阿帕替尼对比替吉奥治疗进展期胃癌疗效和安全性的Meta分析

Meta-analysis of efficacy and safety of apatinib and S-1 as second-line or above treatment for advanced gastric cancer

目的系统评价阿帕替尼对比替吉奥二线及二线以上治疗进展期胃癌的疗效和安全性,为临床用药提供参考。方法计算机检索Cochrane图书馆、Pubmed、中国知网(CNKI)和万方医学网自建库至2017年12月的全部文献,收集阿帕替尼与替吉奥二线及二线以上治疗进展期胃癌的随机对照试验,按照修改后的Jadad评分量表评价纳入研究文献质量,提取纳入文献的相关资料,采用Rev Man 5. 3版统计软件进行Meta分析。结果共纳入8项随机对照研究,合计456例患者。Meta分析结果显示,与替吉奥比较,阿帕替尼能显著提高客观缓解率,差异有统计学意义(RD=0. 12,95%CI:0. 03～0. 20,P=0. 008);阿帕替尼和替吉奥在疾病控制率(RD=0. 05,95%CI:-0. 03～0. 13,P=0. 23)和生活质量改善方面(RD=0. 11,95%CI:-0. 00～0. 22,P=0. 22)的差异无统计学意义。安全性方面,阿帕替尼组高血压的发生率显著高于替吉奥组(OR=15. 27,95%CI:2. 79～83. 76,P=0. 002),恶心呕吐的发生率显著低于替吉奥组(OR=0. 38,95%CI:0. 18～0. 82,P=0. 01),两组中性粒细胞减少、蛋白尿、手足综合征等其他不良反应发生率的差异均无统计学意义。结论阿帕替尼二线及二线以上治疗进展期胃癌较替吉奥能更好地提高客观缓解率,且两药不良反应相当。

Objective To evaluate the efficacy and safety of apatinib and S-1 on advanced gastric cancer as second-line and above treatment in order to provide reference for clinical medication.Methods The pertinent randomized controlled trials （RCTs） about apatinib group and S-1 group as second-line and above treatment for advanced gastric cancer. Studies were retrieved from Cochrane Library, Pubmed, CNKI and Wanfang Database from inception to December 2017. The quality of included studies was evaluated according to modified Jadad scale. Then the related data was extracted and meta-analysis was performed by using Rev Man 5.3 statistical software.Results A total of 8 RCTs were included,involving 456 patients. The results of meta-analysis showed that the objective response rate was significantly improved in apatinib group compared with S-1 group （RD=0.12, 95%CI： 0.03-0.20, P =0.008）. The disease control rate （RD=0.05, 95%CI： -0.03 -0.13, P =0.23） and the quality of life （RD=0.11, 95%CI： -0.00 -0.22, P =0.22） had no difference between the two groups. The incidence of hypertension was increased in apatinib group compared with S-1 group （OR=15.27, 95%CI： 2.79-83.76, P =0.002）. However, nausea and vomiting was decreased with statistically significant difference in apatinib group （OR=0.38, 95%CI： 0.18-0.82, P =0.01）. The occurrence of proteinuria, neutropenia, hand-foot syndrome and other adverse reaction had no difference between the two groups.Conclusion Apatinib can improve overall response rate more effectively compared with S-1 as second-line and above treatment for advanced gastric cancer. Meanwhile, the adverse reactions of apatinib were comparable to S-1.