Gefitinib in Combination With Gemcitabine and Cisplatin in Advanced Non–Small-Cell Lung Cancer: A Phase III Trial—INTACT 1
Giaccone G, Herbst RS, Manegold C, Scagliotti G, Rosell R, Miller V, Natale RB, Schiller JH, von Pawel J, Pluzanska A, Gatzemeier U, Grous J, Ochs JS, Averbuch SD, Wolf MK, Rennie P, Fandi A, Johnson DH. Gefitinib in Combination With Gemcitabine and Cisplatin in Advanced Non–Small-Cell Lung Cancer: A Phase III Trial—INTACT 1. Journal Of Clinical Oncology 2004, 22: 777-784. PMID: 14990632, DOI: 10.1200/jco.2004.08.001.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungCisplatinDeoxycytidineDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleGefitinibGemcitabineHumansLung NeoplasmsMaleMaximum Tolerated DoseMiddle AgedMultivariate AnalysisNeoplasm InvasivenessNeoplasm StagingProbabilityPrognosisQuinazolinesReference ValuesSurvival AnalysisTreatment OutcomeConceptsChemotherapy-naive patientsAdvanced NSCLCLung cancerAdvanced non-small cell lung cancerResponse rateNon-small cell lung cancerEpidermal growth factor receptor tyrosine kinase inhibitor gefitinibEnd pointUnresectable stage IIICycles of chemotherapyEfficacy end pointPhase II trialFirst-line gemcitabineTyrosine kinase inhibitor gefitinibPhase I trialCell lung cancerUnexpected adverse eventsMedian survival timeKinase inhibitor gefitinibFurther preclinical testingDaily gefitinibFavorable tolerabilityII trialPlacebo groupAdverse eventsGefitinib in Combination With Paclitaxel and Carboplatin in Advanced Non–Small-Cell Lung Cancer: A Phase III Trial—INTACT 2
Herbst RS, Giaccone G, Schiller JH, Natale RB, Miller V, Manegold C, Scagliotti G, Rosell R, Oliff I, Reeves JA, Wolf MK, Krebs AD, Averbuch SD, Ochs JS, Grous J, Fandi A, Johnson DH. Gefitinib in Combination With Paclitaxel and Carboplatin in Advanced Non–Small-Cell Lung Cancer: A Phase III Trial—INTACT 2. Journal Of Clinical Oncology 2004, 22: 785-794. PMID: 14990633, DOI: 10.1200/jco.2004.07.215.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCarcinoma, Non-Small-Cell LungDose-Response Relationship, DrugDrug Administration ScheduleFemaleGefitinibHumansInfusions, IntravenousLung NeoplasmsMaleMaximum Tolerated DoseMiddle AgedMultivariate AnalysisNeoplasm StagingPaclitaxelPredictive Value of TestsPrognosisQuinazolinesReference ValuesRisk AssessmentSurvival AnalysisTreatment OutcomeConceptsResponse rateOverall survivalLung cancerActive epidermal growth factor receptor tyrosine kinase inhibitorAdvanced non-small cell lung cancerEpidermal growth factor receptor tyrosine kinase inhibitorsGrowth factor receptor tyrosine kinase inhibitorsNon-small cell lung cancerReceptor tyrosine kinase inhibitorsDose-related diarrheaSignificant prolonged survivalUnexpected safety findingsChemotherapy-naive patientsDouble-blind trialPlacebo-controlled trialPhase II trialBaseline demographic characteristicsPhase I trialCell lung cancerConcentration/time curveTyrosine kinase inhibitorsCarboplatin areaDaily gefitinibGefitinib monotherapyMonotherapy trials