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 antibioticsLUX-head and neck 2: Randomized, double-blind, placebo-controlled, phase III trial of afatinib as adjuvant therapy after chemoradiation (CRT) in primary unresected, high/intermediate-risk, squamous cell cancer of the head and neck (HNSCC) patients (pts).
Burtness B, Haddad R, Dinis J, Trigo Perez J, Yokota T, Viana L, Romanov I, Vermorken J, Bourhis J, Tahara M, Segalla J, Psyrri A, Vasilevskaya I, Nangia C, Chaves-Conde M, Wang B, Gibson N, Ehrnrooth E, Harrington K, Cohen E. LUX-head and neck 2: Randomized, double-blind, placebo-controlled, phase III trial of afatinib as adjuvant therapy after chemoradiation (CRT) in primary unresected, high/intermediate-risk, squamous cell cancer of the head and neck (HNSCC) patients (pts). Journal Of Clinical Oncology 2017, 35: 6001-6001. DOI: 10.1200/jco.2017.35.15_suppl.6001.Peer-Reviewed Original ResearchDisease-free survivalPhase III trialsIII trialsEGFR inhibitionMedian disease-free survivalRecurrent/metastatic diseaseErbB family blocker afatinibPre-planned interim analysisECOG PS 0Median treatment durationSquamous cell cancerDefinitive chemoradiationECOG PSEligible ptsAdvanced HNSCCConcurrent cisplatinN2 diseasePrimary endpointAdjuvant therapyMetastatic diseasePS 0Complete responseDisease recurrenceMedian ageNodal stage
2013
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).
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
2006
A randomized phase II study of BMS-247550 (ixabepilone) given daily x 5 days every 3 weeks or weekly in patients with metastatic or recurrent squamous cell cancer of the head and neck
Burtness B, Goldwasser M, Axelrod R, Argiris A, Forastiere A. A randomized phase II study of BMS-247550 (ixabepilone) given daily x 5 days every 3 weeks or weekly in patients with metastatic or recurrent squamous cell cancer of the head and neck. Journal Of Clinical Oncology 2006, 24: 5532-5532. DOI: 10.1200/jco.2006.24.18_suppl.5532.Peer-Reviewed Original ResearchArm BEligible ptsArm A.Recurrent squamous cell cancerRandomized phase II studyMetastatic/recurrent diseaseECOG PS 0Grade 3/4 anemiaPhase II studySquamous cell cancerDiphenhydramine premedicationMales 69Prior regimensRecurrent SCCHNTaxane exposurePrimary endpointII studyMedian survivalPartial responseProgressive diseasePS 0Recurrent diseaseMotor neuropathyArm ACell cancer