仑伐替尼对比索拉非尼在不可切除性肝癌患者中的有效性和安全性的Meta分析

A Meta-Analysis of the Efficacy and Safety of Lenvatinib versus Sorafenib in Patients with Unresectable Liver Cancer

摘要: 目的：系统评价和分析分子靶向治疗药物仑伐替尼和索拉非尼在不可切除性肝癌中的有效性和安全性。方法：计算机检索中国期刊全文数据库(CNKI)、SCOPUS、万方数据库、Embase、Pubmed、Web of science等数据库搜索仑伐替尼和索拉非尼治疗不可切除肝癌的相关临床研究，由2位评价员独立筛选文献，整个过程隐藏作者姓名、期刊名称、年份和国家，提取数据并纳入评估研究的质量后，采用Revman5.4软件进行分析。结果：根据纳入标准和排除标准，最终纳入7篇文献，其中3篇为随机性对照试验(RCTs)，4篇为回顾性的队列研究，共计2603例肝癌患者，其中索拉非尼组1311名患者，仑伐替尼组1292名患者。通过进行Meta分析得出试验组仑伐替尼患者的PFS优于对比组索拉非尼[HR = 0.68, 95% CI (0.57~0.81), P < 0.05]；但是仑伐替尼组和索拉非尼组在OS的比较差异上无统计学意义[HR = 0.90, 95% CI (0.82~1.00), P > 0.05]；仑伐替尼组与索拉非尼组在ORR方面的比较差异有统计学意义[OR = 6.85, 95% CI (3.34~ 14.04), P < 0.05]。仑伐替尼组与索拉非尼组在不良反应方面主要有高血压、手足综合征、腹泻、体重下降、食欲下降、蛋白尿、皮疹及血液系统不良反应等，通过Meta分析得出二者严重不良反应的差异无统计学意义[HR = 1.36, 95% CI (0.85~2.17), P > 0.05]。结论：与索拉非尼相比，试验组仑伐替尼明显延长了不可切除性肝癌患者的无进展生存期，但总的生存时间无明显差别。仑伐替尼组和索拉非尼组的不良反应主要为高血压。

Abstract: Objective: To systematically evaluate and analyze the efficacy and safety of molecularly targeted therapy drugs lenvatinib and sorafenib in unresectable liver cancer. Methods: The computer re-trieved the Chinese Journal Full-Text Database (CNKI), SCOPUS, Wanfang Database, Embase, Pubmed, Web of science and other databases to search for relevant clinical studies of resectable liver cancer in the treatment of lenvatinib and sorafenib, and the literature was independently screened by two reviewers, and the author’s name, journal name, year and country were hidden in the whole process, and after extracting the data and including the quality of the assessment study, it was analyzed by Revman5.4 software. Results: According to the inclusion criteria and exclusion criteria, seven literature articles were finally included, including 3 randomized controlled trials (RCTs) and 4 retrospective cohort studies, totaling 2603 patients with liver cancer, including 1311 patients in the sorafenib group and 1292 patients in the lenvatinib group. Meta-analysis showed that the PFS of patients with lenvatinib in the experimental group was superior to that of sorafenib in the comparison group [HR = 0.68, 95% CI (0.57~0.81), P < 0.05]; however, the difference in OS between the lenvatinib group and the sorafenib group was not statistically significant [HR = 0.90, 95% CI (0.82~1.00), P > 0.05]; the difference in ORR between the lenvatinib group and the sorafenib group was statistically significant [OR = 6.85, 95% CI (3.34~14.04), P < 0.05]. In terms of adverse reactions, the lenvatinib group and the sorafenib group mainly had hypertension, hand-foot syndrome, diarrhea, weight loss, decreased appetite, proteinuria, rash and hematologic adverse reactions, etc. The difference in serious adverse reactions between the two was not statis-tically significant by Meta-analysis [HR = 1.36, 95% CI (0.85~2.17), P > 0.05]. Conclusion: Compared with sorafenib, the trial group of lenvatinib significantly prolonged the progression-free survival of patients with unresectable liver cancer, but there was no significant difference in overall survival time. Hypertension was mainly observed in the lenvatinib and sorafenib groups.