Aim: To clarify the association between age and treatment outcomes of first-line immune checkpoint inhibitor (ICI) combination therapy for previously untreated advanced renal cell carcinoma (RCC).
Methods: We retrospectively evaluated the clinical data of 246 patients who received ICI combination therapy as a first-line systemic therapy for advanced RCC. The patients were divided into three groups based on age as follows: Age I, ≤ 65 years; Age II, > 65 to ≤ 75 years; and Age III, > 75 years. Survival, tumor response, and toxicity were compared among the three groups.
Results: Of 246 patients, 111 (45%) were treated with ICI dual combination therapy. In them, progression-free survival, overall survival, and objective response rate were not significantly different among age-based subgroups (P > 0.05). The development rates of adverse events of any grade and those of grade ≥3 and the rates of treatment interruption, discontinuation, and glucocorticoid use were not significantly different among the groups (P > 0.05). In the remaining 135 patients (55%) receiving combinations of ICIs with tyrosine kinase inhibitors, similar findings were observed: the survival, tumor response, and toxicity profiles were comparable among age-based subgroups (P > 0.05).
Conclusion: The effectiveness and safety profiles of first-line ICI combination therapy did not deteriorate, even in older patients. These findings suggest that ICI combination therapy for RCC should not be avoided because of chronological age alone. Geriatr Gerontol Int 2025; 25: 1082-1088.
Keywords: IO; TKI; immuno‐oncology; ipilimumab; lenvatinib.
© 2025 Japan Geriatrics Society.