Stocco Alberto, Laurenzi Andrea, Serenari Matteo, Prosperi Enrico, Fallani Guido, Bonatti Chiara, Radi Giorgia, Prior Margherita, Odaldi Federica, Zanfi Chiara, Mirici Cappa Federica, Siniscalchi Antonio, Morelli Maria Cristina, Ravaioli Matteo, Cescon Matteo
Hepatobiliary and Transplant Surgery Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Via Massarenti, 9, 40138 Bologna, Italy.
Department of Medical and Surgical Sciences (DIMEC), University of Bologna, 40138 Bologna, Italy.
Cancers (Basel). 2025 Jun 19;17(12):2046. doi: 10.3390/cancers17122046.
Colorectal liver metastases (CRLM) occur in up to 50% of colorectal cancer with a significant impact on patient survival, of whom only 20-30% will be considered suitable for surgical treatment. Despite the progress in systemic therapies, palliative chemotherapy alone results in a 5-year overall survival (OS) < 10%. Recently, liver transplantation (LT) has been reconsidered as an option and demonstrates improved survival in highly selected patients. This study assessed the impact of implementing a standardised patient selection protocol (LITORALE) on post-transplant outcomes for unresectable CRLM (uCRLM) at a high-volume single centre. Methods: This is a prospective observational study including all consecutive patients transplanted for uCRLM at our institution between July 2015 and September 2024. This prospective observational study evaluated the impact of the LITORALE protocol on post-transplant outcomes in uCRLM patients at a single centre. Patients who underwent LT between July 2015 and September 2024 were grouped into pre-LITORALE (2015-2021) and LITORALE (post-2021) cohorts. Recipient profiles, transplant variables, and post-transplant outcomes were compared. : Twenty-one patients were included (eight pre-LITORALE, thirteen LITORALE). The LITORALE group had a lower median number of lesions (4 vs. 17.5, = 0.004), a smaller major lesion size (3 cm vs. 5.5 cm, = 0.082), and a significantly lower tumour burden score (6.32 vs. 18.02, = 0.002). Similar to recent major clinical trials, one- and three-years OS were 100% and 83%, respectively, after protocol introduction; recurrence patterns were significantly different, with reduced multi-site recurrences (7.7% vs. 50%, = 0.048) and a higher incidence of lung-only recurrences in the LITORALE group (50% vs. 0%, = 0.033). : The introduction of the LITORALE protocol significantly influenced patient selection and recurrence patterns in LT for uCRLM. Although the limited number of patients and the short study timespan highlight the need for future validation, these preliminary results support the adoption of structured, multidisciplinary criteria to optimise oncologic outcomes.
结直肠癌肝转移（CRLM）在高达50%的结直肠癌患者中出现，对患者生存有重大影响，其中只有20%-30%的患者会被认为适合手术治疗。尽管全身治疗取得了进展，但单纯姑息化疗导致的5年总生存率（OS）<10%。最近，肝移植（LT）已被重新视为一种选择，并在经过严格筛选的患者中显示出生存改善。本研究评估了在一个高容量单中心实施标准化患者选择方案（LITORALE）对不可切除CRLM（uCRLM）患者移植后结局的影响。方法：这是一项前瞻性观察性研究，纳入了2015年7月至2024年9月期间在我们机构接受uCRLM移植的所有连续患者。这项前瞻性观察性研究评估了LITORALE方案对单中心uCRLM患者移植后结局的影响。2015年7月至2024年9月期间接受LT的患者被分为LITORALE方案实施前（2015-2021年）和LITORALE方案实施后（2021年后）队列。比较了受者特征、移植变量和移植后结局。结果：共纳入21例患者（8例LITORALE方案实施前患者，13例LITORALE方案实施后患者）。LITORALE方案实施后组的病变中位数较少（4个 vs. 17.5个，P = 0.004），主要病变尺寸较小（3 cm vs. 5.5 cm，P = 0.082），肿瘤负荷评分显著较低（6.32 vs. 18.02，P = 0.002）。与近期的主要临床试验相似，方案引入后1年和3年的OS分别为100%和83%；复发模式有显著差异，LITORALE方案实施后组的多部位复发减少（7.7% vs. 50%，P = 0.048），仅肺部复发的发生率较高（50% vs. 0%，P = 0.033）。结论：LITORALE方案的引入显著影响了uCRLM患者LT的患者选择和复发模式。尽管患者数量有限且研究时间跨度较短，突出了未来验证的必要性，但这些初步结果支持采用结构化的多学科标准来优化肿瘤学结局。
