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-L1A randomized phase 2 trial of the IO102-IO103 (IDO and PD-L1) cancer vaccine plus pembrolizumab as neoadjuvant/adjuvant treatment of patients with solid tumors.
Long G, Haddad R, Robert C, Mortier L, Schadendorf D, Uppaluri R, Svane I, Saiag P, Lim A, Soria Rivas A, Scolyer R, Chaney M, Abildgaard C, Ahmad Q, Ringeisen F, McDowell D, Burtness B. A randomized phase 2 trial of the IO102-IO103 (IDO and PD-L1) cancer vaccine plus pembrolizumab as neoadjuvant/adjuvant treatment of patients with solid tumors. Journal Of Clinical Oncology 2024, 42: tps2701-tps2701. DOI: 10.1200/jco.2024.42.16_suppl.tps2701.Peer-Reviewed Original ResearchEvent-free survivalAdjuvant pembrolizumabNeoadjuvant pembrolizumabCancer vaccinesAdjuvant treatmentCohort CCohort APD-L1-positive cellsRandomized phase 2 trialExpansion of T cellsPost-treatment tumor tissuesPotential anti-tumor activityImmune checkpoint inhibitorsResponse to pembrolizumabLocally advanced diseasePathologic tumor responseTherapeutic cancer vaccinesImmune-suppressive cellsPhase 1/2 trialDisease-free survivalNeo-adjuvant treatmentPhase 2 trialTreatment of multiple tumor typesSquamous cell carcinomaHead and neckIdentifying Opportunities to Deliver High‐Quality Cancer Care Across a Health System: A Clinical Responsibility
Shah H, Cohen O, Bourdillon A, Burtness B, Boffa D, Young M, Judson B, Mehra S. Identifying Opportunities to Deliver High‐Quality Cancer Care Across a Health System: A Clinical Responsibility. Otolaryngology 2024, 171: 445-456. PMID: 38606669, DOI: 10.1002/ohn.755.Peer-Reviewed Original ResearchOral squamous cell carcinomaHealth systemCancer careLymph node yieldDeliver high-quality cancer careHigh-quality cancer careBaseline quality of careReporting of Observational StudiesFragmentation of careQuality of careFacility typeCommunity facilitiesOdds of positive surgical marginsAssociated with increased oddsPositive surgical margin rateCombination groupAcademic centersPositive surgical marginsTreating facility typeSurgical margin ratePrimary outcome measureSquamous cell carcinomaGuideline-adherent treatmentCombined careEpidemiology guidelinesHealth-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 populationLenvatinib ± Pembrolizumab Versus Chemotherapy for Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) That Progressed after Platinum and Immunotherapy: The Phase 2 LEAP-009 Study
Harrington K, Kim H, Salas S, Oliva M, Metcalf R, Bernsdorf M, Kim J, Cohen E, Siu L, Rischin D, Licitra L, Vermorken J, Le Q, Tahara M, Machiels J, O'Hara K, Pathiraja K, Gumuscu B, Bidadi B, Burtness B. Lenvatinib ± Pembrolizumab Versus Chemotherapy for Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) That Progressed after Platinum and Immunotherapy: The Phase 2 LEAP-009 Study. International Journal Of Radiation Oncology • Biology • Physics 2024, 118: e42. DOI: 10.1016/j.ijrobp.2024.01.095.Peer-Reviewed Original ResearchR/M HNSCCHead and neck squamous cell carcinomaPD-1/L1 inhibitorsPlatinum-based therapyPlatinum-based chemotherapyDisease progressionLenvatinib monotherapyECOG PSRecurrent/metastatic (R/M) head and neck squamous cell carcinomaPD-L1 tumor proportion scoreStandard-of-care chemotherapyNeck squamous cell carcinomaTumor proportion scoreProgression-free survivalDuration of responseEfficacy of lenvatinibSecondary end pointsFirst-line treatmentSquamous cell carcinomaEfficacious treatment optionStandard of careOral lenvatinibPembrolizumab monotherapyRECIST v1.1Monotherapy armImpact 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 ResearchDigital spatial profiling links beta-2-microglobulin expression with immune checkpoint blockade outcomes in head and neck squamous cell carcinoma
Gavrielatou N, Vathiotis I, Aung T, Shafi S, Burela S, Fernandez A, Moutafi M, Burtness B, Economopoulou P, Anastasiou M, Foukas P, Psyrri A, Rimm D. Digital spatial profiling links beta-2-microglobulin expression with immune checkpoint blockade outcomes in head and neck squamous cell carcinoma. Cancer Research Communications 2023, 3: 558-563. PMID: 37057033, PMCID: PMC10088911, DOI: 10.1158/2767-9764.crc-22-0299.Peer-Reviewed Original ResearchConceptsDigital spatial profilingB2M expressionOverall survivalM HNSCCImmunotherapy outcomesNeck squamous cell carcinoma (HNSCC) treatmentHigh beta-2 microglobulinSquamous cell carcinoma treatmentCell death protein 1Neck squamous cell carcinomaM expressionPretreatment biopsy samplesImmune checkpoint inhibitorsPD-L1 expressionImmune checkpoint markersDeath protein 1Squamous cell carcinomaB2MBeta-2-microglobulinBeta 2 microglobulin expressionImproved PFSCheckpoint inhibitorsMetastatic headCheckpoint markersImproved survivalRandomized 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 HNSCCTreating Head and Neck Cancer in the Age of Immunotherapy: A 2023 Update
Bhatia A, Burtness B. Treating Head and Neck Cancer in the Age of Immunotherapy: A 2023 Update. Drugs 2023, 83: 217-248. PMID: 36645621, DOI: 10.1007/s40265-023-01835-2.Commentaries, Editorials and LettersConceptsNeck cancerRecurrent/metastatic settingImmune checkpoint inhibitor nivolumabNeck squamous cell carcinomaAge of immunotherapyLate stage HNSCCImmune checkpoint inhibitionPlatinum-containing chemotherapyFirst-line treatmentGrowth factor receptor overexpressionCheckpoint inhibitor nivolumabSquamous cell carcinomaEpidermal growth factor receptor (EGFR) overexpressionPathogenesis of HNSCCTreatment of patientsTreatment of HNSCCManagement of headMonoclonal antibody cetuximabCurative intentPalliative chemotherapyAdvanced diseaseInhibitor nivolumabLocoregional failureMetastatic settingMultimodality therapy
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 Research