Facciorusso Antonio, Tartaglia Nicola, Villani Rosanna, Serviddio Gaetano, Ramai Daryl, Mohan Babu P, Chandan Saurabh, Abd El Aziz Mohamed A, Evangelista Jessica, Cotsoglou Christian, Ambrosi Antonio
Department of Surgical and Medical Sciences, Gastroenterology Unit, University of Foggia Foggia 71122, Italy.
Department of Surgical and Medical Sciences, General Surgery Unit, University of Foggia Foggia 71122, Italy.
Am J Transl Res. 2021 Apr 15;13(4):2379-2387. eCollection 2021.
There is limited evidence on the efficacy of lenvatinib in advanced hepatocellular carcinoma (HCC) patients. Aim of this meta-analysis was to compare lenvatinib and sorafenib as first-line treatment. Computerized bibliographic search was performed on main databases through November 2020. The primary outcome was overall survival, whereas survival rate (at 1-, and 2-year), progression-free survival (PFS), tumor response, and severe adverse event rate were the secondary outcomes. Results were expressed in terms of odds ratio (OR) or hazard ratio (HR) and 95% confidence interval (CI). Five studies enrolling 1481 patients were included. No difference in terms of overall survival was detected (HR 0.81, 0.58-1.11) and median survival was 13.4 months (9.38-17.48) in lenvatinib and 11.4 months (8.46-14.47) in sorafenib patients. Lenvatinib led to a significant improvement of PFS (HR 0.67, 0.48-0.94) and median PFS was 5.88 months (3.68-8) in lenvatinib and 4.17 months (3.08-5.25) in sorafenib patients. Lenvatinib determined a considerably higher rate of objective response (33.3%, 23.6%-43% versus 6.5%, 3.5%-9.5%; OR 7.70, 2.99-19.82), and of disease control rate (76.9%, 70.4%-83.5% versus 52.7%, 40.7%-64.6%; OR 2.41, 1.55-3.77). No difference between lenvatinib and sorafenib in terms of severe adverse event rate was observed (OR 1.31, 0.82-2.09). Lenvatinib prolongs progression-free survival as compared to sorafenib in HCC patients, although this result does not translate to a significant survival benefit.
关于乐伐替尼在晚期肝细胞癌（HCC）患者中的疗效证据有限。本荟萃分析的目的是比较乐伐替尼和索拉非尼作为一线治疗的效果。通过对主要数据库进行计算机化文献检索，截至2020年11月。主要结局是总生存期，而生存率（1年和2年）、无进展生存期（PFS）、肿瘤反应和严重不良事件发生率为次要结局。结果以比值比（OR）或风险比（HR）及95%置信区间（CI）表示。纳入了五项研究，共1481例患者。未检测到总生存期方面的差异（HR 0.81，0.58 - 1.11），乐伐替尼组的中位生存期为13.4个月（9.38 - 17.48），索拉非尼组为11.4个月（8.46 - 14.47）。乐伐替尼使PFS有显著改善（HR 0.67，0.48 - 0.94），乐伐替尼组的中位PFS为5.88个月（3.68 - 8），索拉非尼组为4.17个月（3.08 - 5.25）。乐伐替尼的客观缓解率（33.3%，23.6% - 43% 对比6.5%，3.5% - 9.5%；OR 7.70，2.99 - 19.82）和疾病控制率（76.9%，70.4% - 83.5% 对比52.7%，40.7% - 64.6%；OR 2.41，1.55 - 3.77）明显更高。在严重不良事件发生率方面，未观察到乐伐替尼和索拉非尼之间存在差异（OR 1.31，0.82 - 2.09）。与索拉非尼相比，乐伐替尼可延长HCC患者的无进展生存期，尽管这一结果并未转化为显著的生存获益。
