We summarise the available data for and assess the prognostic value of circulating tumour DNA (ctDNA) in patients treated with systemic therapy for urothelial carcinoma (UC). Studies were deemed eligible if they reported on oncologic outcomes for patients with UC treated with systemic therapy according to the baseline ctDNA profile (before starting systemic therapy) and/or changes over the course of therapy. Five studies met the eligibility criteria. We found a strong association between high baseline ctDNA levels and worse disease-free survival (DFS; hazard ratio [HR] 3.53, 95% confidence interval [CI] 2.58-4.84) and overall survival (OS; HR 2.99, 95% CI 2.17-4.13). Patients with a decline in ctDNA level after immunotherapy had better DFS (HR 0.25, 95% CI 0.13-0.49) and OS (HR 0.10, 95% CI 0.03-0.42) in comparison to patients without a ctDNA decline. Conversely, an increase in ctDNA levels after immunotherapy was associated with worse survival outcomes. Patients with UC who exhibited a decrease in ctDNA levels during systemic therapy had better survival outcomes compared to those with stable or increasing ctDNA levels. PATIENT SUMMARY: Measurement of tumour DNA in blood may help in identifying patients with cancer of the urinary tract who are unlikely to respond to chemotherapy or immunotherapy. This could serve as a biomarker for monitoring cancer treatment.

Department of Urology Comprehensive Cancer Center Medical University of Vienna Vienna Austria

Department of Urology Comprehensive Cancer Center Medical University of Vienna Vienna Austria; Department of Urology King Fahad Specialist Hospital Dammam Saudi Arabia

Department of Urology Comprehensive Cancer Center Medical University of Vienna Vienna Austria; Department of Urology Medical University of Silesia Zabrze Poland

Department of Urology Comprehensive Cancer Center Medical University of Vienna Vienna Austria; Department of Urology Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences Okayama Japan

Department of Urology Comprehensive Cancer Center Medical University of Vienna Vienna Austria; Department of Urology Paracelsus Medical University Salzburg University Hospital Salzburg Salzburg Austria

Department of Urology Comprehensive Cancer Center Medical University of Vienna Vienna Austria; Department of Urology The Jikei University School of Medicine Tokyo Japan

Department of Urology Comprehensive Cancer Center Medical University of Vienna Vienna Austria; Department of Urology University Medical Centre Hamburg Eppendorf Hamburg Germany

Department of Urology Comprehensive Cancer Center Medical University of Vienna Vienna Austria; Institute for Urology and Reproductive Health Sechenov University Moscow Russia

Department of Urology Comprehensive Cancer Center Medical University of Vienna Vienna Austria; Institute for Urology and Reproductive Health Sechenov University Moscow Russia; Karl Landsteiner Institute of Urology and Andrology Vienna Austria; Department of Urology Weill Cornell Medical College New York NY USA; Department of Urology University of Texas Southwestern Dallas TX USA; Department of Urology 2nd Faculty of Medicine Charles University Prague Czech Republic; Hourani Center for Applied Scientific Research Al Ahliyya Amman University Amman Jordan

Department of Urology Comprehensive Cancer Center Medical University of Vienna Vienna Austria; Men's Health and Reproductive Health Research Center Shahid Beheshti University of Medical Sciences Tehran Iran

Department of Urology Comprehensive Cancer Center Medical University of Vienna Vienna Austria; Research Center for Evidence Based Medicine Tabriz University of Medical Sciences Tabriz Iran

Institute for Urology and Reproductive Health Sechenov University Moscow Russia

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