Toward noninvasive follow-up of low-risk bladder cancer – Rationale and concept of the UroFollow trial

Benderska-Söder N, Hovanec J, Pesch B, Goebell P, Roghmann F, Noldus J, Rabinovich J, Wichert K, Gleichenhagen J, Käfferlein HU, Köhler CU, Johnen G, Kernig K, Hakenberg O, Jahn D, Todenhöfer T, Stenzl A, Gleissner J, Gerwert K, El-Mashtoly S, Behrens T, Brüning T, Schmitz-Dräger BJ (2020)

Publication Type: Journal article, Review article

Publication year: 2020

Journal

Urologic Oncology-Seminars and Original Investigations Elsevier

DOI: 10.1016/j.urolonc.2020.01.006

Abstract

Background: Follow-up recommendations for patients with nonmuscle invasive bladder cancer (NMIBC) are largely based upon expert opinion. A growing body of evidence suggests that current follow-up strategies for bladder cancer patients with low and intermediate risk represent overdiagnosis and may lead to overtreatment. The goal of this study is to explore the options of a noninvasive follow-up in patients with pTa G1-2/low-grade NMIBC. Methods: The risks and options for a urine marker-guided, noninvasive follow-up of patients with pTa G1-2/low-grade NMIBC were defined and the study design for a prospective randomized trial (UroFollow) was developed based upon the current literature. Results: The investigators postulated that follow-up of patients with pTa G1-2/low-grade NMIBC requires a high sensitivity of urinary tumor markers. However, data from prospective studies with prediagnostic urine samples are scarce, even for approved markers, and cross-sectional studies with symptomatic patients overestimate the sensitivity. So far, cell-based markers (e.g., uCyt+ and UroVysion) in urine appeared to have higher sensitivities and specificities in low-grade NMIBC than urine cytology and markers analyzing soluble tumor-associated antigens. Marker panels are more sensitive than single-marker approaches at the expense of a lower specificity. Given a prospective randomized comparison with a marker sensitivity of 80% compared to usual care with cystoscopy, the sample size calculation yielded that 62 to 185 patients under study per arm are needed depending on different recurrence rates. Conclusions: Based upon these findings the UroFollow trial has been designed as a prospective randomized study comparing a noninvasive marker-based (UroVysion, NMP22, urine cytology, and ultrasound) follow-up with the current standard of care over a period of 3 years.

Authors with CRIS profile

Peter Goebell Urologische Klinik

Involved external institutions

Institut für Prävention und Arbeitsmedizin der Deutschen Gesetzlichen Unfallversicherung (IPA) DE Germany (DE) St. Elisabeth Gruppe GmbH - Katholische Kliniken Rhein-Ruhr DE Germany (DE) Universität Rostock DE Germany (DE) Ruhr-Universität Bochum (RUB) DE Germany (DE) St. Theresien-Krankenhaus Nürnberg DE Germany (DE) HELIOS Kliniken DE Germany (DE) Eberhard Karls Universität Tübingen DE Germany (DE)

How to cite

APA:

Benderska-Söder, N., Hovanec, J., Pesch, B., Goebell, P., Roghmann, F., Noldus, J.,... Schmitz-Dräger, B.J. (2020). Toward noninvasive follow-up of low-risk bladder cancer – Rationale and concept of the UroFollow trial. Urologic Oncology-Seminars and Original Investigations. https://doi.org/10.1016/j.urolonc.2020.01.006

MLA:

Benderska-Söder, Natalya, et al. "Toward noninvasive follow-up of low-risk bladder cancer – Rationale and concept of the UroFollow trial." Urologic Oncology-Seminars and Original Investigations (2020).

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