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西妥昔单抗治疗食管癌:随机对照试验的更新荟萃分析。

Cetuximab for esophageal cancer: an updated meta-analysis of randomized controlled trials.

机构信息

Department of Head & Neck Surgery, Cancer Hospital, Peking Union Medical College, Chinese Academy of Medical Science, Beijing, 100021, China.

Department of Endocrinology, Xi'an Hong Hui Hospital, Xi'an, 710054, Shanxi Province, China.

出版信息

BMC Cancer. 2018 Nov 26;18(1):1170. doi: 10.1186/s12885-018-5040-z.

Abstract

BACKGROUND

Increasing evidence indicates that cetuximab (CET) combined with chemoradiotherapy may be effective for patients with esophageal cancer. However, the recent results are still contradictory and no consensus has yet been reached on this issue. To evaluate the clinical effects and safety of CET, we conducted an updated meta-analysis by retrieving published data up to June 2018.

METHODS

A comprehensive literature search was performed in several electronic databases, including PubMed, Embase, the Cochrane Library, CNKI database and Chinese Biomedicine Database using subject terms and free terms. Pooled odds ratios (ORs) with 95% confidence intervals (CIs) were calculated to determine the efficiency and safety of CET.

RESULTS

This meta-analysis included 10 randomized controlled trials (RCTs). Five RCTs reported localized esophageal cancer and other five RCTs reported metastatic esophageal cancer. For these patients with localized esophageal cancer, CET could not significantly improve the response rate, overall survival and progression-free survival (PFS, 1-5 years). But CET treatment might increase the incidences of diarrhea (OR = 2.07; CI = 1.01-4.25) and rash (OR = 16.91; CI = 3.20-89.42). For other patients with metastatic esophageal cancer, the addition of CET significantly increased the response rate (OR = 3.34; CI = 1.90-5.88), disease control rate (OR = 2.92; CI = 1.49-5.71) and 2-year overall survival (OR = 2.78; CI = 1.20-6.46) compared with the control group. However, CET could not improve the 1-year overall survival and might make patients with metastatic esophageal cancer more susceptible to rash (OR = 5.50; CI = 2.14-14.14). No significant differences in other adverse effects were found between the two groups.

CONCLUSIONS

Our findings suggested that adding CET to multimodal therapy significantly improved response rate and disease control rate for patients with metastatic esophageal cancer rather than patients with localized esophageal cancer. CET might be a safe therapeutic choice, but CET failed to significantly improve the overall survival and PFS for patients with localized or metastatic esophageal cancer.

摘要

背景

越来越多的证据表明,西妥昔单抗(CET)联合放化疗可能对食管癌患者有效。然而,最近的结果仍然存在矛盾,对此问题尚未达成共识。为了评估 CET 的临床疗效和安全性,我们检索了截至 2018 年 6 月发表的数据,进行了更新的荟萃分析。

方法

我们使用主题词和自由词在几个电子数据库(包括 PubMed、Embase、Cochrane Library、CNKI 数据库和中国生物医学文献数据库)中进行了全面的文献检索。使用合并的优势比(OR)和 95%置信区间(CI)来确定 CET 的疗效和安全性。

结果

本荟萃分析纳入了 10 项随机对照试验(RCT)。其中 5 项 RCT 报道了局限性食管癌,另外 5 项 RCT 报道了转移性食管癌。对于这些局限性食管癌患者,CET 并不能显著提高客观缓解率、总生存期和无进展生存期(PFS,1-5 年)。但 CET 治疗可能会增加腹泻(OR=2.07;CI=1.01-4.25)和皮疹(OR=16.91;CI=3.20-89.42)的发生率。对于其他转移性食管癌患者,加用 CET 可显著提高客观缓解率(OR=3.34;CI=1.90-5.88)、疾病控制率(OR=2.92;CI=1.49-5.71)和 2 年总生存率(OR=2.78;CI=1.20-6.46)。然而,CET 并不能提高 1 年总生存率,并且可能使转移性食管癌患者更容易出现皮疹(OR=5.50;CI=2.14-14.14)。两组间其他不良反应无显著差异。

结论

我们的研究结果表明,在多模态治疗的基础上加用 CET 可显著提高转移性食管癌患者的客观缓解率和疾病控制率,但对局限性食管癌患者并无此作用。CET 可能是一种安全的治疗选择,但未能显著提高局限性或转移性食管癌患者的总生存率和无进展生存期。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f204/6258395/320787e14808/12885_2018_5040_Fig1_HTML.jpg

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