Efficacy and Safety of Nivolumab Plus Ipilimumab for Metastatic Renal Cell Carcinoma in Patients 75 Years and Older: Multicenter Retrospective Study.

Simple Summary: Our multi-center retrospective cohort study assesses the efficacy and safety of nivolumab plus ipilimumab in patients ≥75 years old. A comparison of efficacy between patients ≥75 years (n = 33) and patients <75 years (n = 123) showed no significant differences in objective response rate, disease control rate, progression-free survival, or cancer-specific survival. However, overall survival in patients ≥75 years was significantly poorer than that in patients <75 years. Moreover, an age ≥75 years was shown in multivariable analysis to be a significant independent predictor of poorer overall survival. Toxicity was not significantly different between the two groups. Background/Objectives: The efficacy and safety of nivolumab plus ipilimumab (NIVO + IPI) for elderly patients with metastatic renal cell carcinoma have not been reported with sufficient evidence. Our study therefore aimed to compare the efficacy and safety of NIVO + IPI between patients ≥75 years and patients <75 years with metastatic renal cell carcinoma. Methods: We retrospectively analyzed a multi-center cohort of the 156 patients that received NIVO + IPI treatment at eight institutions. Among them, 33 patients were ≥75 years old, and the remainder were <75 years old. Results: Patient demographics and tumor characteristics were not significantly different between the two groups except for age. The objective response rate, disease control rate, progression-free survival, or cancer-specific survival were not significantly different between the groups. However, overall survival in the patients ≥75 years was significantly shorter than that in the patients <75 years (median: 18 months vs. 46 months, p = 0.01). In addition, an age ≥75 years was shown in multivariable analysis to be a significant independent predictor of poor overall survival. Toxicity did not show any significant variation between the groups. Conclusions: Although the clinical efficacy and safety of NIVO + IPI was demonstrated in patients ≥75 years old, it is suggested that the indication for NIVO + IPI in this age group should be carefully considered, taking into account patients' expected life expectancy. [ABSTRACT FROM AUTHOR]