MP13-05 A RANDOMIZED TRIAL COMPARING TWO DIFFERENT RETENTION PERIODS OF INTRAVESICAL PIRARUBICIN INSTILLATION FOR INTERMEDIATE RISK NON-MUSCLE INVASIVE BLADDER CANCER (NMIBC) AFTER TRANSURETHRAL RESECTION.

Abstract

You have accessJournal of UrologyBladder Cancer: Non-Invasive I1 Apr 2016MP13-05 A RANDOMIZED TRIAL COMPARING TWO DIFFERENT RETENTION PERIODS OF INTRAVESICAL PIRARUBICIN INSTILLATION FOR INTERMEDIATE RISK NON-MUSCLE INVASIVE BLADDER CANCER (NMIBC) AFTER TRANSURETHRAL RESECTION. Ryoma Kurahashi, Yutaka Kasejima, Yoshiaki Kawano, Wataru Takahashi, Takahiro Yamaguchi, Ken-ichiro Tanoue, Hiroshi Sakakida, Junji Yatsuda, Youji Murakami, Yutaka Sugiyama, and Masatoshi Eto Ryoma KurahashiRyoma Kurahashi More articles by this author , Yutaka KasejimaYutaka Kasejima More articles by this author , Yoshiaki KawanoYoshiaki Kawano More articles by this author , Wataru TakahashiWataru Takahashi More articles by this author , Takahiro YamaguchiTakahiro Yamaguchi More articles by this author , Ken-ichiro TanoueKen-ichiro Tanoue More articles by this author , Hiroshi SakakidaHiroshi Sakakida More articles by this author , Junji YatsudaJunji Yatsuda More articles by this author , Youji MurakamiYouji Murakami More articles by this author , Yutaka SugiyamaYutaka Sugiyama More articles by this author , and Masatoshi EtoMasatoshi Eto More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2016.02.2486AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Anthracyclines are recommended reagents for one immediate intravesical instillation after 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 I-PSS), 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 (HR=2.161, 95% C.I.: 0.4317-10.82, p=0.3484). 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. © 2016FiguresReferencesRelatedDetails Volume 195Issue 4SApril 2016Page: e135-e136 Advertisement Copyright & Permissions© 2016MetricsAuthor Information Ryoma Kurahashi More articles by this author Yutaka Kasejima More articles by this author Yoshiaki Kawano More articles by this author Wataru Takahashi More articles by this author Takahiro Yamaguchi More articles by this author Ken-ichiro Tanoue More articles by this author Hiroshi Sakakida More articles by this author Junji Yatsuda More articles by this author Youji Murakami More articles by this author Yutaka Sugiyama More articles by this author Masatoshi Eto More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...