Comparative Analysis of Immune-based Combination Therapy as First-line Treatment for Advanced Renal Cell Carcinoma

Background/Aim: In advanced renal cell carcinoma (RCC), immune checkpoint inhibitor (ICI) combinations (ICI-ICI) and ICI plus tyrosine kinase inhibitor (TKI) combinations (ICI-TKI) are standard first-line therapies. However, real-world data directly comparing these approaches remain limited. This study aimed to compare treatment outcomes between ICI-ICI and ICI-TKI therapies. Patients and Methods: We retrospectively analyzed 58 patients who received first-line ICI-ICI therapy (ipilimumab plus nivolumab) or ICI-TKI therapy (pembrolizumab plus axitinib, avelumab plus axitinib, nivolumab plus cabozantinib, or pembrolizumab plus lenvatinib) for advanced RCC at Nagasaki University Hospital (March 2018 to June 2024). Primary endpoints were progression-free survival (PFS), overall survival, and objective response rate (ORR). Safety profiles were also evaluated. Results: We included 36 patients in the ICI-ICI group and 22 in the ICI-TKI group. The median follow-up was 17.5 months. The median age of patients in the ICI-TKI group was significantly older than that in the ICI-ICI group (74 vs. 66 years, p