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新辅助免疫疗法在可手术切除食管癌中的疗效和安全性:系统评价和荟萃分析。

Efficacy and safety of neoadjuvant immunotherapy in surgically resectable esophageal cancer: A systematic review and meta-analysis.

机构信息

Department of Thoracic Surgery, Tangdu Hospital, Air Force Medical University, 1 Xinsi Road, Xi'an, 710038, China.

Department of Medical Oncology, Senior Department of Oncology, The Fifth Medical Center of PLA General Hospital, 8 Dongdajie Road, Beijing, 100071, China.

出版信息

Int J Surg. 2022 Aug;104:106767. doi: 10.1016/j.ijsu.2022.106767. Epub 2022 Jul 14.

DOI:10.1016/j.ijsu.2022.106767
PMID:35840049
Abstract

BACKGROUND

Neoadjuvant immunotherapy for patients with locally advanced esophageal cancer (EC) has developed rapidly in recent years. The efficacy and safety outcomes may change the recommended neoadjuvant therapeutic regimens for patients with EC.

METHODS

Systematic screening for articles focusing on the efficacy and safety of neoadjuvant immunotherapy in locally advanced and surgically resectable EC was performed using PubMed, Embase, Web of Science and international tumor congresses. Meta-analysis of non-comparative binary outcomes was carried out to combine the main results. The pooled results were compared with the traditional neoadjuvant chemotherapy (nCT) and chemoradiotherapy (nCRT) using direct comparative analysis. The results were expressed as the risk ratio (RR).

RESULTS

A total of 20 articles with 621 patients were included in the present study. The pooled pathological complete response and major pathological response rates were 33.8% (95% CI: 29.6%-37.9%) and 53.5% (95% CI: 47.9%-59%), respectively, in the neoadjuvant immunotherapy combined with chemotherapy (nICT) group and 39.8% (95% CI: 27%-53.9%) and 88.8% (95% CI: 64.8%-97.2%) in the neoadjuvant immunotherapy combined with chemoradiotherapy (nICRT) group, respectively. In addition, the pooled grade 3-4 treatment-related adverse events (TRAEs) rate was 19.4% (95% CI: 11.5%-31.5%) in the nICT group. The results of direct comparison showed that compared with nCRT and nICRT, nICT could improve safety while achieving comparable efficacy. The results of subgroup analysis, sensitivity analysis and publication bias evaluation indicated that the above findings were stable and reliable.

CONCLUSION

The current meta-analysis revealed that neoadjuvant immunotherapy in patients with locally advanced EC was safe and effective and nICT could be used as the recommended neoadjuvant therapeutic option for patients with EC. However, additional studies are urgently needed to reveal the long-term outcomes of neoadjuvant immunotherapy.

摘要

背景

近年来,局部晚期食管癌(EC)患者的新辅助免疫治疗发展迅速。疗效和安全性结果可能会改变 EC 患者推荐的新辅助治疗方案。

方法

使用 PubMed、Embase、Web of Science 和国际肿瘤大会系统地筛选关于局部晚期和可手术切除的 EC 患者新辅助免疫治疗的疗效和安全性的文章。对非比较性二分类结果进行荟萃分析,以合并主要结果。将汇总结果与传统的新辅助化疗(nCT)和放化疗(nCRT)进行直接比较分析。结果以风险比(RR)表示。

结果

共纳入 20 篇文章,共计 621 例患者。新辅助免疫联合化疗(nICT)组的病理完全缓解和主要病理缓解率分别为 33.8%(95% CI:29.6%-37.9%)和 53.5%(95% CI:47.9%-59%),新辅助免疫联合放化疗(nICRT)组分别为 39.8%(95% CI:27%-53.9%)和 88.8%(95% CI:64.8%-97.2%)。此外,nICT 组 3-4 级治疗相关不良事件(TRAEs)发生率为 19.4%(95% CI:11.5%-31.5%)。直接比较结果表明,与 nCRT 和 nICRT 相比,nICT 可提高安全性,同时疗效相当。亚组分析、敏感性分析和发表偏倚评估结果表明,上述发现稳定可靠。

结论

本荟萃分析显示,局部晚期 EC 患者的新辅助免疫治疗安全有效,nICT 可作为 EC 患者的推荐新辅助治疗选择。然而,迫切需要更多的研究来揭示新辅助免疫治疗的长期结果。

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