UROLOGICAL ONCOLOGY

doi: 10.1590/S1677-553820100003000024

Transurethral resection of non-muscle-invasive bladder transitional cell cancers with or without 5-aminolevulinic acid under visible and fluorescent light: results of a prospective, randomised, multicentre study
Schumacher MC, Holmäng S, Davidsson T, Friedrich B, Pedersen J, Wiklund NP
Department of Molecular Medicine and Surgery, Karolinska Institutet, Department of Urology, Stockholm, Sweden
Eur Urol. 2010; 57: 293-9

• Background: Fluorescent light (FL)-guided cystoscopy induced by 5-aminolevulinic acid (5-ALA) has been reported to detect more tumours compared with standard white-light (WL) cystoscopy. Most reports are from single centres with relatively few patients.
  Objective: To evaluate whether 5-ALA-induced FL and WL cystoscopy at transurethral resection (TUR) is superior compared with standard procedures under WL only with respect to tumour recurrence and progression in patients with non-muscle-invasive bladder cancer.
  Design, Setting, and Participants: This randomised, multicentre, observer- and pathologist-blinded, prospective phase 3 clinical trial enrolled 300 patients, and of those patients, 153 were randomised to FL cystoscopy and 147 were randomised to standard WL cystoscopy.
  Intervention: All patients were first inspected under WL and all lesions were recorded. Patients randomised to FL underwent a second inspection. TUR was carried out in both groups.
  Measurements: Control cystoscopy under WL was performed in all patients every 3 mo during the first year after randomisation and biannually thereafter.
  Results and Limitations: At the first TUR, the mean number of resection specimens per patient was 2.5 (FL: 2.5; WL: 2.4; p=0.37) and the resulting mean number of resected tumours was 1.7 with FL and 1.8 with WL (p=0.85). More patients were diagnosed with carcinoma in situ (CIS) in the WL group (13%) than in the FL group (4.2%). Within-patient comparison of FL patients only showed that FL detected more lesions than WL. Tumour lesions solely detected by FL cystoscopy that would not otherwise be detected by WL cystoscopy included 52% dysplasia, 33% CIS, 18% papillary neoplasms, 13% pT1, and 7% pTa. Outcome at 12 mo did not show any difference between groups with regard to recurrence-free and progression-free survival rates.
  Conclusions: In this prospective, randomised, multi-institutional study, we found no clinical advantage of FL cystoscopy compared with WL cystoscopy and TUR.

• Editorial Comment
  This paper put some water into the wine of fluorescence-based cystoscopy and resection (TUR). 300 patients from 5 institutions were randomized and the outcome was compared in terms of resected material and, importantly, in terms of clinical outcome after 12 months. In short, no meaningful differences were detected between both groups and the clinical outcomes were similar. The authors argue that the more “positive” results of other groups in favour of fluorescence-based cystoscopy might be due to the monocentric approach of these groups. In conclusion, there is still the need for more objective analyses such as this one before fluorescence-based cystoscopy or TUR can be regarded as standard in urology.

Dr. Andreas Bohle
Professor of Urology
HELIOS Agnes Karll Hospital
Bad Schwartau, Germany
E-mail: boehle@urologie-bad-schwartau.de