Background Stereotactic ablative radiotherapy (SABR) can deliver tumoricidal doses and achieve long-term control in early hepatocellular carcinoma (HCC). However, limited studies have investigated the safety and effectiveness of SABR in patients with advanced diseases that is unsuitable for transarterial chemoembolization (TACE). Methods In this observational study, we reviewed the medical records of patients with Barcelona Clinic Liver Cancer (BCLC) stage C disease treated with linear accelerator-based SABR between 2008 and 2016. Their tumors were either refractory to TACE or TACE was contraindicated. Overall survival (OS), in-field progression-free survival (IFPFS), and out-field progression-free survival were calculated using Kaplan-Meier analysis. The Cox regression model was used to examine the effects of variables. Treatment-related toxicities were scored according to the Common Terminology Criteria for Adverse Events (version 4.03) and whether patients developed radiation-induced liver disease (RILD) after SABR. Results This study included 32 patients. The mean maximal tumor diameter and tumor volumes were 4.7 cm and 135.9 ml, respectively. Patients received linear accelerator-based SABR with a median prescribed dose of 48 Gy (30-60 Gy) in three to six fractions. Based on the assessment of treatment response by using the Response Evaluation Criteria in Solid Tumors (version 1.1), 19% of patients achieved a complete response and 53% achieved a partial response. After a median follow-up of 18.1 months (4.0-65.9 months), 10, 19, and 9 patients experienced in-field failure, out-field hepatic recurrence, and extrahepatic metastases, respectively. The estimated 2-year OS and IFPFS rates were 54.4% and 62.7%, respectively. In a multivariate analysis, a pretreatment Cancer of the Liver Italian Program (CLIP) score of ⩾2 (p = 0.01) was a prognostic factor for shorter OS, and a biologically effective dose (BED) of < 85 Gy10 (p = 0.011) and a Child-Pugh score of ⩾6 (p = 0.014) were prognostic factors for inferior IFPFS. In this study five and eight patients developed classic and nonclassic RILD, respectively. Conclusions SABR can serve as a salvage treatment for patients with HCC with BCLC stage C disease unsuitable for TACE, in particular, in those with a baseline CLIP score of ⩽1. A BED10 of ⩾85 Gy is an appropriate prescribed dose for tumor control. Because out-field relapse is the major cause of treatment failure, SABR in combination with novel systemic modalities should be investigated in future studies.

中文翻译：

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立体定向消融放疗对不适合经动脉化疗栓塞的晚期肝细胞癌患者的疗效。

背景立体定向消融放疗 (SABR) 可以提供杀肿瘤剂量并在早期肝细胞癌 (HCC) 中实现长期控制。然而，有限的研究调查了 SABR 在不适合经动脉化疗栓塞 (TACE) 的晚期疾病患者中的安全性和有效性。方法 在这项观察性研究中，我们回顾了 2008 年至 2016 年期间接受基于直线加速器的 SABR 治疗的巴塞罗那临床肝癌 (BCLC) C 期疾病患者的病历。他们的肿瘤对 TACE 无效或 TACE 禁忌。使用 Kaplan-Meier 分析计算总生存期 (OS)、场内无进展生存期 (IFPFS) 和场外无进展生存期。Cox回归模型用于检查变量的影响。根据不良事件通用术语标准（4.03 版）以及患者在 SABR 后是否出现放射性肝病（RILD）对治疗相关毒性进行评分。结果 本研究包括 32 名患者。平均最大肿瘤直径和肿瘤体积分别为 4.7 cm 和 135.9 ml。患者接受了基于直线加速器的 SABR，中位处方剂量为 48 Gy（30-60 Gy），分三到六次。根据使用实体瘤反应评估标准（1.1 版）评估治疗反应，19% 的患者达到完全反应，53% 达到部分反应。中位随访 18.1 个月（4.0-65.9 个月）后，分别有 10、19 和 9 名患者经历了场内失败、场外肝复发和肝外转移。估计的 2 年 OS 和 IFPFS 率分别为 54.4% 和 62.7%。在多变量分析中，治疗前意大利肝癌项目 (CLIP) 评分为 2 (p = 0.01) 是较短 OS 的预后因素，生物有效剂量 (BED) < 85 Gy10 (p = 0.011) Child-Pugh 评分 6 (p = 0.014) 是较差 IFPFS 的预后因素。在这项研究中，5 名和 8 名患者分别出现了经典和非经典 RILD。结论 SABR 可作为不适合 TACE 的 BCLC C 期 HCC 患者的抢救治疗，尤其是基线 CLIP 评分为 1 的患者。85 Gy 的 BED10 是控制肿瘤的适当处方剂量。因为场外复发是治疗失败的主要原因，