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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
Author(s) -
O'Brien Timothy,
Ray Eleanor,
Chatterton Kathryn,
Khan Muhammad Shamim,
Chandra Ashish,
Thomas Kay
Publication year - 2013
Publication title -
bju international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.773
H-Index - 148
eISSN - 1464-410X
pISSN - 1464-4096
DOI - 10.1111/bju.12355
Subject(s) - medicine , mitomycin c , bladder cancer , carcinoma in situ , urology , randomized controlled trial , surgery , prospective cohort study , white light , carcinoma , cancer , physics , optics
Objective 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 G uy's H ospital between M arch 2005 and A pril 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.Results 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.Conclusions 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.