Division of Gastroenterology/Hepatology, Department of Medicine, University of California San Francisco, San Francisco, California.
Division of Gastroenterology, Department of Medicine, University of Southern California, Los Angeles, California; Department of Preventive Medicine, University of Southern California, Los Angeles, California.
Clin Gastroenterol Hepatol. 2023 Jun;21(6):1581-1589. doi: 10.1016/j.cgh.2022.08.023. Epub 2022 Aug 28.
BACKGROUND & AIMS: The United Network for Organ Sharing (UNOS) grants priority listing for liver transplant for patients with hepatocellular carcinoma after successful down-staging to Milan criteria. We evaluated the national experience on down-staging by comparing 2 down-staging groups: tumor burden meeting UNOS down-staging (UNOS-DS) inclusion criteria, and all-comers (AC)-DS with initial tumor burden beyond UNOS-DS criteria vs patients always within Milan criteria.
We performed a retrospective analysis of the UNOS database of 23,398 patients listed for liver transplant who had submitted a hepatocellular carcinoma Model for End-Stage Liver Disease exception application from 2010 to 2019, classified as always within Milan (n = 20,579), UNOS-DS (n = 2151), and AC-DS (n = 668).
The 2-year cumulative probabilities of dropout were 19% for Milan, 25% for UNOS-DS (P < .001), and 30% for AC-DS (P < .001). In multivariate analysis of the down-staging groups, factors predicting dropout included Model for End-Stage Liver Disease at listing (hazard ratio [HR], 1.06; P < .001) and initial total tumor diameter (HR, 1.04; P = .002). Compared with α-fetoprotein (AFP) level ≤20 ng/mL, AFP levels of 21 to 100, 101 to 1000, and greater than 1000 ng/mL were associated with a higher risk of dropout (HRs, 1.63, 2.06, and 4.58, respectively; P < .001). A subset of all-comers with AFP levels greater than 100 ng/mL had a 2-year probability of dropout of 52% vs 26% for all others beyond Milan criteria (P < .001).
All-comers had a significantly higher risk for waitlist dropout compared with the UNOS-DS and Milan groups after initial successful down-staging to Milan criteria. In particular, the subgroup of AC-DS with an AFP level greater than 100 ng/mL had a greater than 50% probability of dropout in the next 2 years. These observations suggest a high likelihood of failure when expanding the indications for down-staging.
美国器官共享联合网络（UNOS）为符合米兰标准的肝癌患者成功降期后，给予其肝移植优先名单。我们通过比较 2 个降期组，评估了全国范围内的降期经验：符合 UNOS 降期（UNOS-DS）纳入标准的肿瘤负担组和所有符合条件者（AC）-DS 初始肿瘤负担超出 UNOS-DS 标准与始终符合米兰标准的患者。
我们对 2010 年至 2019 年向 UNOS 数据库提交肝癌模型终末期肝病例外申请的 23398 名接受肝移植的患者进行了回顾性分析，将患者分为始终符合米兰标准（n=20579）、UNOS-DS（n=2151）和 AC-DS（n=668）。
米兰组 2 年累积 dropout 率为 19%，UNOS-DS 组为 25%（P<0.001），AC-DS 组为 30%（P<0.001）。在降期组的多变量分析中，预测 dropout 的因素包括列入名单时的终末期肝病模型（风险比[HR]，1.06；P<0.001）和初始总肿瘤直径（HR，1.04；P=0.002）。与 AFP 水平≤20ng/mL 相比，AFP 水平为 21 至 100ng/mL、101 至 1000ng/mL 和大于 1000ng/mL 与更高的 dropout 风险相关（HR 分别为 1.63、2.06 和 4.58；P<0.001）。所有符合条件者中 AFP 水平大于 100ng/mL 的亚组在接下来的 2 年中 dropout 的概率为 52%，而超出米兰标准的其他所有符合条件者为 26%（P<0.001）。
在最初成功降期至米兰标准后，与 UNOS-DS 和米兰组相比，所有符合条件者的等待名单 dropout 风险显著增加。特别是 AFP 水平大于 100ng/mL 的 AC-DS 亚组在接下来的 2 年内 dropout 的概率大于 50%。这些观察结果表明，在扩大降期适应证时，失败的可能性很大。
