2021
Randomized phase II trial of ficlatuzumab with or without cetuximab in pan-refractory, advanced head and neck squamous cell carcinoma (HNSCC).
Bauman J, Saba N, Roe D, Bauman J, Kaczmar J, Bhatia A, Muzaffar J, Julian R, Wang S, Bearelly S, Baker A, Steuer C, Giri A, Burtness B, Centuori S, Caulin C, Saboda K, Obara S, Chung C. Randomized phase II trial of ficlatuzumab with or without cetuximab in pan-refractory, advanced head and neck squamous cell carcinoma (HNSCC). Journal Of Clinical Oncology 2021, 39: 6015-6015. DOI: 10.1200/jco.2021.39.15_suppl.6015.Peer-Reviewed Original ResearchMedian progression-free survivalOverall response rateHepatocyte growth factorAdvanced HNSCCPartial responsePrimary endpointEvaluable subjectsHPV statusRecurrent/metastatic HNSCCAnti-EGFR monoclonal antibodiesNeck squamous cell carcinomaMajor prognostic variablesPerformance status 0Phase II trialProgression-free survivalNon-comparative trialsSquamous cell carcinomaConfidence intervalsPhase III investigationFC combinationDual pathway inhibitionLFT elevationsPFS endpointPrior cetuximabStatus 0
2020
Pembrolizumab given concomitantly with chemoradiation and as maintenance therapy for locally advanced head and neck squamous cell carcinoma: KEYNOTE-412
Machiels JP, Tao Y, Burtness B, Tahara M, Licitra L, Rischin D, Waldron J, Simon C, Gregoire V, Harrington K, Alves GV, Lima I, Pointreau Y, Hughes B, Aksoy S, Hetnal M, Ge JY, Brown H, Cheng J, Bidadi B, Siu LL. Pembrolizumab given concomitantly with chemoradiation and as maintenance therapy for locally advanced head and neck squamous cell carcinoma: KEYNOTE-412. Future Oncology 2020, 16: 1235-1243. PMID: 32490686, DOI: 10.2217/fon-2020-0184.Peer-Reviewed Original ResearchConceptsNeck squamous cell carcinomaPhase III trialsSquamous cell carcinomaChemoradiation therapyAdvanced headIII trialsCell carcinomaImmune checkpoint inhibitor pembrolizumabLarge phase III trialsCheckpoint inhibitor pembrolizumabUse of pembrolizumabCurrent treatment guidelinesAdvanced HNSCCAdvanced diseaseMaintenance therapyMetastatic HNSCCTreatment guidelinesMaintenance treatmentMultimodal treatmentPembrolizumabPatientsAntitumor activityIB dataChemoradiationHNSCC
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 stage
2016
Antitumor Activity of Pembrolizumab in Biomarker-Unselected Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma: Results From the Phase Ib KEYNOTE-012 Expansion Cohort
Chow LQM, Haddad R, Gupta S, Mahipal A, Mehra R, Tahara M, Berger R, Eder JP, Burtness B, Lee SH, Keam B, Kang H, Muro K, Weiss J, Geva R, Lin CC, Chung HC, Meister A, Dolled-Filhart M, Pathiraja K, Cheng JD, Seiwert TY. Antitumor Activity of Pembrolizumab in Biomarker-Unselected Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma: Results From the Phase Ib KEYNOTE-012 Expansion Cohort. Journal Of Clinical Oncology 2016, 34: 3838-3845. PMID: 27646946, PMCID: PMC6804896, DOI: 10.1200/jco.2016.68.1478.Peer-Reviewed Original ResearchConceptsOverall response rateNeck squamous cell carcinomaProgression-free survivalSquamous cell carcinomaMetastatic headExpansion cohortPD-L1Cell carcinomaAnti-programmed death-1 antibodySix-month progression-free survivalTreatment-related adverse eventsEnd pointDeath-1 antibodyDose of pembrolizumabAntitumor activityPrimary end pointSecondary end pointsHuman papillomavirus (HPV) statusPD-L1 expressionOverall survival rateDurable antitumor activityFrequent dosing scheduleAssociation of responseAdvanced HNSCCM HNSCC
2009
Phase II study of pemetrexed (P) and gemcitabine (G) in patients with advanced head and neck cancer (SCCHN)
Mehra R, Sherman E, Ruth K, Litwin S, Sylvester J, Tuttle H, Burtness B, Cohen R, Langer C. Phase II study of pemetrexed (P) and gemcitabine (G) in patients with advanced head and neck cancer (SCCHN). Journal Of Clinical Oncology 2009, 27: 6052-6052. DOI: 10.1200/jco.2009.27.15_suppl.6052.Peer-Reviewed Original ResearchPhase II studyResponse rateII studyOverall survivalMetastatic squamous cell cancerRecurrent/metastatic SCCHNRecurrent/metastatic diseaseStage 1Adequate bone marrowGrade 4 anemiaGrade 3 toxicityMedian overall survivalSquamous cell cancerLack of efficacyAdvanced HNSCCKarnofsky PSLA-SCCHNMetastatic SCCHNPrior therapyUnconfirmed PRAlternative regimenDefinitive therapyPrimary endpointRecurrent diseaseSecondary endpoints