Single Versus Maintenance Intravesical Chemotherapy for the Prevention of Bladder Recurrence after Radical Nephroureterectomy for Upper Tract Urothelial Carcinoma: A Randomized Clinical Trial.

INTRODUCTION

The objective of this study was to determine the efficiency of 1-year maintenance intravesical chemotherapy (MIC) in reducing bladder recurrence (BR) after radical nephroureterectomy (RNU) for upper tract urothelial carcinoma compared with single intravesical instillation (SIC).

PATIENTS AND METHODS

Between January 2015 and May 2017, patients who underwent RNU were randomized to receive SIC (epirubicin 50 mg) or MIC (once weekly for 6 weeks plus once monthly for 1 year). The primary outcome was the rate of histologically proven BR. The secondary outcomes included chemotherapy-related toxicities and disease-specific survival (DSS). Thirty-five patients in each arm were required to achieve a power of 80%.

RESULTS

A total of 38 (SIC) and 36 (MIC) patients were analyzed. In SIC, BR developed in 5 (13.2%) over a median follow-up of 3 months (range, 3-6 months) compared with 9 (25%) patients over 12 months (range, 3-28 months) in MIC (P = .08). The 6- and 12-month BR-free survivals were the same (86.8%) in SIC versus 88.9% and 83.3% in MIC, respectively (P = .2). Lymphovascular invasion was significantly associated with BR (P = .04). Post-RNU intravesical chemotherapy regimens did not alter DSS. Blood transfusion and advanced tumor stage were independent predictors for DSS. No significant medication toxicity was reported.

CONCLUSIONS

Following RNU, MIC did not change the natural course of BR beyond a single instillation apart from potentially delaying its occurrence. Lymphovascular invasion and blood transfusion were associated with worse BR and DSS outcomes, respectively.