1000 Long term follow up of a prospective randomised trial of Hexylaminolevulinate (HEXVIX ®) photodynamic diagnosis (PDD) assisted versus conventional white-light transurethral resection (TURBT) in newly presenting non-muscle invasive bladder cancer (NMIBC)

Abstract

INTRODUCTION AND OBJECTIVES: Despite Hexvix PDD improving the detection of bladder tumours, in a prospective randomized trial in newly presenting bladder tumours we were unable to demonstrate reduced recurrence in the first year post resection. We now report longer-term follow-up with 3-year recurrence and progression rates from the trial. METHODS: 249 patients with newly presenting suspected NMIBC were enrolled at our institution between March 2005 and April 2010, and randomized to receive either Hexvix PDD assisted TURBT plus single shot Mitomycin C or white-light (W/L) TURBT plus single shot Mitomycin C. Patients with muscle invasive bladder cancer, or a previous history of bladder cancer were excluded. All operations were performed by 3 specialized bladder cancer teams. Subsequent management was standardized for all patients. All data was prospectively collected. RESULTS: 129 patients received Hexvix PDD assisted TURBT and 120 patients received W/L TURBT. 185 of 249 patients were found to have NMIBC (Hexvix e 97, W/L e 88). Final TNM classification was low grade/G1pTa 1⁄4 98 (Hexvix e 50, W/L 48); high grade/G3pTa 1⁄4 28 (Hexvix e 13, W/L 15); high grade/G3pT1 1⁄4 57 (Hexvix e 35, W/L 22). Primary CIS was seen in one patient and secondary CIS in 37 (Hexvix e 25, W/L 12). Of the patients who completed 3-month follow up, 17/86 (20%) in the Hexvix group and 14/82 (17%) in the W/L group had a recurrence (p 1⁄4 0.70). Of the patients who were recurrence free at 3 months and completed 1 year follow up, 10/63 (16%) in the Hexvix group and 15/67 (22%) in the W/L group had a recurrence (p1⁄40.38). Of the patients who were recurrence free at 1 year and completed 3 year follow up, 5/47 (10.6%) in the Hexvix group and 7/46 (15.2%) in the W/L group had a recurrence (p1⁄40.51). 3/97 (3.1%) in the Hexvix group and 4/88 (4.5%) in the W/L group had progressed to muscle invasive disease at 3 years (p1⁄40.61). (Table 1) CONCLUSIONS: Despite improving the accuracy of bladder cancer diagnosis, Hexvix PDD has not been shown in this trial to reduce the recurrence rate or progression rate of NMIBC at 3 years’ follow-up.