Long-term experience with early single Mitomycin C instillations in patients with low-risk non-muscle-invasive bladder cancer: prospective, single-centre randomised trial

Abstract

To study the benefits of a single, early, intravesical instillation of mitomycin C(MMC) after transurethral bladder resection (TURB) in patients with low-risk non-muscle-invasive bladder cancer (NMIBC). In this prospective randomised single-centre trial, 211 patients with primary and low-risk tumours were enrolled between 2000 and 2009. Patients were randomly allocated to receive MMC intravesically within 24h of TUR or no further treatment. The primary end point was recurrence rate reduction. A total of 202 patients (97 in the MMC group and 105 in the control group) remained for analysis after exclusions. Median age was 61years (IQR 42-78), and median follow-up was 90months (IQR 3-112). No significant differences for patients' characteristics were observed between the two groups. During the study period, 10% (10/97) of the patients in the MMC group and 43% (46/105) in the control group experienced a recurrence (P=0.0001). Four patients in the MMC group and 11 (P=0.008) in the control group experienced an early recurrence (within 2years). One patient in the control group presented a tumour progression (T2G3). MMC treatment was associated with a 31% absolute risk reduction of recurrence and a 3.26 numbers needed to treat to prevent one recurrence. In this single-centre, long-term follow-up, experience a single, early instillation of MMC after TUR for low-risk NMIBC is associated with a significant reduction in risk of early and late recurrences.