Background/Objectives: This systematic review and meta-analysis evaluated the effectiveness and the safety of transarterial radioembolization using Holmium-166 microspheres (Ho-166-TARE) for the treatment of primary and secondary liver tumors. The aim of the study was to offer a detailed analysis of clinical outcomes and the potential benefits of this innovative therapy. Methods: The study was conducted according to the PRISMA 2020 guidelines. The systematic search was performed in five databases in November 2023 and updated in June 2024. All 16 eligible studies were original research that evaluated Ho-166-TARE. The endpoints analyzed were disease control rate (DCR), overall survival (OS), progression-free survival (PFS), clinical and laboratory adverse events, healthy-liver- and tumor-liver-absorbed doses. The risk of bias was assessed using the MINORS checklist. Results: The pooled overall disease control rate (DCR) was 72% (95% CI, 46–89%); by mRECIST, it was 93% (95% CI, 71–99%); and by RECIST 1.1, it was 54% (95% CI, 22–83%) at 3-month follow-up. Overall survival (OS) at 3, 6, 12, and 30 months was 98%, 89%, 74%, and 39%, respectively. Severe clinical adverse events were minimal, although some patients showed elevated GGT levels and lymphocytopenia. Tumor-absorbed doses were nearly three times higher than those in healthy liver tissue. Conclusions: These findings suggest that Ho-166-TARE is a safe and effective locoregional treatment option for liver tumors, especially in cases where systemic therapy alone is insufficient or surgical resection is not feasible. Further studies are needed to investigate tumor-specific response, optimize dosimetry strategies, and establish standardized protocols for long-term outcome assessment.
背景/目的：本系统综述与荟萃分析评估了钬-166微球经动脉放射栓塞术（Ho-166-TARE）治疗原发性和继发性肝脏肿瘤的有效性与安全性。本研究旨在对这一创新疗法的临床结局及潜在获益进行详细分析。方法：研究依据PRISMA 2020指南开展。系统检索于2023年11月在五个数据库中完成，并于2024年6月更新。所有16项符合条件的研究均为评估Ho-166-TARE的原始研究。分析的终点包括疾病控制率、总生存期、无进展生存期、临床与实验室不良事件、正常肝组织与肿瘤肝组织的吸收剂量。采用MINORS清单评估偏倚风险。结果：汇总的总体疾病控制率为72%（95% CI，46–89%）；根据mRECIST标准为93%（95% CI，71–99%）；根据RECIST 1.1标准在3个月随访时为54%（95% CI，22–83%）。3、6、12和30个月的总生存率分别为98%、89%、74%和39%。严重临床不良事件极少，尽管部分患者出现GGT水平升高和淋巴细胞减少。肿瘤吸收剂量约为正常肝组织的三倍。结论：这些结果表明，Ho-166-TARE是一种安全有效的肝脏肿瘤局部治疗方案，尤其适用于单纯全身治疗不足或手术切除不可行的情况。未来需进一步研究肿瘤特异性反应、优化剂量测定策略，并建立长期结局评估的标准化方案。
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