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
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 chemoradiotherapy
2014
Phase II Study of Cetuximab in Combination with Cisplatin and Radiation in Unresectable, Locally Advanced Head and Neck Squamous Cell Carcinoma: Eastern Cooperative Oncology Group Trial E3303
Egloff AM, Lee JW, Langer CJ, Quon H, Vaezi A, Grandis JR, Seethala RR, Wang L, Shin DM, Argiris A, Yang D, Mehra R, Ridge JA, Patel UA, Burtness BA, Forastiere AA. Phase II Study of Cetuximab in Combination with Cisplatin and Radiation in Unresectable, Locally Advanced Head and Neck Squamous Cell Carcinoma: Eastern Cooperative Oncology Group Trial E3303. Clinical Cancer Research 2014, 20: 5041-5051. PMID: 25107914, PMCID: PMC4184913, DOI: 10.1158/1078-0432.ccr-14-0051.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Squamous CellCetuximabCisplatinDisease ProgressionFemaleHead and Neck NeoplasmsHumansMaleMiddle AgedNeoplasm MetastasisNeoplasm StagingRadiotherapyRisk FactorsSquamous Cell Carcinoma of Head and NeckTreatment OutcomeConceptsProgression-free survivalOverall survivalLA-SCCHNMaintenance cetuximabAdvanced squamous cell headMedian progression-free survivalTwo-year overall survivalNeck squamous cell carcinomaTumor human papillomavirus (HPV) statusGrade 5 toxicityMedian overall survivalMedian radiotherapy doseMost common gradeCycles of cisplatinHuman papillomavirus (HPV) statusPhase II studySquamous cell headTumor HPV statusLonger overall survivalSquamous cell carcinomaOropharyngeal primaryHPV statusII studyPrimary endpointProtocol treatment
2009
Phase II study of pemetrexed (P) and gemcitabine (G) in patients with advanced head and neck cancer (SCCHN)
Mehra R, Sherman E, Ruth K, Litwin S, Sylvester J, Tuttle H, Burtness B, Cohen R, Langer C. Phase II study of pemetrexed (P) and gemcitabine (G) in patients with advanced head and neck cancer (SCCHN). Journal Of Clinical Oncology 2009, 27: 6052-6052. DOI: 10.1200/jco.2009.27.15_suppl.6052.Peer-Reviewed Original ResearchPhase II studyResponse rateII studyOverall survivalMetastatic squamous cell cancerRecurrent/metastatic SCCHNRecurrent/metastatic diseaseStage 1Adequate bone marrowGrade 4 anemiaGrade 3 toxicityMedian overall survivalSquamous cell cancerLack of efficacyAdvanced HNSCCKarnofsky PSLA-SCCHNMetastatic SCCHNPrior therapyUnconfirmed PRAlternative regimenDefinitive therapyPrimary endpointRecurrent diseaseSecondary endpoints