Background

There are few comparative studies on dual immune checkpoint inhibitors (ICIs) (i.e., IO-IO) and combination therapies comprising ICIs plus tyrosine kinase inhibitors (TKIs) (i.e., IO-TKI) for advanced renal cell carcinoma (RCC), especially in real-world settings.

Methods

We retrospectively evaluated data of 175 patients with IMDC intermediate-risk or poor-risk RCC; as first-line therapy, 103 received IO-IO, and 72 received IO-TKI. An inverse probability of treatment weighting (IPTW) analysis was conducted to balance patients' backgrounds in the IO-IO and IO-TKI groups.

Results

Based on the IPTW analysis, progression-free survival (PFS) was longer in the IO-TKI group than in the IO-IO group (median: 15.6 vs. 8.3 months; p = 0.0386). In contrast, overall survival was not different between groups (median: 46.7 vs. 49.0 months; p = 0.465). Although the IPTW-adjusted objective response rate was not significantly different (51.2% vs. 43.9%; p = 0.359), the progressive disease rate as the best overall response was lower in the IO-TKI group than in the IO-IO group (3.3% vs. 27.4%; p < 0.0001). Regarding the safety profile, the treatment interruption rate was higher in the IO-TKI group than in the IO-IO group (70.3% vs. 49.2%; p = 0.005). In contrast, the IO-IO group had a higher corticosteroid administration rate (43.3% vs. 20.3%; p = 0.001).

Conclusion

IO-TKI therapy exhibited superior effectiveness over IO-IO therapy in terms of PFS improvement and immediate disease progression prevention and was associated with a higher risk of treatment interruption and a lower risk of needing corticosteroids.

中文翻译：

---

一线双重免疫检查点抑制剂疗法与包含免疫检查点抑制剂和酪氨酸激酶抑制剂的联合疗法治疗晚期肾细胞癌：使用真实世界数据的有效性比较分析

背景

关于双重免疫检查点抑制剂（ICIs）（即 IO-IO）和 ICI 联合酪氨酸激酶抑制剂（TKI）（即 IO-TKI）联合疗法治疗晚期肾细胞癌（RCC）的比较研究很少，特别是在现实世界的设置。

方法

我们回顾性评估了 175 例 IMDC 中危或低危 RCC 患者的数据；作为一线治疗，103 例接受 IO-IO，72 例接受 IO-TKI。进行治疗权重逆概率 (IPTW) 分析以平衡 IO-IO 组和 IO-TKI 组患者的背景。

结果

根据 IPTW 分析，IO-TKI 组的无进展生存期 (PFS) 长于 IO-IO 组（中位值：15.6 个月与 8.3 个月；p  = 0.0386）。相比之下，各组之间的总生存期没有差异（中位数：46.7 个月与 49.0 个月；p  = 0.465）。尽管 IPTW 调整后的客观缓解率没有显着差异（51.2% vs. 43.9%；p  = 0.359），但 IO-TKI 组中作为最佳总体缓解的疾病进展率低于 IO-IO 组（ 3.3% 与 27.4%；p  < 0.0001）。关于安全性，IO-TKI 组的治疗中断率高于 IO-IO 组（70.3% vs. 49.2%；p  = 0.005）。相反，IO-IO 组的皮质类固醇给药率较高（43.3% vs. 20.3%；p  = 0.001）。

结论

IO-TKI 疗法在改善 PFS 和立即预防疾病进展方面表现出优于 IO-IO 疗法的有效性，并且与较高的治疗中断风险和较低的需要皮质类固醇的风险相关。