PHOTOdynamic versus white light-guided treatment of non-muscle invasive bladder cancer: randomised trial of clinical and cost-effectiveness

Status: 
Completed
Clinicaltrials.gov identifier: 
ISRCTN84013636
Sponsor: 
National Institute for Health and Care Research Health Technology Assessment and Newcastle upon Tyne NHS Trust
Study Design: 
Patients with NMIBC and intermediate or high risk of recurrence based on visual diagnosis were randomized (1 : 1) to PDD-TURBT or standard white light TURBT.
Rationale: 
Recurrence of non-muscle invasive bladder cancer (NMIBC) is common and the use of photodynamic diagnosis (PDD) at the time of TURBT (transurethral resection of bladder tumor) may assist in identification of tumors and may decrease recurrence of NMIBC over time. Therefore, this study aims to evaluate whether a PDD-assisted TURBT reduces the NMIBC recurrence rate compared to a standard white light (WL)-TURBT.
Endpoints: 
The primary endpoint was time to recurrence at 3 years of follow-up
Comments: 
The authors concluded that a PDD-TURBT did not reduce recurrences and was more expensive than WL-TURBT at 3 years. However, the recurrence rates appeared to clearly diverge over the first 12 months favoring PDD-TURBT. This may imply that the benefit of a single PDD-TURBT may only last for 12 months. Finally, the trial was designed to detect 214 recurrences but only 170 patients recurred so a smaller, clinically significant difference may exist but was not identified because so many patients were excluded from the analysis.
Results: 
A total of 538 patients were recruited (269 patients per group), but 112 patients were excluded due to no histologic diagnosis of NMIBC or having undergone a cystectomy. After a median follow-up of 44 months, 86 of 209 (41.1%) patients in the PDD group and 84 of 217 (38.7%) patients in the white light group had recurrences. Three-year recurrence rates were 57.8% (95% CI: 50.7-64.2) and 61.6% (95% CI: 54.7-67.8) in the PDD and WL groups, respectively. There was no difference in adverse events or health-related quality of life. PDD-TURBT was 876 pounds (95% CI: -766-2518, P = 0.591) more costly than WL-TURBT over a 3-year follow-up period. Immediate postoperative intravesical Mitomycin C was administered in 63.2% of the PDD group and 65.9% of the WL group (p = 0.60).