Maisch Philipp, Hwang Eu Chang, Kim Kwangmin, Narayan Vikram M, Bakker Caitlin, Kunath Frank, Dahm Philipp
Department of Urology, Rechts der Isar Medical Center, Technical University of Munich, Munich, Germany.
Department of Urology and Pediatric Urology, University Hospital Ulm, University of Ulm, Ulm, Germany.
BJU Int. 2024 Oct;134(4):541-550. doi: 10.1111/bju.16368. Epub 2024 Apr 24.
To assess the effects of immunotherapy compared to chemotherapy as first- and second-line treatment of advanced or metastatic urothelial carcinoma.
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.
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).
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.
评估免疫疗法与化疗相比，作为晚期或转移性尿路上皮癌一线和二线治疗的效果。
基于已发表的方案，我们对多个数据库进行了系统检索。两位综述作者独立进行文献筛选，确定相关研究，评估纳入研究的资格，并提取数据。我们使用随机效应模型进行统计分析，并根据推荐分级评估、制定和评价（GRADE）方法按每个结局评估证据质量。
我们纳入了五项随机对照试验，并确定了七项单臂研究。当作为一线治疗使用时，与化疗相比，免疫疗法对任何原因导致的死亡风险可能几乎没有影响（风险比[HR]0.97，95%置信区间[CI]0.87-1.07；中等确定性证据）。免疫疗法对健康相关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）。免疫疗法可能会降低3-5级不良事件的发生率（风险比[RR]0.47，95%CI 0.29-0.75；中等）。在二线治疗中，免疫疗法可能会降低任何原因导致的死亡风险（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）。免疫疗法可能会降低3-5级不良事件的发生率（RR 0.89，95%CI 0.81-0.97；低）。
与化疗相比，免疫疗法在一线治疗中对任何原因导致的死亡风险几乎没有影响。然而，当作为二线治疗使用时，它可能会降低任何原因导致死亡的风险。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疗法的影响。免疫疗法在分别作为一线和二线治疗使用时，可能会降低或可能降低3-5级不良事件的发生率。
