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
2017
LUX-head and neck 2: Randomized, double-blind, placebo-controlled, phase III trial of afatinib as adjuvant therapy after chemoradiation (CRT) in primary unresected, high/intermediate-risk, squamous cell cancer of the head and neck (HNSCC) patients (pts).
Burtness B, Haddad R, Dinis J, Trigo Perez J, Yokota T, Viana L, Romanov I, Vermorken J, Bourhis J, Tahara M, Segalla J, Psyrri A, Vasilevskaya I, Nangia C, Chaves-Conde M, Wang B, Gibson N, Ehrnrooth E, Harrington K, Cohen E. LUX-head and neck 2: Randomized, double-blind, placebo-controlled, phase III trial of afatinib as adjuvant therapy after chemoradiation (CRT) in primary unresected, high/intermediate-risk, squamous cell cancer of the head and neck (HNSCC) patients (pts). Journal Of Clinical Oncology 2017, 35: 6001-6001. DOI: 10.1200/jco.2017.35.15_suppl.6001.Peer-Reviewed Original ResearchDisease-free survivalPhase III trialsIII trialsEGFR inhibitionMedian disease-free survivalRecurrent/metastatic diseaseErbB family blocker afatinibPre-planned interim analysisECOG PS 0Median treatment durationSquamous cell cancerDefinitive chemoradiationECOG PSEligible ptsAdvanced HNSCCConcurrent cisplatinN2 diseasePrimary endpointAdjuvant therapyMetastatic diseasePS 0Complete responseDisease recurrenceMedian ageNodal stageKEYNOTE-412: Pembrolizumab (pembro) in combination with chemoradiation versus chemoradiation alone in locally advanced head and neck squamous cell carcinoma (LA-HNSCC).
Machiels J, Licitra L, Rischin D, Waldron J, Burtness B, Gregoire V, Shekar T, Brown H, Cheng J, Siu L. KEYNOTE-412: Pembrolizumab (pembro) in combination with chemoradiation versus chemoradiation alone in locally advanced head and neck squamous cell carcinoma (LA-HNSCC). Journal Of Clinical Oncology 2017, 35: tps6090-tps6090. DOI: 10.1200/jco.2017.35.15_suppl.tps6090.Peer-Reviewed Original ResearchBlinded independent central reviewConcomitant chemoradiotherapyRECIST v1.1LA-HNSCCP16-positive oropharyngeal cancerPrimary efficacy end pointRecurrent/metastatic HNSCCNeck squamous cell carcinomaDefinitive concomitant chemoradiotherapyECOG PS 0Efficacy end pointOutcome of ptsP16 negative HNSCCEvent-free survivalHalf of patientsSquamous cell carcinomaEnd of treatmentIndependent central reviewQuality of lifeMeasurable diseaseAdvanced diseaseCTCAE v4.0Primary surgeryAdvanced headNeck dissection
2009
A phase III randomized, placebo-controlled trial of docetaxel (D) with or without gefitinib (G) in recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN): A trial of the Eastern Cooperative Oncology Group (ECOG)
Argiris A, Ghebremichael M, Gilbert J, Burtness B, Forastiere A. A phase III randomized, placebo-controlled trial of docetaxel (D) with or without gefitinib (G) in recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN): A trial of the Eastern Cooperative Oncology Group (ECOG). Journal Of Clinical Oncology 2009, 27: 6011-6011. DOI: 10.1200/jco.2009.27.15_suppl.6011.Peer-Reviewed Original ResearchEastern Cooperative Oncology GroupMedian overall survivalArm AM SCCHNPrior chemotherapyAdverse eventsOverall survivalArm BCommon grade 3/4 adverse eventsEpidermal growth factor receptor tyrosine kinase inhibitorsGrowth factor receptor tyrosine kinase inhibitorsECOG performance status 2Grade 3/4 adverse eventsGrade 5 adverse eventsMetastatic squamous cell carcinomaModest single-agent activityReceptor tyrosine kinase inhibitorsECOG PS 0Objective response ratePerformance status 2Phase III randomizedPlacebo-controlled trialTime of progressionCooperative Oncology GroupSingle-agent activityPhase II randomized trial of bortezomib (B) plus irinotecan (I) or B with addition of I at progression in recurrent (R) or metastatic (M) squamous cell carcinoma of the head and neck (SCCHN) (E1304): A trial of the Eastern Cooperative Oncology Group
Gilbert J, Lee J, Argiris A, Feldman L, Haigentz M, Burtness B, Forastiere A. Phase II randomized trial of bortezomib (B) plus irinotecan (I) or B with addition of I at progression in recurrent (R) or metastatic (M) squamous cell carcinoma of the head and neck (SCCHN) (E1304): A trial of the Eastern Cooperative Oncology Group. Journal Of Clinical Oncology 2009, 27: 6020-6020. DOI: 10.1200/jco.2009.27.15_suppl.6020.Peer-Reviewed Original ResearchGrade 5 toxicityArm 2Response rateArm 1Metastatic squamous cell carcinomaEastern Cooperative Oncology GroupCycles of therapyECOG PS 0ECOG PS 1Cooperative Oncology GroupTime of progressionSquamous cell carcinomaSCCHN cell linesPrior chemoPrimary endpointStable diseaseToxic regimenActive therapyOncology GroupPS 0Cell carcinomaNF-κβTumor sensitivityTherapyInhibits growth
2007
Phase II trial of irinotecan/docetaxel for advanced pancreatic cancer with randomization between irinotecan/docetaxel and irinotecan/docetaxel plus C225, a monoclonal antibody to the epidermal growth factor receptor (EGF-r) : Eastern Cooperative Oncology
Burtness B, Powell M, Berlin J, Liles D, Chapman A, Mitchell E, Benson A. Phase II trial of irinotecan/docetaxel for advanced pancreatic cancer with randomization between irinotecan/docetaxel and irinotecan/docetaxel plus C225, a monoclonal antibody to the epidermal growth factor receptor (EGF-r) : Eastern Cooperative Oncology. Journal Of Clinical Oncology 2007, 25: 4519-4519. DOI: 10.1200/jco.2007.25.18_suppl.4519.Peer-Reviewed Original ResearchPhase II trialArm AII trialPS 0Arm BPancreatic cancerMedian survivalOverall survivalRandomized phase II trialECOG PS 0Treatment-related deathsMedian overall survivalMetastatic pancreatic cancerTherapeutic anticoagulationDocetaxel chemotherapyMetastatic patientsPrimary endpointBiologic agentsDistant metastasisHistologic confirmationNormal bilirubinSame therapyYear survivalMedian numberArm 2
2006
A randomized phase II study of BMS-247550 (ixabepilone) given daily x 5 days every 3 weeks or weekly in patients with metastatic or recurrent squamous cell cancer of the head and neck
Burtness B, Goldwasser M, Axelrod R, Argiris A, Forastiere A. A randomized phase II study of BMS-247550 (ixabepilone) given daily x 5 days every 3 weeks or weekly in patients with metastatic or recurrent squamous cell cancer of the head and neck. Journal Of Clinical Oncology 2006, 24: 5532-5532. DOI: 10.1200/jco.2006.24.18_suppl.5532.Peer-Reviewed Original ResearchArm BEligible ptsArm A.Recurrent squamous cell cancerRandomized phase II studyMetastatic/recurrent diseaseECOG PS 0Grade 3/4 anemiaPhase II studySquamous cell cancerDiphenhydramine premedicationMales 69Prior regimensRecurrent SCCHNTaxane exposurePrimary endpointII studyMedian survivalPartial responseProgressive diseasePS 0Recurrent diseaseMotor neuropathyArm ACell cancer