2022
Trilynx: 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
2020
Quality of Life With Pembrolizumab for Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma: KEYNOTE-040
Harrington KJ, Soulières D, Le Tourneau C, Dinis J, Licitra LF, Ahn MJ, Soria A, Machiels JH, Mach N, Mehra R, Burtness B, Ellison MC, Cheng JD, Chirovsky DR, Swaby RF, Cohen EEW. Quality of Life With Pembrolizumab for Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma: KEYNOTE-040. Journal Of The National Cancer Institute 2020, 113: 171-181. PMID: 32407532, PMCID: PMC7850527, DOI: 10.1093/jnci/djaa063.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCetuximabDisease-Free SurvivalDocetaxelHumansMaleMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalPatient Reported Outcome MeasuresQuality of LifeSquamous Cell Carcinoma of Head and NeckConceptsGHS/QoL scoresStandard of careNeck squamous cell carcinomaGlobal health statusSquamous cell carcinomaQOL scoresWeek 15KEYNOTE-040Metastatic HNSCCCell carcinomaNeck cancer-specific modulePlatinum-containing regimenHealth-related qualityCancer-specific moduleQuality of lifeHRQoL benefitsHRQoL populationMetastatic headHRQoL analysisMedian timeLife HeadPembrolizumabPatientsHealth statusEuropean Organization
2019
Afatinib vs Placebo as Adjuvant Therapy After Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck
Burtness B, Haddad R, Dinis J, Trigo J, Yokota T, de Souza Viana L, Romanov I, Vermorken J, Bourhis J, Tahara M, Segalla J, Psyrri A, Vasilevskaya I, Nangia CS, Chaves-Conde M, Kiyota N, Homma A, Holeckova P, Del Campo JM, Asarawala N, Nicolau UR, Rauch D, Even C, Wang B, Gibson N, Ehrnrooth E, Harrington K, Cohen EEW. Afatinib vs Placebo as Adjuvant Therapy After Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck. JAMA Oncology 2019, 5: 1170-1180. PMID: 31194247, PMCID: PMC6567846, DOI: 10.1001/jamaoncol.2019.1146.Peer-Reviewed Original ResearchDisease-free survivalAdverse eventsEastern Cooperative Oncology Group performance statusMedian disease-free survivalDrug-related adverse effectsEnd pointNeck squamous cell cancerIndependent data monitoring committeeErbB family blocker afatinibCommon grade 3More adverse eventsPrimary end pointSecondary end pointsUnacceptable adverse eventsDate of randomizationHealth-related qualitySquamous cell cancerRisk of recurrenceSquamous cell carcinomaSecondary primary tumorsInterim futility analysisData monitoring committeeAcneiform rashAfatinib groupDefinitive chemoradiotherapy
2018
Health-related quality of life (HRQoL) of pembrolizumab (pembro) vs standard of care (SOC) for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) in KEYNOTE-040.
Cohen E, Soulieres D, Le Tourneau C, Dinis J, Licitra L, Ahn M, Soria A, Machiels J, Mach N, Mehra R, Burtness B, Ellison M, Cheng J, Chirovsky D, Swaby R, Harrington K. Health-related quality of life (HRQoL) of pembrolizumab (pembro) vs standard of care (SOC) for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) in KEYNOTE-040. Journal Of Clinical Oncology 2018, 36: 6013-6013. DOI: 10.1200/jco.2018.36.15_suppl.6013.Peer-Reviewed Original Research
2012
LUX head and neck 2: A randomized, double-blind, placebo-controlled, phase III study of afatinib as adjuvant therapy after chemoradiation in primarily unresected, clinically high-risk, head and neck cancer patients.
Burtness B, Bourhis J, Vermorken J, Dai L, Lind C, Ehrnrooth E, Cohen E. LUX head and neck 2: A randomized, double-blind, placebo-controlled, phase III study of afatinib as adjuvant therapy after chemoradiation in primarily unresected, clinically high-risk, head and neck cancer patients. Journal Of Clinical Oncology 2012, 30: tps5599-tps5599. DOI: 10.1200/jco.2012.30.15_suppl.tps5599.Peer-Reviewed Original ResearchDisease-free survivalNeck dissectionPO QDAdvanced squamous cell cancerIrreversible ErbB family blockerAdequate bone marrowErbB family blockerStudy of afatinibSubsequent neck dissectionCompletion of chemoradiationEvidence of diseaseHigh-risk patientsSecond primary tumorsHealth-related qualityBase of tongueSquamous cell cancerRisk of recurrenceNeck cancer patientsPlatinum-based chemoradiationSalivary gland cancerConcurrent cisplatinCurative intentDefinitive chemoradiationPrior therapyStudy medication