2024
649 A phase 1 dose-escalation and expansion study of CUE-101 as monotherapy and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck squamous cell cancer
Chung C, Dimitrios Colevas A, Adkins D, Rodriguez C, Park J, Gibson M, Sukari A, Worden F, Johnson F, Saba N, Burtness B, Julian R, Bauman J, Jotte R, Seiwert T, Dunn L, Chaney M, Agensky L, Goel A, Levisetti M, Margossian S, Quayle S, Pai S. 649 A phase 1 dose-escalation and expansion study of CUE-101 as monotherapy and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck squamous cell cancer. 2024, a745-a745. DOI: 10.1136/jitc-2024-sitc2024.0649.Peer-Reviewed Original ResearchEvaluation of a Novel Prognostic System for Overall Survival in Surgically Resected Oral Cavity Carcinoma
Husain Z, Rybkin A, Lee V, Young M, Eskander A, Burtness B, Park H. Evaluation of a Novel Prognostic System for Overall Survival in Surgically Resected Oral Cavity Carcinoma. International Journal Of Radiation Oncology • Biology • Physics 2024, 120: e759-e760. DOI: 10.1016/j.ijrobp.2024.07.1668.Peer-Reviewed Original ResearchLymphovascular space invasionOral cavity carcinomaOverall survivalIntermediate-riskHigh riskT3/4 diseaseDistant metastasisN stageStandard riskPrediction of distant metastasisGrade 3 tumorsMedian follow-upNational Cancer DatabasePathological risk factorsOral cavity cancerKaplan-Meier methodLog-rank testSubsets of patientsHospital-based cohortClinical trial stratificationHigh-volume hospitalsT3/4 tumorsMedian followSurgical resectionIndividualized treatment selection850MO Phase II randomized trial of chemotherapy followed by surgery and PORT versus surgery and PORT for organ preservation of T3 and T4a (selected T4b) sinonasal squamous cell carcinoma (SNC): A trial of the ECOG-ACRIN cancer research group (EA3163)
Saba N, Flamand Y, Lin D, Chung C, McDonald M, Flampouri S, Khan S, Snyderman C, Hanna E, El-Sayed Y, Solares C, Duan F, Ho A, Samuels M, Swiecicki P, Subramaniam R, Chakravarthy A, Burtness B. 850MO Phase II randomized trial of chemotherapy followed by surgery and PORT versus surgery and PORT for organ preservation of T3 and T4a (selected T4b) sinonasal squamous cell carcinoma (SNC): A trial of the ECOG-ACRIN cancer research group (EA3163). Annals Of Oncology 2024, 35: s614. DOI: 10.1016/j.annonc.2024.08.911.Peer-Reviewed Original Research690TiP HERTHENA-PanTumor01: A global phase II trial of HER3-DXd in metastatic solid tumors
Powles T, Bhatia A, Burtness B, Kogawa T, Nishina T, Nakayama I, Fountzilas C, Castillo D, Mckean M, Meric-Bernstam F, Colombo N, Smithy J, Fayette J, Chandra S, Sternberg D, Sullivan K, Yueh S, Clinthorne G, Kudchadkar R, Hayashi H. 690TiP HERTHENA-PanTumor01: A global phase II trial of HER3-DXd in metastatic solid tumors. Annals Of Oncology 2024, 35: s534-s535. DOI: 10.1016/j.annonc.2024.08.2161.Peer-Reviewed Original Research907P 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 Research945TiP 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 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-L1Multiplexable and Scalable Aqueous Synthesis Platform for Oleate‐Based, Bilayer‐Coated Gold Nanoparticles (Small 25/2024)
Backhaus A, Albrecht J, Alzhanova G, Long A, Arnold W, Lee J, Tse H, Su T, Cruz‐Gomez S, Lee S, Menges F, Parent L, Ratjen L, Burtness B, Fortner J, Zimmerman J. Multiplexable and Scalable Aqueous Synthesis Platform for Oleate‐Based, Bilayer‐Coated Gold Nanoparticles (Small 25/2024). Small 2024, 20 DOI: 10.1002/smll.202470191.Peer-Reviewed Original ResearchCorrelative and spatial biomarker analysis of a phase 1/2b study to evaluate pepinemab in combination with pembrolizumab for first-line treatment of patients with recurrent or metastatic head and neck cancer.
Evans E, Fisher T, Mallow C, Foster A, Leonard J, Chaney M, Mekhail T, Seetharamu N, Steuer C, Saba N, Adkins D, Beck J, Algazi A, Burtness B, Baumgart M, Giampoli E, Hager S, Chay C, Spira A, Zauderer M. Correlative and spatial biomarker analysis of a phase 1/2b study to evaluate pepinemab in combination with pembrolizumab for first-line treatment of patients with recurrent or metastatic head and neck cancer. Journal Of Clinical Oncology 2024, 42: 2603-2603. DOI: 10.1200/jco.2024.42.16_suppl.2603.Peer-Reviewed Original ResearchHead and neck squamous cell carcinomaMyeloid suppressor cellsImmune checkpoint inhibitorsFirst-line treatmentDendritic cellsT cellsB cellsTumor biopsiesLymphoid structuresImmune cellsMetastatic head and neck squamous cell carcinomaActivity of immune checkpoint inhibitorsEfficacy of immune checkpoint inhibitorsSingle-arm open-label studyFirst-line treatment of patientsMetastatic head and neck cancerHead and neck squamous cell carcinoma tumorsImmune checkpoint inhibitor activationOn-treatment tumor biopsiesSuppression of adaptive immunityCD8+ T cellsNeck squamous cell carcinomaHead and neck cancerAnalysis of tumor biopsiesMechanism of immune enhancementA descriptive patient-reported outcomes (PROs) analysis of KEYNOTE-412 to understand head and neck symptom burden.
Siu L, McQuarrie K, Bidadi B, Liu C, Black C, Wang A, Tao Y, Licitra L, Burtness B, Tahara M, Rischin D, Harrington K, Machiels J. A descriptive patient-reported outcomes (PROs) analysis of KEYNOTE-412 to understand head and neck symptom burden. Journal Of Clinical Oncology 2024, 42: 11116-11116. DOI: 10.1200/jco.2024.42.16_suppl.11116.Peer-Reviewed Original ResearchPatient-reported outcomesChemoradiation therapyLA-HNSCCPain killersTumor locationSymptom burdenSolid foodTime of data cut-offPRO scoresQLQ-C30Baseline patient-reported outcomesLocally advanced headPrimary tumor locationData cut-offBaseline PRO scoresWeight lossPatient-reported outcomes analysisBaseline item scoresAssociated with high symptom burdenInvestigating pembrolizumabPatient-reported outcome dataAdvanced headHigh symptom burdenDouble-blindEvent-freeHERTHENA-PanTumor01: A global, multicohort, phase 2 trial of HER3-DXd in relapsed/refractory metastatic solid tumors.
Bhatia A, Hayashi H, Kogawa T, Nishina T, Fountzilas C, Castillo D, McKean M, Colombo N, Smithy J, Fayette J, Chandra S, Powles T, Kudchadkar R, Sternberg D, Sullivan K, Yueh S, Clinthorne G, Burtness B. HERTHENA-PanTumor01: A global, multicohort, phase 2 trial of HER3-DXd in relapsed/refractory metastatic solid tumors. Journal Of Clinical Oncology 2024, 42: tps3164-tps3164. DOI: 10.1200/jco.2024.42.16_suppl.tps3164.Peer-Reviewed Original ResearchHead and neck squamous cell cancerHuman epidermal growth factor receptor 3Platinum-based chemotherapyHER3-DXdPhase 2 trialAntibody-drug conjugatesSolid tumorsHuman anti-HER3 monoclonal antibodyAnti-HER3 monoclonal antibodyAnti-PD-(L)1 therapyGastric cancerHER2-negative gastric cancerTopoisomerase I inhibitor payloadAssociated with poor clinical outcomesEpidermal growth factor receptor 3Anti-HER3 antibodiesGastroesophageal junction cancerHER2+ cancersMetastatic solid tumorsMetastatic breast cancerSquamous cell cancerBRAF wild-typePoor clinical outcomesMultiple tumor typesAcral subtypeA phase 1 dose-escalation and expansion study of CUE-101, given as monotherapy and in combination with pembrolizumab, in patients with recurrent/metastatic HPV16+ head and neck squamous cell cancer (R/M HNSCC).
Colevas A, Chung C, Adkins D, Rodriguez C, Park J, Gibson M, Sukari A, Worden F, Johnson F, Saba N, Burtness B, Julian R, Bauman J, Jotte R, Seiwert T, Dunn L, Chaney M, Margossian S, Levisetti M, Pai S. A phase 1 dose-escalation and expansion study of CUE-101, given as monotherapy and in combination with pembrolizumab, in patients with recurrent/metastatic HPV16+ head and neck squamous cell cancer (R/M HNSCC). Journal Of Clinical Oncology 2024, 42: 6004-6004. DOI: 10.1200/jco.2024.42.16_suppl.6004.Peer-Reviewed Original ResearchCD8+ T cellsR/M HNSCCHuman leukocyte antigenT cellsMedian OSCheckpoint inhibitorsHLA-A*0201Adverse eventsInterleukin-2Combined cohortHead and neck squamous cell cancerE7-specific T cellsPhase 1 dose-escalationRecommended phase 2 doseTumor antigen-specific CD8First-in-human studyTargeted delivery of cytokinesHLA-A*0201 patientsPhase 2 doseDisease control rateGrade 3 AEsInfusion-related reactionsT-cell engagersSquamous cell cancerDelivery of cytokinesA 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 neckLong-term follow up of E3311, a phase II trial of transoral surgery (TOS) followed by pathology-based adjuvant treatment in HPV-associated (HPV+) oropharynx cancer (OPC): A trial of the ECOG-ACRIN Cancer Research Group.
Burtness B, Flamand Y, Quon H, Weinstein G, Mehra R, Garcia J, Kim S, O'malley B, Ozer E, Koch W, Gross N, Bell R, Patel M, Lango M, Morris L, Smith R, Karakla D, Richmon J, Holsinger F, Ferris R. Long-term follow up of E3311, a phase II trial of transoral surgery (TOS) followed by pathology-based adjuvant treatment in HPV-associated (HPV+) oropharynx cancer (OPC): A trial of the ECOG-ACRIN Cancer Research Group. Journal Of Clinical Oncology 2024, 42: 6009-6009. DOI: 10.1200/jco.2024.42.16_suppl.6009.Peer-Reviewed Original ResearchProgression-free survivalIntermediate risk patientsExtranodal extensionOverall survivalPhase II trialRisk patientsSmoking historyPack-yearsPrimary siteLong-term follow-upFavorable pathologic characteristicsMature outcome dataPrescribed radiation doseECOG-ACRIN Cancer Research GroupPost-operative radiationIncreased recurrence riskKaplan-Meier methodLog-rank testPost-operative managementCancer Research GroupHPV+ OPCWeekly cisplatinMedian followN1 diseaseN1 patientsIdentifying 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 guidelinesA Phase 1 Dose-escalation and Expansion Study of CUE-101, Given As Monotherapy in 3rd Line and in Combination with Pembrolizumab in 1st Line Recurrent/Metastatic (R/M) HPV16+ Head and Neck Cancer Patients
Colevas A, Chung C, Adkins D, Rodriguez C, Park J, Gibson M, Sukari A, Burtness B, Johnson F, Julian R, Saba N, Worden F, Dunn L, Seiwert T, Jotte R, Haddad R, Gabrail N, Bauman J, Margossian S, Pai S. A Phase 1 Dose-escalation and Expansion Study of CUE-101, Given As Monotherapy in 3rd Line and in Combination with Pembrolizumab in 1st Line Recurrent/Metastatic (R/M) HPV16+ Head and Neck Cancer Patients. International Journal Of Radiation Oncology • Biology • Physics 2024, 118: e87. DOI: 10.1016/j.ijrobp.2024.01.192.Peer-Reviewed Original ResearchCD8+ T cellsR/M HNSCCHuman leukocyte antigenT cellsHLA-A*0201Phase 1 dose-escalationTumor antigen-specific CD8First-in-human studyHead and neck cancer patientsTargeted delivery of cytokinesHLA-A*0201 patientsHPV16 E7 peptidesRecurrent/metastatic (R/MData cut-offInfusion-related reactionsT-cell engagersDelivery of cytokinesNeck cancer patientsTreatment of patientsPembrolizumab combinationDose escalationEscalating dosesComplete responseMaculopapular rashLeukocyte antigenHealth-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 armDe-Escalated Therapy and Early Treatment of Recurrences in HPV-Associated Head and Neck Cancer: The Potential for Biomarkers to Revolutionize Personalized Therapy
Yarbrough W, Schrank T, Burtness B, Issaeva N. De-Escalated Therapy and Early Treatment of Recurrences in HPV-Associated Head and Neck Cancer: The Potential for Biomarkers to Revolutionize Personalized Therapy. Viruses 2024, 16: 536. PMID: 38675879, PMCID: PMC11053602, DOI: 10.3390/v16040536.Peer-Reviewed Original ResearchConceptsHPV+ HNSCCHPV-associated head and neck cancerHead and neck cancerHuman papillomavirus-associatedDe-escalation therapyDetect recurrent diseaseTreatment of recurrenceHPV-associated cancersHead and neckEarly treatment of recurrencePapillomavirus-associatedDevelopment of biomarkersResponsive tumorsRecurrent diseaseStandard therapyCompanion biomarkersHPV carcinogenesisHPV vaccinationNeck cancerPoor prognosisDecrease morbidityHNSCCEarly treatmentMolecular vulnerabilitiesPersonalized therapyAn algorithm for standardization of tumor Infiltrating lymphocyte evaluation in head and neck cancers
Xirou V, Moutafi M, Bai Y, Nwe Aung T, Burela S, Liu M, Kimple R, Shabbir Ahmed F, Schultz B, Flieder D, Connolly D, Psyrri A, Burtness B, Rimm D. An algorithm for standardization of tumor Infiltrating lymphocyte evaluation in head and neck cancers. Oral Oncology 2024, 152: 106750. PMID: 38547779, PMCID: PMC11060915, DOI: 10.1016/j.oraloncology.2024.106750.Peer-Reviewed Original ResearchConceptsTumor-infiltrating lymphocytesHead and neck cancerTILs evaluationHPV-positiveNeck cancerPrognostic valueHead and neck squamous cell cancer casesTIL variablesAssociated with favorable prognosisHPV-negative headHPV-negative populationHematoxylin-eosin-stained sectionsCox regression analysisPotential clinical implicationsInter-observer variabilityInfiltrating lymphocytesClinicopathological factorsFavorable prognosisValidation cohortTumor cellsCancer casesProspective settingQuPath softwareRetrospective collectionPredictive significance