Niizeki Takashi, Mawatari Seiichi, Shibata Michihiko, Sasaki Ryu, Itoh Shinji, Shakado Satoshi, Sugimoto Rie, Morita Yusuke, Kuwashiro Takuya, Endo Mizuki, Iwao Masao, Motoyoshi Yasuhide, Nakano Masahito, Shimose Shigeo, Takahashi Hirokazu, Yatsuhashi Hiroshi, Hirai Fumihito, Yoshizumi Tomoharu, Miyaaki Hisamitsu, Kawaguchi Takumi, Ido Akio, Harada Masaru
Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Fukuoka, Japan.
Digestive and Lifestyle Diseases, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan.
J Gastroenterol Hepatol. 2025 Aug;40(8):2060-2067. doi: 10.1111/jgh.17024. Epub 2025 May 31.
This study aimed to compare the therapeutic effects and safety of lenvatinib (LEN) plus transcatheter arterial chemoembolization (LEN-TACE) and atezolizumab plus bevacizumab (Atez/Bev) as the first-line therapies in patients with intermediate-stage hepatocellular carcinoma (HCC) beyond the up-to-seven criteria.
We enrolled 768 patients with HCC treated with first-line systemic therapy, and 154 patients were enrolled and categorized into either the LEN-TACE therapy (n = 42) or Atez/Bev (n = 112) groups. After propensity score matching (PSM), 72 patients (LEN-TACE group, n = 36; Atez/Bev group, n = 36) were analyzed.
After PSM, the median progression-free survival showed no significant differences between the LEN-TACE and Atez/Bev groups (8.5 [95% confidence interval (CI): 6.1-10.7] months vs. 8.6 (95% CI: 5.3-12.1) months, respectively; p = 0.973). Regarding median overall survival (OS), no significant differences were noted between the LEN-TACE and Atez/Bev groups (37.3 [95% CI: 31.2-60.2] months vs. 32.4 (95% CI: 19.5-NE) months, respectively; p = 0.183). Regarding adverse events (AEs) of grade ≥ 3, no significant difference was observed between the two groups. Multivariate analysis revealed that the ALBI grade 1 and low AFP levels were independent factors for OS.
LEN-TACE therapy may be one of the effective treatment strategies in intermediate-stage HCC patients beyond the up-to-seven criteria.
本研究旨在比较乐伐替尼（LEN）联合经动脉化疗栓塞术（LEN-TACE）与阿替利珠单抗联合贝伐珠单抗（Atez/Bev）作为超出七项标准的中期肝细胞癌（HCC）患者一线治疗的疗效和安全性。
我们纳入了768例接受一线全身治疗的HCC患者，其中154例患者被纳入并分为LEN-TACE治疗组（n = 42）或Atez/Bev组（n = 112）。经过倾向评分匹配（PSM）后，分析了72例患者（LEN-TACE组，n = 36；Atez/Bev组，n = 36）。
PSM后，LEN-TACE组和Atez/Bev组的中位无进展生存期无显著差异（分别为8.5 [95%置信区间（CI）：6.1-10.7]个月和8.6（95%CI：5.3-12.1）个月；p = 0.973）。关于中位总生存期（OS），LEN-TACE组和Atez/Bev组之间未观察到显著差异（分别为37.3 [95%CI：31.2-60.2]个月和32.4（95%CI：19.5-NE）个月；p = 0.183）。关于≥3级不良事件（AE），两组之间未观察到显著差异。多变量分析显示，ALBI 1级和低甲胎蛋白水平是OS的独立因素。
LEN-TACE治疗可能是超出七项标准的中期HCC患者的有效治疗策略之一。
