Background: Metastatic renal cell carcinoma (mRCC) represents a challenging condition characterised by poor prognosis and limited response to chemoradiotherapy. In this retrospective study, we compared the survival outcomes of first-line ICI regimens versus single-agent TKIs in patients with mRCC from two centres in Saudi Arabia.Methods: This study included 84 patients diagnosed with clear cell mRCC between January 2016 and December 2023. Patients were grouped based on treatment regimens. Progression-free survival (PFS) and overall survival (OS) were analysed using Kaplan–Meier curves and Cox proportional hazards regression.Results: The median first-line PFS was 9.7 months (95% CI: 5.3–14.1) for the overall cohort, with no significant difference between the single-agent tyrosine kinase inhibitor (TKI) group (9.4 months; 95% CI: 6.4–12.4), combination ICI group (9.0 months; 95% CI: 0.0–24.9), and single-agent ICI group (21.2 months; 95% CI: 2.6–39.8;p= 0.591). The median OS for the overall cohort was 42.0 months (95% CI: 14.9–69.2), with the single-agent TKI group having a median OS of 33.3 months (95% CI: 0.0–71.7), the combination ICI group, 42.0 months (95% CI: 0.06–84.0), and the single-agent ICI group, 23.0 months (95% CI: 19.2–26.7;p= 0.73). In comparison, the ICI-based combination therapy group exhibited a higher ORR of 41.0% (95% CI: 26.3–57.8%), while the single-agent ICI group had an ORR of 20.0% (95% CI: 3.5–55.8%). Cox regression identified liver metastasis as a significant independent predictor of PFS (HR = 1.8,p= 0.043), while a lower Karnofsky Performance Status was a significant independent predictor of OS (HR = 3.5,p< 0.001).Conclusions: In real-world practice from Saudi Arabia, first-line, single-agent ICI therapy offers promising anti-tumour activity and non-inferior survival outcomes compared to standard ICI-based combinations and single-agent TKIs.
背景：转移性肾细胞癌（mRCC）是一种预后不良且对放化疗反应有限的难治性疾病。本回顾性研究比较了沙特阿拉伯两家医疗中心mRCC患者接受一线免疫检查点抑制剂（ICI）方案与单药酪氨酸激酶抑制剂（TKI）治疗的生存结局。 方法：本研究纳入2016年1月至2023年12月期间确诊的84例透明细胞型mRCC患者。根据治疗方案对患者进行分组，采用Kaplan-Meier曲线和Cox比例风险回归模型分析无进展生存期（PFS）和总生存期（OS）。 结果：全队列患者的中位一线治疗PFS为9.7个月（95% CI：5.3-14.1），单药TKI组（9.4个月；95% CI：6.4-12.4）、联合ICI组（9.0个月；95% CI：0.0-24.9）与单药ICI组（21.2个月；95% CI：2.6-39.8）间无显著差异（p=0.591）。全队列中位OS为42.0个月（95% CI：14.9-69.2），其中单药TKI组中位OS为33.3个月（95% CI：0.0-71.7），联合ICI组为42.0个月（95% CI：0.06-84.0），单药ICI组为23.0个月（95% CI：19.2-26.7；p=0.73）。比较客观缓解率（ORR），基于ICI的联合治疗组达41.0%（95% CI：26.3-57.8%），而单药ICI组为20.0%（95% CI：3.5-55.8%）。Cox回归分析显示肝转移是PFS的显著独立预测因子（HR=1.8，p=0.043），而较低的卡氏功能状态评分是OS的显著独立预测因子（HR=3.5，p<0.001）。 结论：在沙特阿拉伯的真实世界临床实践中，与标准ICI联合方案及单药TKI相比，一线单药ICI治疗展现出良好的抗肿瘤活性，且生存结局未显劣势。
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