2017
Double‐blind, randomized phase 3 trial of low‐dose 13‐cis retinoic acid in the prevention of second primaries in head and neck cancer: Long‐term follow‐up of a trial of the Eastern Cooperative Oncology Group‐ACRIN Cancer Research Group (C0590)
Bhatia AK, Lee J, Pinto HA, Jacobs CD, Limburg PJ, Rubin P, Arusell RM, Dunphy EP, Khandekar JD, Reiner SA, Baez‐Diaz L, Celano P, Li S, Li Y, Burtness BA, Adams GL, Pandya KJ. Double‐blind, randomized phase 3 trial of low‐dose 13‐cis retinoic acid in the prevention of second primaries in head and neck cancer: Long‐term follow‐up of a trial of the Eastern Cooperative Oncology Group‐ACRIN Cancer Research Group (C0590). Cancer 2017, 123: 4653-4662. PMID: 28786105, PMCID: PMC5693641, DOI: 10.1002/cncr.30920.Peer-Reviewed Original ResearchConceptsSecond primary tumorsOverall survivalFormer smokersDevelopment of SPTsIncidence of SPTsEarly-stage SCCHNFuture prevention trialsImproved overall survivalClinical risk factorsSquamous cell cancerLog-rank testLong-term resultsPotential survival advantageCompeting-risk approachCumulative incidenceIndex tumorCell cancerPrevention trialsPrimary tumorRisk factorsSubset analysisDry skinSurvival advantagePatientsTargeted interventions
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