Reducing the Frequency of Follow-up Cystoscopy in Low-grade pTa Non-muscle-invasive Bladder Cancer Using the ADXBLADDER Biomarker
Rouprêt, Morgan (Sorbonne Université GRC 5 Predictive Onco-Uro. Urology Department. AP-HP. Hôpital Pitié-Salpêtrière)
Gontero, Paolo (Ospedale Molinette)
McCracken, Stuart R.C. (Sunderland Royal Hospital)
Dudderidge, Tim (University Hospital Southampton)
Stockley, Jacqueline (Arquer Diagnostics)
Kennedy, Ashleigh (Arquer Diagnostics)
Rodríguez Faba, Óscar (Institut d'Investigació Biomèdica Sant Pau)
Sieverink, Caroline (Radboud University Medical Centre)
Vanié, Felicien (Hôpital Pitié-Salpêtrière)
Allasia, Marco (Ospedale Molinette)
Witjes, J.Alfred (Radboud University Medical Centre)
Colombel, Marc (Hôpital Edouard Herriot)
Longo, Fabrizio (Università Policlinico Milano)
Montanari, Emanuele (Università Policlinico Milano)
Palou, Joan (Ospedale Molinette)
Sylvester, Richard J. (European Association of Urology Non-muscle-invasive Bladder Cancer Guidelines Panel)
Universitat Autònoma de Barcelona

Fecha:	2022
Resumen:	Non-muscle-invasive bladder cancer (NMIBC) is one of the most expensive cancers owing to frequent follow-up cystoscopies for detection of recurrence. Objective: 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. Results and limitations: 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.
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Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Publicado en:	European Urology Focus, Vol. 8 Núm. 6 (november 2022) , p. 1643-1649, ISSN 2405-4569

DOI: 10.1016/j.euf.2022.02.006
PMID: 35300937

7 p, 637.7 KB

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