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抗PD-1/抗PD-L1抗体疗法治疗晚期胃癌或胃食管交界癌的疗效与安全性:一项荟萃分析。

Efficacy and safety of anti-PD-1/anti-PD-L1 antibody therapy in treatment of advanced gastric cancer or gastroesophageal junction cancer: A meta-analysis.

作者信息

Yang Li, Dong Xian-Zhe, Xing Xiao-Xuan, Cui Xiao-Hui, Li Lin, Zhang Lan

机构信息

Department of Pharmacy, Xuanwu Hospital of Capital Medical University, National Clinical Research Center for Geriatric Diseases, Beijing Engineering Research Center for Nervous System Drugs, Beijing Institute for Brain Disorders, Key Laboratory for Neurodegenerative Diseases of Ministry of Education, Beijing 100053, China.

出版信息

World J Gastrointest Oncol. 2020 Nov 15;12(11):1346-1363. doi: 10.4251/wjgo.v12.i11.1346.

Abstract

BACKGROUND

Faced with limited and inadequate treatment options for patients with advanced gastric cancer or gastroesophageal junction cancer (GC/GEJC), researchers have turned toward, with the support of promising clinical trials, anti-PD-1/anti-PD-L1 antibody therapy. But there are also different clinical trial results. To better assess its efficacy and safety, we integrated data from 13 eligible studies for a systematic review and meta-analysis.

AIM

To comprehensively evaluate the efficacy and safety of anti-PD-1/anti-PD-L1 antibody therapy in the treatment of advanced GC/GEJC patients.

METHODS

PubMed, Web of Science, Cochrane Library ,and EMBASE databases were searched to identify eligible articles with outcomes including objective response rate (ORR), disease control rate (DCR), overall survival (OS), progression-free survival (PFS), and adverse events (AEs) of anti-PD-1/anti-PD-L1 antibody therapy.

RESULTS

Our study encompassed a total of 13 trials totaling 1618 patients. The outcomes showed a pooled ORR and DCR of 15% (95% confidence interval [CI]: 14%-18%) and 40% (95%CI: 33%-46%), respectively. The pooled 6-mo OS and PFS were 54% (95%CI: 45%-64%) and 26% (95%CI: 20%-32%), respectively, and the 12-mo OS and PFS were 42% (95%CI: 21%-62%) and 11% (95%CI: 8%-13%), respectively. In addition, the incidence of any-grade AEs and grade ≥ 3 AEs was 64% (95%CI: 54%-73%) and 18% (95%CI: 16%-20%), respectively. Most importantly, PD-L1 positive patients exhibited a higher ORR rate than PD-L1 negative patients (odds ratio = 2.54, 95%CI: 1.56-4.15).

CONCLUSION

Anti-PD-1/anti-PD-L1 antibody therapy has shown promising anti-tumor efficacy with manageable AEs in advanced GC/GEJC patients, with PD-L1 overexpressing patients exhibiting a higher ORR. What is more, the clinical efficacy of anti-PD-1/PD-L1 combined with traditional chemotherapy drugs is even better, although the occurrence of AEs still causes considerate concerns.

摘要

背景

面对晚期胃癌或胃食管交界癌(GC/GEJC)患者的治疗选择有限且不足的情况,在有前景的临床试验支持下,研究人员转向了抗PD-1/抗PD-L1抗体疗法。但也存在不同的临床试验结果。为了更好地评估其疗效和安全性,我们整合了13项符合条件的研究数据进行系统评价和荟萃分析。

目的

全面评估抗PD-1/抗PD-L1抗体疗法治疗晚期GC/GEJC患者的疗效和安全性。

方法

检索PubMed、Web of Science、Cochrane图书馆和EMBASE数据库,以识别符合条件的文章,其结果包括抗PD-1/抗PD-L1抗体疗法的客观缓解率(ORR)、疾病控制率(DCR)、总生存期(OS)、无进展生存期(PFS)和不良事件(AE)。

结果

我们的研究共纳入13项试验,总计1618例患者。结果显示,汇总的ORR和DCR分别为15%(95%置信区间[CI]:14%-18%)和40%(95%CI:33%-46%)。汇总的6个月OS和PFS分别为54%(95%CI:45%-64%)和26%(95%CI:20%-32%),12个月OS和PFS分别为42%(95%CI:21%-62%)和11%(95%CI:8%-13%)。此外,任何级别的AE和≥3级AE的发生率分别为64%(95%CI:54%-73%)和分别为18%(95%CI:16%-20%)。最重要的是,PD-L1阳性患者的ORR率高于PD-L1阴性患者(优势比=2.54,95%CI:1.56-4.15)。

结论

抗PD-1/抗PD-L1抗体疗法在晚期GC/GEJC患者中显示出有前景的抗肿瘤疗效,且不良事件可控,PD-L1过表达患者的ORR更高。此外,抗PD-1/PD-L1与传统化疗药物联合使用的临床疗效更好,尽管AE的发生仍然引起相当大的关注。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2dde/7667450/6bf70a1028ce/WJGO-12-1346-g001.jpg

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