2017
Trastuzumab emtansine versus treatment of physician's choice in patients with previously treated HER2-positive metastatic breast cancer (TH3RESA): final overall survival results from a randomised open-label phase 3 trial
Krop IE, Kim SB, Martin AG, LoRusso PM, Ferrero JM, Badovinac-Crnjevic T, Hoersch S, Smitt M, Wildiers H. Trastuzumab emtansine versus treatment of physician's choice in patients with previously treated HER2-positive metastatic breast cancer (TH3RESA): final overall survival results from a randomised open-label phase 3 trial. The Lancet Oncology 2017, 18: 743-754. PMID: 28526538, DOI: 10.1016/s1470-2045(17)30313-3.Peer-Reviewed Original ResearchMeSH KeywordsAdo-Trastuzumab EmtansineAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsBreast Neoplasms, MaleBridged-Ring CompoundsChemotherapy-Induced Febrile NeutropeniaDiarrheaEarly Termination of Clinical TrialsFemaleHemorrhageHumansLapatinibMaleMaytansineMiddle AgedNeoplasm MetastasisNeutropeniaPractice Patterns, Physicians'QuinazolinesReceptor, ErbB-2RetreatmentSurvival RateTaxoidsThrombocytopeniaTrastuzumabConceptsHER2-positive advanced breast cancerPhysician's choice groupAdvanced breast cancerWorse adverse eventsProgression-free survivalOverall survivalTrastuzumab emtansineAdverse eventsOverall survival analysisBreast cancerPhysician's choiceTH3RESA trialGrade 3Eastern Cooperative Oncology Group performance statusInvestigator-assessed progression-free survivalOpen-label phase 3 trialHER2-positive metastatic breast cancerSurvival analysisFinal overall survival analysisFinal overall survival resultsAdequate organ functionCommon grade 3Permuted block randomisationTrastuzumab emtansine treatmentSecond interim analysis
2012
Trastuzumab Emtansine for HER2-Positive Advanced Breast Cancer
Verma S, Miles D, Gianni L, Krop IE, Welslau M, Baselga J, Pegram M, Oh DY, Diéras V, Guardino E, Fang L, Lu MW, Olsen S, Blackwell K. Trastuzumab Emtansine for HER2-Positive Advanced Breast Cancer. New England Journal Of Medicine 2012, 367: 1783-1791. PMID: 23020162, PMCID: PMC5125250, DOI: 10.1056/nejmoa1209124.Peer-Reviewed Original ResearchMeSH KeywordsAdo-Trastuzumab EmtansineAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCapecitabineDeoxycytidineDisease-Free SurvivalFemaleFluorouracilHumansIntention to Treat AnalysisKaplan-Meier EstimateLapatinibMaytansineMiddle AgedNeoplasm MetastasisQuinazolinesReceptor, ErbB-2Survival RateTrastuzumabYoung AdultConceptsHER2-positive advanced breast cancerAdvanced breast cancerProgression-free survivalObjective response rateSecondary end pointsT-DM1Overall survivalBreast cancerEnd pointTrastuzumab emtansineInterim analysisResponse rateAdditional secondary end pointsMedian progression-free survivalHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Incidence of thrombocytopeniaMedian overall survivalPrimary end pointSerum aminotransferase levelsPalmar-plantar erythrodysesthesiaSecond interim analysisGrowth factor receptor 2Incidence of diarrheaFactor receptor 2