863PPREDICTIVE FACTORS OF SURVIVAL FOR PATIENTS WITH BLADDER CANCER (BC) IN PHASE I CLINICAL TRIALS

Abstract Background: There are limited anticancer therapies available for BC. Novel targeted therapies (TT) may offer more treatment options. Methods: Retrospective data was collected on clinical treatment and tumour characteristics on patients (pts) with BC treated in the Drug Development Unit, at the Royal Marsden Hospital (RMH) between August 1996 and January 2014.Survival analyses were performed using the Kaplan-Meier method and Cox proportional hazards model, and associations were tested with Fischer's Exact test. Results: 125 pts with BC were referred and 36 (29%) were treated. Median age was 58 yrs (range: 30-68). 7 female, 38% ECOG 0 and 62% ECOG 1-2. Histological types included: transitional cell (n = 24), squamous cell (n = 2), urachal (n = 2), papillary cell (n = 2) and adenocarcinoma (n = 2). 51% pts had 1 line of prior treatment, 33% 2 lines and 16% ≥3 lines.Pts were treated on 20 phase 1 trials; 6 trials were combination chemotherapy and TT, and 14 trials were single agents, targeting: PI3K (n = 3), HDAC (n = 3), EGFR/VEGFR (n = 3), oncolytic viruses (n = 2), mTOR (n = 1), AKT (n = 1), PARP (n = 1), TS (n = 1), c-MET (n = 1), nucleoside (n = 1), microtubule (n = 1), Rho (n = 1) and Bcl2 (n = 1). Median time on trial was 1.8 months (m; range: 0.1 -15.6).Objective response rate was 14%, and the clinical benefit rate (CBR: CR + PR + SD) was 47%, as defined by RECIST 1.0. Median overall survival (OS) for pts with a CB was 9.2 m versus 3.3 m for pts with progressive disease (HR0.29, CI 0.07-0.037,P < 0.0001). In univariate analysis, superior OS was favoured by RMH score 0-1 (HR0.33, CI 0.05-0.55,P = 0.004), and white cell count (WCC)