2017
Biomarkers predict enhanced clinical outcomes with afatinib versus methotrexate in patients with second-line recurrent and/or metastatic head and neck cancer
Cohen EEW, Licitra LF, Burtness B, Fayette J, Gauler T, Clement PM, Grau JJ, del Campo JM, Mailliez A, Haddad RI, Vermorken JB, Tahara M, Guigay J, Geoffrois L, Merlano MC, Dupuis N, Krämer N, Cong XJ, Gibson N, Solca F, Ehrnrooth E, Machiels J. Biomarkers predict enhanced clinical outcomes with afatinib versus methotrexate in patients with second-line recurrent and/or metastatic head and neck cancer. Annals Of Oncology 2017, 28: 2526-2532. PMID: 28961833, PMCID: PMC5834024, DOI: 10.1093/annonc/mdx344.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, IntravenousAdministration, OralAfatinibAntimetabolites, AntineoplasticBiomarkers, TumorBiopsyCarcinoma, Squamous CellDisease-Free SurvivalHead and Neck NeoplasmsHumansMethotrexateNeoplasm MetastasisNeoplasm Recurrence, LocalPredictive Value of TestsQuinazolinesSquamous Cell Carcinoma of Head and NeckConceptsProgression-free survivalMetastatic headEfficacy outcomesMedian progression-free survivalRecurrent/metastatic headNeck squamous cell carcinomaTumor biomarkersNeck 1 trialP16-positive diseaseSecond-line afatinibOverall study populationSubset of patientsP16-negative tumorsSquamous cell carcinomaEnhanced clinical outcomesBiomarker analysisM HNSCCTherapy-naïveBaseline characteristicsStudy entryClinical outcomesHNSCC patientsPlatinum therapyCell carcinomaNeck cancer
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