MP13-06 CAN INTRAVESICAL ADMINISTRATION OF ANTIFIBRINOLYTIC AGENT POTENTIATE THE ACTION OF BACILLUS CALMETTE- GUERIN AFTER TRANSURETHRAL RESECTION OF NON–MUSCLE INVASIVE BLADDER CANCER?: MULTICENTER PROSPECTIVE RANDOMIZED CONTROLLED STUDY.

transurethral resection (TUR) and additional adjuvant instillation in intermediate risk non-muscle invasive bladder cancer (NMIBC) to reduce the risk of recurrence. Pirarubicin (THP), an anthracycline analogue, is widely used reagent for intravesical instillation chemotherapy. Several studies have showed that THP can rapidly penetrate tumor tissue after intravesical instillation. Therefore long instillation time (e.g. 120 min) may not be required for its prophylactic effect against recurrence since it may reduce the risk of adverse events such as cystitis and hematuria without compromising its efficacy. However, there is no high level evidence regarding optimized intravesical THP instillation time in terms of both toxicity and efficacy. METHODS: This randomized, prospective, open-label trial intended to enroll 160 pts with primary NMIBC with intermediate risk based on EORTC criteria. All pts received initial THP instillation within 24 hr after TUR and then intended to continue weekly repetitive THP instillation for a total of 9 treatments. Pts who seemed likely to be at intermediate risk were provisionally registered and then randomized into two groups with different intravesical THP retention times before TUR, (a) 30 min versus (b) 120 min. Follow-up period is 4 years. Primary endpoint is change from baseline in quality of life (e.g. OABSS and IPSS), which will be evaluated prior to THP intravesical instillation. Secondary endpoint is recurrence-free survival. RESULTS: 126 pts were enrolled for provisional registration in this trial and randomized before TUR-B. After excluding pts due to the result of pathology by TUR-B such as benign disease, T1 G3 tumor and concomitance of CIS, 29 pts were assigned to group (a) (30 min), and 26 pts to group (b) (120 min). There is a trend that group (a) is less prone to increase in OABSS after 3rd instillation compared to group (b), which is not statistically significant. Log-rank test shows that there is no significant difference in recurrence-free survival between the groups during follow-up period (HR1⁄42.161, 95% C.I.: 0.4317-10.82, p1⁄40.3484). CONCLUSIONS: Shortening intravesical instillation period to 30 min has little effect on reducing the adverse effect of THP. However, it does not compromise the prophylactic effect on recurrence in intermediate risk NMIBC pts.