PD18-02 INCREASED URINARY VASCULAR ENDOTHELIAL GROWTH FACTOR D (VEGF-D) LEVELS ARE ASSOCIATED WITH RESPONSE TO COMBINED INTRAVESICAL BACILLUS CALMETTE−GUERIN (BCG) AND ORAL SUNITINIB REGIMEN FOR TREATMENT OF HIGH-RISK NON-MUSCLE INVASIVE BLADDER CANCER (NMIBC)

Abstract

INTRODUCTION AND OBJECTIVES:We conducted a phase II trial to evaluate combination therapy with BCG and Sunitinib for prevention of recurrence and progression of high-risk NMIBC with a primary endpoint of 3-month complete response (CR). We hypothesized that adding Sunitinib to BCG could increase the initial CR to therapy by synergistic inhibition of the VEGF pathway. We also measured urine levels of various biomarkers throughout treatment to identify trends that predict and/or explain a response to therapy.METHODS:Patients with high-grade clinical ≤T1N0M0 NMIBC who had not received BCG within 12 months of diagnosis were deemed eligible. Patients received a 6-week induction BCG course followed by 28 days of Sunitinib. CR was determined by biopsy and cytology. Urine samples were collected from patients before and after both BCG and Sunitinib. Urine biomarker levels were measured using a multiplexed bead assay for angiopoietin 2 (AP-2), fibroblast growth factor 2 (FGF-2), interleukin 8 (IL-8), and VEGF-A, -C,...