Department of Hepatobiliary Surgery, Peking University People's Hospital, Beijing, China;Peking University Institute for Organ Transplantation, Beijing, China;Beijing Key Laboratory of Liver Cirrhosis and Liver Cancer, Beijing, China.
Turk J Gastroenterol. 2021 Jan;32(1):30-41. doi: 10.5152/tjg.2020.19877.
Hepatocellular carcinoma (HCC) recurrence is still threatening patient survival after liver transplantation (LT). The efficacy and safety of sorafenib in the setting of post-LT recurrence are still equivocal. This study aims to disclose the efficacy and safety profile of sorafenib in treating post-LT HCC recurrence.
Electronic databases were searched to retrieve relevant publications suitable for inclusion. Data from 23 studies containing 411 patients were analyzed. The primary outcome of interest was 1-year survival rate after sorafenib treatment, and the secondary endpoints included median overall survival (OS), time to progression (TTP), treatment response, and adverse events.
Patients with HCC recurrence after LT treated with sorafenib achieved a 1-year survival rate of 56.8%, with a median OS of 12.8 months and a median TTP of 6.0 months. Univariate logistic regression analysis showed that male gender (P = .048), TTP (P = .021), median duration of sorafenib (P = .021), diarrhea (P = .027), fatigue (P = .044), and partial response (P = .026) were associated with a better 1-year survival rate. In addition, sorafenib exerted a significant superior effect on OS compared with best supportive care in the setting of untreatable post-LT HCC recurrence.
Based on the results of this meta-analysis, sorafenib therapy seems to be safe and feasible and exhibits survival benefit in patients with post-LT HCC recurrence. However, prospective randomized controlled trials with larger sample sizes and more rigorous study design are required to confirm the efficacy of sorafenib.
肝细胞癌（HCC）复发仍然威胁着肝移植（LT）后的患者生存。索拉非尼在 LT 后复发中的疗效和安全性仍存在争议。本研究旨在揭示索拉非尼治疗 LT 后 HCC 复发的疗效和安全性特征。
电子数据库被搜索以检索适合纳入的相关出版物。分析了包含 411 名患者的 23 项研究的数据。主要研究终点为索拉非尼治疗后 1 年的生存率，次要终点包括中位总生存期（OS）、无进展生存期（TTP）、治疗反应和不良事件。
接受索拉非尼治疗的 LT 后 HCC 复发患者的 1 年生存率为 56.8%，中位 OS 为 12.8 个月，中位 TTP 为 6.0 个月。单因素逻辑回归分析显示，男性（P =.048）、TTP（P =.021）、中位索拉非尼持续时间（P =.021）、腹泻（P =.027）、疲劳（P =.044）和部分反应（P =.026）与更好的 1 年生存率相关。此外，与最佳支持治疗相比，在无法治疗的 LT 后 HCC 复发的情况下，索拉非尼治疗在 OS 方面表现出显著优势。
基于这项荟萃分析的结果，索拉非尼治疗似乎是安全可行的，并为 LT 后 HCC 复发患者带来生存获益。然而，需要更大样本量和更严格研究设计的前瞻性随机对照试验来证实索拉非尼的疗效。
