Abstract

INTRODUCTION AND OBJECTIVES: We conducted a randomized, prospective, multicenter study comparing one immediate postoperative intravesical chemotherapy with short-term adjuvant intravesical chemotherapy after transurethral resection of bladder tumor (TURBT) in non-muscle invasive bladder carcinoma (NMIBC) with low or intermediate recurrent risk. The objective is to evaluate the efficacy of intravesical chemotherapy using pirarubicin for patients with low or intermediate risk. METHODS: This studywas approved by the ethics committees of KyotoPrefectural University ofMedicine inSeptember 2010. The recurrent risk was stratified using EAU guidelines on non-muscle-invasive urothelial carcinoma of the bladder, the 2011 update. Between October 2010 and January 2015, 216 patients was enrolled in this study and 97 patients were excluded from this studyafter TURBT for their high recurrent riskofNMIBC. Remaining 109 with low or intermediate recurrent risk of NMIBC were randomized to one immediate postoperative intravesical instillation of pirarubicin (THP) 30mg (GroupA), or additional intravesical chemotherapy of THP 30mg weekly for 8 weeks (Group B). The patients were examined by cystoscopy and urine cytological examination every 3 months after TURBt to determine bladder tumor recurrence. RESULTS: The 2-year recurrence free rate were 65.3% for Group A and 87.2% forGroupB, respectively (log rank test, p1⁄4 0.038). In patients with intermediate recurrent risk, the 2year recurrence free rate were 62.3% inGroupAand86.8% in groupB, respectively (log rank test, p1⁄4 0.0261). In patients with recurrent score between 5 and 9, the 2-year recurrence free ratewere91.7% inGroupAand25.0% inGroupB (log rank test, p1⁄40.0052). There was no patient with progression during this period. Adverse events were documented in 0% and 24.4% in Group A and Group B, respectively. There was no patient with severe adverse event (Grade 3 or more). 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. Our data provide a rationale for adjuvant intravesical chemotherapy after TURBT in NMIBC patients with intermediate recurrent risk.

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