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卡培他滨与替吉奥为基础的化疗方案治疗转移性或复发性胃癌的疗效和安全性:一项系统评价和荟萃分析的临床随机试验。

The efficacy and safety of capecitabine-based versus S-1-based chemotherapy for metastatic or recurrent gastric cancer: a systematic review and meta-analysis of clinical randomized trials.

机构信息

The Second Clinical Medical College, Lanzhou University, Lanzhou 730030, China.

Institute of Clinical Research and Evidence-Based Medicine, Gansu Provincial Hospital, Lanzhou 730000, China.

出版信息

Ann Palliat Med. 2020 May;9(3):883-894. doi: 10.21037/apm.2020.04.26. Epub 2020 Apr 23.

Abstract

BACKGROUND

Gastric cancer (GC), particularly unresectable, metastatic, or recurrent GC, has been characterized by unfavorable prognosis. This meta-analysis of clinical randomized phase II trials was conducted to systematically evaluate the efficacy and safety of capecitabine-based versus S-1-based chemotherapy for metastatic or recurrent GC.

METHODS

We searched PubMed, Embase, Web of Science, and Cochrane Library databases to identify studies eligible for the present analysis. Data were collected from inception to June 20th, 2019. Outcomes included objective response rate (ORR); 6-, 12-, and 18-month progression-free survival (PFS); 1-, 2-, and 3-year overall survival (OS); and adverse events. A meta-analysis was conducted using a random-effects model, and a sensitivity analysis was conducted to examine whether the results of the meta-analysis were robust. Risk ratio (RR) or hazard ratio (HR) with 95% confidence interval (CI) was reported as the main evaluation parameters.

RESULTS

Six eligible studies with 561 subjects were included in the present meta-analysis. There was no significant difference between S-1-based and capecitabine-based chemotherapy in ORR (RR =1.17, 95% CI: 0.95-1.44, P=0.13, I2 =0%); 6-month (HR =0.94, 95% CI: 0.77-1.14, I2 =0%), 12-month (HR =0.89, 95% CI: 0.61-1.31, I2 =0%), and 18-month PFS (HR =1.02, 95% CI: 0.55-1.91, I2 =0%); 1-year (HR =0.99, 95% CI: 0.83-1.18, I2 =0%), 2-year (HR =0.90, 95% CI: 0.58-1.42, I2 =0%), and 3-year OS (HR =1.08, 95% CI: 0.50-2.34, I2 =0%). However, the capecitabine-based chemotherapy had a higher incidence in all grades of hand-foot syndrome (HFS) (RR =3.41, 95% CI: 1.98-5.90, P<0.01, I 2 =39%) and grades 3-4 neutropenia (RR =1.62, 95% CI: 1.05-2.51, P=0.03, I2 =0%).

CONCLUSIONS

In terms of efficacy, capecitabine-based chemotherapy and S-1-based chemotherapy had similar short-term outcomes. Regarding safety, we recommend S-1-based chemotherapy for patients with metastatic or recurrent GC prior to capecitabine-based treatment.

摘要

背景

胃癌(GC),尤其是不可切除、转移性或复发性 GC,其预后一直较差。本项针对临床随机 II 期试验的荟萃分析旨在系统评估卡培他滨为基础与替吉奥为基础化疗在转移性或复发性 GC 中的疗效和安全性。

方法

我们检索了 PubMed、Embase、Web of Science 和 Cochrane Library 数据库,以确定符合本分析条件的研究。数据从开始到 2019 年 6 月 20 日收集。主要结局指标包括客观缓解率(ORR);6、12 和 18 个月无进展生存期(PFS);1、2 和 3 年总生存期(OS);以及不良反应。采用随机效应模型进行荟萃分析,并进行敏感性分析以检验荟萃分析结果的稳健性。报告风险比(RR)或风险比(HR)和 95%置信区间(CI)作为主要评估参数。

结果

纳入了 6 项符合条件的研究,共 561 例患者。卡培他滨为基础与替吉奥为基础化疗在 ORR(RR=1.17,95%CI:0.95-1.44,P=0.13,I 2 =0%);6 个月(HR=0.94,95%CI:0.77-1.14,I 2 =0%)、12 个月(HR=0.89,95%CI:0.61-1.31,I 2 =0%)和 18 个月 PFS(HR=1.02,95%CI:0.55-1.91,I 2 =0%);1 年(HR=0.99,95%CI:0.83-1.18,I 2 =0%)、2 年(HR=0.90,95%CI:0.58-1.42,I 2 =0%)和 3 年 OS(HR=1.08,95%CI:0.50-2.34,I 2 =0%)方面均无显著差异。然而,卡培他滨为基础化疗在手足综合征(HFS)(RR=3.41,95%CI:1.98-5.90,P<0.01,I 2 =39%)和 3-4 级中性粒细胞减少症(RR=1.62,95%CI:1.05-2.51,P=0.03,I 2 =0%)方面的发生率更高。

结论

在疗效方面,卡培他滨为基础化疗和替吉奥为基础化疗具有相似的短期疗效。在安全性方面,我们建议在使用卡培他滨为基础治疗之前,使用替吉奥为基础化疗治疗转移性或复发性 GC 患者。

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