Martina Catalano, Giulia Venturi, Alessia Salfi, Francesco Bloise, Federico Paolieri, Luca Galli, Michele Sisani, Laura Doni, Giandomenico Roviello
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The impact of AEs on progression-free survival (PFS), overall survival (OS), overall response, and disease control rate were analyzed using descriptive statistics, Kaplan-Meier method, and Cox regression.</p><p><strong>Results: </strong>AEs occurred in 78.8% of NI, 87.9% of NC, and 92.3% of PA patients. Grade 3-4 AEs were more common in IO-TKI vs. IO-IO combinations (32.9% vs. 15.1%, <i>p</i> = 0.05). Pruritus and pulmonary events were more frequent with IO-IO, while hypertension and mucositis were more common with IO-TKI. High-grade AEs did not impact PFS or OS, but TKI reduction due to AEs was associated with longer OS (<i>p</i> < 0.01). Steroid use also improved OS (<i>p</i> = 0.04).</p><p><strong>Conclusion: </strong>AEs are common in ICI-based therapies for RCC. While they do not negatively affect survival, their management, especially through dose reductions or steroids, may improve outcomes.</p>","PeriodicalId":13328,"journal":{"name":"Immunotherapy","volume":" ","pages":"247-256"},"PeriodicalIF":2.7000,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12013433/pdf/","citationCount":"0","resultStr":"{\"title\":\"Incidence and impact of immune combination therapies adverse events in advanced renal cell carcinoma patients.\",\"authors\":\"Martina Catalano, Giulia Venturi, Alessia Salfi, Francesco Bloise, Federico Paolieri, Luca Galli, Michele Sisani, Laura Doni, Giandomenico Roviello\",\"doi\":\"10.1080/1750743X.2025.2482510\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Immune (IO)-combination therapies have revolutionized the treatment of advanced renal cell carcinoma (aRCC) but are more frequently associated with adverse events (AEs) compared to tyrosine kinase inhibitors (TKI) alone. 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引用次数: 0
摘要
背景：免疫（IO）联合治疗已经彻底改变了晚期肾细胞癌（aRCC）的治疗，但与单独使用酪氨酸激酶抑制剂（TKI）相比，免疫（IO）联合治疗更频繁地与不良事件（ae）相关。本回顾性研究旨在评估在接受联合治疗的患者中不良事件的发生率和预后意义。方法：我们纳入了2023年11月至2024年6月期间在四个意大利肿瘤中心接受尼武单抗/伊匹单抗（NI）、尼武单抗/卡博赞替尼（NC）或派姆单抗/阿西替尼（PA）治疗的患者。采用描述性统计、Kaplan-Meier法和Cox回归分析ae对无进展生存期（PFS）、总生存期（OS）、总反应和疾病控制率的影响。结果：78.8%的NI、87.9%的NC和92.3%的PA患者发生ae。3-4级ae在IO-TKI组比IO-IO组更常见（32.9%比15.1%,p = 0.05）。瘙痒和肺部事件在IO-IO组更常见，而高血压和粘膜炎在IO-TKI组更常见。高级别ae不影响PFS或OS，但ae导致的TKI降低与更长的OS相关（p p = 0.04）。结论：在基于ci的RCC治疗中，ae是常见的。虽然它们不会对生存产生负面影响，但对其进行管理，特别是通过减少剂量或使用类固醇，可能会改善预后。
Incidence and impact of immune combination therapies adverse events in advanced renal cell carcinoma patients.
Background: Immune (IO)-combination therapies have revolutionized the treatment of advanced renal cell carcinoma (aRCC) but are more frequently associated with adverse events (AEs) compared to tyrosine kinase inhibitors (TKI) alone. This retrospective study aimed to evaluate the incidence and prognostic significance of AEs in patients receiving combination therapies.
Methods: We included patients treated with nivolumab/ipilimumab (NI), nivolumab/cabozantinib (NC), or pembrolizumab/axitinib (PA) at four Italian oncology centers between November 2023 and June 2024. The impact of AEs on progression-free survival (PFS), overall survival (OS), overall response, and disease control rate were analyzed using descriptive statistics, Kaplan-Meier method, and Cox regression.
Results: AEs occurred in 78.8% of NI, 87.9% of NC, and 92.3% of PA patients. Grade 3-4 AEs were more common in IO-TKI vs. IO-IO combinations (32.9% vs. 15.1%, p = 0.05). Pruritus and pulmonary events were more frequent with IO-IO, while hypertension and mucositis were more common with IO-TKI. High-grade AEs did not impact PFS or OS, but TKI reduction due to AEs was associated with longer OS (p < 0.01). Steroid use also improved OS (p = 0.04).
Conclusion: AEs are common in ICI-based therapies for RCC. While they do not negatively affect survival, their management, especially through dose reductions or steroids, may improve outcomes.
期刊介绍：
Many aspects of the immune system and mechanisms of immunomodulatory therapies remain to be elucidated in order to exploit fully the emerging opportunities. Those involved in the research and clinical applications of immunotherapy are challenged by the huge and intricate volumes of knowledge arising from this fast-evolving field. The journal Immunotherapy offers the scientific community an interdisciplinary forum, providing them with information on the most recent advances of various aspects of immunotherapies, in a concise format to aid navigation of this complex field.
Immunotherapy delivers essential information in concise, at-a-glance article formats. Key advances in the field are reported and analyzed by international experts, providing an authoritative but accessible forum for this vitally important area of research. Unsolicited article proposals are welcomed and authors are required to comply fully with the journal''s Disclosure & Conflict of Interest Policy as well as major publishing guidelines, including ICMJE and GPP3.
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