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Prospective trial to identify optimal bladder cancer surveillance protocol: reducing costs while maximizing sensitivity
Author(s) -
Kamat Ashish M.,
Karam Jose A.,
Grossman H. Barton,
Kader A. Karim,
Munsell Mark,
Dinney Colin P.
Publication year - 2011
Publication title -
bju international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.773
H-Index - 148
eISSN - 1464-410X
pISSN - 1464-4096
DOI - 10.1111/j.1464-410x.2010.10026.x
Subject(s) - cystoscopy , medicine , bladder cancer , urology , cytology , cancer , urine cytology , prospective cohort study , urothelial cancer , urinary system , biomarker , surgery , pathology , biochemistry , chemistry
Study Type – Diagnostic (exploratory cohort) Level of Evidence 2b What’s known on the subject? and What does the study add? A plethora of urinary markers are available with the purported benefit of identifying bladder tumours that evade detection with cystoscopy alone. Clinicians often infer that this translates into earlier detection of invasive disease and helps control costs. This prospective trial suggests that in experienced hands, cystoscopy alone is the most cost‐effective strategy to detect recurrence of non‐invasive bladder cancer. Using urinary markers in all patients significantly adds to cost and hence must be individualized. OBJECTIVE • To assess the cost‐effectiveness of using cytological evaluation, NMP22 BladderChek®, and fluorescence in situ hybridization (FISH) UroVysion® 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.