Click here to view as PDF.
A study presented at the ASCO 2010 Genitourinary Cancers Symposium found that adding urine testing to cystoscopy to monitor patients for bladder cancer recurrence greatly increases costs without a corresponding clinical benefit. Nearly 50% of patients treated for early stage or noninvasive bladder cancer experience relapse, and because of this high risk, they must typically undergo cystoscopy every 3 to 6 months for life. An increasing number of physicians are also using urine tests with cystoscopy to monitor patients for recurrence.
Jose Karam, MD, a urologic oncology fellow at the University of Texas M.D. Anderson Cancer Center, said, “Over the years, several urinary assays, or markers, have been developed, and most of these are costly and can result in many false positives.” Karam and his colleagues were concerned that the cost-effectiveness of using urine tests had not been evaluated in a prospective trial.
The researchers enrolled 200 patients with non-muscle invasive bladder cancer. All patients underwent cystoscopy, cytology, NMP22 BladderChek, and FISH Urovysion testing. Medicare 2009 reimbursement data were used to compare cost and accuracy for the 4 most commonly used surveillance strategies and a hypothetical strategy. These included cystoscopy alone; cystoscopy with the NMP22 urine test, the FISH urine test, or urine cytology; or cystoscopy with NMP22 and FISH urine testing.
Each method detected 13 bladder tumors at entry. Cystoscopy produced the fewest number of false positives, and cystoscopy plus FISH had the most false positives (Table
). Follow-up data found that cystoscopy failed to detect 12 cases of bladder cancer at study entry, for the highest failure rate, and it had a 52% detection rate. Cystoscopy plus FISH left the fewest number of cases undetected, for a 72% detection rate. Based on the number of cancers accurately detected, cystoscopy was the least expensive ($7692 each case) and cystoscopy plus FISH was the most expensive ($19,111 each case).
In a press briefing, Karam said cystoscopy alone was the most cost-effective strategy for monitoring patients with superficial bladder cancer for recurrence and that urine testing adds to costs without improving the detection of invasive disease. “Our results suggest that we should be using these markers carefully and judiciously when surveilling patients with bladder cancer,” Karam said. He expressed concern that adding urine tests to cystoscopy “could result in unnecessary procedures and possibly unwarranted patient anxiety.”
Karam said it was too soon to recommend a change in clinical practice. The investigators, however, are designing a multi-institutional prospective study to validate these findings.