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. 2025 Oct;57(10):3191-3198.
doi: 10.1007/s11255-025-04486-2. Epub 2025 Apr 10.

Efficacy and safety of nivolumab plus cabozantinib in octogenarian patients with advanced renal cell carcinoma

Affiliations

Efficacy and safety of nivolumab plus cabozantinib in octogenarian patients with advanced renal cell carcinoma

Yuki Nemoto et al. Int Urol Nephrol. 2025 Oct.

Abstract

Purpose: To clarify the efficacy and safety profile of nivolumab plus cabozantinib combination therapy in advanced renal cell carcinoma patients older than 80 years.

Methods: We retrospectively evaluated 42 patients with advanced renal cell carcinoma treated with nivolumab plus cabozantinib as the first-line therapy at our institution. The patients were categorized according to age as those aged ≥ 80 years and those aged < 80 years. Efficacy was analysed by comparing the progression-free survival, overall survival, objective response rate, and disease control rate between the two groups. Safety was assessed by comparing the incidence of adverse events.

Results: Ten patients (31%) were classified as age ≥ 80 group. No significant differences were observed in the progression-free survival (p = 0.682), the overall survival (p = 0.627), objective response rate (p = 0.195), and disease control rate (p = 0.070) between the two groups. There was no significant difference in the incidence of all grades of adverse events(p = 1.000), but there was a trend toward a higher incidence of grade 3 or higher adverse events in the group of patients aged < 80 years (p = 0.066).

Conclusions: The efficacy and safety of nivolumab plus cabozantinib combination therapy were comparable between the patients aged ≥ 80 years and those aged < 80 years. Thus, chronological age alone is not a contraindication for nivolumab plus cabozantinib combination therapy for advanced renal cell carcinoma.

Keywords: Immunotherapy; Kidney cancer; Programmed cell death protein 1; Renal cancer; Tyrosine kinase inhibitor.

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Conflict of interest statement

Declarations. Conflict of interest: Toshio Takagi received honoraria from Bristol-Myers Squibb and Ono Pharmaceutical. Tsunenori Kondo received honoraria from Pfizer, Novartis, and Bristol-Myers Squibb and Ono Pharmaceutical.

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