Prospective randomized trial of hexylaminolevulinate photodynamic-assisted transurethral resection of bladder tumour (TURBT) plus single-shot intravesical mitomycin C vs conventional white-light TURBT plus mitomycin C in newly presenting non-muscle-invasive bladder cancer
Timothy O’Brien, Eleanor Ray, Kathryn Chatterton, Muhammad Shamim Khan, Ashish Chandra and Kay Thomas
Urology Centre, Guy’s and St Thomas’ NHS Foundation Trust, London, UK
• To determine if photodynamic ‘blue-light’-assisted resection leads to lower recurrence rates in newly presenting non-muscle-invasive bladder cancer (NMIBC).
PATIENTS AND METHODS
• We conducted a prospective randomized trial of hexylaminolevulinate (HAL) photodynamic diagnosis (PDD)-assisted transurethral resection of bladder tumour (TURBT) plus single-shot intravesical mitomycin C vs standard white-light-assisted TURBT plus single-shot intravesical mitomycin C.
• A total of 249 patients with newly presenting suspected NMIBC enrolled at Guy’s Hospital between March 2005 and April 2010. Patients with a history of bladder cancer were excluded.
• The surgery was performed by specialist bladder cancer surgical teams.
• Of the eligible patients, 90% agreed to be randomized.
• Of the 249 patients, 209 (84%) had cancer and in 185 patients (89%) the cancer was diagnosed as NMIBC.
• There were no adverse events related to HAL in any of the patients randomized to the intravesical HAL-PDD arm.
• Single-shot intravesical mitomycin C was administered to 61/97 patients (63%) in the HAL-PDD arm compared with 68/88 patients (77%) in the white-light arm (P = 0.04)
• Intravesical HAL was an effective diagnostic tool for occult carcinoma in situ (CIS). Secondary CIS was identified in 25/97 patients (26%) in the HAL-PDD arm compared with 12/88 patients (14%) in the white-light arm (P = 0.04)
• There was no significant difference in recurrence between the two arms at 3 or 12 months: in the HAL-PDD and the white-light arms recurrence was found in 17/86 and 14/82 patients (20 vs 17%), respectively (P = 0.7) at 3 months, and in 10/63 and 15/67 patients (16 vs 22%), respectively (P = 0.4) at 12 months.
• Despite HAL-PDD offering a more accurate diagnostic assessment of a bladder tumour, in this trial we did not show that this led to lower recurrence rates of newly presenting NMIBC compared with the best current standard of care.