Introduction:

Patients with non-muscle-invasive bladder cancer (NMIBC) suffer high recurrence rates that may lead to greater disease progression and worse overall clinical outcomes. White light cystoscopy (WLC) is the standard of care for monitoring NMIBC though there is substantial evidence that enhanced detection methods such as Blue Light Cystoscopy (BLC) can find further tumors missed by While Light alone. We describe the impact of BLC use on recurrence rates among NMIBC patients in a real-world clinical care setting.

Methods:

The US Blue Light Cystoscopy with Cysview Registry (Clinical Trials: NCT02660645) is a large prospective, longitudinal, real-world evidence study in NMIBC patients who have undergone transurethral resection of the bladder (TURBT) using Blue Light as an adjunct to white light cystoscopy. The data represents an interim analysis of the study, which is projected to enroll 4,400 patients in total. All Registry patients analyzed (n=2055) received Blue Light. They were directly compared to a historical White-Light only control group (n=261) of similar age, stage, grade and clinical management (i.e., intravesical therapy). A Kaplan-Meier model using 95% CIs was used to estimate event-free survival. The Log-Rank Sum test was performed to generate an associated p-value.

Results:

The Kaplan-Maier graph shows recurrence free survival (RFS) curves for the BLC patients within the Cysview Registry against a White Light only arm. Mean follow-up in the BLC Registry study was 27.4 months (26-78 months) and 53 months (37-71 months) for the WL historical control arm. The overall risk of recurrence was significantly lower following BLC compared to While Light cystoscopy alone (Hazard Ratio (HR) 0.33; 95% Confidence Interval (CI) 0.28-0.40, p-value=<.0001). Incidence of lowered recurrence in the BCL arm were durable, as rates tracked over 5-years consistently out-performed white light cystoscopy.

Conclusion:

In a large, multisite Registry study, we report evidence supporting that use of Blue Light Cystoscopy, in combination with conventional White Light Cystoscopy, significantly decreased risk of recurrence and prolonged time interval to recurrence. The results indicate that better tumor detection through enhanced cystoscopy has the potential to translate to more favorable long-term outcomes in a real-world setting. 

Funding: This study was conducted with the financial support of Photocure,Inc.