Chow, George K.

TPS594 Background: The standard treatment for upper tract urothelial carcinoma (UTUC) is radical nephroureterectomy (RNU) with bladder cuff resection. Subsequent intravesical recurrence is common and results in patient morbidity and increased healthcare cost. Level 1 evidence has demonstrated reduction of intravesical recurrence with instillation of intravesical Mitomycin C at 10 days following RNU. However, there has been limited adoption of Mitomycin C due to concerns for toxicity and logistics of postoperative drug delivery. Meanwhile, immediate intravesical gemcitabine has been shown to reduce intravesical recurrence following transurethral resection of bladder cancers without increasing toxicity compared to placebo. Moreover, small series have suggested improved efficacy of intraoperative intravesical chemotherapy for RNU. The purpose of the GEMINI trial, therefore, is to prospectively establish the safety and efficacy of intraoperative instillation of intravesical gemcitabine in patients undergoing RNU for UTUC. Methods: GEMINI is a multi-center open-label, single-arm, Phase II study that aims to enroll 90 patients with cTa-T4N0M0 UTUC. Patients receive intraoperative intravesical instillation of gemcitabine at the beginning of RNU, to be held in the bladder for at least 1 hour. The instilled drug will be drained prior to resection of the bladder cuff. Patients will undergo standard of care postoperative surveillance, including cystoscopy at 3, 6, 12, 18, and 24 months. The primary endpoint is 1-year intravesical recurrence-free survival. The historical event rate for no treatment is 30%, and we estimated a 40% relative reduction in event rate with gemcitabine. The study is powered to provide 80% power to detect this difference based on a one-sided exact test of proportions with alpha level 0.05. Secondary endpoints include time to recurrence and stratification of recurrence free survival by tumor grade, tumor stage, neoadjuvant chemotherapy, ureteral tumor location, and history of bladder cancer. Safety and adverse event endpoints will be evaluated. Complete accrual is expected within 3 years.

SAGE-Journals-Accessible-Video-Player 10.1089/vid.2018.0051.M1 sj-vid-1-vid-10.1089_vid.2018.0051

ObjectiveTo evaluate the long‐term outcomes and potential predictors of treatment failure after robotic sacrocolpopexy.MethodsWe identified 70 consecutive patients from 2002 to 2012 with symptomatic post‐hysterectomy vaginal vault prolapse that underwent robotic sacrocolpopexy. Multiple clinical and surgical variables were evaluated for potential association with treatment failure, which was defined as any repeat operation for recurrent prolapse or mesh‐related complications.ResultsThe median age at surgery was 67 years (interquartile range 59–74 years) and median follow up was 72 months (interquartile range 39–114 months). Overall, six out of 70 patients (8.6%) underwent a total of six secondary surgeries, including four for recurrent prolapse (two anterior repairs, one posterior repair, one apical) and two mesh complications. No patient‐related factors were associated with the risk of repeat surgery: age (P = 0.45), diabetes mellitus (P = 0.24), tobacco use (P = 0.61) or prior prolapse surgery (P = 0.1) on univariate analysis. Freedom from repeat prolapse surgery or surgery for mesh complication was 98% at 1 year, 95% at 3 years and 90% at 6 years. At last follow up, 80% of patients reported that they would or probably would recommend robotic sacrocolpopexy to a family member or friend.ConclusionsRobotic sacrocolpopexy is associated with excellent long‐term outcomes. Recognition of long‐term success is important for preoperative patient counseling.