Efficacy and Safety of Nivolumab With Ipilimumab in Elderly Patients With Advanced Renal Cell Carcinoma

Anticancer Res. 2024 Nov;44(11):5087-5093. doi: 10.21873/anticanres.17333.

Abstract

Background/aim: Nivolumab and ipilimumab (NIVO+IPI) is standard therapy for patients with intermediate and poor risk advanced renal cell carcinoma (RCC). However, the efficacy and safety of NIVO+IPI in elderly patients aged >75 years remains unclear. This study aimed to determine the efficacy and safety of first-line NIVO+IPI treatment in patients aged >75 years with advanced RCC.

Patients and methods: This study included 59 patients with advanced RCC who received NIVO+IPI as first-line therapy between September 2018 and December 2023. Objective response rates (ORRs), along with progression-free survival (PFS) and overall survival (OS) were compared between patients aged <75 years and ≥75 years, to assess survival outcomes.

Results: A total of 46 (78.0%) and 13 (22.0%) patients were classified into <75 years and ≥75 years groups, respectively, at NIVO+IPI initiation. The ORRs were 45.7% for <75 years and 53.8% for ≥75 years (p=0.2422). No significant differences in PFS (p=0.0729) were observed between groups. In contrast, patients aged ≥75 years had better OS than those aged <75 years (p=0.0212). However, no significant difference was observed in the OS between the two groups of patients with clear cell histology (p=0.0532). The incidence of immune-related adverse events higher than Grade 3 was not significantly different between the two groups (p=0.5016).

Conclusion: NIVO and IPI combination therapy is both safe and efficacious in patients aged ≥75 years with advanced RCC.

Keywords: Renal cell carcinoma; elderly patients; immune checkpoint inhibitors; nivolumab plus ipilimumab.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols* / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols* / therapeutic use
  • Carcinoma, Renal Cell* / drug therapy
  • Carcinoma, Renal Cell* / mortality
  • Carcinoma, Renal Cell* / pathology
  • Female
  • Humans
  • Ipilimumab* / administration & dosage
  • Ipilimumab* / adverse effects
  • Ipilimumab* / therapeutic use
  • Kidney Neoplasms* / drug therapy
  • Kidney Neoplasms* / mortality
  • Kidney Neoplasms* / pathology
  • Male
  • Nivolumab* / administration & dosage
  • Nivolumab* / adverse effects
  • Nivolumab* / therapeutic use
  • Progression-Free Survival
  • Retrospective Studies
  • Treatment Outcome

Substances

  • Nivolumab
  • Ipilimumab