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抗 PD-1/抗 PD-L1 抗体治疗在既往治疗的晚期胃或胃食管交界处癌中的安全性和疗效:前瞻性临床试验的荟萃分析。

The safety and efficacy of anti-PD-1/anti-PD-L1 antibody therapy in the treatment of previously treated, advanced gastric or gastro-oesophageal junction cancer: A meta-analysis of prospective clinical trials.

机构信息

Department of Gastrointestinal Surgery, First Hospital of Jilin University, 71, Xinmin Street, Chaoyang District, 130021 Changchun, China.

出版信息

Clin Res Hepatol Gastroenterol. 2020 Apr;44(2):211-222. doi: 10.1016/j.clinre.2019.05.007. Epub 2019 Jun 14.

Abstract

INTRODUCTION

So far, anti-PD-1/anti-PD-L1 antibody therapy is reportedly in treating gastric cancer or gastro-oesophageal junction cancer (GC/GEJC) in a number of clinical trials. Based on this, we conducted current meta-analysis to assess the safety and efficacy of anti-PD-1/anti-PD-L1 antibody for previously treated advanced GC/GEJC patients.

METHODS

We searched five electronic databases for eligible records. Outcomes were presented and analyzed by objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and adverse effects (AEs).

RESULTS

Nine records involving 1388 participants were selected in our study. The pooled ORR, DCR, OS rate (6 month), PFS rate (6 month), OS rate (12 month) and PFS rate (12 month) were 10% (95% confidence interval [CI]: 6%-14%), 32% (95%CI: 25%-38%), 52% (95%CI: 44%-61%), 18% (95%CI: 13%-24%), 40% (95%CI: 31%-48%) and 8% (95%CI: 5%-10%), respectively. Meanwhile, grade≥3 AEs rate was 12% (95% CI: 10%-15%). Programmed death ligand 1 (PD-L1) positive cases had higher rate of ORR (odds ratio [OR]: 3.75, 95%CI: 2.09-6.74, P=0.58) compared with negative cases.

CONCLUSION

The results indicated that anti-PD-1/anti-PD-L1 antibody therapy has an effectual anti-tumor activity and controllable AEs in advanced GC/GEJC patients. Furthermore, overexpression of PD-L1 in advanced GC/GEJC patients had better ORR from anti-PD-1/anti-PD-L1 antibody therapy (PROSPERO registration number: CRD42018116480).

摘要

简介

到目前为止,多项临床试验报道抗 PD-1/抗 PD-L1 抗体在治疗胃癌或胃食管结合部癌(GC/GEJC)方面具有一定疗效。基于此,我们进行了此次荟萃分析,以评估抗 PD-1/抗 PD-L1 抗体在既往治疗的晚期 GC/GEJC 患者中的安全性和有效性。

方法

我们检索了五个电子数据库以获取符合条件的记录。通过客观缓解率(ORR)、疾病控制率(DCR)、无进展生存期(PFS)、总生存期(OS)和不良事件(AE)来呈现和分析结果。

结果

本研究共纳入 9 项研究,涉及 1388 名参与者。汇总的 ORR、DCR、OS 率(6 个月)、PFS 率(6 个月)、OS 率(12 个月)和 PFS 率(12 个月)分别为 10%(95%置信区间 [CI]:6%-14%)、32%(95%CI:25%-38%)、52%(95%CI:44%-61%)、18%(95%CI:13%-24%)、40%(95%CI:31%-48%)和 8%(95%CI:5%-10%)。同时,≥3 级 AEs 的发生率为 12%(95%CI:10%-15%)。与阴性病例相比,程序性死亡配体 1(PD-L1)阳性病例的 ORR 更高(优势比 [OR]:3.75,95%CI:2.09-6.74,P=0.58)。

结论

结果表明,抗 PD-1/抗 PD-L1 抗体治疗在晚期 GC/GEJC 患者中具有有效的抗肿瘤活性和可控制的 AE。此外,晚期 GC/GEJC 患者中 PD-L1 的过表达可使抗 PD-1/抗 PD-L1 抗体治疗的 ORR 更好(PROSPERO 注册号:CRD42018116480)。

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