Abstract: PD19-03
Sources of Funding: None

Introduction

There are insufficient data supporting the general recommendation of the European Association of Urology (EAU) that “all” patients with NMIBC should receive immediate instillation of chemotherapy after transurethral resection of bladder tumor (TURBT). The study objective is to test the value of immediate post-operative intravesical instillation of epirubicin in patients with intermediate and high risk NMIBC.

Methods

After approval of the institutional review board, 260 patients were randomly allocated into two groups, including TURBT alone in arm A and TURBT plus epirubicin 50 mg in 50 ml saline in arm B. All patients were monitored for post-operative complications. Adjuvant instillation therapy was administered to all patients according to risk categorization. Patients were followed every three months by cystourethroscopy and urine cytology. The primary end points were recurrence, progression and/or death from cancer.

Results

Of the 260 patients, 236 were eligible and followed for a mean of 19.6 months. The two study arms were comparable regarding perioperative baseline demographic criteria. Intermediate and high risk groups were defined in 24 and 94 patients in arm A, compared to 28 and 90 in arm B (p=0.64). There was no statistically significant difference between the two arms regarding recurrence rate (27.1% vs. 26.2%), interval to first recurrence (16.3±6.6 vs. 16.4±6.4 months) or progression rate to muscle invasion (8.5% vs. 5.9%). Number of recurrences, size, site and associated CIS in the first recurrence were also comparable between the two arms. Using the 1973 WHO grading system, the number of patients with grade 3 recurrence was higher in arm A (18 patients) than arm B (7 patients). However, using the 2004 WHO/ISUP system, there was no significant difference in the recurrence grade. Recurrence and progression-free survival were comparable between the two arms (Log-rank test; p=0.88 and 0.47, respectively). According to modified Dindo-Clavian system, post-operative complications were all low grade. There was no significant difference between the two arms, regarding the rate and the grade of the reported complications.

Conclusions

These data indicate that immediate post-TURBT instillation of epirubicin is ineffective in intermediate and high risk NMIBC. It neither prolongs time to recurrence, time to progression nor reduces the number of recurrences. We advocate strict specification of patient and tumor criteria in which immediate instillation is indicated.

Funding

None