Abstract：
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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 (p = 0.039, hazard ratio 2.127) alongside age, Child-Pugh class, and alpha-fetoprotein (p = 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.
CONCLUSIONS: SABR is an effective and feasible option for oligometastatic HCC that leads to excellent local tumor control and improves survival without adversely affecting QOL.
UNASSIGNED: 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.
BACKGROUND: NCT05173610.
METHODS: 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.
RESULTS: 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 (p = 0.039, hazard ratio 2.127) alongside age, Child-Pugh class, and alpha-fetoprotein (p = 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.
CONCLUSIONS: SABR is an effective and feasible option for oligometastatic HCC that leads to excellent local tumor control and improves survival without adversely affecting QOL.
UNASSIGNED: 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.
BACKGROUND: NCT05173610.
摘要：
目的：立体定向消融放疗（SABR）可以延长生存期，并为某些寡转移疾病（OMD）患者提供治愈的潜力。然而,关于其在寡转移性肝细胞癌（HCC）中的使用的证据有限。我们旨在前瞻性研究SABR在寡转移性HCC患者中的疗效和安全性。
方法：我们招募了控制原发性肝癌和1至5个适合SABR的转移性病灶患者。主要终点是治疗疗效，定义为总生存期（OS）和无进展生存期（PFS）。次要终点包括到局部进展的时间，客观反应率，疾病控制率,毒性,和生活质量(QOL)，之前使用EORTCQLQ-C30进行评估，SABR后0、1和3个月。
结果：总体而言，在2021年至2022年之间，有40例连续患者在62个病变上接受了SABR。OMD最常见的位置是肺部（48.4％），淋巴结（22.6%），骨（17.7%）。在中位随访15.5个月后，两年OS为80%。PFS中位数为5.3个月，1年和2年PFS率为21.2%和0%，分别。从受控的原发性OMD到OMD的时间较短，与PFS独立相关（p=0.039，危险比2.127）以及年龄，Child-Pugh班,和甲胎蛋白（p=0.002，0.004，0.019，分别）。当地发展的2年时间，客观反应率，疾病控制率为91.1%,75.8%,98.4%,分别。总的来说,10%的患者出现急性毒性,7.5%的人经历了晚期毒性，没有3+级毒性。所有QOL成绩保持稳定,而未接受系统治疗的患者失眠和社会功能评分均得到改善.
结论：SABR是治疗寡转移型HCC的一种有效可行的选择，可实现良好的局部肿瘤控制并提高生存率而不会对QOL产生不利影响。
■立体定向消融放疗（SABR）是一种能够有效消融靶病变的非侵入性治疗方法；然而，在肝细胞癌(HCC)中,寡转移疾病的概念和SABR的潜在益处均未得到明确定义.根据这项研究,SABR是一种有效和安全的治疗方案，产生优异的局部肿瘤控制和生存改善，而不恶化患者的生活质量，无论肿瘤部位。我们还证明，从受控的原发性和较低的甲胎蛋白水平开始出现OMD的患者获得了更好的生存结果。这是SABR在寡转移HCC中的第一个前瞻性研究，为开发改善肿瘤学结果的新策略提供见解。
背景：NCT05173610。
方法：我们招募了控制原发性肝癌和1至5个适合SABR的转移性病灶患者。主要终点是治疗疗效，定义为总生存期（OS）和无进展生存期（PFS）。次要终点包括到局部进展的时间，客观反应率，疾病控制率,毒性,和生活质量(QOL)，之前使用EORTCQLQ-C30进行评估，SABR后0、1和3个月。
结果：总体而言，在2021年至2022年之间，有40例连续患者在62个病变上接受了SABR。OMD最常见的位置是肺部（48.4％），淋巴结（22.6%），骨（17.7%）。在中位随访15.5个月后，两年OS为80%。PFS中位数为5.3个月，1年和2年PFS率为21.2%和0%，分别。从受控的原发性OMD到OMD的时间较短，与PFS独立相关（p=0.039，危险比2.127）以及年龄，Child-Pugh班,和甲胎蛋白（p=0.002，0.004，0.019，分别）。当地发展的2年时间，客观反应率，疾病控制率为91.1%,75.8%,98.4%,分别。总的来说,10%的患者出现急性毒性,7.5%的人经历了晚期毒性，没有3+级毒性。所有QOL成绩保持稳定,而未接受系统治疗的患者失眠和社会功能评分均得到改善.
结论：SABR是治疗寡转移型HCC的一种有效可行的选择，可实现良好的局部肿瘤控制并提高生存率而不会对QOL产生不利影响。
■立体定向消融放疗（SABR）是一种能够有效消融靶病变的非侵入性治疗方法；然而，在肝细胞癌(HCC)中,寡转移疾病的概念和SABR的潜在益处均未得到明确定义.根据这项研究,SABR是一种有效和安全的治疗方案，产生优异的局部肿瘤控制和生存改善，而不恶化患者的生活质量，无论肿瘤部位。我们还证明，从受控的原发性和较低的甲胎蛋白水平开始出现OMD的患者获得了更好的生存结果。这是SABR在寡转移HCC中的第一个前瞻性研究，为开发改善肿瘤学结果的新策略提供见解。
背景：NCT05173610。
