Nivolumab and ipilimumab (nivo+ipi) are recommended for treating metastatic clear cell renal cell carcinoma (mRCC), though their safety and efficacy in older adults remain uncertain. This study examines the outcomes of this regimen in Polish patients aged ≥65 years.
In this multicenter observational study, 138 patients with mRCC who received nivo+ipi between May 2022 and October 2024 were analyzed. Key outcomes included objective response rates (ORR), disease control rate (DCR), and progression-free survival (PFS) with comparisons between patients aged <65 and ≥65 years. Safety was assessed based on the incidence and severity of immune-related adverse events (irAEs). Survival outcomes were analyzed using Kaplan-Meier methods and Cox proportional hazards models, adjusting for potential confounders. A significance level of p < 0.05 was applied.
After a median follow-up of 13 months, the median PFS for the entire cohort was 15.7 months (95% confidence interval [CI]: 10.2-20.8); in patients <65 years, it was 11.3 months, while in those ≥65 years, it was 23 months. Patients ≥65 years had a 40% lower risk of progression than younger patients (hazard ratio 0.6, 95% CI: 0.3-0.9, p=0.03). Patients aged ≥65 years exhibited a higher ORR (46.2% vs. 26%) and DCR (73.8% vs. 63%, p=0.02 for both). The overall incidence of irAEs was comparable between age groups; however, older patients experienced a higher frequency of very severe irAEs (1 vs. 6, p=0.06).
This study demonstrates that nivo+ipi are effective across age groups, with older patients achieving comparable or even superior outcomes with acceptable irAEs rates.
Frontiers in oncology. 2025 Aug 19*** epublish ***
Artur Drobniak, Łukasz Stokłosa, Aleksandra Grela-Wojewoda, Jacek Calik, Natalia Versuti Viegas, Jolanta Dobrzańska, Agnieszka Roman, Marek Szwiec, Anna Bidas, Daria Tusień-Małecka, Angelika Gawlik-Urban, Mirosława Puskulluoglu, Renata Pacholczak-Madej
Department of Chemotherapy, The District Hospital, Sucha Beskidzka, Poland., Department of Clinical Oncology, Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland., Department of Clinical Oncology, University Hospital in Wroclaw, Wrocław, Poland., Department of Oncology, Jagiellonian University Medical College, Krakow, Poland., Department of Clinical Oncology, Ludwik Rydygier Hospital, Krakow, Poland., Department of Surgery and Oncology, University of Zielona Góra, Zielona Góra, Poland., Department of Clinical Oncology, Holy Cross Cancer Center, Kielce, Poland., Clinical and Experimental Oncology Clinic, Institute of Oncology, Karol Marcinkowski Medical University, Poznań, Poland., Clinical Oncology Department with Chemotherapy Subunit, Provincial Hospital Sain Luke, Tarnów, Poland.