“As EpiCheck® results are remarkable, this assay is now included in the diagnostic work-up of UTUC at our center.” [1]
Urothelial carcinomas are most commonly found in the bladder, in which case they are referred to as bladder cancer. However, they can also appear in the upper urinary tract, where they are called upper tract urothelial carcinomas (UTUC).
For the diagnosis and staging of UTUC, the EAU guidelines recommend urethrocystoscopy to rule out a bladder tumour, urine cytology and a computed tomography (CT) urography. If imaging and cytology are not sufficient for the diagnosis and/or risk-stratification of the tumour, the guidelines recommend using a diagnostic ureteroscopy and biopsy [2].
Surveillance regimens of UTUC are also based on urethrocystoscopy and urinary cytology, and last for >5 years. Additionally, repeated ureteroscopy is recommended following kidney-sparing surgery, due to the high risk of disease recurrence [2].
Detecting UTUC is challenging and burdensome. Cytology is even less sensitive for UTUC compared to bladder tumours [3] and carcinoma in situ (CIS) flat lesions are generally not visible with CT [2]. Ureteroscopies and biopsies are very invasive procedures, often failing to achieve definitive results and posing a significant burden on both patients and healthcare systems. Moreover, a diagnostic ureteroscopy before radical nephroureterectomy has been shown to be associated with a subsequent increase in bladder tumours [4,5].
The performance of the EpiCheck® assay in detecting UTUC was evaluated in a single-centre, prospective trial led by Dr. Alberto Breda, head of the oncological urology unit and the kidney transplant team in Fundació Puigvert, Barcelona, Spain [1]. In 80 patients with suspicion or in follow-up for UTUC, urine samples from the lower and upper tract were collected for urine cytology and EpiCheck® before a diagnostic ureteroscopy.
The Bladder EpiCheck® assay achieved high sensitivity and high negative predictive value (NPV) for the detection of high-grade tumours compared to urine cytology. The test performance was better in urine samples collected from the upper tract than in samples collected from the lower tract. Specificity was favourable, allowing to exclude the vast majority of negative cases.
A single-centre, prospective trial evaluating the performance of the Xpert® BC detection in 67 patients with suspicion of UTUC [6]. The sensitivity was higher with the Xpert® BC detection in both upper tract urine samples and in voided urine samples compared to urine cytology.
However, due to the cut-off for positivity (linear discriminant analysis [LDA]=0.45), the Xpert® BC detection specificity was low compared to cytology.
Conclusion
Both the Bladder EpiCheck® and the Xpert® BC detection urinary markers demonstrated high sensitivity for the detection of high-grade UTUC [1,4]. Additionally, the Bladder EpiCheck® demonstrated a high NPV for high-grade UTUC and high sensitivity, thereby ruling out high-grade tumours with a high level of confidence and providing a low rate of false positive results. Because of these excellent biomarker metrics, the Bladder EpiCheck® serves a useful tool for the detection of UTUC.
Watch the presentation on the EpiCheck® assay here.
References
1. Gallioli A, Fontana M, Boissier R, et al. Presented at EAU 2021;abstract P0776.
2. Rouprêt M, Babjuk M, Burger M, et al. European Association of Urology (EAU) 2021 guidelines on upper urinary tract urothelial carcinoma. Update April 2021.
3. Messer J, Shariat SF, Brien JC, et al. BJU Int 2011;108:701-5.
4. Marchioni M, Primiceri G, Luca Cindolo L, et al. BJU Int 2017;120:313-9.
5. Guo RQ, Hong P, Xiong GY, et al. BJU Int 2018;121:184-93.
6. D’Elia C, Trenti E, Folchini DM, et al. Presented at EAU 2021;abstract P0777.
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