2019
O1-8-4 [Encore] Dose justification for [fam-] trastuzumab deruxtecan (DS-8201a) in HER2-positive breast cancer
Takahashi S, Modi S, Tsurutani J, Krop I, Iwata H, Wada R, Yin O, Garimella T, Sugihara M, Zhang L, Lee C, Saito K, Kawasaki Y, Yver A, Tamura K. O1-8-4 [Encore] Dose justification for [fam-] trastuzumab deruxtecan (DS-8201a) in HER2-positive breast cancer. Annals Of Oncology 2019, 30: vi84. DOI: 10.1093/annonc/mdz339.009.Peer-Reviewed Original ResearchObjective response rateInterstitial lung diseaseTrastuzumab deruxtecanOngoing phase 1 studiesImproved progression-free survivalCox proportional hazard modelingHER2-positive breast cancerBenefit/risk profileLogistic regressionProgression-free survivalPhase 1 studyProportional hazard modelingPopulation PK modelDose-finding stageIndividual PK parametersAvailable PK dataILD riskSafety endpointLung diseasePPK modelBC subjectsBreast cancerDose justificationPK parametersPK dataTrastuzumab 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
2018
OA02.07 Updated Results of Phase 1 Study of DS-8201a in HER2-Expressing or –Mutated Advanced Non-Small-Cell Lung Cancer
Tsurutani J, Park H, Doi T, Modi S, Takahashi S, Nakagawa K, Krop I, Waqar S, Yoh K, Li B, Taira S, Jikoh T, Singh J, Sugihara M, Jänne P. OA02.07 Updated Results of Phase 1 Study of DS-8201a in HER2-Expressing or –Mutated Advanced Non-Small-Cell Lung Cancer. Journal Of Thoracic Oncology 2018, 13: s324. DOI: 10.1016/j.jtho.2018.08.244.Peer-Reviewed Original ResearchTrastuzumab deruxtecan (DS-8201a) in subjects with HER2-expressing solid tumors: Long-term results of a large phase 1 study with multiple expansion cohorts.
Iwata H, Tamura K, Doi T, Tsurutani J, Modi S, Park H, Krop I, Sagara Y, Redfern C, Murthy R, Redman R, Shitara K, Fujisaki Y, Sugihara M, Zhang L, Shahidi J, Yver A, Takahashi S. Trastuzumab deruxtecan (DS-8201a) in subjects with HER2-expressing solid tumors: Long-term results of a large phase 1 study with multiple expansion cohorts. Journal Of Clinical Oncology 2018, 36: 2501-2501. DOI: 10.1200/jco.2018.36.15_suppl.2501.Peer-Reviewed Original Research
2012
A phase 1 study of weekly dosing of trastuzumab emtansine (T‐DM1) in patients with advanced human epidermal growth factor 2–positive breast cancer
Beeram M, Krop IE, Burris HA, Girish SR, Yu W, Lu MW, Holden SN, Modi S. A phase 1 study of weekly dosing of trastuzumab emtansine (T‐DM1) in patients with advanced human epidermal growth factor 2–positive breast cancer. Cancer 2012, 118: 5733-5740. PMID: 22648179, DOI: 10.1002/cncr.27622.Peer-Reviewed Original ResearchConceptsHER2-positive metastatic breast cancerMetastatic breast cancerAdverse eventsT-DM1Breast cancerTrastuzumab emtansineObjective partial tumor responseTreatment-related adverse eventsClinical benefit rateDose-escalation studyPartial tumor responsePhase 1 studyTotal trastuzumabDose modificationMedian durationWeekly doseWeekly dosingAdditional patientsTumor responseBenefit rateHuman epidermal growth factorEpidermal growth factorPatientsGrowth factorAntitumor activity