Real-world efficacy and safety of nivolumab and ipilimumab in metastatic renal cell carcinoma: a Polish multicenter study.

IF 3 4区医学 Q2 ONCOLOGY

Future oncology Pub Date : 2025-06-01 Epub Date: 2025-05-20 DOI:10.1080/14796694.2025.2508138

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

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引用次数: 0

Abstract

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.

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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

背景：Nivolumab + ipilimumab （NIVO+IPI）是中低危患者转移性肾细胞癌（mRCC）的一线治疗方案。需要真实世界证据（RWE）研究来验证其在临床实践中的有效性和安全性。方法：这项多中心回顾性研究纳入了2022年5月至2024年12月在波兰9个肿瘤中心接受NIVO+IPI治疗的145例mRCC患者。使用Kaplan-Meier生存估计和Cox比例风险模型分析总生存期（OS）、无进展生存期（PFS）、客观缓解率（ORR）、疾病控制率（DCR）和免疫相关不良事件（irAEs）的数据，p值结果：中位随访10.9个月，中位PFS为12.8个月（95% CI:7.0-18.6），中位OS未达到。ORR和DCR分别为34.5%和66.2%。中危患者ORR和DCR高于低危患者，但无统计学意义。61.4%的患者发生了irae， 25.5%的患者发生了3/4级irae。Karnofsky性能状态p = 0.002)。结论：本研究证实了NIVO+IPI治疗mRCC的实际疗效和安全性，显示出与临床试验相当的结果。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Future oncology ONCOLOGY-

CiteScore

5.40

自引率

3.00%

发文量

335

审稿时长

4-8 weeks

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.