为了验证无复发生存期（RFS）作为替代终点的价值，在肝胆胰（HBP）手术环境中评估无复发生存期与总生存期（OS）之间的相关性。在HBP手术领域可靠的OS替代终点仍然有限。我们分析了2002年9月至2022年6月接受HBP疾病（986例胰管腺癌[PDAC]，1168例胆道肿瘤[BTC]，1043例肝细胞癌[HCC]和1071例结直肠肝转移[CRLM]）根治手术的患者。我们还对新辅助或辅助治疗的随机对照试验进行了PDAC和BTC替代效应的荟萃分析。RFS与OS之间的相关系数在HCC（ρ=0.67）和CRLM（ρ=0.53）中较低，而在PDAC（ρ=0.80）和BTC（ρ=0.75）中较高。在里程碑分析中，术后5年存活与每个时间点（1、2、3和4年）的复发存在与否之间的一致性比率分别为PDAC和BTC的50％、70％、74％和77％以及54％、67％、73％和78％，两者均在3年时逐渐增加并达到平台期。在荟萃分析中，PDAC和BTC的RFS危险比值和OS危险比值的相关系数分别为ρ=0.88（P<0.001）和ρ=0.87（P<0.001）。三年RFS可以作为PDAC和BTC新辅助或辅助治疗临床试验中可靠的OS替代终点。版权所有©2023 Wolters Kluwer Health，Inc.保留所有权利。

To assess the correlation between recurrence-free survival (RFS) and overall survival (OS) in the hepato-biliary-pancreatic (HBP) surgical setting in order to validate RFS as a surrogate endpoint.Reliable surrogate endpoints for OS are still limited in the field of HBP surgery.We analyzed patients who underwent curative resection for HBP disease (986 patients with pancreatic ductal adenocarcinoma [PDAC], 1168 with biliary tract cancer [BTC], 1043 with hepatocellular carcinoma [HCC], and 1071 with colorectal liver metastasis [CRLM]) from September 2002 to June 2022. We also conducted meta-analyses of randomized controlled trials of neoadjuvant or adjuvant therapy to validate the surrogacy in PDAC and BTC.Correlation coefficients between RFS and OS were low for HCC (ρ = 0.67) and CRLM (ρ = 0.53) but strong for PDAC (ρ = 0.80) and BTC (ρ = 0.75). In a landmark analysis, the concordance rates between survival or death at 5 years postoperatively and the presence or absence of recurrence at each time point (1, 2, 3, and 4 y) were 50%, 70%, 74%, and 77% for PDAC and 54%, 67%, 73%, and 78% for BTC, respectively, both increasing and reaching a plateau at 3 years. In a meta-analysis, the correlation coefficients for the RFS hazard ratio and OS hazard ratio in PDAC and BTC were ρ = 0.88 (P < 0.001) and ρ = 0.87 (P < 0.001), respectively.Three-year RFS can be a reliable surrogate endpoint for OS in clinical trials of neoadjuvant or adjuvant therapy for PDAC and BTC.Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.