Safety and efficacy analysis of sunitinib (S), bevacizumab (B), and M-Tor inhibitors in metastatic renal cell cancer (mRCC) patients (pts) with renal insufficiency (RI)

Abstract

5108 Background: S, T (temsirolimus) and E (everolimus) are primarily metabolized in the liver, while the metabolism of B is unclear. There are limited data on the clinical toxicity profile and efficacy of these agents in pts with RI. Methods: The primary objective was to assess the safety and efficacy of S, B, T and E in pts with RI. Medical records of pts with mRCC at Wayne State University, treated on S, B, T or E were reviewed. Pts with a calculated creatinine clearance (CrCl) of ≤ 60ml/min [chronic kidney disease stage 3 or higher per K/DOQI guidelines by the National Kidney Foundation] were deemed to have RI. Data on safety and efficacy of the therapy were collected and analyzed with respect to renal function. Results: 19 of 51 (37%) pts had RI. Pts with RI had a higher median rise in blood pressure (BP) with S and B than pts with normal renal function. Patients with RI had an increased incidence of rash and higher dose interruption rates with m-TOR inhibitors. No major differences in toxicities including cardiac, thyroid, renal, lipid profile abnormalities or hyperglycemia were observed. Similar efficacy was seen in all groups. Conclusions: More than a third of pts with mRCC receiving targeted therapy have RI, hence highlighting the importance of evaluating tolerability of therapies in pts with RI. Therapy with S, B and T/E is well tolerated and efficacy appears to be maintained. Closer monitoring for hypertension is needed in pts receiving S and B. [Table: see text] No significant financial relationships to disclose.