Dose-escalating and pharmacological study of bortezomib in adult cancer patients with impaired renal function: a National Cancer Institute Organ Dysfunction Working Group Study

Purpose To determine the toxicities, pharmacokinetics, pharmacodynamics, and maximum tolerated dose of bortezomib in patients with renal impairment and to develop dosing guidelines for such a patient population. Patients and Methods Sixty-two adult cancer patients received intravenous bortezomib at...

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Bibliographic Details
Published in:Cancer chemotherapy and pharmacology 2011-12, Vol.68 (6), p.1439-1447
Main Authors: Leal, Ticiana B., Remick, Scot C., Takimoto, Chris H., Ramanathan, Ramesh K., Davies, Angela, Egorin, Merrill J., Hamilton, Anne, LoRusso, Patricia A., Shibata, Stephen, Lenz, Heinz-Josef, Mier, James, Sarantopoulos, John, Mani, Sridhar, Wright, John J., Ivy, S. Percy, Neuwirth, Rachel, von Moltke, Lisa, Venkatakrishnan, Karthik, Mulkerin, Daniel
Format: Article
Language:English
Subjects:
Adult
Aged
Aged, 80 and over
Antineoplastic agents
Antineoplastic Agents - administration & dosage
Biological and medical sciences
Boronic Acids - administration & dosage
Boronic Acids - pharmacokinetics
Bortezomib
Cancer Research
Creatinine - blood
Female
Humans
Kidney Diseases - metabolism
Kidney Diseases - physiopathology
Kidney Diseases - therapy
Male
Maximum Tolerated Dose
Medical sciences
Medicine
Medicine & Public Health
Middle Aged
Neoplasms - drug therapy
Neoplasms - physiopathology
Oncology
Original Article
Pharmacology. Drug treatments
Pharmacology/Toxicology
Pyrazines - administration & dosage
Pyrazines - pharmacokinetics
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Summary:Purpose To determine the toxicities, pharmacokinetics, pharmacodynamics, and maximum tolerated dose of bortezomib in patients with renal impairment and to develop dosing guidelines for such a patient population. Patients and Methods Sixty-two adult cancer patients received intravenous bortezomib at 0.7–1.5 mg/m 2 on days 1, 4, 8, and 11 every 3 weeks. Patients were stratified by 24-h creatinine clearance (CrCl) normalized to body surface area (BSA) 1.73 m 2 into five cohorts: normal renal function (≥60 ml/min/1.73 m 2 ); mild dysfunction (40–59 ml/min/1.73 m 2 ); moderate dysfunction (20–39 ml/min/1.73 m 2 ); severe dysfunction (
ISSN:0344-5704
1432-0843
DOI:10.1007/s00280-011-1637-5