Since the introduction of immune checkpoint inhibitors (ICIs) and the approval of their combination with tyrosine kinase inhibitors (TKIs), pharmacotherapy for advanced renal cell carcinoma (RCC) has evolved significantly. Studies have shown that regimens using dual ICIs or a combination of ICIs and TKIs outperform traditional TKI monotherapy. This study evaluates and reports the pharmacotherapeutic approaches for advanced RCC at our institution. Several clinical trials have reported that ICI combination therapy outperforms TKI monotherapy. This study aims to evaluate whether similar trends are observed in real-world clinical settings.

Our study included patients who received first-line medical treatment for advanced RCC at our hospital from April 2007 to September 2024. We evaluated and compared progression-free survival (PFS), overall response rate (ORR), and overall survival (OS) between the TKI monotherapy and ICI combination therapy cohorts.

The study included 89 patients (63 males, 26 females) with a median age of 71 years (range 38-86), of whom 50 had metachronous and 38 had synchronous metastases. A total of 53 patients received TKI monotherapy, while 36 patients received ICI combination therapy. The distribution of IMDC risk groups was as follows: 17% favorable, 64% intermediate, and 19% poor. In the TKI group, the corresponding figures were 19%, 70%, and 11%, respectively. In the ICI combination group, the figures were 14%, 56%, and 30%. The median PFS was 8.5 months in the TKI arm and 15.5 months in the ICI arm (p=0.04). The ORR was 0.32 in the TKI arm and 0.58 in the ICI arm (p=0.02). The median OS was 45.5 months in the TKI group and 40.4 months in the ICI group (p = 0.91).

ICI combination therapy showed a significantly higher response rate and a trend toward longer PFS compared to TKI monotherapy. However, no significant difference in OS was observed between the two groups. This evaluation confirms the superiority of ICI combination therapy in improving PFS and ORR as a first-line pharmacological treatment for advanced RCC in clinical practice.