Fluorescence-guided transurethral resection of bladder tumours reduces bladder tumour recurrence due to less residual tumour tissue in T  a/T1 patients: a randomized two-centre study

Abstract

Trial Registration: trial registry, ClinicalTrials.gov; registration number, NCT00412971; http://www.clinicaltrials.gov/ct2/show/ NCT00412971?spons=%22PhotoCure%22&spons_ex=Y&rank=15• Patients were randomized to cystoscopy and WL TURB (118 patients) or WL TURB followed immediately by HAL TURB (115 patients). Cystoscopy/TURB and bladder biopsies were performed under general anaesthesia. No patients had intravesical chemotherapy immediately after TURB.• Recurrences were verified histologically. RESULTS• The two groups were similar regarding age and previous bladder cancer history.• In all, 90 patients from the HAL TURB group had bladder tumour. Fluorescenceguided cystoscopy after complete WL TURB identified residual tumour tissue in 44 of 90 patients (49%). In 37 of 83 (45%) residual Ta tumour was found; in three of seven residual T1 was found and in four cases carcinoma in situ .• True (and false) positive detection rate of photodynamic diagnosis was 64% (25%) and of white light 83% (16%).• In all, 145 patients were eligible for analysis of tumour recurrence. Twelve patients had their last follow-up after 4 months. The recurrence rate in patients followed for 12 months was 47.3% (35/74) after WL TURB and 30.5% (18/59) after HAL TURB ( P = 0.05).• Kaplan-Meier analyses comprising data from all 145 patients showed that the recurrence-free period was significantly longer in the HAL TURB group than in the WL TURB group ( P = 0.02). CONCLUSION• WL TURB often leaves residual tumour in the bladder. HAL TURB improves the detection of Ta/T1 tumours of the bladder resulting in more complete TURB procedures and thus a reduced recurrence rate. KEYWORDSHexvix®, bladder cancer, fluorescence cystoscopy, recurrence, non-muscleinvasive, residual tumour What's known on the subject? and What does the study add? Photodynamic diagnosis (PDD) improves the diagnostic sensitivity of non-invasive bladder cancer as compared to TURB without PDD.TURB in white light leaves residual tumour in the bladder in up to 49% of the patients. PDD-guided TURB improves the detection of Ta/T1 tumours of the bladder resulting in more complete TURB procedures and thus a reduced tumour recurrence rate. Study Type -Therapy (RCT) Level of Evidence 1b OBJECTIVES• To compare the bladder tumour recurrence rate in stage Ta and T1 tumours after conventional transurethral resection of the bladder in white light (WL TURB) and after fluorescence-guided TURB (HAL TURB) using hexaminolaevulinate (HAL: Hexvix®, Photocure, Norway) for photodynamic diagnosis during 12 months of follow-up.• As secondary objectives, to relate the tumour recurrence rate to fluorescencedetected residual tumour after WL TURB and to assess the false positive rate. PATIENTS AND METHODS• This was a prospective, comparative, randomized, open-label study carried out in hospital outpatient urology clinics and the operating theatre. A total of 233 patients presenting with suspected superficial bladder tumour were recruited. Both patients with new tumours and patients with recurrent tumours were inclu...

Feasibility of Photodynamic Diagnosis for Challenging TUR-Bt Cases Including Muscle Invasive Bladder Cancer, BCG Failure or 2nd-TUR

“…(Grimbergen et al, 2003;Stenzl et al, 2010;Hermann et al, 2011) In present study, false-positive cases were related with recent TURBT history, the use of BCG, and urinary tract infection. In this study, the false positive rate of fluorescence diagnosis was 48.0% (47/98).…”

Safety of Hexaminolevulinate for Blue Light Cystoscopy in Bladder Cancer. A Combined Analysis of the Trials Used for Registration and Postmarketing Data

“…Some of these data have also been reported in the publications of these studies [3][4][5][6][7][8][9]. Since a favorable safety profile is an additional reason to embrace on a new drug or technique when improved effectiveness is proven, this report specifically addresses the safety of HAL-BLC, including repeated use.…”

“…Details and results of these studies have been published before [3][4][5][6][7][8][9]. For all centers in these 6 studies Ethics Committee approval was obtained and for all patients informed consent was obtained.…”

“…HAL blue light cystoscopy (BLC) has proven to detect more bladder tumours, enabling a better tumour resection and better patient management. These effects result in a lower short term and long term recurrence rate of NMIBC [2][3][4][5][6][7][8][9][10]. A recent systemic review showed that 20% more patients with papillary tumors were detected, and 39% more CIS patients [2].…”

Photodynamic therapy for photochemists

“…PD is an approved technique for guiding glioma resection during open surgery (as discussed under brain tumours) and also for guiding endoscopic resection of dysplastic (pre-cancerous) areas in the bladder [11,34].…”