2024
ERBB2 mutations and association with molecular phenotype in urothelial carcinoma.
Machaalani M, El Zarif T, Stockhammer P, Semaan K, Eid M, El Hajj Chehade R, Nawfal R, Yekeduz E, Nassar A, Lee G, Baca S, CHOUEIRI T, Grant M, Bellmunt J. ERBB2 mutations and association with molecular phenotype in urothelial carcinoma. Journal Of Clinical Oncology 2024, 42: 4590-4590. DOI: 10.1200/jco.2024.42.16_suppl.4590.Peer-Reviewed Original ResearchUpper tract UCTumor mutational burdenUrothelial carcinomaERBB2-targeted therapyMutant tumorsUC tumorsERBB2 amplificationMedian tumor mutation burdenHigh tumor mutational burdenWild type tumorsChi-square and Mann-Whitney U testsCombination therapy studiesMolecular phenotypesMann-Whitney U testTumor profile dataERBB2 mutationsBladder UCPolyPhen-2Mutational burdenType tumorsGenomic dataSolid tumorsClinical characteristicsCo-mutationsActivating mutations
2020
Exposure‐Response and Population Pharmacokinetic Analyses of a Novel Subcutaneous Formulation of Daratumumab Administered to Multiple Myeloma Patients
Luo M, Usmani S, Mateos M, Nahi H, Chari A, San‐Miguel J, Touzeau C, Suzuki K, Kaiser M, Carson R, Heuck C, Qi M, Zhou H, Sun Y, Parasrampuria D. Exposure‐Response and Population Pharmacokinetic Analyses of a Novel Subcutaneous Formulation of Daratumumab Administered to Multiple Myeloma Patients. The Journal Of Clinical Pharmacology 2020, 61: 614-627. PMID: 33145788, PMCID: PMC8048619, DOI: 10.1002/jcph.1771.Peer-Reviewed Original ResearchConceptsSubcutaneous formulation of daratumumabIncidence of neutropeniaIntravenous daratumumabMonotherapy studiesCombination therapySubcutaneous daratumumabPK samplingStandard-of-care regimensPeak-to-trough fluctuationHigher trough concentrationsCombination therapy studiesSafety end pointMultiple myeloma patientsPopulation pharmacokinetic analysisCycle 1Flat doseExposure-response analysesMyeloma patientsDaratumumabTrough concentrationsSubcutaneous formulationPharmacokinetic analysisTreatment periodTherapy studiesNeutropenia
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