Renata Pacholczak-Madej, Artur Drobniak, Łukasz Stokłosa, Aleksandra Grela-Wojewoda, Jacek Calik, Natalia Versuti Viegas, Daria Tusień-Małecka, Marek Szwiec, Jolanta Dobrzańska, Agnieszka Roman, Anna Bidas, Angelika Gawlik-Urban, Jerzy Walocha, Paweł Blecharz, Mirosława Puskulluoglu
{"title":"nivolumab和ipilimumab在转移性肾细胞癌中的实际疗效和安全性：波兰多中心研究","authors":"Renata Pacholczak-Madej, Artur Drobniak, Łukasz Stokłosa, Aleksandra Grela-Wojewoda, Jacek Calik, Natalia Versuti Viegas, Daria Tusień-Małecka, Marek Szwiec, Jolanta Dobrzańska, Agnieszka Roman, Anna Bidas, Angelika Gawlik-Urban, Jerzy Walocha, Paweł Blecharz, Mirosława Puskulluoglu","doi":"10.1080/14796694.2025.2508138","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Nivolumab plus ipilimumab (NIVO+IPI) is a first-line treatment for metastatic renal cell carcinoma (mRCC) in intermediate- and poor-risk patients. Real-world evidence (RWE) studies are needed to validate its efficacy and safety in clinical practice.</p><p><strong>Methods: </strong>This multicenter retrospective study included 145 mRCC patients treated with NIVO+IPI at nine oncology centers in Poland between May 2022 and December 2024. Data on overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and immune-related adverseevents (irAEs) were analyzed using Kaplan-Meier survival estimates and Cox proportional hazards models, with p-value <0.05 considered statistically significant.</p><p><strong>Results: </strong>With a limited median follow-up of 10.9 months, median PFS was 12.8 months (95% CI:7.0-18.6), and median OS was not reached. ORR and DCR were 34.5% and 66.2%,respectively. In intermediate-risk patients, ORR and DCR were higher than in poor-risk patients without statistical significance. IrAEs occurred in 61.4% of patients, with grade 3/4 irAEs in 25.5%. Karnofsky Performance Status < 80%, central nervous system metastases, and hepatic irAEs were associated with poorer survival in a multivariate analysis (<i>p</i> = 0.002).</p><p><strong>Conclusions: </strong>This study confirms the real-world efficacy and safety of NIVO+IPI in mRCC, demonstrating outcomes comparable to clinical trials.</p>","PeriodicalId":12672,"journal":{"name":"Future oncology","volume":" ","pages":"1895-1904"},"PeriodicalIF":3.0000,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12150655/pdf/","citationCount":"0","resultStr":"{\"title\":\"Real-world efficacy and safety of nivolumab and ipilimumab in metastatic renal cell carcinoma: a Polish multicenter study.\",\"authors\":\"Renata Pacholczak-Madej, Artur Drobniak, Łukasz Stokłosa, Aleksandra Grela-Wojewoda, Jacek Calik, Natalia Versuti Viegas, Daria Tusień-Małecka, Marek Szwiec, Jolanta Dobrzańska, Agnieszka Roman, Anna Bidas, Angelika Gawlik-Urban, Jerzy Walocha, Paweł Blecharz, Mirosława Puskulluoglu\",\"doi\":\"10.1080/14796694.2025.2508138\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Nivolumab plus ipilimumab (NIVO+IPI) is a first-line treatment for metastatic renal cell carcinoma (mRCC) in intermediate- and poor-risk patients. Real-world evidence (RWE) studies are needed to validate its efficacy and safety in clinical practice.</p><p><strong>Methods: </strong>This multicenter retrospective study included 145 mRCC patients treated with NIVO+IPI at nine oncology centers in Poland between May 2022 and December 2024. Data on overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and immune-related adverseevents (irAEs) were analyzed using Kaplan-Meier survival estimates and Cox proportional hazards models, with p-value <0.05 considered statistically significant.</p><p><strong>Results: </strong>With a limited median follow-up of 10.9 months, median PFS was 12.8 months (95% CI:7.0-18.6), and median OS was not reached. ORR and DCR were 34.5% and 66.2%,respectively. In intermediate-risk patients, ORR and DCR were higher than in poor-risk patients without statistical significance. IrAEs occurred in 61.4% of patients, with grade 3/4 irAEs in 25.5%. Karnofsky Performance Status < 80%, central nervous system metastases, and hepatic irAEs were associated with poorer survival in a multivariate analysis (<i>p</i> = 0.002).</p><p><strong>Conclusions: </strong>This study confirms the real-world efficacy and safety of NIVO+IPI in mRCC, demonstrating outcomes comparable to clinical trials.</p>\",\"PeriodicalId\":12672,\"journal\":{\"name\":\"Future oncology\",\"volume\":\" \",\"pages\":\"1895-1904\"},\"PeriodicalIF\":3.0000,\"publicationDate\":\"2025-06-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12150655/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Future oncology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1080/14796694.2025.2508138\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/5/20 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Future oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/14796694.2025.2508138","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/5/20 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"ONCOLOGY","Score":null,"Total":0}
Real-world efficacy and safety of nivolumab and ipilimumab in metastatic renal cell carcinoma: a Polish multicenter study.
Background: Nivolumab plus ipilimumab (NIVO+IPI) is a first-line treatment for metastatic renal cell carcinoma (mRCC) in intermediate- and poor-risk patients. Real-world evidence (RWE) studies are needed to validate its efficacy and safety in clinical practice.
Methods: This multicenter retrospective study included 145 mRCC patients treated with NIVO+IPI at nine oncology centers in Poland between May 2022 and December 2024. Data on overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and immune-related adverseevents (irAEs) were analyzed using Kaplan-Meier survival estimates and Cox proportional hazards models, with p-value <0.05 considered statistically significant.
Results: With a limited median follow-up of 10.9 months, median PFS was 12.8 months (95% CI:7.0-18.6), and median OS was not reached. ORR and DCR were 34.5% and 66.2%,respectively. In intermediate-risk patients, ORR and DCR were higher than in poor-risk patients without statistical significance. IrAEs occurred in 61.4% of patients, with grade 3/4 irAEs in 25.5%. Karnofsky Performance Status < 80%, central nervous system metastases, and hepatic irAEs were associated with poorer survival in a multivariate analysis (p = 0.002).
Conclusions: This study confirms the real-world efficacy and safety of NIVO+IPI in mRCC, demonstrating outcomes comparable to clinical trials.
期刊介绍：
Future Oncology (ISSN 1479-6694) provides a forum for a new era of cancer care. The journal focuses on the most important advances and highlights their relevance in the clinical setting. Furthermore, Future Oncology delivers essential information in concise, at-a-glance article formats - vital in delivering information to an increasingly time-constrained community.
The journal takes a forward-looking stance toward the scientific and clinical issues, together with the economic and policy issues that confront us in this new era of cancer care. The journal includes literature awareness such as the latest developments in radiotherapy and immunotherapy, concise commentary and analysis, and full review articles all of which provide key findings, translational to the clinical setting.
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