A randomized controlled trial to investigate dwell time of single immediate and additional adjuvant intravesical chemotherapy with pirarubicin for non-muscle-invasive bladder cancer following transurethral resection of bladder tumor

[Introduction] Single immediate and additional adjuvant intravesical chemotherapy is the recommended treatment for intermediate-risk non-muscle-invasive bladder cancer (IR NMIBC) patients after transurethral resection of bladder tumor (TURBT). This study aimed to compare two different intravesical retention times of pirarubicin (THP) in IR NMIBC patients from the perspectives of health-related quality of life (HRQoL) and efficacy. (Methods) One hundred twenty-six patients with bladder tumor were randomized into two study arms prior to TURBT: 30-min and 120-min retention. Patients who were confirmed as IR NMIBC after TURBT received adjuvant intravesical THP instillation. The primary endpoint was change in SF-36 domain scores, International Prostate Symptom Score (IPSS) and Overactive Bladder Symptom Score (OABSS) from the baseline to after treatment. The secondary endpoints were recurrence-free rate, recurrence-free survival and safety. [Results] After TURBT, 59 patients commenced the protocol treatment and 53 patients were assessable as a full analysis set. The changes in scores of SF-36 domains, IPSS and OABSS and recurrence-free survival were not significantly different between the two arms. The most common adverse events (AEs) were urinary tract pain (57.1% vs. 68.0%), urinary frequency (46.4% vs. 24.0%) and hematuria (14.3% vs. 4.0%). More patients in the 120-min group discontinued the treatment due to urinary tract pain. One patient with Grade 3 urinary tract pain and prostate infection was observed only in the 120-min group (1 patient in each AE). [Conclusion) Thirty-min dwell time for intravesical THP chemotherapy for preventing IR NMIBC recurrence may reduce the risk of adverse events.