2021
Randomized 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
2017
Phase III randomized trial of chemotherapy with or without bevacizumab (B) in patients (pts) with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN): Survival analysis of E1305, an ECOG-ACRIN Cancer Research Group trial.
Argiris A, Li S, Savvides P, Ohr J, Gilbert J, Levine M, Haigentz M, Saba N, Chakravarti A, Ikpeazu C, Schneider C, Pinto H, Forastiere A, Burtness B. Phase III randomized trial of chemotherapy with or without bevacizumab (B) in patients (pts) with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN): Survival analysis of E1305, an ECOG-ACRIN Cancer Research Group trial. Journal Of Clinical Oncology 2017, 35: 6000-6000. DOI: 10.1200/jco.2017.35.15_suppl.6000.Peer-Reviewed Original ResearchMedian overall survivalOverall survivalArm BM SCCHNAUC 6Hazard ratioArm AResponse rateMetastatic squamous cell carcinomaAnti-VEGF monoclonal antibodyCarboplatin AUC 6Objective response ratePerformance status 0Trial of chemotherapyFirst-line treatmentSquamous cell carcinomaImproved response ratesA vs BEligible ptsMedian PFSOropharyngeal primaryPlatinum doubletsStatus 0Primary endpointProphylactic antibiotics
2011
A phase 2 trial of bortezomib followed by the addition of doxorubicin at progression in patients with recurrent or metastatic adenoid cystic carcinoma of the head and neck
Argiris A, Ghebremichael M, Burtness B, Axelrod RS, Deconti RC, Forastiere AA. A phase 2 trial of bortezomib followed by the addition of doxorubicin at progression in patients with recurrent or metastatic adenoid cystic carcinoma of the head and neck. Cancer 2011, 117: 3374-3382. PMID: 21246525, PMCID: PMC3135694, DOI: 10.1002/cncr.25852.Peer-Reviewed Original ResearchConceptsAdenoid cystic carcinomaStable diseaseEvaluable patientsObjective responseCystic carcinomaEastern Cooperative Oncology Group performance status 0Day 1Common distant metastatic siteGrade 3 sensory neuropathyMedian progression-free survivalMetastatic adenoid cystic carcinomaGrade 3 anorexiaPerformance status 0Phase 2 trialProgression-free survivalTime of progressionSingle-agent bortezomibCombination of bortezomibDistant metastatic sitesAddition of doxorubicinMeasurable diseaseStatus 0Disease stabilizationFrequent toxicitiesPrior therapy
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 disease
2006
A phase II trial of PS-341 (bortezomib) followed by the addition of doxorubicin at progression in incurable adenoid cystic carcinoma of the head and neck: An Eastern Cooperative Oncology Group study
Argiris A, Goldwasser M, Burtness B, Deconti R, Axelrod R, Van Waes C, Forastiere A. A phase II trial of PS-341 (bortezomib) followed by the addition of doxorubicin at progression in incurable adenoid cystic carcinoma of the head and neck: An Eastern Cooperative Oncology Group study. Journal Of Clinical Oncology 2006, 24: 5573-5573. DOI: 10.1200/jco.2006.24.18_suppl.5573.Peer-Reviewed Original ResearchStable diseaseEvaluable ptsNeutropenia 5Cystic carcinomaEastern Cooperative Oncology Group StudyECOG performance status 0Median progression-free survivalGrade 3/4 toxicitiesPerformance status 0Absolute neutrophil countPhase II trialProgression-free survivalTime of progressionAdenoid cystic carcinomaDistant metastatic sitesNF-κB activityAddition of doxorubicinBaseline tumorDiarrhea 5Measurable diseasePrior therapyStatus 0Thrombocytopenia 5Disease stabilizationII trial