Immunotherapy for advanced or metastatic urothelial carcinoma: an abridged Cochrane review.

Objectives: To assess the effects of immunotherapy compared to chemotherapy as first‐ and second‐line treatment of advanced or metastatic urothelial carcinoma. Methods: Based on a published protocol, we performed a systematic search of multiple databases. Two review authors independently performed the literature selection, identified relevant studies, assessed the eligibility of studies for inclusion, and extracted data. We performed statistical analyses using a random‐effects model and assessed the quality of the evidence on a per‐outcome basis according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Results: We included five randomised controlled trials and also identified seven single‐arm studies. When used as first‐line therapy, immunotherapy probably has little to no effect on the risk of death from any cause compared to chemotherapy (hazard ratio [HR] 0.97, 95% confidence interval [CI] 0.87–1.07; moderate‐certainty evidence). immunotherapy probably has little to no effect on health‐related quality of life (mean difference [MD] 4.10, 95% CI 3.83–4.37; moderate). Immunotherapy probably reduces grade 3–5 adverse events (risk ratio [RR] 0.47, 95% CI 0.29–0.75; moderate). In the second‐line setting immunotherapy may reduce the risk of death from any cause (HR 0.72, 95% CI 0.63–0.81; low). Immunotherapy may have little to no effect on health‐related quality of life when compared to chemotherapy (MD 4.82, 95% CI −3.11 to 12.75; low). Immunotherapy may reduce grade 3–5 adverse events (RR 0.89, 95% CI 0.81–0.97; low). Conclusions: Compared to chemotherapy, immunotherapy has little to no effect on the risk of death from any cause in a first‐line setting. Nevertheless, it may reduce the risk of death from any cause when used as second‐line therapy. The health‐related quality of life of participants receiving first‐ and second‐line therapy does not appear to be affected by immunotherapy. Immunotherapy probably reduces or may reduce grade 3–5 adverse events when used as first‐ and second‐line therapy, respectively. [ABSTRACT FROM AUTHOR]