Systematic Review of Efficacy and Safety of Apatinib Mesylate in the Treatment of Advanced Gastric Cancer

doi:10.14009/j.issn.1672-2124.2021.06.016

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Systematic Review of Efficacy and Safety of Apatinib Mesylate in the Treatment of Advanced Gastric Cancer

更新时间：2022-10-08

- Systematic Review of Efficacy and Safety of Apatinib Mesylate in the Treatment of Advanced Gastric Cancer
- Vol. 21, Issue 6, Pages: 705-710(2021)
- 作者机构：
  
  北京医院药学部国家老年医学中心中国医学科学院老年医学研究院北京市药物临床风险与个体化应用评价重点实验室(北京医院)
- 作者简介：
- 基金信息：
- DOI：10.14009/j.issn.1672-2124.2021.06.016
  CLC： R735.2
- Published：2021，
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Systematic Review of Efficacy and Safety of Apatinib Mesylate in the Treatment of Advanced Gastric Cancer. [J]. 21(6):705-710(2021)
DOI：

Systematic Review of Efficacy and Safety of Apatinib Mesylate in the Treatment of Advanced Gastric Cancer. [J]. 21(6):705-710(2021) DOI： 10.14009/j.issn.1672-2124.2021.06.016.

摘要

目的:系统评价甲磺酸阿帕替尼递增式给药治疗晚期胃癌的有效性和安全性。方法:计算机检索the Cochrane Library、Pub Med、EMBase、中国知网、万方数据库和中国生物医学文献数据库

纳入从建库至2021年2月发表的甲磺酸阿帕替尼递增式给药治疗晚期胃癌的随机对照试验(研究组患者采用递增式给药方案口服甲磺酸阿帕替尼;对照组患者按照药品说明书推荐常规剂量口服甲磺酸阿帕替尼)

经文献筛选、提取资料并评价纳入研究的偏倚风险后

采用Rev Man 5.4软件进行荟萃分析(Meta分析)。结果:共纳入6篇文献

包括521例患者(研究组患者261例

对照组患者260例)。Meta分析结果显示

有效性方面

研究组患者的完全缓解率(OR=2.32

95%CI=1.38～3.91

P=0.002)、部分缓解率(OR=1.68

95%CI=1.16～2.43

P=0.006)、缓解率(OR=2.76

95%CI=1.80～4.23

P <0.000 01)、进展率(OR=0.38

95%CI=0.23～0.62

P=0.000 1)和疾病控制率(OR=2.68

95%CI=1.64～4.40

P <0.000 1)均显著优于对照组

差异均有统计学意义;安全性方面

研究组患者的蛋白尿发生率(RD=-0.06

95%CI=-0.12～-0.00

P=0.04)、手足综合征发生率(OR=0.26

95%CI=0.16～0.43

P <0.000 01)、胃肠道反应发生率(OR=0.22

95%CI=0.13～0.37

P <0.000 01)、消化道出血发生率(OR=0.26

95%CI=0.11～0.64

P=0.003)、肝功能异常发生率(RD=-0.07

95%CI=-0.13～-0.01

P=0.02)和高血压发生率(RD=-0.07

95%CI=-0.13～-0.00

P=0.04)均显著低于对照组

差异均有统计学意义。结论:现有证据表明

甲磺酸阿帕替尼递增式给药治疗晚期胃癌安全、有效

较常规给药方式有明显优势。结果证据受纳入研究的数量和质量限制

上述结论有待更多高质量研究予以验证。

Abstract

OBJECTIVE: To systematically evaluate the efficacy and safety of increasing dose of apatinib mesylate in the treatment of advanced gastric cancer. METHODS: The Cochrane Library

Pub Med

EMBase

CNKI

Wanfang database and CBM database were retrieved to collect the randomized controlled trial of increasing dose of apatinib mesylate in the treatment of advanced gastric cancer（ the study group received apatinib mesylate orally with an incremental dosing regimen

while the control group was given apatinib mesylate orally at the regular dose recommended in the drug instructions）

the retrieval time was from the establishment of the databe to Feb. 2021. After literature screening

data extraction and evaluation of the risk of bias in the included literature

RevMan 5. 4 software was used for Meta-analysis. RESULTS: Totally 6 literature were collected

including 521 patients（ with 261 patients in the study group and 260 patients in the control group）. Meta-analysis results showed that the complete remission rate（ OR = 2. 32

95% CI = 1. 38-3. 91

P = 0. 002） and partial remission rate（ OR = 1. 68

95% CI = 1. 16-2. 43

P =0. 006）

remission rate（ OR = 2. 76

95% CI = 1. 80-4. 23

P < 0. 000 01）

progression rate（ OR = 0. 38

95% CI =0. 23-0. 62

P = 0. 000 1） and disease control rate（ OR = 2. 68

95% CI = 1. 64-4. 40

P < 0. 000 1） in the study group were significantly better than those in the control group

the differences were statistically significant. The incidence of urinary protein（ RD =-0. 06

95% CI =-0. 12--0. 00

P = 0. 04）

the incidence of hand-foot syndrome（ OR =0. 26

95% CI = 0. 16-0. 43

P < 0. 000 01）

the incidence of gastrointestinal reaction（ OR = 0. 22

95% CI = 0. 13-0. 37

P < 0. 000 01）

the incidence of gastrointestinal bleeding（ OR = 0. 26

95% CI = 0. 11-0. 64

P = 0. 003）

the incidence of abnormal liver function（ RD =-0. 07

95% CI =-0. 13--0. 01

P = 0. 02） and the incidence of hypertension（ RD =-0. 07

95% CI =-0. 13--0. 00

P = 0. 04） in the study group were significantly lower than those in the control group

and the differences were statistically significant. CONCLUSIONS: Available evidence suggests that increasing dose of apatinib mesylate is safe and effective in the treatment of advanced gastric cancer

with significant advantages over conventional dosing. The evidence for the results is limited by the number and quality of included literature

and the above findings need to be validated by additional high-quality studies.

关键词

甲磺酸阿帕替尼递增式给药晚期胃癌Meta分析随机对照试验

Keywords

Apatinib mesylateIncreasing doseAdvanced gastric cancerMeta-analysisRandomized controlled trial

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