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 data