Pruthi, Raj S.

290 Background: Previous studies have shown robot assisted radical cystectomy (RARC) to have equivalent perioperative outcomes to open radical cystectomy. There are few reports that have examined the oncologic results of RARC specifically with respect to node-positive patients. We report the outcomes of node-positive patients who have undergone RARC with medium-term (at least 1 year) follow-up. Methods: A total of 275 patients underwent RARC at two institutions for invasive bladder cancer between 2005-present. We examined the 50 patients with node-positive disease that had a minimum of one year follow-up. Oncologic outcomes, recurrence free survival (RFS), and disease specific survival (DSS) were analyzed and compared to the open literature. Results: Mean clinical follow up in this case series was 29 months (range 12–64 months). The mean number of lymph nodes removed was 18 (range 5–35), and mean number of positive LNs was 3.1 (range 1–12). Overall rate of LN positivity was 26%. Mean LN density was 18%. Seventeen (34%) patients had ≤ pT2 disease and 33 (66%) pT3/T4 disease. At this follow-up, 29 patients have recurred, 21 patients died of disease, giving a RFS and DSS of 42% and 58%, respectively. Mean (median) time to recurrence was 10.2 months (9 months). A total of 60% of patients received peri-operative chemotherapy in this cohort. These findings are consistent with prior reports of such oncologic outcomes in node-positive patients in open series. Conclusions: The oncologic follow-up of patients undergoing RARC with LN positive disease appears to have acceptable outcomes during medium term (mean 29 months) follow-up. As our follow-up increases, we expect to continue to accurately define the long-term clinical suitability and oncologic success of this procedure in this high-risk population. No significant financial relationships to disclose.

288 Background: We report our experience with robot assisted radical cystectomy (RARC) with regard to medium-term (at least 2 year) oncologic outcomes. Methods: A total of 275 patients have undergone RARC and urinary diversion at two institutions for invasive bladder cancer between 2005-present. We performed a retrospective analysis of the 139 patients who underwent RARC with a minimum of 2 years follow-up. Medium term oncologic outcomes including recurrence rates, time to recurrence, recurrence free survival (RFS), disease specific survival (DSS) were analyzed. Follow-up was measured from time of surgery to time of most recent clinical follow-up. Results: This cohort of patients consisted of 108 men (78%) and 31 women (22%) at a mean age of 67.3 years (range 45-86 years). Sixty-one (44%) patients had ≤ pT2 disease, 38 (27%) pT3/T4 disease, and 40 (29%) N+ disease. The mean number of lymph nodes removed was 18 (range 3-41). The average clinical follow up in this case series was nearly 3 years with a mean of 35.9 months (range 24-64 months). At this follow-up, 39 patients have recurred, 27 patients died of disease, and 5 patients died of other causes giving an overall RFS, DSS, and OS rates of 80%, 71%, and 68%, respectively. The mean (median) time to recurrence was 12.3 months (10 months). These findings are consistent with prior reports of the oncologic outcomes for open radical cystectomy. Conclusions: The oncologic follow-up of patients undergoing RARC appears to be favorable with acceptable outcomes in the medium-term (mean – 3 years). As our follow-up increases, we should expect to truly define the long-term clinical appropriateness and oncologic success of this procedure. No significant financial relationships to disclose.

The purpose of the RAZOR (randomized open vs robotic cystectomy) study is to compare open radical cystectomy ( ORC ) vs robot‐assisted RC ( RARC ), pelvic lymph node dissection ( PLND ) and urinary diversion for oncological outcomes, complications and health‐related quality of life ( HRQL ) measures with a primary endpoint of 2‐year progression‐free survival ( PFS ). RAZOR is a multi‐institutional, randomized, non‐inferior, phase III trial that will enrol at least 320 patients with T 1– T 4, N 0– N 1, M 0 bladder cancer with ≈160 patients in both the RARC and ORC arms at 15 participating institutions. Data will be collected prospectively at each institution for cancer outcomes, complications of surgery and HRQL measures, and then submitted to trial data management services Cancer Research and Biostatistics ( CRAB ) for final analyses. To date, 306 patients have been randomized and accrual to the RAZOR trial is expected to conclude in 2014. In this study, we report the RAZOR trial experimental design, objectives, data safety, and monitoring, and accrual update. The RAZOR trial is a landmark study in urological oncology, randomizing T 1– T 4, N 0– N 1, M 0 patients with bladder cancer to ORC vs RARC , PLND and urinary diversion. RAZOR is a multi‐institutional, non‐inferiority trial evaluating cancer outcomes, surgical complications and HRQL measures of ORC vs RARC with a primary endpoint of 2‐year PFS . Full data from the RAZOR trial are not expected until 2016–2017.