Phase III Randomized, Placebo-Controlled Trial of Docetaxel With or Without Gefitinib in Recurrent or Metastatic Head and Neck Cancer: An Eastern Cooperative Oncology Group Trial
Argiris A, Ghebremichael M, Gilbert J, Lee JW, Sachidanandam K, Kolesar JM, Burtness B, Forastiere AA. Phase III Randomized, Placebo-Controlled Trial of Docetaxel With or Without Gefitinib in Recurrent or Metastatic Head and Neck Cancer: An Eastern Cooperative Oncology Group Trial. Journal Of Clinical Oncology 2013, 31: 1405-1414. PMID: 23460714, PMCID: PMC3612594, DOI: 10.1200/jco.2012.45.4272.Peer-Reviewed Original ResearchMeSH KeywordsAdultAge FactorsAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Squamous CellDiarrheaDocetaxelDrug Administration ScheduleErbB ReceptorsFatigueFemaleGefitinibGenotypeHead and Neck NeoplasmsHumansKaplan-Meier EstimateLeukopeniaMaleMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalProto-Oncogene ProteinsProto-Oncogene Proteins c-metProto-Oncogene Proteins p21(ras)QuinazolinesRas ProteinsTaxoidsTreatment OutcomeConceptsAddition of gefitinibPerformance statusArm ADisease progressionEastern Cooperative Oncology Group performance statusEastern Cooperative Oncology Group trialEpidermal growth factor receptor tyrosine kinase inhibitorsGrowth factor receptor tyrosine kinase inhibitorsReceptor tyrosine kinase inhibitorsGrade 3/4 diarrheaPhase III randomizedSingle-agent gefitinibTrials of docetaxelUnplanned subset analysisECOG performance statusGrade 3/4 toxicitiesMedian overall survivalTime of progressionSquamous cell carcinomaTyrosine kinase inhibitorsEligible patientsMetastatic SCCHNWeekly docetaxelMetastatic headOverall survival