2019
Trastuzumab deruxtecan (DS-8201a) in patients with advanced HER2-positive breast cancer previously treated with trastuzumab emtansine: a dose-expansion, phase 1 study
Tamura K, Tsurutani J, Takahashi S, Iwata H, Krop IE, Redfern C, Sagara Y, Doi T, Park H, Murthy RK, Redman RA, Jikoh T, Lee C, Sugihara M, Shahidi J, Yver A, Modi S. Trastuzumab deruxtecan (DS-8201a) in patients with advanced HER2-positive breast cancer previously treated with trastuzumab emtansine: a dose-expansion, phase 1 study. The Lancet Oncology 2019, 20: 816-826. PMID: 31047803, DOI: 10.1016/s1470-2045(19)30097-x.Peer-Reviewed Original ResearchMeSH KeywordsAdo-Trastuzumab EmtansineAgedAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalBreast NeoplasmsCamptothecinFemaleFollow-Up StudiesHumansImmunoconjugatesMaximum Tolerated DoseMiddle AgedPrognosisReceptor, ErbB-2Salvage TherapySurvival RateTissue DistributionTrastuzumabConceptsHER2-positive breast cancerTreatment-emergent adverse eventsAdvanced-stage breast cancerTrastuzumab emtansine treatmentTrastuzumab deruxtecanPhase 1 trialBreast cancerAdverse eventsProgressive diseaseSerious treatment-emergent adverse eventsWorse treatment-emergent adverse eventsAdvanced HER2-positive breast cancerSolid tumorsTopoisomerase I inhibitor payloadFrequent grade 3Grade 3 eventsTreatment-related deathsManageable safety profileAdvanced solid tumorsMultiple-dose studyPhase 1 studyInterstitial lung diseaseWithdrawal of consentWhite blood cellsYears of age
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