Mariussi Miriana, Gallo Ruelas Mariano, Costa de Oliveira Lima Laura, Furtado Leite Felipe, Juliano Silva Cunha Marcela, Guedes Moreira Valle Leonardo, Boueri Affonso Breno, Galastri Francisco Leonardo, Serrano Uson Junior Pedro Luiz, Yuri Itaya Yamaga Lilian, Nasser Felipe, Gobbo Garcia Rodrigo
Department of Interventional Radiology, Hospital Israelita Albert Einstein, São Paulo, SP, 05652-900, Brazil.
Instituto de Investigación Nutricional, Lima, 15024, Peru.
Dig Dis Sci. 2025 Jun 26. doi: 10.1007/s10620-025-09139-z.
The aim of this systematic review and meta-analysis is to determine the efficacy and safety of selective internal radiation therapy (SIRT) using yttrium-90 (Y-90) combined with immune checkpoint inhibitors (ICIs) in the treatment of hepatocellular carcinoma (HCC).
We systematically searched Embase, Cochrane Central Register of Controlled Trials, Pubmed/Medline, and Web of Science from inception to September 10th of 2024 for studies published with the following medical subject heading terms: "selective internal radiation therapy", "immunotherapy", "immune checkpoint inhibitors", and "hepatocellular carcinoma". In addition, the references of included studies and systematic reviews were evaluated for additional studies. The outcomes of interest were median overall survival (mOS), median progression-free survival (mPFS), median time to tumor progression (mTTP), objective response rate (ORR), disease control rate (DCR), and adverse events (AEs). A subgroup analysis of ORR was conducted based on patients' BCLC staging, along with a comparison between studies that initiated ICIs prior to SIRT and those that administered SIRT before ICIs.
The review included seven studies, consisting of four clinical trials and three retrospective cohort studies, with a total of 184 patients. The pooled analysis demonstrated an ORR of 58.08% (95% CI: 39.07-77.09) and a DCR of 85.03% (95% CI: 76.23-93.83). The pooled mTTP, mPFS and mOS resulted in 7.17 months (95% CI: 5.05-9.29), 7.12 months (95% CI: 5.29-8.95) and 20.43 months (95% IC: 17.58-23.29), respectively. The subgroup analysis of ORR according to the patients' BCLC staging, including BCLC-B and BCLC-C, resulted in a pooled ORR of 75.71% (95% CI: 57.71-93.71) and 60.86% (95% CI: 37.10-84.63), respectively, with no significant difference between groups (p = 0.33). There was no significant difference in the subgroup analysis between studies that initiated ICIs prior to SIRT and those that administered SIRT before starting ICIs. During treatment 53.48% (95% CI: 25.89-80.06) of the patients experienced grades 1-2 adverse events, and 16.17% (95% CI: 6.52-28.52) experienced grades 3-4 adverse events. One patient in the analysis experienced a grade 5 adverse event.
The findings of this systematic review and meta-analysis indicate that the combination of SIRT using Y-90 with ICIs may offer a durable treatment response and promising efficacy with an acceptable safety profile for HCC. However, results should be interpreted with caution due to the limited number of published studies and the need for further investigation regarding patient selection, treatment sequence, efficacy, and safety.
本系统评价和荟萃分析的目的是确定使用钇-90（Y-90）的选择性内放射治疗（SIRT）联合免疫检查点抑制剂（ICI）治疗肝细胞癌（HCC）的疗效和安全性。
我们系统检索了Embase、Cochrane对照试验中央登记库、Pubmed/Medline和Web of Science，检索时间从数据库建立至2024年9月10日，检索发表的研究时使用了以下医学主题词：“选择性内放射治疗”、“免疫治疗”、“免疫检查点抑制剂”和“肝细胞癌”。此外，还对纳入研究和系统评价的参考文献进行评估以寻找其他研究。感兴趣的结局指标为总生存期中位数（mOS）、无进展生存期中位数（mPFS）、肿瘤进展时间中位数（mTTP）、客观缓解率（ORR）、疾病控制率（DCR）和不良事件（AE）。根据患者的巴塞罗那临床肝癌（BCLC）分期对ORR进行亚组分析，并比较在SIRT之前开始使用ICI的研究与在ICI之前进行SIRT的研究。
该评价纳入了7项研究，包括4项临床试验和3项回顾性队列研究，共184例患者。汇总分析显示ORR为58.08%（95%CI：39.07 - 7
