未经授权:根据LT前成像±甲胎蛋白(AFP)水平选择肝细胞癌(HCC)患者进行肝移植(LT),但LT前肿瘤评估和外植体之间的差异是常见的。我们的目的是设计一个基于外植体的复发风险重新评估评分,以完善LT后复发的预测,并提供一个指导LT后管理的框架。
UNASSIGNED:包括在2000年至2018年期间在47个中心接受HCC移植的成年患者。在欧洲训练队列(TC;n=1,359)中使用竞争风险回归分析开发了复发预测模型,并在拉丁美洲验证队列(VC;n=1,085)中进行了测试。
未经评估:在TC中,76.4%的HCC患者符合米兰标准,89.9%的AFP评分≤2分。复发风险重新评估(R3)-AFP模型是基于与TC复发独立相关的变量(具有相关权重)设计的:≥4个结节(风险比[SHR]的子分布=1.88,1点),最大结节大小(3-6cm:SHR=1.83,1点;>6cm:SHR=5.82,5点),存在微血管侵犯(MVI;SHR=2.69,2分),核等级>II(SHR=1.20,1分),和最后的LT前AFP值(101-1,000ng/ml:SHR=1.57,1分;>1,000ng/ml:SHR=2.83,2分)。沃尔伯的c指数为0.76(95%CI0.72-0.80),显著优于无AFP的R3模型(0.75;95%CI0.72-0.79;p=0.01)。确定了四个5年复发风险类别:非常低(得分=0;5.5%),低(1-2分;15.1%),高(3-6分;39.1%),非常高(>6分;73.9%)。R3-AFP评分在VC中表现良好(Wolber'sc指数为0.78;95%CI0.73-0.83)。
UNASSIGNED:R3分数包括最后的LT前AFP值(R3-AFP分数)提供了一个用户友好的,设计LT后监测策略的标准化框架,协议,或肝癌的辅助治疗试验不限于米兰标准。
未经评估:NCT03775863。
UASSIGNED:考虑到LT肿瘤前评估和外植体之间的差异是常见的,重新评估LT术后复发的风险对于进一步完善HCC患者的治疗至关重要.在接受HCC移植的大型国际患者队列中,我们基于与LT术后复发独立相关的变量设计并验证了R3-AFP模型(结节数,最大结节的大小,MVI的存在,核级,和最后的LT前AFP值)。包括最后可用的LT前AFP值的R3-AFP模型优于仅基于外植体特征的原始R3模型。最终的R3-AFP评分系统提供了一个强大的框架来设计LT后监测策略,协议,或辅助治疗试验,无论用于选择肝癌患者的LT标准如何。
UNASSIGNED: Patients with hepatocellular carcinoma (HCC) are selected for liver transplantation (LT) based on pre-LT imaging ± alpha-foetoprotein (AFP) level, but discrepancies between pre-LT tumour assessment and explant are frequent. Our aim was to design an explant-based recurrence risk reassessment score to refine prediction of recurrence after LT and provide a framework to guide post-LT management.
UNASSIGNED: Adult patients who underwent transplantation between 2000 and 2018 for HCC in 47 centres were included. A prediction model for recurrence was developed using competing-risk regression analysis in a European training cohort (TC; n = 1,359) and tested in a Latin American validation cohort (VC; n=1,085).
UNASSIGNED: In the TC, 76.4% of patients with HCC met the Milan criteria, and 89.9% had an AFP score of ≤2 points. The recurrence risk reassessment (R3)-AFP model was designed based on variables independently associated with recurrence in the TC (with associated weights): ≥4 nodules (sub-distribution of hazard ratio [SHR] = 1.88, 1 point), size of largest nodule (3-6 cm: SHR = 1.83, 1 point; >6 cm: SHR = 5.82, 5 points), presence of microvascular invasion (MVI; SHR = 2.69, 2 points), nuclear grade >II (SHR = 1.20, 1 point), and last pre-LT AFP value (101-1,000 ng/ml: SHR = 1.57, 1 point; >1,000 ng/ml: SHR = 2.83, 2 points). Wolber\'s c-index was 0.76 (95% CI 0.72-0.80), significantly superior to an R3 model without AFP (0.75; 95% CI 0.72-0.79; p = 0.01). Four 5-year recurrence risk categories were identified: very low (score = 0; 5.5%), low (1-2 points; 15.1%), high (3-6 points; 39.1%), and very high (>6 points; 73.9%). The R3-AFP score performed well in the VC (Wolber\'s c-index of 0.78; 95% CI 0.73-0.83).
UNASSIGNED: The R3 score including the last pre-LT AFP value (R3-AFP score) provides a user-friendly, standardised framework to design post-LT surveillance strategies, protocols, or adjuvant therapy trials for HCC not limited to the Milan criteria.
UNASSIGNED: NCT03775863.
UNASSIGNED: Considering discrepancies between pre-LT tumour assessment and explant are frequent, reassessing the risk of recurrence after LT is critical to further refine the management of patients with HCC. In a large and international cohort of patients who underwent transplantation for HCC, we designed and validated the R3-AFP model based on variables independently associated with recurrence post-LT (number of nodules, size of largest nodule, presence of MVI, nuclear grade, and last pre-LT AFP value). The R3-AFP model including last available pre-LT AFP value outperformed the original R3 model only based on explant features. The final R3-AFP scoring system provides a robust framework to design post-LT surveillance strategies, protocols, or adjuvant therapy trials, irrespective of criteria used to select patients with HCC for LT.