A Phase Ii Multicenter Study Of Neoadjuvant Dose-Dense Methotrexate, Vinblastine, Doxorubicin, And Cisplatin (Ddmvac) Chemotherapy With Pegfilgrastim Support In Patients (Pts) Muscle-Invasive Urothelial Cancer (Miuc): Safety, Pathologic, Radiologic, And Molecular Correlates

278 Background: ddMVAC is associated with high responses rate (RR) in advanced urothelial cancer (UC). We embarked on a study in MIUC to determine pathologic RR and its correlation with clinical and radiological outcomes as well as DNA excision repair pathway biomarkers (ERCC1, PAR, BRCA1, and BRCA2).Patients with cT2-T4, N0-1, M0 UC, and adequate kidney and marrow function were enrolled on a prospective multicenter phase II trial. Four cycles of ddMVAC were given followed by radical cystectomy (RC). The primary endpoint was pathologic downstaging to Grade 3 related to chemotherapy were observed in 10% of pts and included mucositis, hand-foot skin reaction, hypokalemia and neutropenia. No neutropenic fevers were seen. Median and 18-month disease-free survival (DFS) is provided in Table. Tissue biomarker analyses will be presented.ddMVAC regimen is well tolerated and results in significant pathologic and radiologic downstaging in pts with MIUC.NCT00808639. [Table: see text].