Table_1_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.docx

Background and aimsA 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.
MethodsThe 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.
ResultsIn 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, p<0.001 and z=16.17, p<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, p<0.001 and z=49.17, p<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.
ConclusionAdvanced 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 registrationhttps://www.crd.york.ac.uk/prospero/, identifier CRD42023452422.

背景与研究目的 单一免疫检查点抑制剂（immune checkpoint inhibitor, ICI）方案治疗晚期胆道癌（bile tract cancer, BTC）的疗效有限，因此临床常采用免疫检查点抑制剂联合治疗方案。本荟萃分析旨在评估免疫检查点抑制剂联合疗法治疗晚期胆道癌的有效性与安全性。
研究方法 本研究方案已在PROSPERO平台注册（注册号：CRD42023452422）。我们对相关研究报道的中位无进展生存期（progression-free survival, PFS）、中位总生存期（overall survival, OS）、客观缓解率（objective response rate, ORR）、疾病控制率（disease control rate, DCR）以及≥3级不良事件（adverse events, AEs）数据进行合并分析，以评估免疫检查点抑制剂联合疗法的疗效与安全性。
研究结果 本荟萃分析共纳入15项研究，涉及665例患者。总体客观缓解率与疾病控制率分别为34.6%与77.6%。总体中位无进展生存期与总生存期分别为6.06个月[95%置信区间（confidence interval, CI）：4.91–7.21]与12.11个月（95% CI：10.66–13.55）。相较于仅接受其他治疗的患者，接受免疫检查点抑制剂联合治疗的患者中位无进展生存期与总生存期显著延长（z=9.69，p<0.001和z=16.17，p<0.001）。一线治疗患者的中位无进展生存期与总生存期显著长于非一线治疗患者（z=11.19，p<0.001和z=49.17，p<0.001）。合并后的总体≥3级不良事件发生率为38.2%（95% CI：0.268–0.497），且不受免疫检查点抑制剂联合其他治疗方式或治疗线数的影响。
研究结论 晚期胆道癌患者可从免疫检查点抑制剂联合治疗中获益，且未增加额外不良事件风险。但仍需联合化疗或放疗以获得更佳治疗效果。
系统评价注册：https://www.crd.york.ac.uk/prospero/，标识符CRD42023452422。