2024
HERTHENA-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 subtypeLenvatinib ± 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 arm
2022
A new prognostic model in patients with recurrent or metastatic head and neck cancer treated with chemotherapy: An analysis of ECOG-ACRIN E1305.
Argiris A, Flamand Y, Savvides P, Johnson J, Li S, Forastiere A, Burtness B. A new prognostic model in patients with recurrent or metastatic head and neck cancer treated with chemotherapy: An analysis of ECOG-ACRIN E1305. Journal Of Clinical Oncology 2022, 40: 6026-6026. DOI: 10.1200/jco.2022.40.16_suppl.6026.Peer-Reviewed Original ResearchOverall survivalFirst-line treatmentMedian OSPrognostic factorsHazard ratioBone/liver metastasesRM-SCCHNFirst-lineFirst-line treatment of patientsMultivariate modelMetastatic squamous cell carcinomaPhase III randomized trialRisk factorsCancer treated with chemotherapyPlatinum-based chemotherapyECOG performance statusCooperative group trialsSquamous cell carcinomaHead and neckTumor cell differentiationTreatment of patientsPrognostic scoring modelCox proportional hazards modelsProportional hazards modelPrior radiationTrilynx: A Phase 3 Trial of Xevinapant and Concurrent Chemoradiotherapy (CRT) for Locally Advanced Head and Neck Cancer
Schoenfeld J, Cohen E, Nutting C, Licitra L, Burtness B, Omar M, Bouisset F, Nauwelaerts H, Urfer Y, Zanna C, Bourhis J. Trilynx: A Phase 3 Trial of Xevinapant and Concurrent Chemoradiotherapy (CRT) for Locally Advanced Head and Neck Cancer. International Journal Of Radiation Oncology • Biology • Physics 2022, 112: e20-e21. DOI: 10.1016/j.ijrobp.2021.12.046.Peer-Reviewed Original ResearchProgression-free survivalConcurrent CRTConcurrent chemoradiotherapyEvent-free survivalOverall survivalEFS eventsLA-SCCHNAdvanced squamous cell carcinomaRandomized phase 2 studyDefinitive concurrent chemoradiotherapyECOG PS 0T cell-dependent pathwayLocoregional control rateObjective response ratePhase 2 studyPhase 3 trialPlatinum-based chemotherapyHealth-related qualitySquamous cell carcinomaStandard concurrent chemoradiotherapyBiomarkers of responseStandard of careThree-year followIntensity-modulated radiotherapyExposure-response relationship
2021
TrilynX: A phase 3 trial of xevinapant and concurrent chemoradiation for locally advanced head and neck cancer.
Bourhis J, Burtness B, Licitra L, Nutting C, Schoenfeld J, Sarkouh R, Bouisset F, Nauwelaerts H, Urfer Y, Zanna C, Cohen E. TrilynX: A phase 3 trial of xevinapant and concurrent chemoradiation for locally advanced head and neck cancer. Journal Of Clinical Oncology 2021, 39: tps6091-tps6091. DOI: 10.1200/jco.2021.39.15_suppl.tps6091.Peer-Reviewed Original ResearchEvent-free survivalEFS eventsConcurrent chemoradiationAdvanced squamous cell carcinomaRandomized phase 2 studyECOG PS 0T cell-dependent pathwayLocoregional control ratePhase 2 studyPhase 3 trialPlatinum-based chemotherapySquamous cell carcinomaBiomarkers of responseStandard of careThree-year followIntensity-modulated radiotherapyExposure-response relationship× ULNBackbone therapyDefinitive chemoradiationEligible patientsLA-SCCHNMonotherapy periodX ULNConcurrent chemoradiotherapyChemotherapy and radiotherapy in locally advanced head and neck cancer: an individual patient data network meta-analysis
Petit C, Lacas B, Pignon J, Le Q, Grégoire V, Grau C, Hackshaw A, Zackrisson B, Parmar M, Lee J, Ghi M, Sanguineti G, Temam S, Cheugoua-Zanetsie M, O'Sullivan B, Posner M, Vokes E, Hernandez J, Szutkowski Z, Lartigau E, Budach V, Suwiński R, Poulsen M, Kumar S, Laskar S, Mazeron J, Jeremic B, Simes J, Zhong L, Overgaard J, Fortpied C, Torres-Saavedra P, Bourhis J, Aupérin A, Blanchard P, Groups M, Adelstein D, Agarwal J, Alfonsi M, Argiris A, Aupérin A, Bacigalupo A, Bar-Ad V, Bartelink H, Beadle B, Belkacemi Y, Bensadoun R, Bernier J, Blanchard P, Bourhis J, Bratland Å, Brizel D, Budach V, Budach W, Burtness B, Calais G, Campbell B, Caudell J, Chabaud S, Chamorey E, Chaukar D, Cheugoua-Zanetsie M, Cho K, Choussy O, Hernandez J, Denham J, Dobrowsky W, Dominello M, Driessen C, Fallai C, Forastiere A, Fortpied C, Fountzilas G, Garaud P, Garden A, Gery B, Ghadjar P, Ghi M, Laskar S, Graff-Cailleaud P, Grau C, Gregoire V, Hackshaw A, Haddad E, Haffty B, Hansen A, Hay J, Hayoz S, Horiot J, Hitt R, Jeremic B, Johansen J, Jones C, Julieron M, Kristensen C, Kumar S, Lacas B, Langendijk J, Lapeyre M, Lartigau E, Licitra L, Le Q, Lee J, Lee P, Lewin F, Li Y, Lopes A, Lotayef M, Maciejewski B, Mazeron J, Mehta S, Michalski W, Moon J, Moon S, Moyal E, Nankivell M, Nilsson P, Olmi P, Orecchia R, O'Sullivan B, Overgaard J, Parmar M, Petit C, Pignon J, Pointreau Y, Posner M, Poulsen M, Quon H, Racadot S, Rosenthal D, Rovea P, Redda M, Sanguineti G, Shenouda G, Simes J, Sharma A, Simon C, Sire C, Skladowski K, Spencer S, Staar S, Strojan P, Stromberger C, Suwinski R, Szutkowski Z, Takácsi-Nagy Z, Tao Y, Temam S, Thomson D, Tobias J, Torres-Saavedra P, Torri V, Tripcony L, Trotti A, Tseroni V, van Herpen C, van Tinteren H, Vermorken J, Viegas C, Vokes E, Waldron J, Wernecke K, Widder J, Wolf G, Wong S, Wu J, Yamazaki H, Zaktonik B, Zackrisson B, Zhong L. Chemotherapy and radiotherapy in locally advanced head and neck cancer: an individual patient data network meta-analysis. The Lancet Oncology 2021, 22: 727-736. PMID: 33862002, DOI: 10.1016/s1470-2045(21)00076-0.Peer-Reviewed Original ResearchConceptsOverall survivalLocoregional therapyAdvanced headNeck cancerConcomitant chemotherapyConcomitant chemoradiotherapyIndividual patient data networkNeck squamous cell cancerAltered fractionation radiotherapyNon-metastatic headRole of chemotherapyPlatinum-based chemotherapySquamous cell cancerModalities of treatmentLog-rank testIndividual patient dataCochran's Q statisticInstitut National du CancerP scoreInduction chemotherapyFractionation radiotherapyPrimary endpointHazard ratioHyperfractionated radiotherapySurvival benefit
2020
351 Pembrolizumab plus lenvatinib vs chemotherapy and lenvatinib monotherapy for recurrent/metastatic head and neck squamous cell carcinoma that progressed on platinum therapy and immunotherapy: LEAP-009
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. 351 Pembrolizumab plus lenvatinib vs chemotherapy and lenvatinib monotherapy for recurrent/metastatic head and neck squamous cell carcinoma that progressed on platinum therapy and immunotherapy: LEAP-009. Journal For ImmunoTherapy Of Cancer 2020, 8: a376-a376. DOI: 10.1136/jitc-2020-sitc2020.0351.Peer-Reviewed Original ResearchPlatinum-based chemotherapyRecurrent/metastatic headNeck squamous cell carcinomaECOG performance statusSquamous cell carcinomaDisease progressionLenvatinib monotherapyM HNSCCCell carcinomaRECIST v1.1SOC chemotherapyMetastatic headMonotherapy armPerformance statusTreatment optionsPhase Ib/II trialStandard first-line treatment optionPD-L1 tumor proportion scoreFirst-line treatment optionAdvanced renal cell carcinomaJ Clin OncolSafety of pembrolizumabPD-1 inhibitorsPlatinum-containing chemotherapyAdvanced solid tumors
2019
Phase III Randomized Trial of Chemotherapy With or Without Bevacizumab in Patients With Recurrent or Metastatic Head and Neck Cancer.
Argiris A, Li S, Savvides P, Ohr JP, Gilbert J, Levine MA, Chakravarti A, Haigentz M, Saba NF, Ikpeazu CV, Schneider CJ, Pinto HA, Forastiere AA, Burtness B. Phase III Randomized Trial of Chemotherapy With or Without Bevacizumab in Patients With Recurrent or Metastatic Head and Neck Cancer. Journal Of Clinical Oncology 2019, 37: 3266-3274. PMID: 31618129, PMCID: PMC6980834, DOI: 10.1200/jco.19.00555.Peer-Reviewed Original ResearchMeSH KeywordsAgedAntineoplastic Agents, ImmunologicalAntineoplastic Combined Chemotherapy ProtocolsBevacizumabDisease ProgressionDrug Administration ScheduleFemaleHead and Neck NeoplasmsHumansMaleNeoplasm Recurrence, LocalProgression-Free SurvivalSquamous Cell Carcinoma of Head and NeckTime FactorsUnited StatesConceptsAddition of bevacizumabProgression-free survivalOverall survivalResponse rateMedian progression-free survivalMetastatic squamous cell carcinomaPlatinum-based chemotherapy doubletsTreatment-related grade 3Phase III randomized trialsTreatment-related deathsMedian overall survivalPlatinum-based chemotherapySquamous cell carcinomaBetter toxicity profileBiomarker-driven studiesOverall response rateHumanized monoclonal antibodyVascular endothelial growth factorEndothelial growth factorChemotherapy doubletsMedian OSMetastatic SCCHNOS ratesEligible patientsMetastatic head
2012
Multi-Modality Therapy for Cancer of the Esophagus and GE Junction
Tejani MA, Burtness BA. Multi-Modality Therapy for Cancer of the Esophagus and GE Junction. Current Treatment Options In Oncology 2012, 13: 390-402. PMID: 22592595, DOI: 10.1007/s11864-012-0193-5.Peer-Reviewed Original ResearchConceptsGastroesophageal junctionNeoadjuvant platinum-based chemotherapyPostoperative adjuvant chemotherapyPlatinum-based chemotherapyIncidence of adenocarcinomaSubgroup of patientsHigh mortality rateAdjuvant chemotherapyOpinion statementCancersInduction chemotherapyNeoadjuvant treatmentPreoperative chemoradiationDistant recurrenceModality therapySystemic therapyDistal esophagusAdvanced tumorsPredictive biomarkersMortality rateTherapeutic outcomesChemotherapyEsophagusTherapyTherapy deliveryChemoradiation