Pharmacokinetics and Safety of Bortezomib In Patients with Advanced Malignancies and Varying Degrees of Liver Dysfunction: Results of the Phase 1 National Cancer Institute Organ Dysfunction Working Group Study NCI 6432
Venkatakrishnan K, Ramanathan R, Sarantopoulos J, Mulkerin D, Shibata S, Hamilton A, Dowlati A, Mani S, Rudek M, Ivy P, Takimoto C, Neuwirth R, Parasuraman S, LoRusso P. Pharmacokinetics and Safety of Bortezomib In Patients with Advanced Malignancies and Varying Degrees of Liver Dysfunction: Results of the Phase 1 National Cancer Institute Organ Dysfunction Working Group Study NCI 6432. Blood 2010, 116: 3975. DOI: 10.1182/blood.v116.21.3975.3975.Peer-Reviewed Original ResearchMild hepatic impairmentSevere hepatic impairmentNormal hepatic functionCancer Therapy Evaluation ProgramHepatic impairmentHepatic function× ULNAdverse eventsDay 1Advanced malignanciesDose escalationNational Cancer Institute Cancer Therapy Evaluation ProgramHI groupGeometric least square mean ratioDay 8Least square mean ratioPoor hepatic functionSevere HI groupsSubsequent dose escalationUS Prescribing InformationCommon adverse eventsECOG performance statusMost adverse eventsPhase 1 studySafety of bortezomib