Effectiveness and safety of nivolumab and ipilimumab in older adults with renal cell carcinoma: findings from a multicenter observational study in Poland
BackgroundNivolumab 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.MethodsIn this multicent...
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Frontiers Media S.A.
2025-08-01
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| Series: | Frontiers in Oncology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fonc.2025.1617743/full |
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| author | Artur Drobniak Łukasz Stokłosa Łukasz Stokłosa Aleksandra Grela-Wojewoda Jacek Calik Natalia Versuti Viegas Jolanta Dobrzańska Jolanta Dobrzańska Agnieszka Roman Marek Szwiec Anna Bidas Daria Tusień-Małecka Angelika Gawlik-Urban Angelika Gawlik-Urban Angelika Gawlik-Urban Mirosława Puskulluoglu Renata Pacholczak-Madej Renata Pacholczak-Madej Renata Pacholczak-Madej |
| author_facet | Artur Drobniak Łukasz Stokłosa Łukasz Stokłosa Aleksandra Grela-Wojewoda Jacek Calik Natalia Versuti Viegas Jolanta Dobrzańska Jolanta Dobrzańska Agnieszka Roman Marek Szwiec Anna Bidas Daria Tusień-Małecka Angelika Gawlik-Urban Angelika Gawlik-Urban Angelika Gawlik-Urban Mirosława Puskulluoglu Renata Pacholczak-Madej Renata Pacholczak-Madej Renata Pacholczak-Madej |
| author_sort | Artur Drobniak |
| collection | DOAJ |
| description | BackgroundNivolumab 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.MethodsIn 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.ResultsAfter 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).ConclusionsThis study demonstrates that nivo+ipi are effective across age groups, with older patients achieving comparable or even superior outcomes with acceptable irAEs rates. |
| format | Article |
| id | doaj-art-5633ec874cb343e9a5a2b62ebc7dd7b7 |
| institution | DOAJ |
| issn | 2234-943X |
| language | English |
| publishDate | 2025-08-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Oncology |
| spelling | doaj-art-5633ec874cb343e9a5a2b62ebc7dd7b72025-08-20T03:07:12ZengFrontiers Media S.A.Frontiers in Oncology2234-943X2025-08-011510.3389/fonc.2025.16177431617743Effectiveness and safety of nivolumab and ipilimumab in older adults with renal cell carcinoma: findings from a multicenter observational study in PolandArtur Drobniak0Łukasz Stokłosa1Łukasz Stokłosa2Aleksandra Grela-Wojewoda3Jacek Calik4Natalia Versuti Viegas5Jolanta Dobrzańska6Jolanta Dobrzańska7Agnieszka Roman8Marek Szwiec9Anna Bidas10Daria Tusień-Małecka11Angelika Gawlik-Urban12Angelika Gawlik-Urban13Angelika Gawlik-Urban14Mirosława Puskulluoglu15Renata Pacholczak-Madej16Renata Pacholczak-Madej17Renata Pacholczak-Madej18Department of Chemotherapy, The District Hospital, Sucha Beskidzka, PolandDepartment of Chemotherapy, The District Hospital, Sucha Beskidzka, PolandDepartment of Chemotherapy, The Specialistic Hospital, Nowy Targ, PolandDepartment of Clinical Oncology, Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, PolandDepartment of Clinical Oncology, University Hospital in Wroclaw, Wrocław, PolandDepartment of Clinical Oncology, University Hospital in Wroclaw, Wrocław, PolandDepartment of Oncology, Jagiellonian University Medical College, Krakow, PolandOncology Clinical Department, The University Hospital, Krakow, PolandDepartment of Clinical Oncology, Ludwik Rydygier Hospital, Krakow, PolandDepartment of Surgery and Oncology, University of Zielona Góra, Zielona Góra, PolandDepartment of Clinical Oncology, Holy Cross Cancer Center, Kielce, Poland0Clinical and Experimental Oncology Clinic, Institute of Oncology, Karol Marcinkowski Medical University, Poznań, Poland1Clinical Oncology Department with Chemotherapy Subunit, Provincial Hospital Sain Luke, Tarnów, Poland2Faculty of Health Protection, Tarnów University, Tarnów, Poland3Department of Gynecological Oncology, Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, PolandDepartment of Clinical Oncology, Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, PolandDepartment of Chemotherapy, The District Hospital, Sucha Beskidzka, Poland3Department of Gynecological Oncology, Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland4Department of Anatomy, Jagiellonian University, Medical College, Krakow, PolandBackgroundNivolumab 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.MethodsIn 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.ResultsAfter 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).ConclusionsThis study demonstrates that nivo+ipi are effective across age groups, with older patients achieving comparable or even superior outcomes with acceptable irAEs rates.https://www.frontiersin.org/articles/10.3389/fonc.2025.1617743/fullrenal cell carcinomanivolumab and ipilimumabimmune checkpoint inhibitorselderlytreatment outcome |
| spellingShingle | Artur Drobniak Łukasz Stokłosa Łukasz Stokłosa Aleksandra Grela-Wojewoda Jacek Calik Natalia Versuti Viegas Jolanta Dobrzańska Jolanta Dobrzańska Agnieszka Roman Marek Szwiec Anna Bidas Daria Tusień-Małecka Angelika Gawlik-Urban Angelika Gawlik-Urban Angelika Gawlik-Urban Mirosława Puskulluoglu Renata Pacholczak-Madej Renata Pacholczak-Madej Renata Pacholczak-Madej Effectiveness and safety of nivolumab and ipilimumab in older adults with renal cell carcinoma: findings from a multicenter observational study in Poland Frontiers in Oncology renal cell carcinoma nivolumab and ipilimumab immune checkpoint inhibitors elderly treatment outcome |
| title | Effectiveness and safety of nivolumab and ipilimumab in older adults with renal cell carcinoma: findings from a multicenter observational study in Poland |
| title_full | Effectiveness and safety of nivolumab and ipilimumab in older adults with renal cell carcinoma: findings from a multicenter observational study in Poland |
| title_fullStr | Effectiveness and safety of nivolumab and ipilimumab in older adults with renal cell carcinoma: findings from a multicenter observational study in Poland |
| title_full_unstemmed | Effectiveness and safety of nivolumab and ipilimumab in older adults with renal cell carcinoma: findings from a multicenter observational study in Poland |
| title_short | Effectiveness and safety of nivolumab and ipilimumab in older adults with renal cell carcinoma: findings from a multicenter observational study in Poland |
| title_sort | effectiveness and safety of nivolumab and ipilimumab in older adults with renal cell carcinoma findings from a multicenter observational study in poland |
| topic | renal cell carcinoma nivolumab and ipilimumab immune checkpoint inhibitors elderly treatment outcome |
| url | https://www.frontiersin.org/articles/10.3389/fonc.2025.1617743/full |
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