Nappo G, D'Ambra V, Ricci C, Pagnanelli M, Rebasti V, Alves G, Crippa S, Rimassa L, Casadei R, Zerbi A
Pancreatic Surgery Unit, IRCCS Humanitas Research Hospital, Rozzano, Italy.
Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy.
Updates Surg. 2025 Sep 1. doi: 10.1007/s13304-025-02383-y.
The role of adjuvant therapy (AT) after pancreaticoduodenectomy (PD) for distal cholangiocarcinoma (DC) remains controversial. This systematic review and meta-analysis aimed to evaluate the impact of AT on overall survival (OS) and disease-free survival (DFS) in patients with resected DC. A systematic review was conducted following PRISMA guidelines (PROSPERO: CRD42024561780). PubMed, Scopus, Web of Science, and Cochrane databases were searched for studies published between January 2000 and August 2023. Eligible studies included patients who underwent PD for DC, comparing AT to follow-up (FUP) alone. Primary endpoints were OS and DFS, analyzed using hazard ratios (HR) with 95% confidence intervals (CI). Meta-regression explored potential sources of heterogeneity. The analysis included 22 studies with 7078 patients (3860 FUP group, 3218 AT group): of the studies, only 3 (13.6%) were RCTs (even if none of them was specifically designed for DC). AT significantly improved OS (HR 0.80; 95% CI 0.73-0.89; p < 0.001) and DFS (HR 0.84; 95% CI 0.74-0.96; p = 0.023) compared to FUP. Subgroup analysis showed a greater benefit for chemo-radiotherapy (OS HR 0.81; 95% CI 0.72-0.91) over chemotherapy alone (OS HR 0.78; 95% CI 0.64-0.94). High heterogeneity (I = 98%) was identified among the included studies. This meta-analysis demonstrates that AT is associated with improved survival outcomes in patients undergoing PD for DC. However, the significant limitations of the existing literature, particularly the lack of RCTs designed specifically for DC, necessitate caution, especially on which type of chemotherapy should be adopted.
辅助治疗（AT）在远端胆管癌（DC）胰十二指肠切除术（PD）后的作用仍存在争议。本系统评价和荟萃分析旨在评估AT对接受DC切除术患者总生存期（OS）和无病生存期（DFS）的影响。按照PRISMA指南（国际前瞻性系统评价注册库：CRD42024561780）进行系统评价。检索了PubMed、Scopus、Web of Science和Cochrane数据库中2000年1月至2023年8月发表的研究。符合条件的研究包括接受DC的PD患者，将AT与单纯随访（FUP）进行比较。主要终点为OS和DFS，使用风险比（HR）及95%置信区间（CI）进行分析。Meta回归探讨了异质性的潜在来源。分析纳入了22项研究，共7078例患者（FUP组3860例，AT组3218例）：在这些研究中，只有3项（13.6%）为随机对照试验（RCTs）（即使其中没有一项是专门针对DC设计的）。与FUP相比，AT显著改善了OS（HR 0.80；95% CI 0.73 - 0.89；p < 0.001）和DFS（HR 0.84；95% CI 0.74 - 0.96；p = 0.023）。亚组分析显示，与单纯化疗（OS HR 0.78；95% CI 0.64 - 0.94）相比，放化疗（OS HR 0.81；95% CI 0.72 - 0.91）的获益更大。纳入研究中存在高度异质性（I = 98%）。本荟萃分析表明，AT与接受DC的PD患者生存结局改善相关。然而，现有文献存在显著局限性，尤其是缺乏专门针对DC设计的RCTs，因此需要谨慎，特别是在应采用何种化疗方案方面。
