Long-Term Decrease in Bladder Cancer Recurrence with Hexaminolevulinate Enabled Fluorescence Cystoscopy

Abstract

Purpose We assessed the impact that hexaminolevulinate fluorescence cystoscopic detection of papillary, non-muscle invasive bladder cancer has on long-term recurrence rates. Materials and Methods Long-term follow-up was assessed in 551 participants enrolled in a prospective, randomized study of fluorescence cystoscopy for Ta or T1 urothelial bladder cancer. In the original study, 280 patients in the white light cystoscopy group and 271 in the fluorescence cystoscopy group were followed with cystoscopy for 3, 6, and 9 months following the initial resection or until recurrence. A study extension protocol obtained long-term follow-up of these patients. Results Follow-up information was obtained for 261 of the 280 (93%) participants in the white light group and 255 of the 271 (94%) participants in the fluorescence group. Median follow-up in the white light and fluorescence groups were 53.0 and 55.1 months, respectively. In the white light and fluorescence groups, 83 (31.8%) and 97 (38%) of the participants remained tumor free, respectively. The median recurrence free survival was 9.6 months in the white light group and 16.4 months in the fluorescence group, p = 0.04. The rates of intravesical therapy were similar in the white light (46%) and fluorescence groups (45%). Cystectomy was performed in 22/280 (7.9%) in the white light group and 13/271 (4.8%) in the fluorescence group, p = 0.16. Conclusions Hexaminolevulinate fluorescence cystoscopy significantly improves long-term bladder cancer recurrence free survival with a trend towards improved bladder preservation.

Observational Studies Requested by European Health Authorities: Governmental Interference or an Enhancement of Everyday Urological Practice? The Hexvix® Observational Patients Evaluation Study as an Example of What to Expect

“…With regard to efficacy, the increased detection and the decreased recurrence observed in the HOPE study with PDD were consistent with the pivotal trials by Fradet et al [5] and Grossman et al [11] , and the meta-analysis by Burger et al [14] . The HOPE study, therefore, provides evidence that PDD use in everyday clinical routine replicates the positive results obtained in the research setting.…”

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

“…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].…”

“…Based on the reduction in long term recurrence rate [10] the registered indication of this drug changed from a pure detection tool to a drug that improves diagnosis and management of bladder cancer patients. The European Association of Urology (EAU) guideline recommends BLC in certain cases of (suspected) NMIBC [11].…”

Approaching the optimal transurethral resection of a bladder tumor

“…[41][42][43] Another prospective randomized control trial revealed a median recurrence-free survival of 9.6 months in WLC compared with 16.4 months in FC. [44] . Geavlete et al [45] used HAL in high-risk bladder cancer and reported that at re-resection at 6 weeks, there was a shortterm recurrence rate of 11% with FC versus 31% with WLC alone.…”