A phase II trial of neoadjuvant cisplatin (C), gemcitabine (G), and sunitinib (S) in muscle-invasive urothelial carcinoma (miUC): Results from Hoosier Oncology Group GU07-123 trial.

e15173 Background: Neoadjuvant platinum-based chemotherapy has demonstrated survival benefits in miUC patients. Mediators of tumor angiogenesis including the vascular endothelial growth factor receptor (VEGFR) play a critical role in UC metastases. A phase II study of neoadjuvant cisplatin (C), gemcitabine (G), and the multi-targeted VEGFR tyrosine kinase inhibitor sunitinib (S) in miUC patients was conducted to determine the clinical efficacy and safety of the CGS regimen. Methods: Muscle-invasive UC patients with ECOG performance status (PS) 0-1 and creatinine clearance > 60 ml/min received C 60 mg/m2 iv d1, G 800 mg/m2 iv d1, 8, and S 37.5 mg po d1-14 on a q21d cycle for a maximum of 4 cycles followed by cystectomy. The primary endpoint was pathologic complete response rate (pCR). Results: 9 pts were enrolled and treated. Patient demographics included: median age – 70, M/F – 8/1, ECOG PS 0/1 – 6/3. Baseline tumor staging included: T2 – 4, T3 – 2, T4a – 3. All patients were clinically N0 M0. All 9 patie...