An incidence of renal failure in patients receiving renally adjusted zoledronic acid.

Abstract

e19581 Background: Acute renal failure (ARF) is an adverse event associated with the use of zoledronic acid, which was recognized during the registry trial. In 2005, the FDA label recommended specific zoledronic acid dosing based on creatinine clearance in renally impaired cancer patients. There is a lack of literature regarding the clinical impact of this recommendation. Methods: This was a retrospective, single institution study evaluating all patients receiving zoledronic acid from August 29, 2001 to September 30, 2009. Patients were eligible if they had cancer with bone metastasis and received at least 1 infusion of zoledronic acid. Any patients receiving zoledronic acid within 14 days of previous dose or having ARF within 1 month of eligibility were excluded. Acute renal failure was defined as an increase in serum creatinine (SCr) of 0.5 or 1.0 for baseline SCr was <1.4 or ≥ 1.4, respectively. Results: 220 patients met the study inclusion criteria, 184 with normal baseline renal function (Creatinine Clearance (CrCl) of > 60 mL/min; group 1 (G1)) and 36 with impaired renal function (CrCl 30 to 60 mL/min; group 2 (G2)). Prostate cancer (G1 49% vs. G2 64%) and multiple myeloma (G1 20% vs. G2 19%) were the most common cancers between the groups. There was a significant difference in mean age (G1 64 vs. G2 75 years; p<0.05) and CrCL (G1 91 vs. G2 49 mL/min; p<0.05) at baseline. There were 38 patients (20.7%) who developed renal failure in G1compared with 7 patients (19.4%) in G2 (p = 0.87). The mean time to ARF was 6.1 months in both groups (p = NS). Acute renal failure based on CrCL (≥ 25% decline in CrCL) was similar between groups (G1 39.1% vs. G2 41.7; p = 0.78), as well. One patient in each group required dialysis due to renal failure. Conclusions: The incidence of acute renal failure is similar between patients with normal baseline renal function compared with impaired function when zoledronic acid dose is appropriately adjusted in renally impaired patients. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Novartis