Randomized study of intravesical chemotherapy using pirarubicin in patients with non-muscle-invasive bladder cancer in Japan: Comparing one immediate postoperative intravesical chemotherapy with short-term adjuvant intravesical chemotherapy after TURBT: Subanalysis in patients with intermediate risk.

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4536 Background: The objective is to evaluate the efficacy defining of 2-year tumor recurrence free rate of intravesical chemotherapy using pirarubicin (THP) for patients with intermediate risk. Methods: Between October 2010 and January 2015, 206 patients were enrolled in this study and finally 113 were randomized to one immediate postoperative intravesical instillation of THP 30mg (Group A), or additional intravesical instillation of THP 30mg weekly for 8 weeks after single postoperative instillation (Group B). The recurrent risk was stratified using EAU guidelines on non-muscle-invasive urothelial carcinoma of the bladder, the 2009 update. Of 113, 100 with intermediate risk were analyzed in this study. The patients were examined by cystoscopy and urine cytology every 3 months after trans urethral resection to determine bladder tumor recurrence. The primary endpoint was 2 year-recurrence-free survival rates. A statistical analysis was performed by SAS (SAS Institute Inc., Cary, USA). Results: The 2-year recurrence free survival rates were 66.2% in Group A and 86.1% in Group B, respectively (log rank test, p = 0.0043). In patients with recurrence score between 5 and 9, the 2-year recurrence free survival was 92.3% in Group B and 22.2% in Group A (log rank test, p = 0.0013). Cox regression analysis revealed that only additional instillation of THP was significant independent factor for recurrence free rate in patients with intermediate risk. There was no patient with progression during this period. Frequent adverse effects were frequent urination and micturition pain without severe adverse effect (Grade 3 or more). Limitation of this study is a failure to enroll sufficient number for statistical analysis. Conclusions: Additional instillation of THP 30mg weekly for 8 weeks reduced the risk of tumor recurrence without severe toxicity in NMIBC patients with intermediate recurrent risk.