Zhang Yao-Jun, Chen Jinbin, Zhou Zhongguo, Hu Dandan, Wang Juncheng, Pan Yangxun, Fu Yizhen, Hu Zili, Xu Li, Chen Min-Shan
From the State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, and Department of Liver Surgery, Sun Yat-sen University Cancer Center, 651 Dongfeng Rd East, Guangzhou, Guangdong 510060, China.
Radiology. 2025 Feb;314(2):e241096. doi: 10.1148/radiol.241096.
Background Radiofrequency ablation (RFA) has comparable clinical outcomes to surgical resection (SR) for treating small recurrent hepatocellular carcinoma (HCC). However, whether combined transarterial chemoembolization (TACE) with RFA (hereafter, TACE-RFA) outperforms SR for treating small late-recurrence HCCs remains unknown. Purpose To compare the clinical outcome of TACE-RFA with that of SR in patients with small late-recurrence HCCs. Materials and Methods This randomized clinical trial recruited patients between July 2013 and March 2019. Patients with small late-recurrence HCCs (a single recurrent HCC nodule [≤ 5 cm in diameter] or three or fewer nodules [each ≤ 3 cm in diameter] and recurrence at least 12 months after radical therapy of primary HCC) were randomly assigned to receive TACE-RFA or SR. The primary end point was overall survival (OS). The secondary end points included recurrence-free survival (RFS) and the incidence of complications. OS and RFS were assessed using the Kaplan-Meier method and log-rank test. Results In the intention-to-treat analysis, 210 patients (mean age, 52 years ± 12 [SD]; 194 male) were included, with 105 patients in each group. The 1-, 3-, and 5-year OS rates were 99%, 81%, and 69%, respectively, in the TACE-RFA group and 96%, 81%, and 76%, respectively, in the SR group (hazard ratio [HR], 1.34; 95% CI: 0.81, 2.23; = .26). The 1-, 3-, and 5-year RFS rates were 71%, 38%, and 24%, respectively, in the TACE-RFA group and 73%, 43%, and 29%, respectively, in the SR group (HR, 1.05; 95% CI: 0.76, 1.45; = .78). The incidence of complications was greater in the SR group than in the TACE-RFA group (41% [43 of 104] vs 24% [23 of 96]; = .01). Conclusion For patients with small late-recurrence HCCs, TACE-RFA did not yield better survival outcomes than SR. However, the incidence of complications was lower in patients who received TACE-RFA therapy. ClinicalTrials.gov Identifier: NCT01833286 © RSNA, 2025 See also the editorial by Ronot in this issue.
在治疗小的复发性肝细胞癌（HCC）方面，射频消融（RFA）与手术切除（SR）具有相当的临床疗效。然而，对于治疗小的晚期复发性HCC，经动脉化疗栓塞（TACE）联合RFA（以下简称TACE-RFA）是否优于SR尚不清楚。目的：比较TACE-RFA与SR治疗小的晚期复发性HCC患者的临床疗效。材料与方法：本随机临床试验于2013年7月至2019年3月招募患者。小的晚期复发性HCC患者（单个复发性HCC结节[直径≤5 cm]或3个或更少结节[每个直径≤3 cm]且在原发性HCC根治性治疗后至少12个月复发）被随机分配接受TACE-RFA或SR。主要终点是总生存期（OS）。次要终点包括无复发生存期（RFS）和并发症发生率。采用Kaplan-Meier法和对数秩检验评估OS和RFS。结果：在意向性分析中，纳入210例患者（平均年龄52岁±12[标准差]；194例男性），每组105例。TACE-RFA组的1年、3年和5年OS率分别为99%、81%和69%，SR组分别为96%、81%和76%（风险比[HR]，1.34；95%置信区间：0.81，2.23；P = 0.26）。TACE-RFA组的1年、3年和5年RFS率分别为71%、38%和24%，SR组分别为73%、43%和29%（HR，1.05；95%置信区间：0.76，1.45；P = 0.78）。SR组的并发症发生率高于TACE-RFA组（41%[104例中的43例]对24%[96例中的23例]；P = 0.01）。结论：对于小的晚期复发性HCC患者，TACE-RFA的生存结局并不优于SR。然而，接受TACE-RFA治疗的患者并发症发生率较低。ClinicalTrials.gov标识符：NCT01833286 © RSNA，2025 另见本期Ronot的社论。
