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
2014
Trastuzumab Emtansine in Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer: An Integrated Safety Analysis
Diéras V, Harbeck N, Budd GT, Greenson JK, Guardino AE, Samant M, Chernyukhin N, Smitt MC, Krop IE. Trastuzumab Emtansine in Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer: An Integrated Safety Analysis. Journal Of Clinical Oncology 2014, 32: 2750-2757. PMID: 25024070, DOI: 10.1200/jco.2013.54.4999.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerHER2-positive metastatic breast cancerHuman epidermal growth factor receptor 2Adverse eventsDrug discontinuationSafety profileT-DM1Trastuzumab emtansineBreast cancerGrade 3Dose reductionEpidermal growth factor receptor 2Human epidermal growth factor receptorCommon grade 3Grade adverse eventsRandomized phase IISelect adverse eventsBreast cancer settingGreater adverse eventsGrowth factor receptor 2Single-arm studyT-DM1 treatmentFavorable safety profileFactor receptor 2Epidermal growth factor receptor