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.
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