T. S. O`Brien and colleagues (London, UK) won the second prize for Best Abstract in Oncology during the 26th Annual EAU Congress held recently in Vienna, Austria. Below is the winning abstract, unedited and without additional commentary:
Title: A prospective randomised trial of Hexylaminolevulinate (Hexvix) assisted transurethral resection (TURBT) plus single shot intravesical mitomycin (MMC) versus conventional white light TURBT plus single shot MMC in newly presenting bladder cancer.
Authors List: O`Brien, T.S.1, Chatterton, K.1, Ray, E.R.1, Wilby, D.1, Chandra, A.2, Dickinson, F.1, Khan, M.S.1, Thomas, K.1 1Guys Hospital, Dept. of Urology, London, United Kingdom, 2Guys Hospital, Dept. of Pathology, London, United Kingdom
Introduction & Objectives
Photodynamic ‘blue-light’ cystoscopy is recognised to provide a more complete assessment of a bladder tumour than white-light cystoscopy. Whether this translates into lower recurrence rates following initial resection is unknown because previous studies often included patients with recurrent tumours; did not offer the control group best current treatment i.e. TURBT plus single shot intravesical chemotherapy; used surrogate end-points e.g. histology rather than recurrence; and in older trials used 5-aminolaevulinate as the photosensitiser.
Material & Methods
249 patients enrolled at a single centre, between March 2005 and April 2010 into a randomised trial of Hexvix assisted blue-light (B/L) TURBT plus single shot intravesical MMC versus white-light (W/L) TURBT plus single shot MMC. All patients had suspected non-muscle invasive bladder cancer (NMIBC) based on appearance at flexible cystoscopy or imaging. Patients with a previous history of bladder cancer were excluded. 129 patients randomised to B/L and 120 to W/L. 183 (73%) patients were male; mean age 68 (range 29-95); 201 (80%) presented with macroscopic haematuria. Primary endpoints: tumour recurrence within 3/12 and at 12/12 post initial TURBT (Pearson chi square).
In 207/249 (83%) histology revealed cancer, and in 184/207 (89%) the diagnosis was NMIBC (B/L 99: W/L 85). Final TNM classification was low grade/G1pTa =98 (B/L 50: W/L 48) ; high grade/G3pTa = 28 (B/L 13:W/L 15); high grade/G3pT1=57 (B/L 35:W/L 22). Primary CIS was seen in one patient and secondary CIS in 37 (B/L 25:W/L 12). 128/184 (70%) patients received single dose MMC (B/L 62:W/L 66).
MMC was not administered to 56 (30%) patients due to concerns about the safety of intravesical MMC after a deep resection. 8/184 (4%) (B/L 5:W/L 3) patients did not undergo a cystoscopy within 3/12 (3 died, 2 refused, 2 lost, 1 discharged). There was no statistically significant difference in recurrence between the 2 arms at 3 or 12 months. 3/12 recurrence: 17/94 (18%) B/L vs. 14/82 (17%) W/L (p=0.86).
By November 2010, of those 145 patients (B/L 77:W/L 68) recurrence free at 3/12, 10 patients (4 B/L:6 W/L) were still awaiting their 12/12 cystoscopy, and a further 8 patients had been lost to follow up (B/L 7: W/L 1) (5 died, 1 refused, 2 lost). Recurrence at 12/12 was seen in 10/66 B/L (15%) vs. 12/61 (20%) W/L (p=0.50). No adverse reactions attributable to Hexvix were seen.
Although photodynamic diagnosis offers a more accurate diagnostic assessment of a bladder tumour, in this trial we have not shown that this reduces recurrence. Novel treatment strategies need to be developed to be used in combination with improved diagnostic tools, such as photodynamic diagnosis, if recurrence rates are to be reduced in NMIBC.
Source: 2nd Prize Best Abstract (Oncology), Abstract 435, Poster Session, 26th Annual EAU Congress, Vienna, Austria, March 18-22, 2011.