转移性肾细胞癌 (mRCC) 的治疗选择正在迅速扩大，使用检查点抑制剂的免疫治疗是大多数患者的一线或二线选择。本回顾性分析的目的是探讨检查点抑制剂的现实影响使用大型真实世界数据库，将基于免疫疗法的疗法与使用其他类型靶向疗法的疗法进行比较。RenIS（mRCC 患者登记处）被用作数据源。对仅使用 TKI 或 mTOR 抑制剂治疗的队列 [靶向治疗 (TT) 队列] 与在任何治疗方案中接受使用检查点抑制剂的免疫治疗 (IO) 的患者 (IO 队列) 的结果进行了比较。从登记处提取了总共 1981 名患者的数据，包括 TT 队列中的 1767 名患者和 IO 队列中的 214 名患者。从一线治疗开始起的中位总生存期为 24.5 个月，而未达到（p < 0.001） ）在 TT 队列与 IO 队列中分别 [HR 0.23，95% CI (0.17-0.31)，p < 0.001]。 TT 队列与 IO 队列的 5 年生存概率分别为 24.2% 和 67.9%。任何治疗方案中的免疫疗法都与较低的死亡风险相关。与接受非免疫靶向治疗的患者相比，接受免疫治疗作为第一或第二治疗线的患者的总体生存率更高。在现实世界的 mRCC 患者中，免疫治疗与显着的生存获益相关。目前的回顾性分析显示了二线免疫疗法对既往接受过酪氨酸激酶抑制剂治疗的患者的现实益处。© 2023。作者，获得 Springer Nature Switzerland AG 的独家许可。

Treatment options for metastatic renal cell carcinoma (mRCC) are rapidly expanding, and immunotherapy using checkpoint inhibitors is a first- or second-line option for most patients.The objective of the present retrospective analysis was to explore the real-world impact of checkpoint inhibitor-based immunotherapy compared with therapy using other types of targeted therapies using a large real-world database.RenIS, a registry of patients with mRCC was used as a data source. Outcomes were compared for cohorts treated with TKIs or mTOR inhibitors only [targeted therapy (TT) cohort] versus patients who received immunotherapy (IO) using a checkpoint inhibitor in any line of treatment (IO cohort). Data from a total of 1981 patients were extracted from the registry, including 1767 patients in the TT cohort and 214 patients in the IO cohort.The median overall survival from the initiation of first-line treatment was 24.5 months versus not reached (p < 0.001) in the TT cohort versus the IO cohort, respectively [HR 0.23, 95% CI (0.17-0.31), p < 0.001]. The probability of 5-year survival was 24.2 versus 67.9% in the TT cohort versus the IO cohort, respectively. Immunotherapy in any line of treatment was associated with a lower risk of death. Overall survival was superior for patients receiving immunotherapy as the first or second treatment line compared with patients treated with non-immunological targeted therapy.In real-world patients with mRCC, immunotherapy is associated with significant survival benefit. The present retrospective analysis shows the real-world benefit of second-line immunotherapy in patients previously treated with tyrosine-kinase inhibitors.© 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.