Chen YiXing, Hu Yong, Shen Jie, Du ShiSuo, Yan Jing, Zhou LeYuan, Wang Zhe, Lu HaiJie, Xiao Lei, Yang Ping, Zhu WenChao, Wang Jun, Yang GuoWei, Luo JianFeng, Liu Rong, Zeng ZhaoChong
Department of Radiation Oncology, Zhongshan Hospital, Fudan University, Shanghai, China.
Comprehensive Cancer Centre, Department of Oncology, Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing, China.
Int J Radiat Oncol Biol Phys. 2025 Feb 1;121(2):414-422. doi: 10.1016/j.ijrobp.2024.09.021. Epub 2024 Sep 17.
To compare the outcomes of transarterial chemoembolization (TACE) alone with those of TACE combined with external beam radiation therapy (EBRT) in patients with hepatocellular carcinoma (HCC) in a multicenter randomized study.
From 2017 to 2022, 74 HCC patients with tumors confined to the liver without vascular invasion were treated with either TACE only (TACE group, 39 patients) or TACE combined with EBRT (TACE + EBRT group, 35 patients). The primary outcome measured was overall survival (OS). Secondary outcomes included progression-free survival (PFS), local tumor control, and the assessment of treatment-related toxicity.
Due to slow accrual, the trial was closed prematurely after enrolling 74 patients. All patients received 2 cycles of TACE before randomization. The TACE and TACE + EBRT groups showed comparable patient and tumor characteristics. The TACE group underwent a median of 3 TACE cycles, and the TACE + EBRT group received 2 cycles of TACE, and a median of 5500 cGy in 15 fractions. For the TACE group, the median local control (LC) duration was 13.1 months, whereas for the TACE + EBRT group, the median LC was not achieved (P < .001). The PFS was recorded at 11.6 months in the TACE group compared with 15.4 months in the TACE + EBRT group (P = .072). The median OS reached 36.8 months for the TACE group and extended to 47.1 months for the TACE + EBRT group (P = .654). The incidence of toxicity was comparable between both groups.
Although the number of patients enrolled in this clinical trial did not meet expectations. TACE combined with EBRT was shown to be more effective than TACE alone in improving LC without increasing toxicity, whereas PFS and OS were slightly improved. TACE + EBRT can be used as a standard treatment option for patients with inoperable but confined intrahepatic HCC.
在一项多中心随机研究中，比较单纯经动脉化疗栓塞术（TACE）与TACE联合外照射放疗（EBRT）治疗肝细胞癌（HCC）患者的疗效。
2017年至2022年，74例肿瘤局限于肝脏且无血管侵犯的HCC患者，分别接受单纯TACE治疗（TACE组，39例患者）或TACE联合EBRT治疗（TACE + EBRT组，35例患者）。测量的主要结局为总生存期（OS）。次要结局包括无进展生存期（PFS）、局部肿瘤控制以及治疗相关毒性评估。
由于入组缓慢，在纳入74例患者后该试验提前终止。所有患者在随机分组前均接受2个周期的TACE治疗。TACE组和TACE + EBRT组的患者和肿瘤特征具有可比性。TACE组接受TACE治疗的中位周期数为3个，TACE + EBRT组接受2个周期的TACE治疗，并在15次分割中接受中位剂量为5500 cGy的放疗。对于TACE组，中位局部控制（LC）持续时间为13.1个月，而TACE + EBRT组未达到中位LC（P < .001）。TACE组的PFS记录为11.6个月，而TACE + EBRT组为15.4个月（P = .072）。TACE组的中位OS达到36.8个月，TACE + EBRT组延长至47.1个月（P = .654）。两组的毒性发生率相当。
尽管该临床试验入组的患者数量未达预期。但TACE联合EBRT在提高LC方面比单纯TACE更有效，且未增加毒性，而PFS和OS略有改善。TACE + EBRT可作为无法手术但局限于肝内的HCC患者的标准治疗选择。
