Objective: There is limited information regarding the benefits of Lenvatinib-transcatheter arterial chemoembolization (LEN-TACE) sequential therapy for unresectable hepatocellular carcinoma (u-HCC). We compared the efficacy and safety of LEN-TACE sequential therapy to LEN monotherapy and investigated the factors contributing to the LEN-TACE sequential therapy deep response. Methods: We enrolled a multi-center cohort of 247 patients with u-HCC treated with LEN between 2018 and 2020. Propensity score matching identified sixty-three matching pairs of patients with well-balanced characteristics. We retrospectively compared the clinical outcomes, including overall survival (OS), progression-free survival (PFS), and incidence of adverse events (AEs), between the LEN-TACE and LEN monotherapy groups. Additionally, we evaluated the tumor response, change in albumin-bilirubin (ALBI) score, factors affecting PFS and OS, and independent predictors contributing to the LEN-TACE sequential therapy deep response. In this study, at eight weeks after resumption of LEN after initial TACE, "deep response" was defined as achieving CR or PR on mRECIST, and at least a 30% decrease in the sum of diameters of target lesions, taking the baseline sum diameters as the reference. Results: The OS and PFS in the LEN-TACE group were significantly higher than those in the LEN monotherapy group (P = 0.002 and P = 0.037, respectively). The incidence of AEs related to LEN was not significantly different between the two groups. In LEN-TACE sequential therapy, the objective response rate was 61.9%, and the disease control rate was 74.6%, according to the mRECIST criteria. No significant change in the ALBI score was observed during sequential LEN-TACE therapy. Multivariable analyses revealed that deep response was independently associated with the outcome of the initial response to LEN by mRECIST: PR (odds ratio: 13.75, 95% CI: 0.41–1.32, P <0.001). Conclusions: LEN-TACE sequential therapy may provide more clinical benefits than LEN monotherapy in u-HCC patients who responded to initial LEN treatment. Objective response according to mRECIST to initial LEN is an independent factor contributing to LEN-TACE sequential therapy deep response.


中文翻译：

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mRECIST 对初始乐伐替尼治疗的客观反应是导致乐伐替尼-经导管动脉化疗栓塞序贯治疗肝细胞癌深度反应的独立因素

目的：关于乐伐替尼-经导管动脉化疗栓塞 (LEN-TACE) 序贯疗法治疗不可切除的肝细胞癌 (u-HCC) 的益处的信息有限。我们比较了 LEN-TACE 序贯疗法与 LEN 单药疗法的疗效和安全性，并调查了导致 LEN-TACE 序贯疗法深度反应的因素。方法：我们在 2018 年至 2020 年期间招募了 247 名接受 LEN 治疗的 u-HCC 患者的多中心队列。倾向评分匹配确定了 63 对具有均衡特征的匹配患者。我们回顾性比较了 LEN-TACE 和 LEN 单药治疗组之间的临床结果，包括总生存期 (OS)、无进展生存期 (PFS) 和不良事件 (AE) 的发生率。此外，我们评估了肿瘤反应，白蛋白-胆红素 (ALBI) 评分的变化、影响 PFS 和 OS 的因素以及导致 LEN-TACE 序贯治疗深度反应的独立预测因素。在这项研究中，在初始 TACE 后恢复 LEN 后 8 周，“深度反应”被定义为在 mRECIST 上达到 CR 或 PR，并且目标病灶的直径总和至少减少 30%，取基线总直径作为参考。结果：LEN-TACE 组的 OS 和 PFS 显着高于 LEN 单药治疗组（分别为 P = 0.002 和 P = 0.037）。与 LEN 相关的 AE 发生率在两组之间没有显着差异。根据mRECIST标准，LEN-TACE序贯治疗的客观缓解率为61.9%，疾病控制率为74.6%。在连续 LEN-TACE 治疗期间未观察到 ALBI 评分有显着变化。多变量分析显示，深度反应与 mRECIST 对 LEN 的初始反应结果独立相关：PR（优势比：13.75，95% CI：0.41-1.32，P <0.001）。结论：对于对初始 LEN 治疗有反应的 u-HCC 患者，LEN-TACE 序贯治疗可能比 LEN 单药治疗提供更多的临床益处。根据 mRECIST 对初始 LEN 的客观反应是导致 LEN-TACE 序贯治疗深度反应的独立因素。在对初始 LEN 治疗有反应的 u-HCC 患者中，LEN-TACE 序贯治疗可能比 LEN 单药治疗提供更多的临床益处。根据 mRECIST 对初始 LEN 的客观反应是导致 LEN-TACE 序贯治疗深度反应的独立因素。在对初始 LEN 治疗有反应的 u-HCC 患者中，LEN-TACE 序贯治疗可能比 LEN 单药治疗提供更多的临床益处。根据 mRECIST 对初始 LEN 的客观反应是导致 LEN-TACE 序贯治疗深度反应的独立因素。