2020
Comparing programmed death ligand 1 scores for predicting pembrolizumab efficacy in head and neck cancer
Emancipator K, Huang L, Aurora-Garg D, Bal T, Cohen EEW, Harrington K, Soulières D, Le Tourneau C, Licitra L, Burtness B, Swaby R. Comparing programmed death ligand 1 scores for predicting pembrolizumab efficacy in head and neck cancer. Modern Pathology 2020, 34: 532-541. PMID: 33239737, DOI: 10.1038/s41379-020-00710-9.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalB7-H1 AntigenBiomarkers, TumorBiopsyClinical Decision-MakingClinical Trials, Phase III as TopicDecision Support TechniquesDisease ProgressionHead and Neck NeoplasmsHumansImmunohistochemistryPredictive Value of TestsProgression-Free SurvivalRandomized Controlled Trials as TopicRetrospective StudiesSquamous Cell Carcinoma of Head and NeckTime FactorsConceptsTumor proportion scoreObjective response ratePD-L1 expression statusDeath ligand 1 (PD-L1) expressionNeck squamous cell carcinomaImmune checkpoint inhibitorsLigand 1 expressionPD-L1 statusProgression-free survivalSquamous cell carcinomaKEYNOTE-040Pembrolizumab efficacyCheckpoint inhibitorsOverall survivalMetastatic HNSCCCell carcinomaNeck cancerClinical trialsProportion scoreInvestigator's choiceResponse rateExpression statusYouden indexHNSCCPatientsReply to “Keynote 48: Is it really for everyone?”
Burtness B, Ge J. Reply to “Keynote 48: Is it really for everyone?”. Oral Oncology 2020, 112: 104983. PMID: 33032941, DOI: 10.1016/j.oraloncology.2020.104983.Peer-Reviewed Original ResearchAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalCetuximabHumansSquamous Cell Carcinoma of Head and NeckPembrolizumab 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 ResearchMeSH KeywordsAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalChemoradiotherapyCombined Modality TherapyHumansMaintenance ChemotherapyNeoplasm MetastasisNeoplasm StagingSquamous Cell Carcinoma of Head and NeckConceptsNeck 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
2019
Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study
Burtness B, Harrington KJ, Greil R, Soulières D, Tahara M, de Castro G, Psyrri A, Basté N, Neupane P, Bratland Å, Fuereder T, Hughes BGM, Mesía R, Ngamphaiboon N, Rordorf T, Ishak W, Hong RL, Mendoza R, Roy A, Zhang Y, Gumuscu B, Cheng JD, Jin F, Rischin D, Investigators K, Lerzo G, Tatangelo M, Varela M, Zarba J, Boyer M, Gan H, Gao B, Hughes B, Mallesara G, Rischin D, Taylor A, Burian M, Fuereder T, Greil R, Barrios C, de Castro D, Castro G, Franke F, Girotto G, Lima I, Nicolau U, Pinto G, Santos L, Victorino A, Chua N, Couture F, Gregg R, Hansen A, Hilton J, McCarthy J, Soulieres D, Ascui R, Gonzalez P, Villanueva L, Torregroza M, Zambrano A, Holeckova P, Kral Z, Melichar B, Prausova J, Vosmik M, Andersen M, Gyldenkerne N, Jurgens H, Putnik K, Reinikainen P, Gruenwald V, Laban S, Aravantinos G, Boukovinas I, Georgoulias V, Psyrri A, Kwong D, Al-Farhat Y, Csoszi T, Erfan J, Horvai G, Landherr L, Remenar E, Ruzsa A, Szota J, Billan S, Gluck I, Gutfeld O, Popovtzer A, Benasso M, Bui S, Ferrari V, Licitra L, Nole F, Fujii T, Fujimoto Y, Hanai N, Hara H, Matsumoto K, Mitsugi K, Monden N, Nakayama M, Okami K, Oridate N, Shiga K, Shimizu Y, Sugasawa M, Tahara M, Takahashi M, Takahashi S, Tanaka K, Ueda T, Yamaguchi H, Yamazaki T, Yasumatsu R, Yokota T, Yoshizaki T, Kudaba I, Stara Z, Ishak W, Cheah S, Ponce J, Mendoza R, Hernandez C, Soto F, Buter J, Hoeben A, Oosting S, Suijkerbuijk K, Bratland A, Brydoey M, Alvarez R, Mas L, Caguioa P, Querol J, Regala E, Tamayo M, Villegas E, Kawecki A, Karpenko A, Klochikhin A, Smolin A, Zarubenkov O, Goh B, Cohen G, du Toit J, Jordaan C, Landers G, Ruff P, Szpak W, Tabane N, Brana I, Docampo L, Lavernia J, Mesia R, Abel E, Muratidu V, Nielsen N, Cristina V, Rordorf T, Rothschild S, Hong R, Wang H, Yang M, Yeh S, Yen C, Ngamphaiboon N, Soparattanapaisarn N, Sriuranpong V, Aksoy S, Cicin I, Ekenel M, Harputluoglu H, Ozyilkan O, Harrington K, Agarwala S, Ali H, Alter R, Anderson D, Bruce J, Burtness B, Campbell N, Conde M, Deeken J, Edenfield W, Feldman L, Gaughan E, Goueli B, Halmos B, Hegde U, Hunis B, Jotte R, Karnad A, Khan S, Laudi N, Laux D, Martincic D, McCune S, McGaughey D, Misiukiewicz K, Mulford D, Nadler E, Neupane P, Nunnink J, Ohr J, O'Malley M, Patson B, Paul D, Popa E, Powell S, Redman R, Rella V, Lima C, Sivapiragasam A, Su Y, Sukari A, Wong S, Yilmaz E, Yorio J. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study. The Lancet 2019, 394: 1915-1928. PMID: 31679945, DOI: 10.1016/s0140-6736(19)32591-7.Peer-Reviewed Original ResearchConceptsCombined positive scoreSecond interim analysisProgression-free survivalPD-L1 combined positive scoreAppropriate first-line treatmentFirst-line treatmentOverall survivalSquamous cell carcinomaChemotherapy groupMetastatic HNSCCInterim analysisAdverse eventsAlone groupCell carcinomaFinal analysisCell death ligand 1 (PD-L1) expressionDeath ligand 1 (PD-L1) expressionMetastatic squamous cell carcinomaNeck squamous cell carcinomaCause adverse eventsPD-L1 positivityLigand 1 expressionPD-L1 expressionTotal populationIncurable recurrentPhase III Randomized Trial of Chemotherapy With or Without Bevacizumab in Patients With Recurrent or Metastatic Head and Neck Cancer.
Argiris A, Li S, Savvides P, Ohr JP, Gilbert J, Levine MA, Chakravarti A, Haigentz M, Saba NF, Ikpeazu CV, Schneider CJ, Pinto HA, Forastiere AA, Burtness B. Phase III Randomized Trial of Chemotherapy With or Without Bevacizumab in Patients With Recurrent or Metastatic Head and Neck Cancer. Journal Of Clinical Oncology 2019, 37: 3266-3274. PMID: 31618129, PMCID: PMC6980834, DOI: 10.1200/jco.19.00555.Peer-Reviewed Original ResearchMeSH KeywordsAgedAntineoplastic Agents, ImmunologicalAntineoplastic Combined Chemotherapy ProtocolsBevacizumabDisease ProgressionDrug Administration ScheduleFemaleHead and Neck NeoplasmsHumansMaleNeoplasm Recurrence, LocalProgression-Free SurvivalSquamous Cell Carcinoma of Head and NeckTime FactorsUnited StatesConceptsAddition of bevacizumabProgression-free survivalOverall survivalResponse rateMedian progression-free survivalMetastatic squamous cell carcinomaPlatinum-based chemotherapy doubletsTreatment-related grade 3Phase III randomized trialsTreatment-related deathsMedian overall survivalPlatinum-based chemotherapySquamous cell carcinomaBetter toxicity profileBiomarker-driven studiesOverall response rateHumanized monoclonal antibodyVascular endothelial growth factorEndothelial growth factorChemotherapy doubletsMedian OSMetastatic SCCHNOS ratesEligible patientsMetastatic headHyperprogression after one dose of nivolumab in sinonasal cancer: A case report
Xiang JJ, Uy NF, Minja FJ, Verter EE, Burtness BA. Hyperprogression after one dose of nivolumab in sinonasal cancer: A case report. The Laryngoscope 2019, 130: 907-910. PMID: 31058321, DOI: 10.1002/lary.28042.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Agents, ImmunologicalCarcinoma, Squamous CellDisease ProgressionFemaleHumansMiddle AgedNivolumabParanasal Sinus NeoplasmsConceptsImmune checkpoint inhibitorsDose of nivolumabSquamous cell carcinomaSinonasal cancerCell carcinomaDisease progressionMaxillary sinus squamous cell carcinomaSinus squamous cell carcinomaNeck squamous cell carcinomaComplete vision lossICI initiationCheckpoint inhibitorsFirst doseLytic metastasesDistal metastasisCase reportIntracranial invasionVision lossImproved outcomesHyperprogressionIndividual riskDoseNivolumabCarcinomaMetastasisPTEN loss is associated with resistance to cetuximab in patients with head and neck squamous cell carcinoma
Eze N, Lee JW, Yang DH, Zhu F, Neumeister V, Sandoval-Schaefer T, Mehra R, Ridge JA, Forastiere A, Chung CH, Burtness B. PTEN loss is associated with resistance to cetuximab in patients with head and neck squamous cell carcinoma. Oral Oncology 2019, 91: 69-78. PMID: 30926065, PMCID: PMC6855599, DOI: 10.1016/j.oraloncology.2019.02.026.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Agents, ImmunologicalCetuximabFemaleHumansMaleMiddle AgedPTEN PhosphohydrolaseSquamous Cell Carcinoma of Head and NeckConceptsNeck squamous cell carcinomaEpidermal growth factor receptorSquamous cell carcinomaCell carcinomaCetuximab-based therapyTrial of cisplatinTrials (RCTs) of cetuximabPotential predictive biomarkersPTEN expressionLack of benefitPI3K mutationsPI3K p110αHigh PTEN expressionPI3K pathwayGrowth factor receptorHot spot mutationsStandard therapySuperior PFSMultivariable analysisPredictive biomarkersLoss of expressionSuch therapyCommon abnormalityCetuximabSide effects
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