Update on AVOREN trial in metastatic renal cell carcinoma (mRCC): Efficacy and safety in subgroups of patients (pts) and pharmacokinetic (PK) analysis

5025 Background: Results from the phase III AVOREN trial have shown that first-line treatment with bevacizumab (BEV; Avastin®) + interferon-α2a (IFN) significantly improves progression-free survival (PFS) in pts with mRCC compared with IFN + placebo (median: 10.2 vs 5.4 mths, HR=0.63; p=0.0001). Pts with predominantly (>50%) clear cell RCC were eligible for inclusion. Methods: A retrospective analysis was conducted to determine the efficacy of BEV + IFN in subgroups of pts with reference to histology, renal function and baseline VEGF levels. BEV and IFN concentrations were determined. All pts had undergone nephrectomy, allowing tumour histology to be more accurately determined than with biopsy, and had a KPS score ≥70%. Creatinine clearance (CLcr) was calculated based on creatinine values at baseline (normal CLcr, ≥75mL/min in males and ≥65mL/min in females). Results: 85 (13%) pts in the AVOREN trial had a mixture of clear cell (>50%) and other histology mRCC. The remainder had clear cell only. In these s...