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 outcomes
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 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 trial
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
Prognostic 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
2010
Tumor molecular correlates of unresectable, locally advanced head and neck squamous cell carcinoma (SCCHN) response to concurrent radiation (RT), cisplatin (DDP), and cetuximab (C225) in a phase II trial (ECOG 3303).
Egloff A, Lee J, Vaezi A, Langer C, Forastiere A, Quon H, Burtness B, Grandis J. Tumor molecular correlates of unresectable, locally advanced head and neck squamous cell carcinoma (SCCHN) response to concurrent radiation (RT), cisplatin (DDP), and cetuximab (C225) in a phase II trial (ECOG 3303). Journal Of Clinical Oncology 2010, 28: 5537-5537. DOI: 10.1200/jco.2010.28.15_suppl.5537.Peer-Reviewed Original Research
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
2007
Phase II Trial of Weekly Docetaxel/Irinotecan Combination in Advanced Pancreatic Cancer
Burtness B, Thomas L, Sipples R, McGurk M, Salikooti S, Christoforou M, Mirto G, Salem R, Sosa J, Kloss R, Rahman Z, Chung G, Lacy J, Murren JR. Phase II Trial of Weekly Docetaxel/Irinotecan Combination in Advanced Pancreatic Cancer. The Cancer Journal 2007, 13: 257-262. PMID: 17762761, DOI: 10.1097/ppo.0b013e31813c1174.Peer-Reviewed Original ResearchConceptsAdvanced pancreatic cancerPancreatic cancerEligible patientsIrinotecan combinationPartial responseComplete responseEastern Cooperative Oncology Group performance status 0Principal grade 3/4 toxicitiesWorld Health Organization criteriaSafety of docetaxelGrade 3/4 toxicitiesObjective response ratePerformance status 0One-year survivalPhase II trialCombination of docetaxelNormal bilirubin levelsEvaluable patientsFebrile neutropeniaMeasurable diseaseStatus 0Toxic deathsUnresectable diseaseII trialRecurrent diseasePhase II trial of irinotecan/docetaxel for advanced pancreatic cancer with randomization between irinotecan/docetaxel and irinotecan/docetaxel plus C225, a monoclonal antibody to the epidermal growth factor receptor (EGF-r) : Eastern Cooperative Oncology
Burtness B, Powell M, Berlin J, Liles D, Chapman A, Mitchell E, Benson A. Phase II trial of irinotecan/docetaxel for advanced pancreatic cancer with randomization between irinotecan/docetaxel and irinotecan/docetaxel plus C225, a monoclonal antibody to the epidermal growth factor receptor (EGF-r) : Eastern Cooperative Oncology. Journal Of Clinical Oncology 2007, 25: 4519-4519. DOI: 10.1200/jco.2007.25.18_suppl.4519.Peer-Reviewed Original ResearchPhase II trialArm AII trialPS 0Arm BPancreatic cancerMedian survivalOverall survivalRandomized phase II trialECOG PS 0Treatment-related deathsMedian overall survivalMetastatic pancreatic cancerTherapeutic anticoagulationDocetaxel chemotherapyMetastatic patientsPrimary endpointBiologic agentsDistant metastasisHistologic confirmationNormal bilirubinSame therapyYear survivalMedian numberArm 2Her signaling in pancreatic cancer
Burtness B. Her signaling in pancreatic cancer. Expert Opinion On Biological Therapy 2007, 7: 823-829. PMID: 17555368, DOI: 10.1517/14712598.7.6.823.Peer-Reviewed Original ResearchMeSH KeywordsAnimalsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntimetabolites, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsCetuximabDeoxycytidineEpidermal Growth FactorErlotinib HydrochlorideGemcitabineHumansLapatinibOrganoplatinum CompoundsOxaliplatinPancreatic NeoplasmsProtein Kinase InhibitorsQuinazolinesReceptor, ErbB-2Signal TransductionTreatment OutcomeConceptsPhase II trialPhase III trialsPancreatic cancerEpidermal growth factor receptorII trialIII trialsRandomized phase II trialTreatment-refractory cancerManagement of patientsPhase I trialEGFR antibody cetuximabAddition of erlotinibGrowth factor receptorGemcitabine chemotherapyMedian survivalStandard therapyI trialPatient selectionSignificant prolongationMetastatic cancerAntibody cetuximabTherapeutic targetGemcitabineEGFR/Cancer