver-operating-characteristic analysisReceiver-operating-characteristic curvePET radiomic featuresUnivariate logistic regressionF-FDGPrimary tumorTraining cohortValidation cohortRadiomic biomarkersUnivariate analysisInterindividual comparabilityPredictive valueDegree of reproducibilityMedian areaRadiomic markersLogistic regressionAUCThe role of surgery and deescalation for HPV‐related oropharyngeal cancer
Contrera K, Patel M, Burtness B, Mehra R, Ferris R. The role of surgery and deescalation for HPV‐related oropharyngeal cancer. Cancer 2024 PMID: 38497569, DOI: 10.1002/cncr.35287.Peer-Reviewed Original Research
2023
106P Treatment sequencing in PD-L1–positive recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): Exploratory analysis of the phase III KEYNOTE-048 study
Greil R, Burtness B, Laban S, Braña I, Nin R, Fuereder T, Bratland Å, Licitra L, Rordorf T, Psyrri A, Popovtzer A, Hughes B, Tahara M, Lin J, Gumuscu B, Lerman N, Harrington K. 106P Treatment sequencing in PD-L1–positive recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): Exploratory analysis of the phase III KEYNOTE-048 study. Immuno-Oncology Technology 2023, 20: 100578. DOI: 10.1016/j.iotech.2023.100578.Peer-Reviewed Original ResearchEmerging Prognostic and Predictive Significance of Stress Keratin 17 in HPV-Associated and Non HPV-Associated Human Cancers: A Scoping Review
Lozar T, Wang W, Gavrielatou N, Christensen L, Lambert P, Harari P, Rimm D, Burtness B, Kuhar C, Carchman E. Emerging Prognostic and Predictive Significance of Stress Keratin 17 in HPV-Associated and Non HPV-Associated Human Cancers: A Scoping Review. Viruses 2023, 15: 2320. PMID: 38140561, PMCID: PMC10748233, DOI: 10.3390/v15122320.Peer-Reviewed Original ResearchConceptsSquamous cell carcinomaTriple-negative breast cancerCancer typesPredictive significancePrognostic factorsClinical outcomesPrognostic significanceCell carcinomaHuman cancersCervical squamous cell carcinomaNeck squamous cell carcinomaAvailable clinical evidenceCochrane Central RegisterInferior clinical outcomesPositive prognostic factorNegative predictive factorNegative prognostic factorWeb of ScienceCentral RegisterControlled TrialsCervical cancerClinical evidencePredictive factorsPancreatic cancerEligible studiesPembrolizumab 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 subgroupSubgroupsPS3-3 Pembrolizumab + chemoradiation therapy for locally advanced head and neck squamous cell carcinoma (HNSCC): KEYNOTE-412
Tahara M, Machiels J, Tao Y, Burtness B, Rischin D, Alves G, Lima I, Hughes B, Pointreau Y, Aksoy S, Laban S, Greil R, Burian M, Hetnal M, Licitra L, Swaby R, Zhang Y, Bidadi B, Siu L. PS3-3 Pembrolizumab + chemoradiation therapy for locally advanced head and neck squamous cell carcinoma (HNSCC): KEYNOTE-412. Annals Of Oncology 2023, 34: s1380. DOI: 10.1016/j.annonc.2023.09.109.Peer-Reviewed Original ResearchEvaluating the medical management of locally advanced and metastatic basal cell carcinoma: A single institutional retrospective analysis investigating efficacy, safety, and tolerability
Belzer A, Pach J, Mortlock R, Clune J, Olino K, Sznol M, Bhatia A, Burtness B, Christensen S, Leventhal J. Evaluating the medical management of locally advanced and metastatic basal cell carcinoma: A single institutional retrospective analysis investigating efficacy, safety, and tolerability. JAAD International 2023, 11: 174-175. PMID: 37252181, PMCID: PMC10213716, DOI: 10.1016/j.jdin.2023.02.007.Peer-Reviewed Original Research
2022
Outcomes Stratification of Head and Neck Cancer Using Pre- and Post-treatment DNA Methylation From Peripheral Blood
Qian D, Ulrich B, Peng G, Zhao H, Conneely K, Miller A, Bruner D, Eldridge R, Wommack E, Higgins K, Shin D, Saba N, Smith A, Burtness B, Park H, Stokes W, Beitler J, Xiao C. Outcomes Stratification of Head and Neck Cancer Using Pre- and Post-treatment DNA Methylation From Peripheral Blood. International Journal Of Radiation Oncology • Biology • Physics 2022, 115: 1217-1228. PMID: 36410685, DOI: 10.1016/j.ijrobp.2022.11.009.Peer-Reviewed Original ResearchConceptsRecurrence-free survivalWorse recurrence-free survivalOverall survivalMethylation risk scoreRadiation therapyValidation cohortPeripheral bloodDiscovery cohortOutcome stratificationShorter recurrence-free survivalNeck squamous cell carcinomaGastrostomy tube insertionHigher neutrophil countOral cavity cancerAforementioned risk factorsSquamous cell carcinomaPeripheral blood samplesNonmetastatic HNSCCNeutrophil countPrognostic factorsCox regressionPrognostic valueCell carcinomaTube insertionImmune modulation133 Spatially defined gene signatures uncover the association of extracellular matrix genes with immunotherapy resistance in head and neck squamous cell carcinoma
Gavrielatou N, Warrell J, Aung T, Vathiotis L, Economopoulou P, Burtness B, Psyrri A, Rimm D. 133 Spatially defined gene signatures uncover the association of extracellular matrix genes with immunotherapy resistance in head and neck squamous cell carcinoma. 2022, a146-a146. DOI: 10.1136/jitc-2022-sitc2022.0133.Peer-Reviewed Original ResearchPembrolizumab With or Without Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Updated Results of the Phase III KEYNOTE-048 Study
Harrington KJ, Burtness B, Greil R, Soulières D, Tahara M, de Castro G, Psyrri A, Brana I, Basté N, Neupane P, Bratland Å, Fuereder T, Hughes BGM, Mesia R, Ngamphaiboon N, Rordorf T, Ishak W, Lin J, Gumuscu B, Swaby RF, Rischin D. Pembrolizumab With or Without Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Updated Results of the Phase III KEYNOTE-048 Study. Journal Of Clinical Oncology 2022, 41: 790-802. PMID: 36219809, PMCID: PMC9902012, DOI: 10.1200/jco.21.02508.Peer-Reviewed Original ResearchConceptsPD-L1 CPSNeck squamous cell carcinomaSquamous cell carcinomaRecurrent/metastatic headMetastatic headCell carcinomaOverall survivalNext-line therapyObjective response ratePembrolizumab-based therapyProgression-free survivalDeath ligand 1Long-term efficacyKEYNOTE-048Data cutoffSurvival benefitTotal populationMedian studyPembrolizumabResponse rateCarcinomaPositive scoreLigand 1Subsequent treatmentEfficacyClinical 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 Network658MO Pembrolizumab (pembro) vs standard-of-care (SOC) in previously treated recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): 6-year follow-up of KEYNOTE-040
Soulieres D, Harrington K, Le Tourneau C, Silva J, Licitra L, Ahn M, Soria A, Machiels J, Mach N, Mehra R, Burtness B, Lin J, Lerman N, Gumuscu B, Cohen E. 658MO Pembrolizumab (pembro) vs standard-of-care (SOC) in previously treated recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): 6-year follow-up of KEYNOTE-040. Annals Of Oncology 2022, 33: s843. DOI: 10.1016/j.annonc.2022.07.782.Peer-Reviewed Original Research659MO Pembrolizumab with or without chemotherapy for first-line treatment of recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): 5-year results from KEYNOTE-048
Tahara M, Greil R, Rischin D, Harrington K, Burtness B, De Castro G, Psyrri A, Brana I, Neupane P, Bratland Å, Fuereder T, Hughes B, Nin R, Ngamphaiboon N, Rordorf T, Ishak W, Lin J, Gumuscu B, Lerman N, Soulieres D. 659MO Pembrolizumab with or without chemotherapy for first-line treatment of recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): 5-year results from KEYNOTE-048. Annals Of Oncology 2022, 33: s844. DOI: 10.1016/j.annonc.2022.07.783.Peer-Reviewed Original ResearchLBA5 Primary results of the phase III KEYNOTE-412 study: Pembrolizumab (pembro) with chemoradiation therapy (CRT) vs placebo plus CRT for locally advanced (LA) head and neck squamous cell carcinoma (HNSCC)
Machiels J, Tao Y, Burtness B, Tahara M, Rischin D, Alves G, Lima I, Hughes B, Pointreau Y, Aksoy S, Laban S, Greil R, Burian M, Hetnal M, Licitra L, Swaby R, Zhang Y, Gumuscu B, Bidadi B, Siu L. LBA5 Primary results of the phase III KEYNOTE-412 study: Pembrolizumab (pembro) with chemoradiation therapy (CRT) vs placebo plus CRT for locally advanced (LA) head and neck squamous cell carcinoma (HNSCC). Annals Of Oncology 2022, 33: s1399. DOI: 10.1016/j.annonc.2022.08.029.Peer-Reviewed Original ResearchCurrent Therapy for Metastatic Head and Neck Cancer: Evidence, Opportunities, and Challenges.
Wise-Draper TM, Bahig H, Tonneau M, Karivedu V, Burtness B. Current Therapy for Metastatic Head and Neck Cancer: Evidence, Opportunities, and Challenges. American Society Of Clinical Oncology Educational Book 2022, 42: 1-14. PMID: 35486888, DOI: 10.1200/edbk_350442.Peer-Reviewed Original ResearchConceptsNeck squamous cell carcinomaSquamous cell carcinomaMetastatic headCell carcinomaSystemic therapyFirst-line systemic therapyFirst-line immunotherapyInclusion of chemotherapyImmune checkpoint blockadeNew systemic therapiesNumber of patientsAggressive local managementCombination immunotherapyLocoregional therapyOligometastatic diseaseCheckpoint blockadeNovel immunotherapiesPD-L1Lung metastasesRetrospective studyBiomarker subgroupsCurrent therapiesNeck cancerAblative approachesAntiangiogenic agentsPredictive Molecular Biomarkers for HPV-Associated Head and Neck Squamous Cell Carcinoma
Yarbrough W, Schrank T, Blumberg J, Patel S, Hackman T, Lumley C, Burtness B, Issaeva N. Predictive Molecular Biomarkers for HPV-Associated Head and Neck Squamous Cell Carcinoma. International Journal Of Radiation Oncology • Biology • Physics 2022, 112: e17-e18. DOI: 10.1016/j.ijrobp.2021.12.178.Peer-Reviewed Original ResearchNeck squamous cell carcinomaSquamous cell carcinomaNF-kB activityGene expression classifierCell carcinomaPatient outcomesPrognostic biomarkerNF-kBNF-kB pathway genesBetter recurrence-free survivalGoal of physiciansHPV-Associated HeadProgression-free survivalRecurrence-free survivalHigh cure ratesTCGA dataIndependent patient cohortsPredictive molecular biomarkersNF-kB target genesQuality of lifeExpression classifierHNSCC survivorsInduction chemotherapyOPSCC tumorsConcurrent chemoradiation
2021
P-88 First-Line Pembrolizumab With or Without Lenvatinib in Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC): Phase 3 LEAP-010 Study
Harrington K, Siu L, Burtness B, Cohen E, Licitra L, Rischin D, Zhu Y, Okpara C, Pinheiro C, Swaby R, Machiels J, Tahara M. P-88 First-Line Pembrolizumab With or Without Lenvatinib in Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC): Phase 3 LEAP-010 Study. Oral Oncology 2021, 118: 7-8. DOI: 10.1016/s1368-8375(21)00375-4.Peer-Reviewed Original Research