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AUA 2020

AUA 2020: Diagnostic Performance of MCM5 in the Diagnosis of Recurrent Bladder Cancer: Results from a Large Prospective, Blinded, Multicenter European Study

(UroToday.com) The gold standard for surveillance in follow up of non-muscle invasive bladder cancer (NMIBC) is cystoscopy combined with cytology. However, the established sensitivity of cytology is very low. Urine biomarkers can act as a non-invasive method for detecting the presence of bladder cancer.  Despite urine tests being known to have a positive impact on the quality of follow-up cystoscopy, they have previously failed to be utilized in clinical practice due to: (i) a lack of high-quality prospective studies that reflect clinical practice, and (ii) poor performance and diagnostic accuracy. ADXBLADDER is a test based upon the detection of the MCM5 protein in the urine sediment, with MCM5 detection being indicative of the presence of a tumor. At the American Urological Association 2020 Virtual Annual Meeting, Dr. Joan Palou and colleagues presented results of their study determining the diagnostic performance of ADXBLADDER in the detection of non-muscle invasive bladder cancer recurrence. 



Between August 2017 and July 2019 this study was a multicenter prospective, blind study carried out at 21 centers. Patients over 18 years of age, with a previous diagnosis of non-muscle invasive bladder cancer undergoing cystoscopic surveillance, able to provide 10 mL of urine, and informed consent were recruited. Full void urine samples were collected and the ADXBLADDER test performed; ADXBLADDER results were compared to diagnosis obtained by cystoscopy and pathology. The study flow diagram is as follows:

AUA2020_ADXBLADDER_results.png

Of the 1,431 eligible patients enrolled, 127 bladder cancer recurrences were diagnosed (8.9% prevalence). Overall sensitivity for ADXBLADDER was 44.9% (95% CI 36.1%-54%) with specificity 71.1% (95% CI 68.5-73.5%) and NPV of 93% (95% CI 91.2-94.5%). ADXBLADDER sensitivity in detecting non-pTaLG tumors was 75.6% (95% CI 59.7-87.6%), with a NPV of 99.0% (95% CI 98.2-99.5%):

AUA2020_ADXBLADDER_sensitivity.png

A subset of the study population (n=503) had matching cytology. In this sub-group ADXBLADDER demonstrated a significantly higher sensitivity of 51.9% (95% CI: 37.8-65.7%), versus the sensitivity of cytology 16.7% (95% CI 7.9-29.3%, p=0.0002):

AUA2020_ADXBLADDER.png

There were no significant differences in the performance of ADXBLADDER due to age, sex, or treatment received. 

Dr. Palou concluded his presentation of ADXBLADDER for detecting the recurrence of non-muscle invasive bladder cancer with the following take-home messages:
  • This study demonstrates that in the follow up of non-muscle invasive bladder cancer patients, ADXBLADDER is able to exclude the presence of the most aggressive tumors with a NPV of 99%, with significantly higher sensitivity than cytology in all tumor types
  • ADXBLADDER detected at least twice the number of recurrences than cytology for low-grade, high-grade, and CIS
  • There were no significant differences in performance observed due to age, sex or treatment received
  • These results reveal a compelling case for ADXBLADDER to replace cytology in the follow-up strategy of non-muscle invasive bladder cancer patients 
Presented by: Joan Palou, MD, Fundacio Puigvert, Universitat Autònoma de Barcelona, Barcelona, Spain

Written by: Zachary Klaassen, MD, MSc – Assistant Professor of Urology, Georgia Cancer Center, Augusta University/Medical College of Georgia Twitter: @zklaassen_m, at the 2020 American Urological Association (AUA) Annual Meeting, Virtual Experience #AUA20, June 27- 28, 2020