2022
Results from the phase 1/2 study of patritumab deruxtecan, a HER3-directed antibody-drug conjugate (ADC), in patients with HER3-expressing metastatic breast cancer (MBC).
Krop I, Masuda N, Mukohara T, Takahashi S, Nakayama T, Inoue K, Iwata H, Toyama T, Yamamoto Y, Hansra D, Takahashi M, Osaki A, Koyama K, Inoue T, Yonekura T, Mostillo J, Ohwada S, Tanaka Y, Sternberg D, Yonemori K. Results from the phase 1/2 study of patritumab deruxtecan, a HER3-directed antibody-drug conjugate (ADC), in patients with HER3-expressing metastatic breast cancer (MBC). Journal Of Clinical Oncology 2022, 40: 1002-1002. DOI: 10.1200/jco.2022.40.16_suppl.1002.Peer-Reviewed Original ResearchMetastatic breast cancerAntibody-drug conjugatesAnti-HER3 monoclonal antibodyInvestigational antibody-drug conjugateTopoisomerase I inhibitor payloadWhite blood cell countDose-finding portionGrade 5 eventsMedian treatment durationPhase 1/2 studyInterstitial lung diseaseBlood cell countMedian study durationECOG PSData cutoffDose expansionCentral adjudicationMetastatic diseaseNeutrophil countPrior linesMedian agePhase 1/2Platelet countSafety profileLung disease
2012
A population pharmacokinetic/pharmacodynamic model of thrombocytopenia characterizing the effect of trastuzumab emtansine (T-DM1) on platelet counts in patients with HER2-positive metastatic breast cancer
Bender BC, Schaedeli-Stark F, Koch R, Joshi A, Chu YW, Rugo H, Krop IE, Girish S, Friberg LE, Gupta M. A population pharmacokinetic/pharmacodynamic model of thrombocytopenia characterizing the effect of trastuzumab emtansine (T-DM1) on platelet counts in patients with HER2-positive metastatic breast cancer. Cancer Chemotherapy And Pharmacology 2012, 70: 591-601. PMID: 22886072, DOI: 10.1007/s00280-012-1934-7.Peer-Reviewed Original ResearchConceptsT-DM1 3.6Incidence of gradePK/PD modelBaseline characteristicsPlatelet countT-DM1Semimechanistic PK/PD modelHER2-positive metastatic breast cancerPharmacodynamic modelPD modelHuman epidermal growth factor receptorGrade 3 thrombocytopeniaPatient baseline characteristicsPhase II studyDose-limiting toxicityMetastatic breast cancerPatient's platelet countSingle-agent studiesPD parametersEpidermal growth factor receptorAntibody-drug conjugatesGrowth factor receptorDose delaysFirst doseII study
2011
A semi-physiologic population pharmacokinetic/pharmacodynamic (PK/PD) model of thrombocytopenia (TCP) characterizing the effect of trastuzumab-DM1 (T-DM1) on platelet counts in patients with HER2-positive MBC.
Bender B, Schaedeli Stark F, Joshi A, Chu Y, Rugo H, Krop I, Girish S, Gupta M. A semi-physiologic population pharmacokinetic/pharmacodynamic (PK/PD) model of thrombocytopenia (TCP) characterizing the effect of trastuzumab-DM1 (T-DM1) on platelet counts in patients with HER2-positive MBC. Journal Of Clinical Oncology 2011, 29: 605-605. DOI: 10.1200/jco.2011.29.15_suppl.605.Peer-Reviewed Original Research