2024
Surrogate Endpoints in p16-Positive Squamous Cell Carcinoma of the Oropharynx
Gharzai L, Morris E, Nguyen-Tan P, Rosenthal D, Gillison M, Harari P, Garden A, Zanotti K, Caudell J, Jones C, Mitchell D, Krempl G, Ridge J, Gensheimer M, Bonner J, Le Q, Torres-Saavedra P, Mierzwa M, Schipper M. Surrogate Endpoints in p16-Positive Squamous Cell Carcinoma of the Oropharynx. International Journal Of Radiation Oncology • Biology • Physics 2024, 118: e14. DOI: 10.1016/j.ijrobp.2024.01.035.Peer-Reviewed Original ResearchLocoregional progression-free survivalProgression-free survivalP16-positive oropharyngeal cancerOverall survivalOropharyngeal cancerIncreasing incidence of HPV-related cancersIncidence of HPV-related cancersP16-positive squamous cell carcinomaOptimal treatment paradigmMedian follow-upHPV-related cancersSquamous cell carcinomaMulticenter randomized trialClinical trial endpointsLocoregional progressionDistant metastasisLocal progressionCell carcinomaDefinitive treatmentTreatment paradigmDMFSFollow-upRandomized trialsIncreased incidenceTreatment effectsSurrogate endpoints in clinical trials of p16-positive squamous cell carcinoma of the oropharynx: an individual patient data meta-analysis
Gharzai L, Morris E, Suresh K, Nguyen-Tân P, Rosenthal D, Gillison M, Harari P, Garden A, Koyfman S, Caudell J, Jones C, Mitchell D, Krempl G, Ridge J, Gensheimer M, Bonner J, Filion E, Dunlap N, Stokes W, Le Q, Torres-Saavedra P, Mierzwa M, Schipper M. Surrogate endpoints in clinical trials of p16-positive squamous cell carcinoma of the oropharynx: an individual patient data meta-analysis. The Lancet Oncology 2024, 25: 366-375. PMID: 38423050, PMCID: PMC10962533, DOI: 10.1016/s1470-2045(24)00016-0.Peer-Reviewed Original ResearchConceptsLocoregional progression-free survivalProgression-free survivalIntermediate clinical endpointsMetastasis-free survivalOverall survivalClinical endpointsOropharyngeal cancerComposite endpointIncidence of human papillomavirus (HPV)-related cancersP16-positive squamous cell carcinomaHuman papillomavirus (HPV)-related cancersP16-positive oropharyngeal cancerCancer treated with chemotherapyIndividual patient data meta-analysisMedian follow-upPatient data meta-analysisSquamous-cell carcinomaSquamous cell carcinomaPatient levelClinical trial endpointsTreatment effectsData meta-analysisLocoregional progressionNational Cancer InstituteDistant metastasis
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
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