Introduction

White light (WL) cystoscopy is the current standard of care for bladder cancer surveillance. Multiple studies have demonstrated that blue light cystoscopy (BLC) with HAL in the operating room (OR) improves detection of bladder cancer with reduction in recurrence rates when compared to WL TURBT. The objective of this study was to determine if Blue Light Flexible cystoscopy (BLFC) in the office setting can improve detection of tumors in the surveillance setting when compared to WL cystoscopy alone.

Methods

Patients with a high risk of recurrence based on history of multiple tumors, recurrent tumors and/or high grade tumors were included for their first surveillance visit. Patients who had received intravesical therapy within 6 weeks were excluded. In the clinic setting, all patients received intravesical HAL, which was retained for 1 to 3 hours before examination. The bladder was inspected under WL using flexible cystosocpy, and all suspicious lesions were documented. Some patients were randomised to WL only, in order to avoid observational bias. The rest underwent immediate subsequent investigation with BLFC. The first four patients enrolled at each site were training patients and not included in the efficacy analysis. Those suspected of recurrence were referred to the OR within 6 weeks, where WL and BLC were repeated. All suspected lesions underwent biopsy or resection. A panel of independent pathologists blinded to the origin of the specimen achieved a consensus read. The primary endpoint was the proportion of patients with histologically confirmed malignancy which was detected with BLC only. Additional endpoints included false positive rates, detection of CIS and number of additional tumors detected with BLC only.

Results

Seventeen academic institutions in the US participated in the study and 304 patients were enrolled. Of the 234 non-training patients who proceeded through randomization, 103 patients were referred to the OR with a suspected recurrence for WL and BLC. Approximately 80% of the patients had a history of CIS or HG Ta/T1 tumor. Full results are expected by end of April, 2017.

Conclusions

In the surveillance setting, an increase in detection of tumor recurrence using BLFC may provide a significant advantage for patients potentially leading to less extensive and more cost effective management.

Funding

Photocure Inc