安罗替尼对晚期恶性肿瘤疗效和安全性的Meta分析

Efficacy and safety of anlotinib for advanced malignant tumor:a Meta-analysis

目的探讨安罗替尼治疗晚期非小细胞肺癌、乳腺癌、胃癌、软组织肉瘤和结直肠癌等晚期恶性肿瘤的疗效和安全性。方法计算机检索Pubmed、The Cochrane Library、EMbase、VIP、CKNI、万方数据库,按照纳入和排除标准筛选文献和提取资料后,使用RevMan 5.3软件对数据行Meta分析。结果共纳入11项随机对照试验,共947例患者。Meta分析结果显示,与对照组相比,试验组患者客观缓解率(OR=4.21,95%CI:2.62~6.75,P<0.01)、疾病控制率(OR=6.06,95%CI:4.46~8.23,P<0.01)均明显提高;总生存期(HR=0.70,95%CI:0.57~0.87,P<0.01)、无进展生存期(HR=0.26,95%CI:0.21~0.33,P<0.01)均明显延长。亚组分析中,安罗替尼单药或化疗联合安罗替尼治疗均可提高患者客观缓解率、疾病控制率,且安罗替尼单药疗效更佳;对于非小细胞肺癌和其他肿瘤,安罗替尼治疗均可提高患者客观缓解率、疾病控制率,且安罗替尼治疗非小细胞肺癌效果更好。安全性方面:试验组高血压(RR=4.55,95%CI:3.28~6.30,P<0.01)、手足综合征(RR=5.09,95%CI:3.24~8.00,P<0.01)、咯血(RR=2.43,95%CI:1.50~3.94,P<0.01)发生率均高于对照组;其余不良反应如WBC减少、粒细胞减少、贫血、高甘油三酯血症、恶心、呕吐、腹泻,两组比较差异均无统计学意义(均P>0.05)。结论安罗替尼可提高晚期恶性肿瘤临床疗效,同时需注意高血压、手足综合征、咯血等不良反应。

Objective To evaluate the efficacy and safety of anlotinib in the treatment of advanced non-small cell lung cancer(NSCLC),breast cancer,gastric cancer,soft tissue sarcoma and colorectal cancer by Meta-analysis.Methods The PubMed,Cochrane Library,EMBASE,VIP,CKNI and Wanfang databases were searched for studies on anlotinib in treatment of advanced NSCLC,breast cancer,gastric cancer,soft tissue sarcoma and colorectal cancer.The literature was screened and extracted according to the inclusion and exclusion criteria,and Meta-analysis was performed by RevMan 5.3 software.Results A total of 11 randomized controlled trials involving 947 patients were included for analysis.Meta-analysis showed that compared with the control group,the treatment group significantly improved the objective remission rate(OR=4.21,95%CI:2.62-6.75,P<0.01),disease control rate(OR=6.06,95%CI:4.46-8.23,P<0.01),prolonged the total survival period(HR=0.70,95%CI:0.57-0.87,P<0.01),progression free survival period(HR=0.26,95%CI:0.21-0.33,P<0.01).In subgroup analysis,the objective remission rate and disease control rate of patients were improved by monotherapy of anlotinib or anlotinib combined with chemotherapy,and the curative effect of single drug of anlotinib was better.The objective remission rate and disease control rate of patients were improved by monotherapy of anlotinib,and the efficacy for NSCLC patients was better.In terms of safety,hypertension(RR=4.55,95%CI:3.28-6.30,P<0.01),hand foot syndrome(RR=5.09,95%CI:3.24-8.00,P<0.01)and hemoptysis(RR=2.43,95%CI:1.50-3.94,P<0.01)were observed in the treatment group,and incidence was higher than that of the control group,however,there were no significant differences in the incidence of other adverse reactions such as leukopenia,granulocytopenia,anemia,hypertriglyceridemia,nausea,vomiting,diarrhea between two groups.Conclusion Anlotinib can improve the clinical efficacy for advanced malignant tumor,however it may have higher incidence of adverse reactions such as hypertension,hand foot syndrome,hemoptysis and so on.