Non-muscle-invasive bladder cancer (NMIBC) is one of the most expensive cancers owing to frequent follow-up cystoscopies for detection of recurrence.
To assess if the noninvasive ADXBLADDER urine test could permit a less intensive surveillance schedule for patients with low-grade (LG) pTa tumor without carcinoma in situ (CIS) at the previous diagnosis.
In a prospective, double-blind, multicenter study, 629 patients underwent follow-up cystoscopy, transurethral resection of bladder tumor/biopsy of suspect lesions, and ADXBLADDER testing.
Diagnostic test accuracy and decision curve analysis were used to evaluate the impact of ADXBLADDER on decision-making on whether to perform follow-up cystoscopy. The primary endpoint was the negative predictive value (NPV) of ADXBLADDER for detection of high-grade and/or CIS (HG/CIS) recurrence and its impact on reducing unnecessary cystoscopies.
ADXBLADDER had sensitivity of 66.7% (95% confidence interval [CI] 34.9-90.1%) and an NPV of 99.15% (95% CI 97.8-99.8%) for detection of HG/CIS recurrence. The probability of HG/CIS recurrence was 5.0% for ADXBLADDER-positive patients and 0.85% for ADXBLADDER-negative patients. For HG/CIS recurrence threshold probabilities between 0.85% and 5.0%, ADXBLADDER yields a net benefit with omission of cystoscopy for ADXBLADDER-negative patients. The corresponding net reduction in unnecessary cystoscopies ranges from 11 to 62 per 100 patients.
Patients with LG pTa tumor at the previous diagnosis, for which the risk of HG/CIS recurrence is low and the ADXBLADDER NPV for ruling out HG/CIS recurrence is 99.15%, are ideally suited for a less intensive, personalized follow-up surveillance strategy using ADXBLADDER, with omission of cystoscopy for ADXBLADDER-negative patients.
ADXBLADDER is a urine test that can predict the probability of recurrence of bladder cancer. Patients diagnosed with low-grade cancer confined to the bladder mucosa are ideally suited for less intensive follow-up using this test, which could reduce unnecessary cystoscopy procedures for those with a negative result, potentially improve quality of life, and reduce overall health care costs.
European urology focus. 2022 Mar 14 [Epub ahead of print]
Morgan Rouprêt, Paolo Gontero, Stuart R C McCracken, Tim Dudderidge, Jacqueline Stockley, Ashleigh Kennedy, Oscar Rodriguez, Caroline Sieverink, Felicien Vanié, Marco Allasia, J Alfred Witjes, Marc Colombel, Fabrizio Longo, Emanuele Montanari, Joan Palou, Richard J Sylvester
Sorbonne Université GRC 5 Predictive Onco-Uro, Urology Department, AP-HP, Hôpital Pitié-Salpêtrière, Paris, France., Department of Urology, Ospedale Molinette, Turin, Italy., Department of Urology, Sunderland Royal Hospital, Sunderland, UK., Department of Urology, University Hospital Southampton, Southampton, UK., Arquer Diagnostics, Sunderland, UK., Department of Urology, Fundacio Puigvert, Barcelona, Spain., Department of Urology, Radboud University Medical Centre, Nijmegen, The Netherlands., Department of Urology, Hôpital Edouard Herriot, Lyon, France., Department of Urology, Università Policlinico Milano, Milan, Italy., European Association of Urology Non-muscle-invasive Bladder Cancer Guidelines Panel, Brussels, Belgium. Electronic address: .