Objectives: To evaluate whether soluble Fas (sFas) in urine is an independent predictor of non-muscle-invasive bladder cancer (NMIBC). Methods: We performed a prospective chart review which included 128 subjects with NMIBC and 88 controls. The first morning voided urine sample (10-20 ml) was obtained from preoperative patients and controls. Expression levels of sFas in urine were analyzed using enzyme-linked immunosorbent assay. Clinical and pathological data, European Organisation for Research and Treatment of Cancer (EORTC) risk group category, follow-up data and urinary sFas values were gathered from each patient, and each prognostic outcome was evaluated. Results: sFas levels were significantly higher in the urine of patients with NMIBC than of those without NMIBC (p = 0.000). The level was significantly higher in cases with a higher stage or grade or high-risk and recurrent disease than in those with a lower stage or grade or low-risk and nonrecurrent disease (each p < 0.05). Kaplan-Meier estimates revealed a significant difference in time to recurrence based on sFas levels in the urine of the NMIBC patients (log-rank test; p = 0.000). On multivariate Cox regression analysis, EORTC risk group category (hazards ratio [HR] = 3.250, p = 0.000) and urinary sFas level (HR = 1.403, p = 0.015) were the independent predictors of NMIBC recurrence. Conclusions: Our study indicated that urinary sFas assay results may help identify NMIBC patients at risk of tumor recurrence. These data can be used to design a future follow-up schedule and treatment strategy for NMIBC patients.

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