A urine test can cut the number of cystoscopies necessary to follow up high-risk bladder cancer patients without increasing the risk of recurrence, a study has found.
After surgery, doctors perform cystoscopies to monitor high-risk bladder cancer patients for recurrence. The procedure involves inserting a flexible probe through the urethra so the physician can inspect the bladder lining for signs of cancer. Cystoscopies are common procedures and serious complications are rare. There is a small risk of infection, though, and very rarely the bladder is damaged.
A noninvasive test could reduce those risks while sparing patients pain and discomfort. Companies have developed urine tests; however, the European Association of Urology (EAU) guidelines continue to recommend the use of cystoscopies because of the limited sensitivity of noninvasive tests in low-grade recurrences.
Danish physicians recently shared data on what happens when cystoscopies are replaced by urine tests at the European Association of Urology Congress held in Paris from April 5 through April 8. Investigators randomized 313 people to undergo three cystoscopies per year, the standard of care in Denmark, or to undergo one cystoscopy and two tests with Cepheid’s urine biomarker diagnostic Xpert Bladder Cancer Monitor. Cepheid funded the study.
Patients who tested positive on Xpert underwent a cystoscopy. After two years, 44% of assessments of patients in the urine test group involved cystoscopies, meaning Xpert more than halved the use of the invasive procedure.
The study also found evidence that the urine test may detect cancer earlier than cystoscopies. Some people tested positive on the urine test, but the cystoscopy was clear. In more than half of those “false positive” results, the researchers found evidence of cancer recurrence at a later visit.
Joost Boormans, professor of urology at Erasmus University Medical Centre in Rotterdam, the Netherlands, discussed the findings and how practice could change once the researchers have the final results in a statement.
“This trial shows us a possible means of reducing cystoscopies,” Boormans said. “If the final results later this year do confirm that the urine test can pick up cancer recurrence as effectively as cystoscopies, then this is something we need to look at introducing into clinical practice as soon as possible, because it reduces demand on our resources and helps to make healthcare more accessible.”
EAU evaluated Xpert and other bladder cancer urine tests such as Nucleix’s EpiCheck and Arquer Diagnostics’ ADX Bladder for its guidelines on monitoring patients. The professional body concluded that “no urinary marker can replace cystoscopy during follow-up or lower cystoscopy frequency in a routine fashion” but noted that sensitivity was improving.
