669 PROSPECTIVE RANDOMIZED PHASE II TRIAL OF SINGLE EARLY INTRAVESICAL INSTILLATION OF (2′R)-4′-O-TETRAHYDROPYRANYL-DOXORUBICIN (THP) FOR PREVENTION OF BLADDER RECURRENCE AFTER NEPHROURETERECTOMY FOR UPPER URINARY TRACT UROTHELIAL CARCINOMA (UUT-UC)

Abstract

You have accessJournal of UrologyUrothelial Cancer: Upper Tract Tumors1 Apr 2011669 PROSPECTIVE RANDOMIZED PHASE II TRIAL OF SINGLE EARLY INTRAVESICAL INSTILLATION OF (2′R)-4′-O-TETRAHYDROPYRANYL-DOXORUBICIN (THP) FOR PREVENTION OF BLADDER RECURRENCE AFTER NEPHROURETERECTOMY FOR UPPER URINARY TRACT UROTHELIAL CARCINOMA (UUT-UC) Akihiro Ito, Makoto Satoh, Ichiro Shintaku, Shigeto Ishidoya, Yoichi Arai, and Tohoku Urological EBM Study Group Akihiro ItoAkihiro Ito Sendai, Japan More articles by this author , Makoto SatohMakoto Satoh Sendai, Japan More articles by this author , Ichiro ShintakuIchiro Shintaku Sendai, Japan More articles by this author , Shigeto IshidoyaShigeto Ishidoya Sendai, Japan More articles by this author , Yoichi AraiYoichi Arai Sendai, Japan More articles by this author , and Tohoku Urological EBM Study Group More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2011.02.1599AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Approximately 5% to 50% patients have bladder recurrence after nephroureterectomy for UUT-UC. However standard prophylactic treatment against recurrence has not been established. We evaluated the efficacy of a single early intravesical instillation of THP for prevention of bladder recurrence after nephroureterectomy for UUT-UC. METHODS From December 2005 to November 2008, 77 patients from 11 institutions in the Tohoku Urological EBM Study Group who were clinically diagnosed with UUT-UC were pre-operatively enrolled in this study. Patients were randomly assigned to receive instillation of THP (30mg/30ml) into the bladder within 48 hours after nephroureterectomy or no instillation. The prophylactic and toxic effects of THP instillation were investigated. RESULTS Of the 77 patients, 3 were excluded after surgery because they did not have pathologically confirmed urothelial carcinoma and 2 were excluded for other reasons. The remaining 72 patients were evaluable for this study. Of the 72 patients, 21 (29.2%) had subsequent bladder recurrence; most recurrences were observed at the first cystoscopic examination after nephroureterectomy. Significantly fewer patients who had THP instilled had a recurrence compared with the control group (6/36 [16.7%] vs 15/36 [41.6%]; p = 0.0247). There were no significant differences in median time to first bladder recurrence between groups. No remarkable adverse events were observed in the THP- treated group. CONCLUSIONS The single intravesical instillation of THP immediately after nehproureterectomy was well tolerated and effective for preventing bladder recurrences. A phase III, large-scale, multicenter study is needed to confirm the therapeutic efficacy of THP instillation. © 2011 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 185Issue 4SApril 2011Page: e270-e271 Advertisement Copyright & Permissions© 2011 by American Urological Association Education and Research, Inc.MetricsAuthor Information Akihiro Ito Sendai, Japan More articles by this author Makoto Satoh Sendai, Japan More articles by this author Ichiro Shintaku Sendai, Japan More articles by this author Shigeto Ishidoya Sendai, Japan More articles by this author Yoichi Arai Sendai, Japan More articles by this author Tohoku Urological EBM Study Group More articles by this author Expand All Advertisement Advertisement PDF DownloadLoading ...