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
2012
Primary results from EMILIA, a phase III study of trastuzumab emtansine (T-DM1) versus capecitabine (X) and lapatinib (L) in HER2-positive locally advanced or metastatic breast cancer (MBC) previously treated with trastuzumab (T) and a taxane.
Pegram M, Blackwell K, Miles D, Bianchi G, Krop I, Welslau M, Baselga J, Oh D, Dieras V, Guardino E, Olsen S, Fang L, Lu M, Verma S. Primary results from EMILIA, a phase III study of trastuzumab emtansine (T-DM1) versus capecitabine (X) and lapatinib (L) in HER2-positive locally advanced or metastatic breast cancer (MBC) previously treated with trastuzumab (T) and a taxane. Journal Of Clinical Oncology 2012, 30: 98-98. DOI: 10.1200/jco.2012.30.27_suppl.98.Peer-Reviewed Original ResearchMetastatic breast cancerT-DM1End pointProgressive diseaseAdverse eventsCytotoxic agent DM1Primary end pointUnexpected safety signalsPalmar-plantar erythrodysesthesiaPhase III studyFinal PFS analysisRefractory HER2Prior therapyBaseline demographicsIII studyMedian durationRandomized studyPlantar erythrodysesthesiaUnmanageable toxicityDisease characteristicsAdvanced BCTrastuzumab emtansineNovel therapiesSafety signalsBreast cancerPrimary results from EMILIA, a phase III study of trastuzumab emtansine (T-DM1) versus capecitabine (X) and lapatinib (L) in HER2-positive locally advanced or metastatic breast cancer (MBC) previously treated with trastuzumab (T) and a taxane.
Blackwell K, Miles D, Gianni L, Krop I, Welslau M, Baselga J, Pegram M, Oh D, Dieras V, Olsen S, Fang L, Lu M, Guardino E, Verma S. Primary results from EMILIA, a phase III study of trastuzumab emtansine (T-DM1) versus capecitabine (X) and lapatinib (L) in HER2-positive locally advanced or metastatic breast cancer (MBC) previously treated with trastuzumab (T) and a taxane. Journal Of Clinical Oncology 2012, 30: lba1-lba1. DOI: 10.1200/jco.2012.30.18_suppl.lba1.Peer-Reviewed Original ResearchMetastatic breast cancerT-DM1End pointProgressive diseaseAdverse eventsCytotoxic agent DM1Primary end pointUnexpected safety signalsPalmar-plantar erythrodysesthesiaPhase III studyFinal PFS analysisRefractory HER2Prior therapyBaseline demographicsIII studyMedian durationRandomized studyPlantar erythrodysesthesiaUnmanageable toxicityDisease characteristicsAdvanced BCTrastuzumab emtansineNovel therapiesSafety signalsBreast cancer