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Therapeutic Methods and Therapies TCIM
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Clin Genitourin Cancer ; 7(2): E10-5, 2009 Aug.
Article in English | MEDLINE | ID: mdl-19692316

ABSTRACT

PURPOSE: Sorafenib is an oral Raf kinase inhibitor, approved for the treatment of advanced renal cancer. Clinical investigation of the safety and feasibility of sorafenib therapy in patients with impaired renal function was performed in this study. MATERIALS AND METHODS: The protocol was approved by the Human Investigation Committee of Wayne State University. Medical records of patients with metastatic renal cancer at Wayne State University started on sorafenib between November 2005 to January 2007 were reviewed. Patients with a calculated creatinine clearance (CrCl) of 60 mL/min or less (chronic kidney disease stage 3 or greater per Kidney Disease Outcomes Quality Initiative guidelines) were deemed to have renal insufficiency. RESULTS: A total of 32 patients who met the selection criteria were analyzed. Fourteen of 32 (44%) patients had renal insufficiency (range, 32-60 mL/min). Median age was 71 years in patients with CrCl < or = 60 mL/min and 54 years in those with > 60 mL/min. Incidence of diarrhea (57% vs. 33%) and hand-foot syndrome (86% vs. 56%) were higher in the renal-dysfunction group. Dose interruptions and dose reductions were noted in 57% and 43% of patients with renal dysfunction versus 28% and 22% in those without. No significant differences were noted in response rate, progression-free survival or overall survival. CONCLUSION: Renal insufficiency is frequently observed in patients with advanced renal cancer. Sorafenib therapy can be safely delivered in patients with mild and moderate renal dysfunction, and efficacy appears to be maintained.


Subject(s)
Antineoplastic Agents/therapeutic use , Benzenesulfonates/therapeutic use , Kidney Neoplasms/drug therapy , Kidney/physiopathology , Protein Kinase Inhibitors/therapeutic use , Pyridines/therapeutic use , Adult , Aged , Aged, 80 and over , Benzenesulfonates/adverse effects , Female , Humans , Kidney Neoplasms/mortality , Kidney Neoplasms/pathology , Kidney Neoplasms/physiopathology , Male , Middle Aged , Neoplasm Metastasis , Niacinamide/analogs & derivatives , Phenylurea Compounds , Pyridines/adverse effects , Sorafenib
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