Stereotactic ablative radiotherapy (SABR) can extend survival and offers the potential for cure in some patients with oligometastatic disease (OMD). However, limited evidence exists regarding its use in oligometastatic hepatocellular carcinoma (HCC). We aimed to prospectively investigate the efficacy and safety of SABR in patients with oligometastatic HCC. We enrolled patients with controlled primary HCC and one to five metastatic lesions amenable to SABR. The primary endpoint was treatment efficacy defined as overall survival (OS) and progression-free survival (PFS). The secondary endpoints included time to local progression, objective response rate, disease control rate, toxicities, and quality of life (QOL), assessed using the EORTC QLQ-C30 before, and 0, 1, and 3 months after SABR. Overall, 40 consecutive patients received SABR on 62 lesions between 2021 and 2022. The most common locations for OMD were the lungs (48.4%), lymph nodes (22.6%), and bone (17.7%). After a median follow-up of 15.5 months, the 2-year OS was 80%. Median PFS was 5.3 months, with 1- and 2-year PFS rates of 21.2% and 0%, respectively. A shorter time to OMD from the controlled primary independently correlated with PFS ( 0.039, hazard ratio 2.127) alongside age, Child-Pugh class, and alpha-fetoprotein ( = 0.002, 0.004, 0.019, respectively). The 2-year time to local progression, objective response rate, and disease control rate were 91.1%, 75.8%, and 98.4%, respectively. Overall, 10% of patients experienced acute toxicity, and 7.5% experienced late toxicity, with no grade 3+ toxicity. All QOL scores remained stable, whereas the patients without systemic treatments had improved insomnia and social functioning scores. SABR is an effective and feasible option for oligometastatic HCC that leads to excellent local tumor control and improves survival without adversely affecting QOL. Stereotactic ablative radiotherapy (SABR) is a non-invasive treatment approach capable of efficiently ablating the target lesion; however, neither the oligometastatic disease concept nor the potential benefits of SABR have been well-defined in hepatocellular carcinoma (HCC). According to this study, SABR is an effective and safe treatment option for oligometastatic HCC, yielding excellent local tumor control and survival improvement without worsening patients’ quality of life, regardless of tumor sites. We also demonstrated that patients with a later presentation of OMD from the controlled primary and lower alpha-fetoprotein levels achieved better survival outcomes. This is the first prospective study of SABR in oligometastatic HCC, providing insights for the development of novel strategies to improve oncologic outcomes. NCT05173610

中文翻译：

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立体定向消融放疗对寡转移性肝细胞癌患者的疗效：一项 II 期研究

立体定向消融放射治疗 (SABR) 可以延长生存期，并为一些寡转移性疾病 (OMD) 患者提供治愈的可能性。然而，关于其在寡转移性肝细胞癌（HCC）中的应用的证据有限。我们的目的是前瞻性研究 SABR 在寡转移性 HCC 患者中的疗效和安全性。我们招募了原发性 HCC 得到控制且具有 1 至 5 个适合 SABR 的转移灶的患者。主要终点是治疗效果，定义为总生存期（OS）和无进展生存期（PFS）。次要终点包括局部进展时间、客观缓解率、疾病控制率、毒性和生活质量 (QOL)，在 SABR 之前、之后 0、1 和 3 个月使用 EORTC QLQ-C30 进行评估。总体而言，2021 年至 2022 年间，有 40 名连续患者在 62 个病灶上接受了 SABR。OMD 最常见的部位是肺部 (48.4%)、淋巴结 (22.6%) 和骨骼 (17.7%)。中位随访 15.5 个月后，2 年 OS 为 80%。中位 PFS 为 5.3 个月，1 年和 2 年 PFS 率分别为 21.2% 和 0%。从受控原发灶到 OMD 的较短时间与 PFS 独立相关（0.039，风险比 2.127），同时与年龄、Child-Pugh 分级和甲胎蛋白（分别 = 0.002、0.004、0.019）相关。 2年局部进展时间、客观缓解率和疾病控制率分别为91.1%、75.8%和98.4%。总体而言，10% 的患者经历了急性毒性，7.5% 的患者经历了晚期毒性，但没有 3 级以上毒性。所有生活质量评分保持稳定，而未经系统治疗的患者失眠和社会功能评分有所改善。 SABR 是寡转移性 HCC 的有效且可行的选择，可实现出色的局部肿瘤控制并提高生存率，而不会对生活质量产生不利影响。立体定向消融放射治疗（SABR）是一种能够有效消融靶病灶的非侵入性治疗方法；然而，寡转移性疾病的概念和 SABR 在肝细胞癌 (HCC) 中的潜在益处均尚未明确定义。根据这项研究，SABR 是寡转移性 HCC 的一种有效且安全的治疗选择，无论肿瘤部位如何，都可以实现出色的局部肿瘤控制和生存改善，而不会恶化患者的生活质量。我们还证明，由于原发性受​​控和较低甲胎蛋白水平而导致后期出现 OMD 的患者获得了更好的生存结果。这是 SABR 在寡转移性 HCC 中的第一项前瞻性研究，为开发改善肿瘤结果的新策略提供了见解。 NCT05173610