微血管侵犯的肝细胞癌边缘切除术后辅助立体定向体部放疗：一项随机对照试验。
Adjuvant stereotactic body radiotherapy after marginal resection for hepatocellular carcinoma with microvascular invasion: A randomised controlled trial.
作者信息
Shi Changying, Li Yong, Geng Li, Shen Weifeng, Sui Chengjun, Dai Binghua, Lu Jiongjiong, Pan Mianshun, Yang Jiamei
机构信息
Department of Liver Surgery, Eastern Hepatobiliary Surgery Hospital, Affiliated to Second Military Medical University, Shanghai, China.
Department of Radiation Oncology, Eastern Hepatobiliary Surgery Hospital, Affiliated to Second Military Medical University, Shanghai, China; Center of Radiation Oncology, Wujing Hospital, Shanghai, China.
出版信息
Eur J Cancer. 2022 May;166:176-184. doi: 10.1016/j.ejca.2022.02.012. Epub 2022 Mar 15.
BACKGROUND
Marginal resection frequently occurred in hepatectomy for hepatocellular carcinoma (HCC), leading to increased local recurrence, especially among patients with microvascular invasion (MVI). Stereotactic body radiotherapy (SBRT) showed effectiveness in controlling tumour and tumour thrombosis. This study aimed to investigate the efficacy of SBRT, targeting on suboptimal resection margin, as adjuvant setting in MVI-positive HCC.
METHODS
This was a single-centre randomised controlled trial conducted in Eastern Hepatobiliary Surgery Hospital, Shanghai, China. Participants with MVI-positive HCC receiving marginal resection were randomly assigned to the postoperative adjuvant SBRT or surgery alone (SA) group. SBRT was delivered by the CyberKnife® system with marker tracking devices, targeting on resection margin one month after surgery. The disease-free survival (DFS) and overall survival (OS) were compared between the groups, and the adverse events (AEs) were monitored. This trial was registered on ClinicalTrials.gov, NCT04891874.
FINDINGS
A total of 76 participants were enrolled, with 38 in each group. The one-, three-, and five-year DFS rates were 92.1%, 65.8%, and 56.1% in SBRT group versus 76.3%, 36.8%, and 26.3% in SA group, respectively (p = 0.005). The one-, three-, and five-year OS rates were 100%, 89.5%, and 75.0% in SBRT group versus 100.0%, 68.4%, and 53.7% in SA group, respectively (p = 0.053). The total dose of SBRT for single participant was 35 Gy, and the biological effective dose (BED) was 59.5 Gy. The overall incidence of radiotherapy-related AE was 31.6% (12/38), and no grade 3 or higher grade AE was developed.
INTERPRETATION
SBRT on the resection margin provides a safe therapeutic modality of adjuvant setting in MVI-positive HCC with suboptimal resection margin. It prevents local recurrence and improves DFS.
TRIAL REGISTRATION NUMBER
NCT04891874.
背景
在肝细胞癌（HCC）肝切除术中，边缘切除经常发生，导致局部复发增加，尤其是在有微血管侵犯（MVI）的患者中。立体定向体部放疗（SBRT）在控制肿瘤和肿瘤血栓形成方面显示出有效性。本研究旨在探讨针对切缘欠佳的SBRT作为MVI阳性HCC辅助治疗的疗效。
方法
这是一项在中国上海东方肝胆外科医院进行的单中心随机对照试验。接受边缘切除的MVI阳性HCC患者被随机分配到术后辅助SBRT组或单纯手术（SA）组。SBRT由带有标记跟踪装置的射波刀系统实施，术后1个月针对切缘进行治疗。比较两组的无病生存期（DFS）和总生存期（OS），并监测不良事件（AE）。该试验已在ClinicalTrials.gov上注册，注册号为NCT04891874。
结果
共纳入76名参与者，每组38名。SBRT组的1年、3年和5年DFS率分别为92.1%、65.8%和56.1%，而SA组分别为76.3%、36.8%和26.3%（p = 0.005）。SBRT组的1年、3年和5年OS率分别为100%、89.5%和75.0%，而SA组分别为100.0%、68.4%和53.7%（p = 0.053）。单个参与者的SBRT总剂量为35 Gy，生物等效剂量（BED）为59.5 Gy。放疗相关AE的总发生率为31.6%（12/38），未发生3级或更高级别的AE。
解读
对切缘进行SBRT为切缘欠佳的MVI阳性HCC提供了一种安全的辅助治疗方式。它可预防局部复发并改善DFS。
试验注册号
NCT04891874。
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