2023
Radiotherapy Plus Cisplatin With or Without Lapatinib for Non–Human Papillomavirus Head and Neck Carcinoma
Wong S, Torres-Saavedra P, Saba N, Shenouda G, Bumpous J, Wallace R, Chung C, El-Naggar A, Gwede C, Burtness B, Tennant P, Dunlap N, Redman R, Stokes W, Rudra S, Mell L, Sacco A, Spencer S, Nabell L, Yao M, Cury F, Mitchell D, Jones C, Firat S, Contessa J, Galloway T, Currey A, Harris J, Curran W, Le Q. Radiotherapy Plus Cisplatin With or Without Lapatinib for Non–Human Papillomavirus Head and Neck Carcinoma. JAMA Oncology 2023, 9: 1565-1573. PMID: 37768670, PMCID: PMC10540060, DOI: 10.1001/jamaoncol.2023.3809.Peer-Reviewed Original ResearchConceptsProgression-free survivalAdverse event ratesOverall survivalStage IIIClinical trialsAcute adverse event ratesProgression-free survival ratesEnd pointEvent ratesAnti-epidermal growth factor receptor (EGFR) antibodiesBenefit of chemoradiotherapyZubrod performance statusPrimary end pointSecondary end pointsCycles of cisplatinAddition of lapatinibEGFR antibody therapyGrowth factor receptor antibodyLog-rank testDual EGFRPlus CisplatinFrontline therapyPerformance statusAntibody therapyNeck carcinoma
2022
Outcomes by tobacco history in E3311, a phase II trial of transoral surgery (TOS) followed by pathology-based adjuvant treatment in HPV-associated (HPV+) oropharynx cancer (OPC): A trial of the ECOG-ACRIN Cancer Research Group.
Mehra R, Flamand Y, Quon H, Garcia J, Weinstein G, Duvvuri U, O'Malley B, Ozer E, Thomas G, Koch W, Gross N, Bell R, Saba N, Lango M, Bayon R, Burtness B, Ferris R. Outcomes by tobacco history in E3311, a phase II trial of transoral surgery (TOS) followed by pathology-based adjuvant treatment in HPV-associated (HPV+) oropharynx cancer (OPC): A trial of the ECOG-ACRIN Cancer Research Group. Journal Of Clinical Oncology 2022, 40: 6077-6077. DOI: 10.1200/jco.2022.40.16_suppl.6077.Peer-Reviewed Original ResearchProgression-free survivalOropharynx cancerOverall survivalSmoking statusTransoral surgeryAdjuvant treatmentPerformance statusPrimary siteECOG-ACRIN Cancer Research GroupFirst treatment approachHistory of smokingPhase II trialKaplan-Meier methodLog-rank testCancer Research GroupSignificant differencesWilcoxon rank sum testChi-square testRank sum testDefinitive chemoradiationEvaluable ptsOS ratesEfficacy outcomesExtranodal extensionII trialPhase 2 LEAP-009: Lenvatinib (Lenva) With or Without Pembrolizumab (Pembro) vs. Chemotherapy (Chemo) for Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) That has Progressed on Platinum and Immunotherapy
Harrington K, Cohen E, Siu L, Rischin D, Licitra L, Vermorken J, Le Q, Tahara M, Machiels J, Hawk N, Ge J, Bidadi B, Swaby R, Burtness B. Phase 2 LEAP-009: Lenvatinib (Lenva) With or Without Pembrolizumab (Pembro) vs. Chemotherapy (Chemo) for Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) That has Progressed on Platinum and Immunotherapy. International Journal Of Radiation Oncology • Biology • Physics 2022, 112: e43-e44. DOI: 10.1016/j.ijrobp.2021.12.101.Peer-Reviewed Original ResearchPD-1/PD-L1 inhibitorsECOG performance statusPD-L1 inhibitorsM HNSCCDisease progressionRECIST v1.1Monotherapy armPerformance statusPO QDPD-L1 tumor proportion scoreOptimal second-line regimenEnd pointNeck squamous cell carcinomaPrimary end pointSecondary end pointsSecond-line regimenFirst-line treatmentTumor proportion scoreKey eligibility criteriaSquamous cell carcinomaInterim futility analysisMeasurable diseaseSOC chemotherapyMetastatic headUnacceptable toxicity
2021
Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): An update on 107 randomized trials and 19,805 patients, on behalf of MACH-NC Group
Lacas B, Carmel A, Landais C, Wong SJ, Licitra L, Tobias JS, Burtness B, Ghi MG, Cohen EEW, Grau C, Wolf G, Hitt R, Corvò R, Budach V, Kumar S, Laskar SG, Mazeron JJ, Zhong LP, Dobrowsky W, Ghadjar P, Fallai C, Zakotnik B, Sharma A, Bensadoun RJ, Redda M, Racadot S, Fountzilas G, Brizel D, Rovea P, Argiris A, Nagy ZT, Lee JW, Fortpied C, Harris J, Bourhis J, Aupérin A, Blanchard P, Pignon JP, Group M, Adelstein D, Alfonsi M, Belkacemi Y, Bar-Ad V, Bernier J, Bratland Å, Calais G, Campbell B, Caudell J, Chabaud S, Chamorey E, Chaukar D, Choi K, Choussy O, Collette L, Cruz J, Dani C, Dauzier E, Forastiere A, Garaud P, Gregoire V, Hackshaw A, Haddad E, Haffty B, Hansen A, Hayoz S, Horiot J, Jeremic B, Karrison T, Langendijk J, Lapeyre M, Lartigau E, Leong T, Le Q, Lee P, Lewin F, Lin A, Lopes A, Mehta S, Moon J, Moyal E, Occéan B, Olmi P, Orecchia R, O'Sullivan B, Overgaard J, Petit C, Quon H, Sanguineti G, Satar T, Simes J, Simon C, Sire C, Staar S, Stromberger C, Strojan P, Temam S, Thomson D, Timochenko A, Torri V, Tseroni V, Vermorken J, Vokes E, Waldron J, Wernecke K, Widder J, Zackrisson B. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): An update on 107 randomized trials and 19,805 patients, on behalf of MACH-NC Group. Radiotherapy And Oncology 2021, 156: 281-293. PMID: 33515668, PMCID: PMC8386522, DOI: 10.1016/j.radonc.2021.01.013.Peer-Reviewed Original ResearchConceptsLoco-regional treatmentConcomitant CTConcomitant chemotherapyOverall survivalNeck cancerNon-metastatic headPoor performance statusSquamous cell headIndividual patient dataNon-metastatic carcinomasAddition of inductionFixed-effects modelPerformance statusPatient ageDistant metastasisRandomized trialsMain endpointCell headStage IIIMeta-AnalysisPatientsChemotherapyPatient dataTrialsCancer
2020
351 Pembrolizumab plus lenvatinib vs chemotherapy and lenvatinib monotherapy for recurrent/metastatic head and neck squamous cell carcinoma that progressed on platinum therapy and immunotherapy: LEAP-009
Harrington K, Cohen E, Siu L, Rischin D, Licitra L, Vermorken J, Le Q, Tahara M, Machiels J, Hawk N, Ge J, Bidadi B, Swaby R, Burtness B. 351 Pembrolizumab plus lenvatinib vs chemotherapy and lenvatinib monotherapy for recurrent/metastatic head and neck squamous cell carcinoma that progressed on platinum therapy and immunotherapy: LEAP-009. Journal For ImmunoTherapy Of Cancer 2020, 8: a376-a376. DOI: 10.1136/jitc-2020-sitc2020.0351.Peer-Reviewed Original ResearchPlatinum-based chemotherapyRecurrent/metastatic headNeck squamous cell carcinomaECOG performance statusSquamous cell carcinomaDisease progressionLenvatinib monotherapyM HNSCCCell carcinomaRECIST v1.1SOC chemotherapyMetastatic headMonotherapy armPerformance statusTreatment optionsPhase Ib/II trialStandard first-line treatment optionPD-L1 tumor proportion scoreFirst-line treatment optionAdvanced renal cell carcinomaJ Clin OncolSafety of pembrolizumabPD-1 inhibitorsPlatinum-containing chemotherapyAdvanced solid tumorsPredictive classifier for intensive treatment of head and neck cancer
Zakeri K, Rotolo F, Lacas B, Vitzthum LK, Le Q, Gregoire V, Overgaard J, Hackshaw A, Zackrisson B, Parmar MKB, Burtness BA, Ghi MG, Sanguineti G, O’Sullivan B, Fortpied C, Bourhis J, Shen H, Harris J, Michiels S, Pignon J, Mell LK, Intergroup F. Predictive classifier for intensive treatment of head and neck cancer. Cancer 2020, 126: 5263-5273. PMID: 33017867, DOI: 10.1002/cncr.33212.Peer-Reviewed Original ResearchConceptsOverall survivalIntensive treatmentΩ scoreNeck cancerGood performance statusEffect of chemotherapyOral cavity sitesPerformance statusAdvanced headRandomized trialsControl armHigh riskN categoryPatientsRelative hazardYounger ageEvent riskEvent regressionCancerCancer progressionUnknown statusTreatment effectsChemotherapyScoresTreatment
2019
Randomized, Phase II Study Prospectively Evaluating Treatment of Metastatic Esophageal, Gastric, or Gastroesophageal Cancer by Gene Expression of ERCC1: SWOG S1201.
Iqbal S, McDonough S, Lenz HJ, Ilson D, Burtness B, Nangia CS, Barzi A, Schneider CJ, Liu JJ, Dotan E, Guthrie KA, Hochster HS. Randomized, Phase II Study Prospectively Evaluating Treatment of Metastatic Esophageal, Gastric, or Gastroesophageal Cancer by Gene Expression of ERCC1: SWOG S1201. Journal Of Clinical Oncology 2019, 38: 472-479. PMID: 31815582, PMCID: PMC7007287, DOI: 10.1200/jco.19.00925.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsDNA-Binding ProteinsEndonucleasesEsophageal NeoplasmsEsophagogastric JunctionFemaleFluorouracilGene ExpressionHumansLeucovorinMaleMiddle AgedNeoplasm MetastasisOrganoplatinum CompoundsOxaliplatinPrognosisProgression-Free SurvivalProportional Hazards ModelsProspective StudiesStomach NeoplasmsYoung AdultConceptsProgression-free survivalAdvanced esophagogastric cancerPhase II studyPlatinum-based therapyOverall survivalII studySuperior median progression-free survivalMedian progression-free survivalMRNA expressionRegimen of irinotecanUpper GI tumorsZubrod performance statusPercent of patientsOccurrence of gradeStandard of careMetastatic esophagealEsophagogastric cancerPerformance statusUntreated patientsGastroesophageal cancerGI tumorsTreatment armsFOLFOXPlatinum sensitivityPatients
2013
Baseline health perceptions, dysphagia, and survival in patients with head and neck cancer
Lango MN, Egleston B, Fang C, Burtness B, Galloway T, Liu J, Mehra R, Ebersole B, Moran K, Ridge JA. Baseline health perceptions, dysphagia, and survival in patients with head and neck cancer. Cancer 2013, 120: 840-847. PMID: 24352973, PMCID: PMC3951722, DOI: 10.1002/cncr.28482.Peer-Reviewed Original ResearchConceptsDisease-related deathPatient-reported health stateDisease recurrenceBaseline dysphagiaWeight lossNeck cancerHealth perceptionPatient-reported dysphagiaECOG performance statusAdvanced T classificationProspective cohort studyGeneral health perceptionRisk of deathNeck cancer patientsPatient-reported measuresLogistic regression analysisHealth statesCurative intentDysphagia measuresCohort studyIdentifies patientsPerformance statusEuroQol-5DMale patientsSWAL-QOLPhase III Randomized, Placebo-Controlled Trial of Docetaxel With or Without Gefitinib in Recurrent or Metastatic Head and Neck Cancer: An Eastern Cooperative Oncology Group Trial
Argiris A, Ghebremichael M, Gilbert J, Lee JW, Sachidanandam K, Kolesar JM, Burtness B, Forastiere AA. Phase III Randomized, Placebo-Controlled Trial of Docetaxel With or Without Gefitinib in Recurrent or Metastatic Head and Neck Cancer: An Eastern Cooperative Oncology Group Trial. Journal Of Clinical Oncology 2013, 31: 1405-1414. PMID: 23460714, PMCID: PMC3612594, DOI: 10.1200/jco.2012.45.4272.Peer-Reviewed Original ResearchMeSH KeywordsAdultAge FactorsAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Squamous CellDiarrheaDocetaxelDrug Administration ScheduleErbB ReceptorsFatigueFemaleGefitinibGenotypeHead and Neck NeoplasmsHumansKaplan-Meier EstimateLeukopeniaMaleMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalProto-Oncogene ProteinsProto-Oncogene Proteins c-metProto-Oncogene Proteins p21(ras)QuinazolinesRas ProteinsTaxoidsTreatment OutcomeConceptsAddition of gefitinibPerformance statusArm ADisease progressionEastern Cooperative Oncology Group performance statusEastern Cooperative Oncology Group trialEpidermal growth factor receptor tyrosine kinase inhibitorsGrowth factor receptor tyrosine kinase inhibitorsReceptor tyrosine kinase inhibitorsGrade 3/4 diarrheaPhase III randomizedSingle-agent gefitinibTrials of docetaxelUnplanned subset analysisECOG performance statusGrade 3/4 toxicitiesMedian overall survivalTime of progressionSquamous cell carcinomaTyrosine kinase inhibitorsEligible patientsMetastatic SCCHNWeekly docetaxelMetastatic headOverall survival
2009
Phase II trial of docetaxel–irinotecan combination in advanced esophageal cancer
Burtness B, Gibson M, Egleston B, Mehra R, Thomas L, Sipples R, Quintanilla M, Lacy J, Watkins S, Murren JR, Forastiere AA. Phase II trial of docetaxel–irinotecan combination in advanced esophageal cancer. Annals Of Oncology 2009, 20: 1242-1248. PMID: 19429872, PMCID: PMC2699385, DOI: 10.1093/annonc/mdn787.Peer-Reviewed Original ResearchConceptsAdvanced esophageal cancerPartial responseComplete responseEligible patientsEsophageal cancerEastern Cooperative Oncology Group performance statusMetastatic squamous cell carcinomaSafety of docetaxelPhase II trialSquamous cell carcinomaPrincipal toxic effectsAssessable patientsEsophagogastric cancerMeasurable diseaseToxic deathsII trialCN patientsMedian survivalPerformance statusNormal bilirubinPreclinical evidenceMedian timeCell carcinomaMyocardial infarctionTumor assessment
2008
A randomized phase II study of ixabepilone (BMS-247550) given daily × 5 days every 3 weeks or weekly in patients with metastatic or recurrent squamous cell cancer of the head and neck: an Eastern Cooperative Oncology Group study
Burtness BA, Manola J, Axelrod R, Argiris A, Forastiere AA. A randomized phase II study of ixabepilone (BMS-247550) given daily × 5 days every 3 weeks or weekly in patients with metastatic or recurrent squamous cell cancer of the head and neck: an Eastern Cooperative Oncology Group study. Annals Of Oncology 2008, 19: 977-983. PMID: 18296423, DOI: 10.1093/annonc/mdm591.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibiotics, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Squamous CellCombined Modality TherapyDisease-Free SurvivalDocetaxelDrug Administration ScheduleDrug Resistance, NeoplasmEpothilonesFemaleHead and Neck NeoplasmsHematologic DiseasesHumansInfusions, IntravenousMaleMiddle AgedPaclitaxelPeripheral Nervous System DiseasesRecurrenceSalvage TherapySurvival AnalysisTaxoidsConceptsTaxane-naive patientsArm BEastern Cooperative Oncology Group performance statusEastern Cooperative Oncology Group StudyRecurrent squamous cell cancerSensory/motor neuropathyRandomized phase II studyMetastatic/recurrent diseaseCommon grade 3Grade 3 neuropathyPhase II studyPrimary end pointSquamous cell cancerSquamous cell carcinomaEligible patientsPrior regimensWeekly ixabepiloneRecurrent diseaseII studyMedian survivalPartial responsePerformance statusMotor neuropathyCell cancerCell carcinoma