2024
945TiP JADE: A phase (ph) III study to evaluate dostarlimab vs placebo (PBO) as sequential therapy after chemoradiation (CRT) in patients (pts) with locally advanced unresected head and neck squamous cell carcinoma (LA-HNSCC)
Machiels J, Burtness B, Harrington K, Saba N, Tahara M, Crossman T, Hua L, Perera A, Theti D, Zografos E, Siu L. 945TiP JADE: A phase (ph) III study to evaluate dostarlimab vs placebo (PBO) as sequential therapy after chemoradiation (CRT) in patients (pts) with locally advanced unresected head and neck squamous cell carcinoma (LA-HNSCC). Annals Of Oncology 2024, 35: s655. DOI: 10.1016/j.annonc.2024.08.2145.Peer-Reviewed Original ResearchA descriptive patient-reported outcomes (PROs) analysis of KEYNOTE-412 to understand head and neck symptom burden.
Siu L, McQuarrie K, Bidadi B, Liu C, Black C, Wang A, Tao Y, Licitra L, Burtness B, Tahara M, Rischin D, Harrington K, Machiels J. A descriptive patient-reported outcomes (PROs) analysis of KEYNOTE-412 to understand head and neck symptom burden. Journal Of Clinical Oncology 2024, 42: 11116-11116. DOI: 10.1200/jco.2024.42.16_suppl.11116.Peer-Reviewed Original ResearchPatient-reported outcomesChemoradiation therapyLA-HNSCCPain killersTumor locationSymptom burdenSolid foodTime of data cut-offPRO scoresQLQ-C30Baseline patient-reported outcomesLocally advanced headPrimary tumor locationData cut-offBaseline PRO scoresWeight lossPatient-reported outcomes analysisBaseline item scoresAssociated with high symptom burdenInvestigating pembrolizumabPatient-reported outcome dataAdvanced headHigh symptom burdenDouble-blindEvent-freeHealth-Related Quality of Life (HRQoL) Data From KEYNOTE-412: Chemoradiotherapy (CRT) with or Without Pembrolizumab (pembro) in Patients (pts) with Locally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC)
Machiels J, TAO Y, Burtness B, Tahara M, Rischin D, Alves G, Lima I, Hughes B, Pointreau Y, Aksoy S, Laban S, Greil R, Burian M, Hetnal M, Licitra L, Black C, Norquist J, Gumuscu B, Bidadi B, Siu L. Health-Related Quality of Life (HRQoL) Data From KEYNOTE-412: Chemoradiotherapy (CRT) with or Without Pembrolizumab (pembro) in Patients (pts) with Locally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC). International Journal Of Radiation Oncology • Biology • Physics 2024, 118: e39-e40. DOI: 10.1016/j.ijrobp.2024.01.091.Peer-Reviewed Original ResearchBL to weekLA-HNSCCEQ-5D VASLSM changeLocally advanced head and neck squamous cell carcinomaAdvanced head and neck squamous cell carcinomaQLQ-H&N35Head and neck squamous cell carcinomaNeck squamous cell carcinomaEnd pointsPrespecified secondary end pointsSecondary end pointsSquamous cell carcinomaExploratory end pointsCompliance rateQLQ-C30Disease symptom scoreDose of treatmentPatient-reported outcomesPhysical function scoresCell carcinomaPembroHealth-related quality of lifeChemoradiotherapyAnalysis population
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