ObjectivesTo assess the effects of immunotherapy compared to chemotherapy as first‐ and second‐line treatment of advanced or metastatic urothelial carcinoma.MethodsBased 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.ResultsWe 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).ConclusionsCompared 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.

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晚期或转移性尿路上皮癌的免疫治疗：Cochrane 简评

目的 评估免疫疗法与化疗作为晚期或转移性尿路上皮癌一线和二线治疗的效果。方法根据已发表的方案，我们对多个数据库进行了系统搜索。两位综述作者独立进行文献选择、确定相关研究、评估研究纳入的资格并提取数据。我们使用随机效应模型进行统计分析，并根据建议评估、制定和评价分级 (GRADE) 方法评估每个结果的证据质量。结果我们纳入了五项随机对照试验，还确定了七项单一研究‐手臂研究。当用作一线治疗时，与化疗相比，免疫疗法对全因死亡风险几乎没有影响（风险比 [HR] 0.97，95% 置信区间 [CI] 0.87-1.07；中等质量证据） 。免疫疗法对健康相关的生活质量可能几乎没有影响（平均差 [MD] 4.10，95% CI 3.83-4.37；中等）。免疫疗法可能会减少 3-5 级不良事件（风险比 [RR] 0.47，95% CI 0.29-0.75；中等）。在二线治疗中，免疫治疗可能会降低全因死亡的风险（HR 0.72，95% CI 0.63-0.81；低）。与化疗相比，免疫疗法对健康相关的生活质量可能几乎没有影响（MD 4.82，95% CI -3.11 至 12.75；低）。免疫治疗可减少 3-5 级不良事件（RR 0.89，95% CI 0.81-0.97；低）。结论与化疗相比，免疫治疗对一线环境中全因死亡风险几乎没有影响。尽管如此，当用作二线治疗时，它可能会降低任何原因导致的死亡风险。接受一线和二线治疗的参与者的健康相关生活质量似乎不受免疫治疗的影响。当免疫疗法分别用作一线和二线治疗时，可能会减少或可能减少 3-5 级不良事件。