Hexaminolevulinate Guided Fluorescence Cystoscopy Reduces Recurrence in Patients With Nonmuscle Invasive Bladder Cancer

Abstract

Purpose To assess the impact that improved detection of non-muscle invasive bladder cancer with hexaminolevulinate (HAL) fluorescence cystoscopy may have on early recurrence rates. Materials and methods This prospective, randomized study enrolled 814 patients suspected of having bladder cancer at increased risk for recurrence. All patients underwent white light cystoscopy and mapping of lesions, followed by transurethral resection of the bladder (TURB) where indicated. Patients in the fluorescence group also received intravesical hexaminolevulinate solution at least one hour before cystoscopy to induce fluorescence of cancerous lesions, and underwent additional inspection with blue light before and after TURB. Adjuvant intravesical therapy was based on risk. Follow up cystoscopies at 3, 6 and 9 months were conducted with white light. Results Detection was carried out as a within-patient comparison in the fluorescence group. In this group, 286 patients were found to have at least one Ta or T1 tumor (ITT). In 47 (16%), at least one of the tumors was seen only with fluorescence (p=0.001). During the 9 month follow-up period (ITT), there were tumor recurrences in 128/271 patients (47%) in the fluorescence group and 157/280 patients (56%) in the white light group (p=0.026). The relative reduction in recurrence rate was 16%. Conclusions HAL fluorescence cystoscopy significantly improves detection of Ta and T1 lesions and significantly reduces the rate of tumor recurrence at 9 months.

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.…”

“…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].…”

957 Long-term reduction in bladder cancer recurrence with hexaminolevulinate enabled fluorescence cystoscopy

“…6 While fluorescence cystoscopy does require some training, the learning curve is short. This multi-institutional study included many sites that had no prior experience with this technique.…”

“…9 We now provide long-term follow-up of the outcomes of the patients enrolled in the international, prospective, phase III study of hexaminolevulinate fluorescence cystoscopy vs. white light cystoscopy. 6 …”