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抗表皮生长因子受体药物治疗食管癌的疗效和安全性:系统评价和荟萃分析。

Efficacy and safety of anti-epidermal growth factor receptor agents for the treatment of oesophageal cancer: a systematic review and meta-analysis.

机构信息

School of Nursing, Liaoning University of Traditional Chinese Medicine, Shenyang, China.

School of Nursing, Tianjin Medical University, Tianjin, China.

出版信息

BMJ Open. 2021 Mar 22;11(3):e046352. doi: 10.1136/bmjopen-2020-046352.

Abstract

OBJECTIVES

Despite remarkable advances in the treatment of oesophageal cancer (OC), the role of antiepidermal growth factor receptor (anti-EGFR) agents in treating OC remains controversial. Herein, a systematic review and meta-analysis were conducted to elucidate the efficacy and safety of anti-EGFR agents in patients with OC.

DESIGN

Meta-analysis of randomised controlled trials (RCTs) identified by searching the PubMed, Embase, Web of Science, ClinicalTrials.gov, Cochrane Library, Chinese Biology Medicine, China National Knowledge Infrastructure and Wanfang Data Knowledge Service Platform databases from inception to December 2019. We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

SETTING

RCTs from any country and healthcare setting.

PARTICIPANTS

Patients with OC.

INTERVENTIONS

Combination therapy with anti-EGFR agents and conventional treatments versus conventional treatments alone in patients with OC.

PRIMARY AND SECONDARY OUTCOME MEASURES

Overall survival (OS) and progression-free survival (PFS) were primary outcome measures, and objective response rate (ORR), disease control rate (DCR) and treatment toxicities were secondary outcome measures.

RESULTS

In total, 25 RCTs comprising 3406 patients with OC were included. Overall, anti-EGFR treatment significantly improved the OS (HR: 0.81, 95% CI 0.74 to 0.89, p<0.00001), ORR (relative risk (RR): 1.33, 95% CI 1.16 to 1.52, p<0.0001) and DCR (RR: 1.22, 95% CI 1.11 to 1.34, p<0.0001) but not PFS (HR: 0.91, 95% CI 0.76 to 1.08, p=0.26). Anti-EGFR treatment was significantly associated with higher incidences of myelosuppression, diarrhoea, acne-like rash and hypomagnesaemia.

CONCLUSIONS

Overall, anti-EGFR agents have positive effects on OS, the ORR and DCR in OC. However, considering the high incidence of adverse effects, such as myelosuppression, diarrhoea, acne-like rashes and hypomagnesaemia, careful monitoring of patients with OC is recommended during anti-EGFR treatment.

TRIAL REGISTRATION NUMBER

CRD42020169230.

摘要

目的

尽管在治疗食管癌(OC)方面取得了显著进展,但抗表皮生长因子受体(anti-EGFR)药物在治疗 OC 中的作用仍存在争议。本系统评价和荟萃分析旨在阐明抗 EGFR 药物在 OC 患者中的疗效和安全性。

设计

通过检索 PubMed、Embase、Web of Science、ClinicalTrials.gov、Cochrane 图书馆、中国生物医学文献数据库、中国知网和万方数据知识服务平台数据库,对截至 2019 年 12 月发表的随机对照试验(RCT)进行荟萃分析。我们遵循系统评价和荟萃分析的首选报告项目指南。

设置

来自任何国家和医疗保健环境的 RCT。

参与者

OC 患者。

干预措施

抗 EGFR 药物联合常规治疗与 OC 患者单独常规治疗。

主要和次要结局测量

总生存期(OS)和无进展生存期(PFS)为主要结局测量,客观缓解率(ORR)、疾病控制率(DCR)和治疗毒性为次要结局测量。

结果

共纳入 25 项 RCT,包括 3406 例 OC 患者。总体而言,抗 EGFR 治疗显著改善了 OS(HR:0.81,95%CI 0.74 至 0.89,p<0.00001)、ORR(相对风险(RR):1.33,95%CI 1.16 至 1.52,p<0.0001)和 DCR(RR:1.22,95%CI 1.11 至 1.34,p<0.0001),但 PFS 无显著改善(HR:0.91,95%CI 0.76 至 1.08,p=0.26)。抗 EGFR 治疗与更高的骨髓抑制、腹泻、痤疮样皮疹和低镁血症发生率相关。

结论

总体而言,抗 EGFR 药物对 OC 的 OS、ORR 和 DCR 具有积极影响。然而,考虑到不良反应(如骨髓抑制、腹泻、痤疮样皮疹和低镁血症)发生率较高,建议在 OC 患者接受抗 EGFR 治疗期间进行密切监测。

试验注册号

CRD42020169230。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d50f/7986677/603b73791d25/bmjopen-2020-046352f01.jpg

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