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
2012
LUX head and neck 2: A randomized, double-blind, placebo-controlled, phase III study of afatinib as adjuvant therapy after chemoradiation in primarily unresected, clinically high-risk, head and neck cancer patients.
Burtness B, Bourhis J, Vermorken J, Dai L, Lind C, Ehrnrooth E, Cohen E. LUX head and neck 2: A randomized, double-blind, placebo-controlled, phase III study of afatinib as adjuvant therapy after chemoradiation in primarily unresected, clinically high-risk, head and neck cancer patients. Journal Of Clinical Oncology 2012, 30: tps5599-tps5599. DOI: 10.1200/jco.2012.30.15_suppl.tps5599.Peer-Reviewed Original ResearchDisease-free survivalNeck dissectionPO QDAdvanced squamous cell cancerIrreversible ErbB family blockerAdequate bone marrowErbB family blockerStudy of afatinibSubsequent neck dissectionCompletion of chemoradiationEvidence of diseaseHigh-risk patientsSecond primary tumorsHealth-related qualityBase of tongueSquamous cell cancerRisk of recurrenceNeck cancer patientsPlatinum-based chemoradiationSalivary gland cancerConcurrent cisplatinCurative intentDefinitive chemoradiationPrior therapyStudy medication
2006
Phase II, parallel-design study of preoperative combined modality therapy and the matrix metalloprotease (mmp) inhibitor prinomastat in patients with esophageal adenocarcinoma
Heath EI, Burtness BA, Kleinberg L, Salem RR, Yang SC, Heitmiller RF, Canto MI, Knisely JP, Topazian M, Montgomery E, Tsottles N, Pithavala Y, Rohmiller B, Collier M, Forastiere AA. Phase II, parallel-design study of preoperative combined modality therapy and the matrix metalloprotease (mmp) inhibitor prinomastat in patients with esophageal adenocarcinoma. Investigational New Drugs 2006, 24: 135-140. PMID: 16502351, DOI: 10.1007/s10637-006-5934-5.Peer-Reviewed Original ResearchConceptsPathologic complete response rateThrombo-embolic eventsParallel design studyModality therapyResponse rateAdvanced esophageal cancer patientsRandomized phase IIComplete response rateEvidence of diseaseProgression-free survivalEsophageal cancer patientsOverall response ratePhase IIAdjuvant paclitaxelConcurrent radiotherapyEligible patientsPreoperative treatmentMusculoskeletal toxicityOverall survivalResectable adenocarcinomaDisease relapsePreoperative stagingTreatment armsDisease improvementContinuous infusion