2024
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
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
Phase 2 LEAP-009: Lenvatinib (Lenva) With or Without Pembrolizumab (Pembro) vs. Chemotherapy (Chemo) for Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) That has Progressed on Platinum and Immunotherapy
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. Phase 2 LEAP-009: Lenvatinib (Lenva) With or Without Pembrolizumab (Pembro) vs. Chemotherapy (Chemo) for Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) That has Progressed on Platinum and Immunotherapy. International Journal Of Radiation Oncology • Biology • Physics 2022, 112: e43-e44. DOI: 10.1016/j.ijrobp.2021.12.101.Peer-Reviewed Original ResearchPD-1/PD-L1 inhibitorsECOG performance statusPD-L1 inhibitorsM HNSCCDisease progressionRECIST v1.1Monotherapy armPerformance statusPO QDPD-L1 tumor proportion scoreOptimal second-line regimenEnd pointNeck squamous cell carcinomaPrimary end pointSecond-line regimenSecondary end pointsFirst-line treatmentTumor proportion scoreKey eligibility criteriaSquamous cell carcinomaInterim futility analysisMeasurable diseaseSOC chemotherapyMetastatic headUnacceptable toxicity
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 tumorsPhase III LEAP-010 study: first-line pembrolizumab with or without lenvatinib in 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, Lee C, Pinheiro C, Swaby R, Machiels J, Tahara M. Phase III LEAP-010 study: first-line pembrolizumab with or without lenvatinib in recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Journal Of Clinical Oncology 2020, 38: tps6589-tps6589. DOI: 10.1200/jco.2020.38.15_suppl.tps6589.Peer-Reviewed Original ResearchBlinded independent central reviewCombined positive scoreFirst-line pembrolizumabM HNSCCDisease progressionRECIST v1.1PD-L1PD-L1 combined positive scoreECOG performance status 0PD-1 inhibitor pembrolizumabRecurrent/metastatic headEnd pointNeck squamous cell carcinomaCycles of pembrolizumabFirst-line monotherapyPerformance status 0Phase 1b/2 trialManageable safety profileObjective response ratePrimary end pointSecondary end pointsHuman papillomavirus (HPV) statusPD-L1 statusPhase 3 studyProgression-free survival
2019
Hyperprogression after one dose of nivolumab in sinonasal cancer: A case report
Xiang JJ, Uy NF, Minja FJ, Verter EE, Burtness BA. Hyperprogression after one dose of nivolumab in sinonasal cancer: A case report. The Laryngoscope 2019, 130: 907-910. PMID: 31058321, DOI: 10.1002/lary.28042.Peer-Reviewed Original ResearchConceptsImmune checkpoint inhibitorsDose of nivolumabSquamous cell carcinomaSinonasal cancerCell carcinomaDisease progressionMaxillary sinus squamous cell carcinomaSinus squamous cell carcinomaNeck squamous cell carcinomaComplete vision lossICI initiationCheckpoint inhibitorsFirst doseLytic metastasesDistal metastasisCase reportIntracranial invasionVision lossImproved outcomesHyperprogressionIndividual riskDoseNivolumabCarcinomaMetastasis
2014
Induction cetuximab, paclitaxel, and carboplatin followed by chemoradiation with cetuximab, paclitaxel, and carboplatin for stage III/IV head and neck squamous cancer: a phase II ECOG-ACRIN trial (E2303)
Wanebo HJ, Lee J, Burtness BA, Ridge JA, Ghebremichael M, Spencer SA, Psyrri D, Pectasides E, Rimm D, Rosen FR, Hancock MR, Tolba KA, Forastiere AA. Induction cetuximab, paclitaxel, and carboplatin followed by chemoradiation with cetuximab, paclitaxel, and carboplatin for stage III/IV head and neck squamous cancer: a phase II ECOG-ACRIN trial (E2303). Annals Of Oncology 2014, 25: 2036-2041. PMID: 25009013, PMCID: PMC4176450, DOI: 10.1093/annonc/mdu248.Peer-Reviewed Original ResearchConceptsEvent-free survivalStage III/IV headResponse/survivalInduction therapyComplete responseStage III/IV HNSCCNeck squamous cell carcinomaPrimary site biopsiesTreatment-related deathsPathologic complete responseNeck squamous cancerSquamous cell carcinomaProtein expression statusEligible patientsSite biopsiesOverall survivalCell carcinomaPromising survivalSquamous cancerDisease progressionChemoradiationRadiation therapyPatientsWeek 9Cetuximab
2013
Extranodal Extension of Metastatic Papillary Thyroid Carcinoma: Correlation with Biochemical Endpoints, Nodal Persistence, and Systemic Disease Progression
Lango M, Flieder D, Arrangoiz R, Veloski C, Yu JQ, Li T, Burtness B, Mehra R, Galloway T, Ridge JA. Extranodal Extension of Metastatic Papillary Thyroid Carcinoma: Correlation with Biochemical Endpoints, Nodal Persistence, and Systemic Disease Progression. Thyroid 2013, 23: 1099-1105. PMID: 23421588, PMCID: PMC3770240, DOI: 10.1089/thy.2013.0027.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAutoantibodiesBiomarkersCarcinomaCarcinoma, PapillaryDisease ProgressionFemaleHumansKaplan-Meier EstimateLogistic ModelsLymph NodesLymphatic MetastasisMaleMiddle AgedMultivariate AnalysisNeck DissectionNeoplasm Recurrence, LocalNeoplasm StagingOdds RatioPhiladelphiaProportional Hazards ModelsRadiotherapy, AdjuvantReoperationRetrospective StudiesRisk FactorsThyroglobulinThyroid Cancer, PapillaryThyroid NeoplasmsThyroidectomyTime FactorsTreatment OutcomeYoung AdultConceptsComplete biochemical responseMetastatic papillary thyroid carcinomaSystemic disease progressionPapillary thyroid carcinomaExtranodal extensionDisease progressionRAI administrationUntreated patientsNeck dissectionTumor persistenceT4 classificationThyroid carcinomaLong-term clinical outcomesPresence of ENECenter cohort studyGross residual diseaseRadioactive iodine treatmentTherapeutic neck dissectionAnti-thyroglobulin antibodiesRecurrence/persistenceNational Cancer InstituteSuspicious imagingDistant diseaseNodal diseasePrior surgeryPhase III Randomized, Placebo-Controlled Trial of Docetaxel With or Without Gefitinib in Recurrent or Metastatic Head and Neck Cancer: An Eastern Cooperative Oncology Group Trial
Argiris A, Ghebremichael M, Gilbert J, Lee JW, Sachidanandam K, Kolesar JM, Burtness B, Forastiere AA. Phase III Randomized, Placebo-Controlled Trial of Docetaxel With or Without Gefitinib in Recurrent or Metastatic Head and Neck Cancer: An Eastern Cooperative Oncology Group Trial. Journal Of Clinical Oncology 2013, 31: 1405-1414. PMID: 23460714, PMCID: PMC3612594, DOI: 10.1200/jco.2012.45.4272.Peer-Reviewed Original ResearchMeSH KeywordsAdultAge FactorsAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Squamous CellDiarrheaDocetaxelDrug Administration ScheduleErbB ReceptorsFatigueFemaleGefitinibGenotypeHead and Neck NeoplasmsHumansKaplan-Meier EstimateLeukopeniaMaleMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalProto-Oncogene ProteinsProto-Oncogene Proteins c-metProto-Oncogene Proteins p21(ras)QuinazolinesRas ProteinsTaxoidsTreatment OutcomeConceptsAddition of gefitinibPerformance statusArm ADisease progressionEastern Cooperative Oncology Group performance statusEastern Cooperative Oncology Group trialEpidermal growth factor receptor tyrosine kinase inhibitorsGrowth factor receptor tyrosine kinase inhibitorsReceptor tyrosine kinase inhibitorsGrade 3/4 diarrheaPhase III randomizedSingle-agent gefitinibTrials of docetaxelUnplanned subset analysisECOG performance statusGrade 3/4 toxicitiesMedian overall survivalTime of progressionSquamous cell carcinomaTyrosine kinase inhibitorsEligible patientsMetastatic SCCHNWeekly docetaxelMetastatic headOverall survival
2000
Phase I studies of anti-epidermal growth factor receptor chimeric antibody C225 alone and in combination with cisplatin.
Baselga J, Pfister D, Cooper MR, Cohen R, Burtness B, Bos M, D’Andrea G, Seidman A, Norton L, Gunnett K, Falcey J, Anderson V, Waksal H, Mendelsohn J. Phase I studies of anti-epidermal growth factor receptor chimeric antibody C225 alone and in combination with cisplatin. Journal Of Clinical Oncology 2000, 18: 904-14. PMID: 10673534, DOI: 10.1200/jco.2000.18.4.904.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsArea Under CurveCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellCetuximabCisplatinDose-Response Relationship, DrugDrug Administration ScheduleErbB ReceptorsFemaleGene Expression Regulation, NeoplasticHead and Neck NeoplasmsHumansInfusions, IntravenousLung NeoplasmsMaleNeoplasms, Glandular and EpithelialRecombinant Fusion ProteinsRemission InductionSafetyConceptsAntibody dosesMultiple doseSystemic clearancePhase I clinical trialWeeks of therapyDose-dependent pharmacokineticsCell lung cancerChimeric monoclonal antibodyCoadministration of cisplatinEpidermal growth factor receptorMurine chimeric monoclonal antibodyGrowth factor receptorDisease stabilizationPartial responseAdvanced tumorsSingle doseLung cancerClinical trialsDisease progressionEpithelial tumorsNonlinear pharmacokineticsPatientsDose levelsAntibody C225Relevant doses