Prospective trial to identify optimal bladder cancer surveillance protocol: reducing costs while maximizing sensitivity

OBJECTIVE To assess the cost-effectiveness of using cytological evaluation, NMP22 BladderChek (R), and fluorescence in situ hybridization (FISH) UroVysion (R) in addition to cystoscopy in patients with a history of bladder cancer undergoing surveillance for recurrence. PATIENTS AND METHODS In all, 200 consecutive patients with a history of bladder cancer not invading the muscle were prospectively enrolled at The University of Texas MD Anderson Cancer Center. Five surveillance strategies were compared: (i) cystoscopy alone; (ii) cystoscopy and NMP22; (iii) cystoscopy and FISH; (iv) cystoscopy and cytology; and (v) cystoscopy and positive NMP22 confirmed by positive FISH. The cost per cancer detected was calculated. For patients with an initial positive test and negative cystoscopy, tumour detected at first follow-up was assumed to be too small to be visualized at the initial assessment and the biomarker was credited with early detection. RESULTS Cancer was detected in 13 patients at study entry. Detection rates for the five surveillance strategies were: (i) 52%, (ii) 56%, (iii) 72%, (iv) 60%, and (v) 56%. The costs per tumour detected (at the time of initial marker analysis) were (i) $7692; (ii) $12 000; (iii) $26 462; (iv) $11 846; and (v) $10 292. When early detection of biomarkers was factored in, the CPTD became: (i) $7692; (ii) $11 143; (iii) $19 111; (iv) $10 267; and (v) $9557. There were 12 new cancers detected at first follow-up (median time, 4.1 months). None of the tumours detected by biomarkers but not by cystoscopy were invasive. CONCLUSIONS Cystoscopy alone remains the most cost-effective strategy to detect recurrence of bladder cancer not invading the muscle. The addition of urinary markers adds to cost, without improved detection of invasive disease.