☆ 4.6 Article

Comparison of the performances of the ADXBLADDER test and urinary cytology in the follow-up of non-muscle-invasive bladder cancer: a blinded prospective multicentric study

BJU INTERNATIONAL (2021)

Journal

BJU INTERNATIONAL

Volume 127, Issue 2, Pages 198-204

Publisher

WILEY

DOI: 10.1111/bju.15194

Keywords

biomarker; bladder cancer; follow-up; cytology MCM5; non-muscle-invasive bladder cancer; surveillance; #uroonc; #BladderCancer; #blcsm; #utuc

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Abstract

Comparing the performance of the ADXBLADDER test with cytology in detecting non-muscle-invasive bladder cancer recurrences, ADXBLADDER demonstrated superior sensitivity, specificity, and negative predictive value. The results suggest that ADXBLADDER has the potential to be a more reliable alternative to urine cytology in the follow-up of non-muscle-invasive bladder cancer.

Objective To compare directly the performance of the ADXBLADDER test with that of cytology in the detection of non-muscle-invasive bladder cancer (NMIBC) recurrences. Background ADXBLADDER is a urine test based on the detection of MCM5, a DNA licensing factor expressed in all cells capable of dividing. Expression is usually restricted to the basal stem cell compartment; however, in malignancy, MCM5-expressing cells can be found throughout the epithelium. Detection of MCM5 in urine sediment can be indicative of the presence of a bladder tumour. Patients and Methods A multicentre prospective, blinded study was carried out from August 2017 and July 2019 at 21 European Union centres, 14 of which collected matching cytology data. Urine was collected from patients prior to cystoscopy. Urine cytology and ADXBLADDER were performed and compared to the diagnosis obtained by cystoscopy. The performance of cytology and ADXBLADDER were then compared. Results The overall performance of ADXBLADDER demonstrated a sensitivity of 51.9%, a specificity of 66.4%, and a negative predictive value (NPV) of 92%. The sensitivity of ADXBLADDER for low- and high-grade recurrences was 44.1% and 58.8%, respectively. By contrast, cytology sensitivity was 16.7%, specificity was 98% and NPV was 90.7%. Cytology sensitivity for both low- and high-grade disease was 17.6%. Conclusions ADXBLADDER detection of both low- and high-grade NMIBC recurrence is superior to that of cytology, with ADXBLADDER able to exclude the presence of high-grade recurrence in 97.8% of cases compared to 97.1% with cytology. These results show that ADXBLADDER has promise as a more reliable alternative to urine cytology in the follow-up of NMIBC.

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Tryptophan-kynurenine ratio as a biomarker of bladder cancer

Sze Han Lee, Ratha Mahendran, Sin Mun Tham, Thomas Paulraj Thamboo, Billy Jianhao Chionh, Yi Xin Lim, Woon Chau Tsang, Qing Hui Wu, Jun Yang Chia, Melissa Hui Wen Tay, Benjamin Yen Seow Goh, Kelven Weijing Chen, Jeane Zepeda Mallari, Revathi Periaswami, Lata Raman, Shoa Nian Choo, Dorinda Yan Qin Kioh, Edmund Chiong, Kesavan Esuvaranathan, Eric Chun Yong Chan

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