This was a prospective cohort study on patients with non-muscle invasive urothelial cancer who were attending follow-up sessions between 2018 and 2022 at the Urology and Medical Oncology Service of the South Catalonia Oncology Institute. The cohort consisted of 70 patients, of whom 58 were male. Most of these patients (approximately 62%) had high-grade urothelial carcinoma. Recurrence was observed in almost 50% of the cohort. Analysis of 82 urinary cytology specimens from the patients indicated that 7.32% were category I, 30.49% were category II, 41.46% were category III, 19.51% were category IV, and 1.22% were category V according to the Paris scoring system. Analysis of 71 urine DNA methylation tests revealed that 71.83% were negative while 25.35% were positive. Stratification across the different diagnostic groups showed that category I patient DNA methylation tests were negative in five cases and invalid in one, category II tests were negative in fifteen cases and positive in two, category III tests that consist of atypical urothelial cells were negative in sixteen and positive in five. Category IV and V tests were negative in one case, positive in thirteen cases, and invalid in one. As a comparison, patients with painless hematuria all exhibited negative DNA methylation tests.
Sensitivity rates were similar between the urine DNA methylation test and cytology, at 91.67% and 90%, respectively. The positive predictive value (PPV) was 81.82% for cytology and 78.57% for the DNA methylation test, while the negative predictive value (NPV) was 94.12% for cytology and 97.14% for the DNA methylation test. For high-grade urothelial carcinomas specifically, the sensitivity rates for the DNA methylation test and cytology were 85.71% and 90.91%, respectively, while the specificity rates were 92.31% and 83.33%, respectively. The PPV was 62.50% for urine cytology and 70.57% for the DNA methylation test, while the NPV was 96.77% for urine cytology and 96.77% for the DNA methylation test.
The findings from this study emphasize the validity of the urine DNA methylation test in patients with urothelial carcinoma, which was consistent with results from standard urine cytology testing and exhibited acceptable sensitivity rates. Nevertheless, the study had a relatively small sample size of patients with both urine cytology and DNA methylation test results. Emerging urinary DNA genomic and methylome applications are promising a change of the surveillance landscape in this setting.
Written by: Bishoy M. Faltas, MD, Director of Bladder Cancer Research, Englander Institute for Precision Medicine, Weill Cornell Medicine, New York City, New York
References:
- Peña KB, Riu F, Hernandez A, Guilarte C, Badia J, Parada D. Usefulness of the Urine Methylation Test (Bladder EpiCheck®) in Follow-Up Patients with Non-Muscle Invasive Bladder Cancer and Cytological Diagnosis of Atypical Urothelial Cells-An Institutional Study. J Clin Med. 2022;11(13):3855. Published 2022 Jul 3. doi:10.3390/jcm11133855
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