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BRIEF RESEARCH REPORT article

Front. Oncol.

Sec. Cancer Immunity and Immunotherapy

Volume 15 - 2025 | doi: 10.3389/fonc.2025.1617743

This article is part of the Research TopicAdvancing Immunotherapy in the Elderly: Overcoming Metabolic and Inflammatory BarriersView all 4 articles

Effectiveness and safety of nivolumab and ipilimumab in older adults with renal cell carcinoma: findings from a multicenter observational study in Poland

Provisionally accepted
Artur  DrobniakArtur Drobniak1Łukasz  StokłosaŁukasz Stokłosa1Aleksandra  Grela-WojewodaAleksandra Grela-Wojewoda2Jacek  CalikJacek Calik3Natalia  Versuti ViegasNatalia Versuti Viegas3Jolanta  DobrzańskaJolanta Dobrzańska4Agnieszka  RomanAgnieszka Roman5Marek  SzwiecMarek Szwiec6Anna  BidasAnna Bidas7Daria  Tusień-MałeckaDaria Tusień-Małecka8Angelika  Gawlik-UrbanAngelika Gawlik-Urban2Miroslawa  PuskulluogluMiroslawa Puskulluoglu2*Renata  Pacholczak-MadejRenata Pacholczak-Madej2*
  • 1Department of Chemotherapy, The District Hospital, Sucha Beskidzka, Poland
  • 2Maria Skłodowska-Curie National Institute of Oncology, Kraków, Poland
  • 3University Hospital in Wrocław, Wrocław, Poland
  • 4University Hospital in Krakow, Krakow, Lesser Poland, Poland
  • 5Ludwik Rydygier Memorial Specialized Hospital in Krakow, Krakow, Poland
  • 6University of Zielona Góra, Zielona Góra, Lubusz, Poland
  • 7Holy Cross Cancer Center, Kielce, Świętokrzyskie, Poland
  • 8Poznan University of Medical Sciences, Poznań, Greater Poland, Poland

The final, formatted version of the article will be published soon.

Background: 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. Methods: 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 immunerelated 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.Results: 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).Conclusions: This study demonstrates that nivo+ipi are effective across age groups, with older patients achieving comparable or even superior outcomes with acceptable irAEs rates.

Keywords: Renal cell carcinoma, nivolumab and ipilimumab, immune checkpoint inhibitors, Elderly, treatment outcome

Received: 24 Apr 2025; Accepted: 31 Jul 2025.

Copyright: © 2025 Drobniak, Stokłosa, Grela-Wojewoda, Calik, Versuti Viegas, Dobrzańska, Roman, Szwiec, Bidas, Tusień-Małecka, Gawlik-Urban, Puskulluoglu and Pacholczak-Madej. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence:
Miroslawa Puskulluoglu, Maria Skłodowska-Curie National Institute of Oncology, Kraków, Poland
Renata Pacholczak-Madej, Maria Skłodowska-Curie National Institute of Oncology, Kraków, Poland

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