Prosperi Enrico, Cescon Matteo, Lai Quirino, Bonatti Chiara, Prosperi Edoardo, Rizzo Francesca, Maroni Lorenzo, Laurenzi Andrea, Serenari Matteo, Morelli Maria Cristina, Ravaioli Matteo
Hepatobiliary and Transplant Surgery Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, 40138 Bologna, Italy.
Department of Medical and Surgical Sciences (DIMEC), University of Bologna, 40126 Bologna, Italy.
Cancers (Basel). 2025 May 21;17(10):1720. doi: 10.3390/cancers17101720.
The Italian Score for Organ Allocation (ISO), a transplant benefit oriented allocation system, was introduced in Italy in 2016. The main objective of this study is to identify risk factors for Drop-Out in hepatocellular (HCC) patients enlisted for LT before (Pre-ISO Era) and after ISO (ISO Era) introduction, while the secondary objective is to evaluate the survival results.
CIFs for liver transplantation and Drop-Out were estimated and compared between eras. Factors associated with Drop-Out were identified through multivariable competing risks regression. Survival results were compared using the log-rank test.
Between 2011 and 2020, 410 patients with HCC were listed for LT. We observed 103 vs. 217 LT and 49 vs. 41 Drop-Outs ( < 0.001) during the Pre-ISO and ISO Era, respectively. In the multivariable analysis, ISO ([sHR] 0.43; 95%CI 0.28-0.66, < 0.001) and Alcoholic Cirrhosis ([sHR] 0.27, 95%CI 0.11-0.70; = 0.007) were revealed to be protective factors for Drop-Out. One year after listing, the CI for Drop-Out decreased from 13.2% to 6.2% ( = 0.02). Despite no differences observed in post-LT survival, a significant difference in the intention-to-treat survival from enlisting was found ( = 0.0019).
Among other factors, ISO results were protective for the Drop-Out risk in HCC patients awaiting LT, with a benefit in ITT-OS survival.
意大利器官分配评分系统（ISO）是一种以移植获益为导向的分配系统，于2016年在意大利引入。本研究的主要目的是确定在引入ISO之前（ISO前时代）和之后（ISO时代）登记接受肝移植（LT）的肝细胞癌（HCC）患者退出的风险因素，次要目的是评估生存结果。
估计并比较不同时代肝移植和退出的累积发生率函数（CIFs）。通过多变量竞争风险回归确定与退出相关的因素。使用对数秩检验比较生存结果。
2011年至2020年期间，410例HCC患者登记接受LT。在ISO前时代和ISO时代，我们分别观察到103例和217例LT以及49例和41例退出（<0.001）。在多变量分析中，ISO（[sHR]0.43；95%CI 0.28 - 0.66，<0.001）和酒精性肝硬化（[sHR]0.27，95%CI 0.11 - 0.70；=0.007）被发现是退出的保护因素。登记后一年，退出的CI从13.2%降至6.2%（=0.02）。尽管LT后生存无差异，但从登记开始的意向性治疗生存存在显著差异（=0.0019）。
在其他因素中，ISO结果对等待LT的HCC患者的退出风险具有保护作用，在意向性治疗总生存方面有获益。
