Phase III Randomized Trial of Cisplatin Plus Placebo Compared With Cisplatin Plus Cetuximab in Metastatic/Recurrent Head and Neck Cancer: An Eastern Cooperative Oncology Group Study
Burtness B, Goldwasser MA, Flood W, Mattar B, Forastiere AA. Phase III Randomized Trial of Cisplatin Plus Placebo Compared With Cisplatin Plus Cetuximab in Metastatic/Recurrent Head and Neck Cancer: An Eastern Cooperative Oncology Group Study. Journal Of Clinical Oncology 2005, 23: 8646-8654. PMID: 16314626, DOI: 10.1200/jco.2005.02.4646.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Squamous CellCetuximabCisplatinCross-Over StudiesDose-Response Relationship, DrugDrug HypersensitivityErbB ReceptorsFemaleFollow-Up StudiesHead and Neck NeoplasmsHematologic DiseasesHumansImmunohistochemistryMaleMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalSeverity of Illness IndexSkin DiseasesSurvival AnalysisTime FactorsTreatment OutcomeConceptsProgression-free survivalAddition of cetuximabRecurrent/metastatic squamous cell carcinomaMedian progression-free survivalMetastatic squamous cell carcinomaEpidermal growth factor receptorSquamous cell carcinomaOverall survivalArm BArm AResponse rateEnd pointHazard ratioCell carcinomaCorrelation of EGFREastern Cooperative Oncology Group StudyMetastatic/recurrent headPhase III randomized trialsCetuximab-treated patientsMedian overall survivalObjective response ratePrimary end pointSecondary end pointsClinical end pointsDevelopment of rash