2021
Updated report of a phase II randomized trial of transoral surgical resection followed by low-dose or standard postoperative therapy in resectable p16+ locally advanced oropharynx cancer: A trial of the ECOG-ACRIN cancer research group (E3311).
Ferris R, Flamand Y, Weinstein G, Li S, Quon H, Mehra R, Garcia J, Ringash J, Lewin J, Duvvuri U, O'Malley B, Ozer E, Thomas G, Koch W, Kupferman M, Bell R, Saba N, Lango M, Wagner L, Burtness B. Updated report of a phase II randomized trial of transoral surgical resection followed by low-dose or standard postoperative therapy in resectable p16+ locally advanced oropharynx cancer: A trial of the ECOG-ACRIN cancer research group (E3311). Journal Of Clinical Oncology 2021, 39: 6010-6010. DOI: 10.1200/jco.2021.39.15_suppl.6010.Peer-Reviewed Original ResearchPrimary transoral surgeryOropharynx cancerArm BPatient-reported outcomesPostoperative RTTransoral surgeryArm AHuman papillomavirus-associated oropharynx cancerECOG-ACRIN Cancer Research GroupAdvanced oropharynx cancerArm DStandard postoperative therapyPhase II trialProportion of patientsCancer Research GroupNeck cancer-specific qualityPre-specified endpointsTransoral surgical resectionDeintensification strategiesFavorable QOLIneligible patientsPathologic riskPostoperative chemoradiationAdjuvant therapyII trial
2016
Safety and clinical activity of pembrolizumab for treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-012): an open-label, multicentre, phase 1b trial
Seiwert TY, Burtness B, Mehra R, Weiss J, Berger R, Eder JP, Heath K, McClanahan T, Lunceford J, Gause C, Cheng JD, Chow LQ. Safety and clinical activity of pembrolizumab for treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-012): an open-label, multicentre, phase 1b trial. The Lancet Oncology 2016, 17: 956-965. PMID: 27247226, DOI: 10.1016/s1470-2045(16)30066-3.Peer-Reviewed Original ResearchConceptsMetastatic squamous cell carcinomaSquamous cell carcinomaDrug-related adverse eventsPost-baseline scanPhase 1b trialProportion of patientsCell carcinomaAdverse eventsPD-L1Anti-programmed death receptor 1 antibodyDeath receptor-1 (PD-1) antibodiesPositive squamous cell carcinomaActivity of pembrolizumabDose of pembrolizumabDrug-related rashMeaningful antitumour activityFull analysis setHPV-negative patientsSerious adverse eventsHPV-positive patientsPD-L1 expressionResponse Evaluation CriteriaTreatment of recurrentOverall responseDrug-related deathsPembrolizumab for patients with PD-L1-positive advanced gastric cancer (KEYNOTE-012): a multicentre, open-label, phase 1b trial
Muro K, Chung HC, Shankaran V, Geva R, Catenacci D, Gupta S, Eder JP, Golan T, Le DT, Burtness B, McRee AJ, Lin CC, Pathiraja K, Lunceford J, Emancipator K, Juco J, Koshiji M, Bang YJ. Pembrolizumab for patients with PD-L1-positive advanced gastric cancer (KEYNOTE-012): a multicentre, open-label, phase 1b trial. The Lancet Oncology 2016, 17: 717-726. PMID: 27157491, DOI: 10.1016/s1470-2045(16)00175-3.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsPost-baseline scanPhase 1b trialGastro-oesophageal junctionPD-L1Gastric cancerAdverse eventsMetastatic adenocarcinomaGrade 3 peripheral sensory neuropathyPositive advanced gastric cancerSolid Tumors version 1.1Anti-PD-1 antibodyDose of pembrolizumabGrade 3 fatigueGrade 4 pneumonitisMetastatic PD-L1Treatment-related deathsUnacceptable toxic effectsManageable toxicity profilePeripheral sensory neuropathyProportion of patientsResponse Evaluation CriteriaAdvanced gastric cancerPopulation of patientsClinical disease progression