2024
Long-term follow up of 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.
Burtness B, Flamand Y, Quon H, Weinstein G, Mehra R, Garcia J, Kim S, O'malley B, Ozer E, Koch W, Gross N, Bell R, Patel M, Lango M, Morris L, Smith R, Karakla D, Richmon J, Holsinger F, Ferris R. Long-term follow up of 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 2024, 42: 6009-6009. DOI: 10.1200/jco.2024.42.16_suppl.6009.Peer-Reviewed Original ResearchProgression-free survivalIntermediate risk patientsExtranodal extensionOverall survivalPhase II trialRisk patientsSmoking historyPack-yearsPrimary siteLong-term follow-upFavorable pathologic characteristicsMature outcome dataPrescribed radiation doseECOG-ACRIN Cancer Research GroupPost-operative radiationIncreased recurrence riskKaplan-Meier methodLog-rank testPost-operative managementCancer Research GroupHPV+ OPCWeekly cisplatinMedian followN1 diseaseN1 patients
2023
Paclitaxel With or Without Cixutumumab as Second-Line Treatment of Metastatic Esophageal or Gastroesophageal Junction Cancer: A Randomized Phase II ECOG-ACRIN Trial
Stockton S, Catalano P, Cohen S, Burtness B, Mitchell E, Dotan E, Lubner S, Kumar P, Mulcahy M, Fisher G, Crandall T, Benson A. Paclitaxel With or Without Cixutumumab as Second-Line Treatment of Metastatic Esophageal or Gastroesophageal Junction Cancer: A Randomized Phase II ECOG-ACRIN Trial. The Oncologist 2023, 28: 827-e822. PMID: 37104870, PMCID: PMC10485278, DOI: 10.1093/oncolo/oyad096.Peer-Reviewed Original ResearchConceptsProgression-free survivalSecond-line therapyGastroesophageal junction cancerArm AMetastatic esophagealJunction cancerArm BMedian progression-free survivalRandomized phase II trialMedian overall survivalObjective response rateSecond-line treatmentAdvanced esophageal cancerInsulin-like growth factor 1 receptorPhase II trialStandard of careGrowth factor 1 receptorFactor 1 receptorStable diseaseII trialMetastatic settingPrimary endpointOverall survivalPreclinical evidenceClinical outcomesRandomized Phase II Trial of Ficlatuzumab With or Without Cetuximab in Pan-Refractory, Recurrent/Metastatic Head and Neck Cancer
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, Klein R, Saboda K, Obara S, Chung C. Randomized Phase II Trial of Ficlatuzumab With or Without Cetuximab in Pan-Refractory, Recurrent/Metastatic Head and Neck Cancer. Journal Of Clinical Oncology 2023, 41: 3851-3862. PMID: 36977289, DOI: 10.1200/jco.22.01994.Peer-Reviewed Original ResearchConceptsMedian progression-free survivalProgression-free survivalObjective response rateRecurrent/metastatic headCMET overexpressionMetastatic headCombination armAntiepidermal growth factor receptor monoclonal antibodyNoncomparative phase II studyRecurrent/metastatic HNSCCRandomized phase II trialEnd pointNeck squamous cell carcinomaHPV negative subgroupPhase II studyPrimary end pointSecondary end pointsHPV-positive diseaseHuman papillomavirus (HPV) statusMajor prognostic factorPhase II trialKey eligibility criteriaSquamous cell carcinomaReceptor monoclonal antibodyHPV-negative HNSCC
2022
Phase II Study of Enzalutamide for Patients With Androgen Receptor–Positive Salivary Gland Cancers (Alliance A091404)
Ho AL, Foster NR, Zoroufy AJ, Campbell JD, Worden F, Price K, Adkins D, Bowles DW, Kang H, Burtness B, Sherman E, Morton R, Morris LGT, Nadeem Z, Katabi N, Munster P, Schwartz GK. Phase II Study of Enzalutamide for Patients With Androgen Receptor–Positive Salivary Gland Cancers (Alliance A091404). Journal Of Clinical Oncology 2022, 40: 4240-4249. PMID: 35867947, PMCID: PMC9916043, DOI: 10.1200/jco.22.00229.Peer-Reviewed Original ResearchConceptsSalivary gland cancerPrimary end pointProgression-free survivalAndrogen receptorStable diseaseEnd pointOverall survivalPartial responseGland cancerTumor regressionPartial response/stable diseaseBest overall response rateMedian progression-free survivalResponse/stable diseaseHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Common adverse eventsMedian overall survivalPhase II studySecondary end pointsPhase II trialFree testosterone levelsGrowth factor receptor 2Overall response rateProgression of diseaseOutcomes 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 trial
2021
TRYHARD, a randomized phase II trial (RTOG Foundation 3501) of concurrent accelerated radiation plus cisplatin (cis) with or without lapatinib (Lap) for stage III- IV Non-HPV head and neck carcinoma (HNC).
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, Mell L, Spencer S, Stokes W, Yao M, Mitchell D, Harris J, Curran W, Le Q. TRYHARD, a randomized phase II trial (RTOG Foundation 3501) of concurrent accelerated radiation plus cisplatin (cis) with or without lapatinib (Lap) for stage III- IV Non-HPV head and neck carcinoma (HNC). Journal Of Clinical Oncology 2021, 39: 6014-6014. DOI: 10.1200/jco.2021.39.15_suppl.6014.Peer-Reviewed Original ResearchProgression-free survivalPhase II trialOverall survivalStage IIIII trialArm AGrade 3Treatment-related grade 3Randomized phase II trialFinal analysisEffects of chemoradiationBaseline patient characteristicsDays of therapyAdverse event ratesSurvival of patientsCycles of CDDPLog-rank testDual EGFRA vs BMucositis ratesRash ratesPFS ratePrimary endpointSecondary endpointsFrontline therapyUpdated 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 trialRandomized 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
Randomized, phase II study of ficlatuzumab with or without cetuximab in patients with pan-refractory, recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).
Bauman J, Roe D, Saba N, Bauman J, Kaczmar J, Burtness B, Muzaffar J, Julian R, Wang S, Bearelly S, Baker A, Steuer C, Bhatia A, Giri A, Caulin C, Stabile L, Centuori S, Chung C. Randomized, phase II study of ficlatuzumab with or without cetuximab in patients with pan-refractory, recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Journal Of Clinical Oncology 2020, 38: tps6594-tps6594. DOI: 10.1200/jco.2020.38.15_suppl.tps6594.Peer-Reviewed Original ResearchProgression-free survivalOverall response rateM HNSCCPhase II trialHepatocyte growth factorII trialCetuximab resistanceMulticenter phase II trialRecurrent/metastatic headTotal peripheral T cellsRandomized phase II trialExpression of HGFPoor progression-free survivalNeck squamous cell carcinomaPeripheral immune profileKey secondary endpointPhase II studyKey eligibility criteriaSquamous cell carcinomaPeripheral T cellsPI3K/AktIgG1 monoclonal antibodyTwo-arm designECOG 0EGFR monotherapy
2019
Alliance A091404: A phase II study of enzalutamide (NSC# 766085) for patients with androgen receptor-positive salivary cancers.
Ho A, Foster N, Zoroufy A, Worden F, Price K, Adkins D, Bowles D, Kang H, Burtness B, Sherman E, Morton R, Katabi N, Munster P, Schwartz G. Alliance A091404: A phase II study of enzalutamide (NSC# 766085) for patients with androgen receptor-positive salivary cancers. Journal Of Clinical Oncology 2019, 37: 6020-6020. DOI: 10.1200/jco.2019.37.15_suppl.6020.Peer-Reviewed Original ResearchProgression-free survivalSalivary gland cancerProgression of diseaseAndrogen receptorOverall survivalStable diseaseMedian progression-free survivalGood responsePhase II studyFirst prospective trialPhase II trialEligible patientsPrior therapyRECIST v1.1Salivary cancerUnconfirmed PRHormonal therapyII trialPrimary endpointSecondary endpointsII studyProspective trialGland cancerClinical activityConfirmatory scanPoint/Counterpoint: Do We De-escalate Treatment of HPV-Associated Oropharynx Cancer Now? And How?
Wirth LJ, Burtness B, Nathan CO, Grégoire V, Richmon J. Point/Counterpoint: Do We De-escalate Treatment of HPV-Associated Oropharynx Cancer Now? And How? American Society Of Clinical Oncology Educational Book 2019, 39: 364-372. PMID: 31099643, DOI: 10.1200/edbk_238315.Peer-Reviewed Original ResearchConceptsDe-escalate treatmentOropharyngeal carcinomaHPV-positive oropharyngeal carcinomaNeck cancer clinical researchNew systemic agentsPhase II trialPhase III trialsTreatment-related morbidityHigh cure ratesCancer clinical researchConcurrent cisplatinII trialOropharynx cancerPrimary surgeryDose intensityIII trialsInstitutional seriesInvasive resectionMultimodality treatmentSystemic agentsSystemic therapyPrimary diseaseCure rateToxic therapiesMultimodality strategy
2017
Phase II trial of ribociclib and everolimus in p16 low anaplastic thyroid cancer (ATC).
Tawfik B, Gerber D, Burtness B, Hughes R, Myers L, Sumer B, Truelson J, Strom T, Kurian P, Saleem S, Pearson J, Zhu H, Khan S. Phase II trial of ribociclib and everolimus in p16 low anaplastic thyroid cancer (ATC). Journal Of Clinical Oncology 2017, 35: tps6098-tps6098. DOI: 10.1200/jco.2017.35.15_suppl.tps6098.Peer-Reviewed Original ResearchAnaplastic thyroid cancerThyroid cancerCell cycle progressionII trialCycle progressionResponse ratePhase I/II trialOpen-label trialRare thyroid cancerPhase II trialAggressive clinical courseCDK 4/6 inhibitorsEffective treatment optionOverall response rateMTOR inhibitor everolimusATC cell linesRapid cell cycle progressionMedian OSATC patientsPrimary endpointSecondary endpointsMetastatic diseaseTrue response rateAdditional patientsClinical course
2016
E1308: Phase II Trial of Induction Chemotherapy Followed by Reduced-Dose Radiation and Weekly Cetuximab in Patients With HPV-Associated Resectable Squamous Cell Carcinoma of the Oropharynx— ECOG-ACRIN Cancer Research Group
Marur S, Li S, Cmelak AJ, Gillison ML, Zhao WJ, Ferris RL, Westra WH, Gilbert J, Bauman JE, Wagner LI, Trevarthen DR, Balkrishna J, Murphy BA, Agrawal N, Colevas AD, Chung CH, Burtness B. E1308: Phase II Trial of Induction Chemotherapy Followed by Reduced-Dose Radiation and Weekly Cetuximab in Patients With HPV-Associated Resectable Squamous Cell Carcinoma of the Oropharynx— ECOG-ACRIN Cancer Research Group. Journal Of Clinical Oncology 2016, 35: 490-497. PMID: 28029303, PMCID: PMC5455313, DOI: 10.1200/jco.2016.68.3300.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Squamous CellCetuximabChemoradiotherapyDisease-Free SurvivalDrug Administration ScheduleExanthemaFemaleHuman papillomavirus 16HumansInduction ChemotherapyMaleMiddle AgedNeutropeniaOropharyngeal NeoplasmsPapillomavirus InfectionsRadiotherapy DosageRemission InductionConceptsOropharyngeal squamous cell carcinomaComplete clinical responseCycle of ICPhase II trialProgression-free survivalSquamous cell carcinomaWeekly cetuximabII trialCell carcinomaPack-year smoking historyResectable squamous cell carcinomaFavorable-risk patientsPrimary end pointOverall survival rateHigh cure ratesCancer Research GroupGy of radiationRadiation doseLong-term toxicityRadiation dose reductionChemoradiation resultsICS respondersInduction chemotherapyLate sequelaeClinical responsePhase II trial of carboplatin/paclitaxel and cetuximab, followed by carboplatin/paclitaxel/cetuximab and erlotinib, in metastatic or recurrent squamous cell carcinoma of the head and neck.
Bhatia A, Mehra R, Khan S, Egleston B, Alpaugh R, Lango M, Ridge J, Burtness B. Phase II trial of carboplatin/paclitaxel and cetuximab, followed by carboplatin/paclitaxel/cetuximab and erlotinib, in metastatic or recurrent squamous cell carcinoma of the head and neck. Journal Of Clinical Oncology 2016, 34: 6027-6027. DOI: 10.1200/jco.2016.34.15_suppl.6027.Peer-Reviewed Original ResearchRandomized Phase II Trial of Irinotecan/Docetaxel or Irinotecan/Docetaxel Plus Cetuximab for Metastatic Pancreatic Cancer
Burtness B, Powell M, Catalano P, Berlin J, Liles DK, Chapman AE, Mitchell E, Benson AB. Randomized Phase II Trial of Irinotecan/Docetaxel or Irinotecan/Docetaxel Plus Cetuximab for Metastatic Pancreatic Cancer. American Journal Of Clinical Oncology 2016, 39: 340-345. PMID: 24685886, PMCID: PMC4177955, DOI: 10.1097/coc.0000000000000068.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAgedAnticoagulantsAntineoplastic Combined Chemotherapy ProtocolsCA-19-9 AntigenCamptothecinCetuximabDiarrheaDisease-Free SurvivalDocetaxelEnoxaparinFemaleHumansIrinotecanMaleMiddle AgedPancreatic NeoplasmsResponse Evaluation Criteria in Solid TumorsSurvival RateTaxoidsThromboembolismConceptsProgression-free survivalMetastatic pancreatic cancerAddition of cetuximabGrade 3/4 toxicitiesOverall survivalArm APancreatic cancerResponse rateArm B.Arm B. Median progression-free survivalMedian progression-free survivalPrincipal grade 3/4 toxicitiesRandomized phase II trialIrinotecan/docetaxelPhase II trialEligible patientsII trialPrimary endpointSecondary endpointsThromboembolic eventsDocetaxel combinationIrinotecan combinationObjective responseIrinotecan therapyMetastatic adenocarcinoma
2014
Afatinib versus placebo as adjuvant therapy after chemoradiation in a double-blind, phase III study (LUX-Head & Neck 2) in patients with primary unresected, clinically intermediate-to-high-risk head and neck cancer: study protocol for a randomized controlled trial
Burtness B, Bourhis JP, Vermorken JB, Harrington KJ, Cohen E. Afatinib versus placebo as adjuvant therapy after chemoradiation in a double-blind, phase III study (LUX-Head & Neck 2) in patients with primary unresected, clinically intermediate-to-high-risk head and neck cancer: study protocol for a randomized controlled trial. Trials 2014, 15: 469. PMID: 25432788, PMCID: PMC4289298, DOI: 10.1186/1745-6215-15-469.Peer-Reviewed Original ResearchMeSH KeywordsAfatinibAntineoplastic AgentsCarcinoma, Squamous CellChemoradiotherapyChemotherapy, AdjuvantClinical ProtocolsDisease-Free SurvivalDouble-Blind MethodErbB ReceptorsHead and Neck NeoplasmsHumansMolecular Targeted TherapyNeoplasm Recurrence, LocalNeoplasm StagingProtein Kinase InhibitorsQuality of LifeQuinazolinesResearch DesignRisk FactorsSquamous Cell Carcinoma of Head and NeckTime FactorsTreatment OutcomeConceptsEpidermal growth factor receptorDisease-free survivalErbB family membersAdvanced diseaseOropharynx cancerOverall survivalEndpoint measuresUnfavourable riskPrimary siteHigh-risk HNSCC patientsHPV-positive oropharynx cancerIrreversible ErbB family blockerDisease-free survival ratesRandomized phase II trialNeck squamous cell carcinomaErbB family blockerHigh-risk headHigh-risk HNSCCPrimary endpoint measureGood clinical conditionEvidence of diseaseLymph node involvementPhase II trialPhase III studyUnacceptable adverse eventsPrognostic Biomarkers in Phase II Trial of Cetuximab-Containing Induction and Chemoradiation in Resectable HNSCC: Eastern Cooperative Oncology Group E2303
Psyrri A, Lee JW, Pectasides E, Vassilakopoulou M, Kosmidis EK, Burtness BA, Rimm DL, Wanebo HJ, Forastiere AA. Prognostic Biomarkers in Phase II Trial of Cetuximab-Containing Induction and Chemoradiation in Resectable HNSCC: Eastern Cooperative Oncology Group E2303. Clinical Cancer Research 2014, 20: 3023-3032. PMID: 24700741, PMCID: PMC4049169, DOI: 10.1158/1078-0432.ccr-14-0113.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCarboplatinCarcinoma, Squamous CellCetuximabChemoradiotherapyDisease-Free SurvivalDrug Resistance, NeoplasmFemaleFluorescent Antibody TechniqueHead and Neck NeoplasmsHumansInduction ChemotherapyKaplan-Meier EstimateMaleMiddle AgedMitogen-Activated Protein Kinase KinasesPaclitaxelPhosphatidylinositol 3-KinasesPrognosisProportional Hazards ModelsProto-Oncogene Proteins c-aktRas ProteinsSignal TransductionSquamous Cell Carcinoma of Head and NeckTissue Array AnalysisConceptsProgression-free survivalEvent-free survivalPhase II trialOverall survivalII trialTissue microarrayStage III/IV headMultivariable Cox proportional hazards modelsMultivariable Cox regression analysisNeck squamous cell cancerRAS/MAPK/ERKCox proportional hazards modelInsulin-like growth factor 1 receptorLarge prospective studiesCox regression analysisInferior overall survivalKaplan-Meier methodSquamous cell cancerLog-rank testGrowth factor 1 receptorProportional hazards modelPI3K/Akt pathwayFactor 1 receptorPI3K/AktEGF receptorPrognostic significance of human papillomavirus in recurrent or metastatic head and neck cancer: an analysis of Eastern Cooperative Oncology Group trials
Argiris A, Li S, Ghebremichael M, Egloff AM, Wang L, Forastiere AA, Burtness B, Mehra R. Prognostic significance of human papillomavirus in recurrent or metastatic head and neck cancer: an analysis of Eastern Cooperative Oncology Group trials. Annals Of Oncology 2014, 25: 1410-1416. PMID: 24799460, PMCID: PMC4071756, DOI: 10.1093/annonc/mdu167.Peer-Reviewed Original ResearchConceptsProgression-free survivalHuman papillomavirusOverall survivalMetastatic SCCHNClinical outcomesClinical trialsEastern Cooperative Oncology Group trialMetastatic squamous cell carcinomaP16-negative patientsP16-positive patientsHPV-negative patientsObjective response ratePhase II trialPhase III trialsFavorable prognostic factorSquamous cell carcinomaUnfavorable risk factorsWide spectrum probeII trialMetastatic headHazard ratioIII trialsMedian survivalObjective responseHPV DNA
2013
Analysis of HPV and ERCC1 in recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN).
Mehra R, Egloff A, Li S, Yang D, Wang L, Zhu F, Forastiere A, Burtness B, Argiris A. Analysis of HPV and ERCC1 in recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). Journal Of Clinical Oncology 2013, 31: 6006-6006. DOI: 10.1200/jco.2013.31.15_suppl.6006.Peer-Reviewed Original ResearchCisplatin/paclitaxelHazard ratioHuman papillomavirusCisplatin/5-FUResponse rateM SCCHNOdds ratioExact testAnalysis of HPVMetastatic squamous cell carcinomaDocetaxel/irinotecanTumor p16 statusObjective response ratePhase II trialSquamous cell carcinomaCox regression modelLog-rank testPotential confounding factorsFisher's exact testHPV-/p16Better OSII trialHPV DNAClinical outcomesCell carcinomaE 1308: A phase II trial of induction chemotherapy (IC) followed by cetuximab with low dose versus standard dose IMRT in patients with human papilloma virus (HPV)-associated resectable squamous cell carcinoma of the oropharynx (OPSCC).
Marur S, Li S, Cmelak A, Gillison M, Ferris R, Bauman J, Zhao W, Westra W, Chung C, Wagner L, Trevarthen D, Jahagirdar B, Colevas A, Burtness B. E 1308: A phase II trial of induction chemotherapy (IC) followed by cetuximab with low dose versus standard dose IMRT in patients with human papilloma virus (HPV)-associated resectable squamous cell carcinoma of the oropharynx (OPSCC). Journal Of Clinical Oncology 2013, 31: 6005-6005. DOI: 10.1200/jco.2013.31.15_suppl.6005.Peer-Reviewed Original ResearchClinical complete responseGrade 3/4 toxicitiesInduction chemotherapyLow doseBetter overall clinical responseCycles of ICPost-treatment neck dissectionResectable squamous cell carcinomaStage III/IVAOverall clinical responseWeek x 3Phase II trialSquamous cell carcinomaHuman papilloma virusPost-baseline measurementRadiation dose reductionEligible ptsHPV-OPSCCYear PFSOPSCC patientsPrimary endpointSecondary endpointsClinical responseCurrent smokersII trial