Xu Ranning, Zhou Jian, Yang Jian, Yu Yanxi, Wang Hao, Zhang Ziqi, Yang Jian, Zhang Guo, Liao Rui
Department of Hepatobiliary Surgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Department of Hepatobiliary Surgery, The People's Hospital of Rongchang District, Chongqing, China.
Biosci Trends. 2025 Jan 14;18(6):555-562. doi: 10.5582/bst.2024.01376. Epub 2024 Dec 8.
The current state of systemic therapy for advanced biliary tract cancer (BTC) has undergone significant changes. Currently, there are no clinical trials directly comparing various first-line systemic therapy regimens to each other, and these trials are unlikely to be conducted in the future. In this systematic review, after various abstracts and full-text articles published from the establishment of the database until October 2024 were searched, we included and analysed phase 3 clinical trials to evaluate the efficacy of different first-line systemic treatment regimens in advanced BTC. We used the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guidelines and a random effects model to pool the overall effects. Finally, seven low-risk-of-bias trials (with all of the trials representing first-line trials) were included. A total of 4033 patients were included in seven first-line trials. In terms of progression-free survival (PFS), network meta-analysis revealed that durvalumab + gemcitabine + cisplatin (GemCis) triple therapy, S-1 + GemCis triple therapy, and pembrolizumab + GemCis triple therapy were superior to GemCis. In terms of overall survival (OS), network meta-analysis revealed that durvalumab + GemCis triple therapy and pembrolizumab + GemCis triple therapy outperformed GemCis. According to the ranking of the P scores, durvalumab + GemCis triple therapy ranked first in PFS and second in OS. Therefore, the advantages of molecular immunotherapy have gradually become known, which suggests that future trials should focus on other potential combinations and molecular immunotargeted therapies.
晚期胆管癌（BTC）全身治疗的现状已发生显著变化。目前，尚无直接比较各种一线全身治疗方案的临床试验，且未来也不太可能开展此类试验。在本系统评价中，检索了从数据库建立至2024年10月发表的各种摘要和全文文章后，我们纳入并分析了3期临床试验，以评估不同一线全身治疗方案在晚期BTC中的疗效。我们采用系统评价和Meta分析的首选报告项目（PRISMA）报告指南及随机效应模型来汇总总体效应。最终，纳入了7项低偏倚风险试验（所有试验均为一线试验）。7项一线试验共纳入4033例患者。在无进展生存期（PFS）方面，网状Meta分析显示，度伐利尤单抗+吉西他滨+顺铂（GemCis）三联疗法、S-1+GemCis三联疗法以及帕博利珠单抗+GemCis三联疗法均优于GemCis。在总生存期（OS）方面，网状Meta分析显示，度伐利尤单抗+GemCis三联疗法和帕博利珠单抗+GemCis三联疗法优于GemCis。根据P评分排名，度伐利尤单抗+GemCis三联疗法在PFS中排名第一，在OS中排名第二。因此，分子免疫疗法的优势已逐渐为人所知，这表明未来的试验应聚焦于其他潜在的联合治疗方案和分子免疫靶向疗法。
