2024
A randomized phase 2 trial of the IO102-IO103 (IDO and PD-L1) cancer vaccine plus pembrolizumab as neoadjuvant/adjuvant treatment of patients with solid tumors.
Long G, Haddad R, Robert C, Mortier L, Schadendorf D, Uppaluri R, Svane I, Saiag P, Lim A, Soria Rivas A, Scolyer R, Chaney M, Abildgaard C, Ahmad Q, Ringeisen F, McDowell D, Burtness B. A randomized phase 2 trial of the IO102-IO103 (IDO and PD-L1) cancer vaccine plus pembrolizumab as neoadjuvant/adjuvant treatment of patients with solid tumors. Journal Of Clinical Oncology 2024, 42: tps2701-tps2701. DOI: 10.1200/jco.2024.42.16_suppl.tps2701.Peer-Reviewed Original ResearchEvent-free survivalAdjuvant pembrolizumabNeoadjuvant pembrolizumabCancer vaccinesAdjuvant treatmentCohort CCohort APD-L1-positive cellsRandomized phase 2 trialExpansion of T cellsPost-treatment tumor tissuesPotential anti-tumor activityImmune checkpoint inhibitorsResponse to pembrolizumabLocally advanced diseasePathologic tumor responseTherapeutic cancer vaccinesImmune-suppressive cellsPhase 1/2 trialDisease-free survivalNeo-adjuvant treatmentPhase 2 trialTreatment of multiple tumor typesSquamous cell carcinomaHead and neck
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
KEYNOTE-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
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 9CetuximabPrognostic Biomarkers in Phase II Trial of Cetuximab-Containing Induction and Chemoradiation in Resectable HNSCC: Eastern Cooperative Oncology Group E2303
Psyrri A, Lee JW, Pectasides E, Vassilakopoulou M, Kosmidis EK, Burtness BA, Rimm DL, Wanebo HJ, Forastiere AA. Prognostic Biomarkers in Phase II Trial of Cetuximab-Containing Induction and Chemoradiation in Resectable HNSCC: Eastern Cooperative Oncology Group E2303. Clinical Cancer Research 2014, 20: 3023-3032. PMID: 24700741, PMCID: PMC4049169, DOI: 10.1158/1078-0432.ccr-14-0113.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCarboplatinCarcinoma, Squamous CellCetuximabChemoradiotherapyDisease-Free SurvivalDrug Resistance, NeoplasmFemaleFluorescent Antibody TechniqueHead and Neck NeoplasmsHumansInduction ChemotherapyKaplan-Meier EstimateMaleMiddle AgedMitogen-Activated Protein Kinase KinasesPaclitaxelPhosphatidylinositol 3-KinasesPrognosisProportional Hazards ModelsProto-Oncogene Proteins c-aktRas ProteinsSignal TransductionSquamous Cell Carcinoma of Head and NeckTissue Array AnalysisConceptsProgression-free survivalEvent-free survivalPhase II trialOverall survivalII trialTissue microarrayStage III/IV headMultivariable Cox proportional hazards modelsMultivariable Cox regression analysisNeck squamous cell cancerRAS/MAPK/ERKCox proportional hazards modelInsulin-like growth factor 1 receptorLarge prospective studiesCox regression analysisInferior overall survivalKaplan-Meier methodSquamous cell cancerLog-rank testGrowth factor 1 receptorProportional hazards modelPI3K/Akt pathwayFactor 1 receptorPI3K/AktEGF receptor