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
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 therapy
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
2016
Randomized 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 events
2007
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
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
2006
2111 ECOG 1200: A Randomized Phase II Trial of Gemcitabine Plus Radiotherapy vs Gemcitabine, 5-Fluorouracil and Cisplatin Followed by Radiotherapy and 5-Fluorouracil in Patients With Locally Advanced, Potentially Resectable Pancreatic Adenocarcinoma
Landry J, Catalano P, Hoffman J, Staley C, Harris W, Burtness B, Frontiera M, Berlin J, Benson A. 2111 ECOG 1200: A Randomized Phase II Trial of Gemcitabine Plus Radiotherapy vs Gemcitabine, 5-Fluorouracil and Cisplatin Followed by Radiotherapy and 5-Fluorouracil in Patients With Locally Advanced, Potentially Resectable Pancreatic Adenocarcinoma. International Journal Of Radiation Oncology • Biology • Physics 2006, 66: s272. DOI: 10.1016/j.ijrobp.2006.07.515.Peer-Reviewed Original Research