免疫检查点抑制剂联合其他靶向或免疫治疗方案治疗晚期胆道癌的临床结局：系统评价和荟萃分析。

Clinical outcomes of immune checkpoint inhibitor combined with other targeted or immunological therapy regimens for the treatment of advanced bile tract cancer: a systematic review and meta-analysis.

机构信息

Department of Hepatobiliary and Pancreatic Surgery I, General Surgery Center, The First Hospital of Jilin University, Changchun, China.

Department of Hematology, The First Hospital of Jilin University, Changchun, China.

出版信息

Front Immunol. 2024 May 22;15:1378760. doi: 10.3389/fimmu.2024.1378760. eCollection 2024.

DOI:10.3389/fimmu.2024.1378760

PMID:38840927

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11150610/

Abstract

BACKGROUND AND AIMS

A single immune checkpoint inhibitor (ICI) regimen has limited value in treating advanced bile tract cancer (BTC); therefore, ICI combination therapy is often applied. This meta-analysis aimed to evaluate the effectiveness and safety of ICI combination therapy for advanced BTC.

METHODS

The study protocol was registered on PROSPERO (CRD42023452422). Data on the median progression-free survival (PFS), median overall survival (OS), objective response rate (ORR), disease control rate (DCR), and grade ≥3 adverse events (AEs) reported in relevant studies were pooled and analyzed to determine the efficacy and safety of ICI combination therapy.

RESULTS

In total, 15 studies with 665 patients were included in this meta-analysis. The overall ORR and DCR were 34.6% and 77.6%, respectively. The overall median PFS and OS were 6.06 months [95% confidence interval (CI): 4.91-7.21] and 12.11 months (95% CI: 10.66-13.55), respectively. Patients receiving ICI combination therapy in addition to other therapies had a considerably prolonged median PFS and OS (z=9.69, <0.001 and z=16.17, <0.001). Patients treated as first-line treatment had a substantially longer median PFS and OS compared to patients treated as non-first-line treatment (z=11.19, <0.001 and z=49.17, <0.001). The overall pooled grade ≥3 AEs rate was 38.2% (95% CI: 0.268-0.497) and was not influenced by whether ICI therapy was combined with other treatments or not or the treatment line.

CONCLUSION

Advanced BTC patients may benefit from ICI combination treatment without additional AEs. However, concurrent chemotherapy or radiotherapy is still needed to achieve better outcomes.

SYSTEMATIC REVIEW REGISTRATION

https://www.crd.york.ac.uk/prospero/, identifier CRD42023452422.

摘要

背景和目的

单一免疫检查点抑制剂（ICI）方案在治疗晚期胆道癌（BTC）方面价值有限；因此，ICI 联合治疗通常应用。本荟萃分析旨在评估 ICI 联合治疗晚期 BTC 的有效性和安全性。

方法

本研究方案已在 PROSPERO（CRD42023452422）上注册。汇总并分析相关研究中报告的中位无进展生存期（PFS）、中位总生存期（OS）、客观缓解率（ORR）、疾病控制率（DCR）和≥3 级不良事件（AE）的发生率，以评估 ICI 联合治疗的疗效和安全性。

结果

本荟萃分析共纳入 15 项研究，共 665 例患者。总体 ORR 和 DCR 分别为 34.6%和 77.6%。总体中位 PFS 和 OS 分别为 6.06 个月[95%置信区间（CI）：4.91-7.21]和 12.11 个月（95% CI：10.66-13.55）。与仅接受其他治疗的患者相比，接受 ICI 联合治疗的患者中位 PFS 和 OS 显著延长（z=9.69，<0.001 和 z=16.17，<0.001）。作为一线治疗的患者与作为二线治疗的患者相比，中位 PFS 和 OS 显著延长（z=11.19，<0.001 和 z=49.17，<0.001）。总体≥3 级 AE 发生率为 38.2%（95% CI：0.268-0.497），与是否联合 ICI 治疗以及治疗线无关。