Data Sheet 1_Preoperative prognostic model combining tumor burden score and tumor markers to predict long-term outcomes following hepatectomy for intrahepatic cholangiocarcinoma: a multi-institutional analysis.docx

Background and aimIntrahepatic cholangiocarcinoma (ICC) is an aggressive liver malignancy with limited prognostic tools to guide treatment strategies. This study aimed to develop and validate a preoperative prognostic model combining tumor burden score (TBS), carcinoembryonic antigen (CEA), and carbohydrate antigen 19-9 (CA19-9), termed the TCCA model, to predict outcomes in patients with ICC undergoing hepatectomy.
MethodsPatients who underwent curative resection for ICC between 2014 and 2020 were retrospectively identified from a multi-institutional database. The impact of the TCCA model on overall survival (OS) and recurrence-free survival (RFS) was evaluated in training and validation cohorts. Predictive performance was evaluated using the area under the Receiver Operating Characteristic curve (AUC), the Akaike Information Criterion (AIC), and the C-index.
ResultsA total of 849 patients were included. Lower TCCA scores were associated with better median OS (score 0: 59.7 months; score 1: 31.3 months; score 2: 19.4 months; score 3: 11.5 months, respectively) and median RFS (28.8; 15.4; 9.7; 8.1 months, respectively). The TCCA model performed well in both the training cohort (AUC: 0.697 for OS and 0.649 for RFS) and the validation cohort (AUC: 0.672 for OS and 0.632 for RFS), outperforming the 8th edition TNM system and other models, with the highest C-index (0.734) and lowest AIC (3840). Subgroup analyses demonstrated that the TCCA model maintained good discriminative ability among patients with negative CEA or CA19–9 levels.
ConclusionThe TCCA model accurately stratifies ICC patients for OS and RFS after resection. It provides a simple and practical tool for preoperative risk assessment, supporting individualized surgical decision-making and individualized patient counseling.

背景与研究目的：肝内胆管癌（Intrahepatic cholangiocarcinoma, ICC）是一类侵袭性肝脏恶性肿瘤，目前可供指导治疗策略的预后评估手段较为有限。本研究旨在构建并验证一款联合肿瘤负荷评分（tumor burden score, TBS）、癌胚抗原（carcinoembryonic antigen, CEA）以及糖类抗原19-9（carbohydrate antigen 19-9, CA19-9）的术前预后模型，命名为TCCA模型，用于预测接受肝切除术的肝内胆管癌患者的预后结局。

研究方法：本研究从多中心数据库中回顾性筛选2014年至2020年间接受肝内胆管癌根治性切除术的患者。在训练队列与验证队列中评估TCCA模型对总生存期（overall survival, OS）与无复发生存期（recurrence-free survival, RFS）的影响。采用受试者工作特征曲线下面积（area under the Receiver Operating Characteristic curve, AUC）、赤池信息准则（Akaike Information Criterion, AIC）以及C指数对模型的预测性能进行评估。

研究结果：本研究共纳入849例患者。TCCA评分越低，患者的中位总生存期（评分0：59.7个月；评分1：31.3个月；评分2：19.4个月；评分3：11.5个月）与中位无复发生存期（分别为28.8、15.4、9.7、8.1个月）越长。TCCA模型在训练队列（总生存期AUC为0.697，无复发生存期AUC为0.649）与验证队列（总生存期AUC为0.672，无复发生存期AUC为0.632）中均表现优异，其性能优于第8版TNM分期系统及其他模型，拥有最高的C指数（0.734）与最低的赤池信息准则值（3840）。亚组分析显示，在癌胚抗原或糖类抗原19-9水平阴性的患者中，TCCA模型仍保持良好的区分能力。

研究结论：TCCA模型可精准对接受肝切除术的肝内胆管癌患者的总生存期与无复发生存期进行风险分层。该模型操作简便、实用性强，可用于术前风险评估，为个体化手术决策制定以及患者个体化咨询提供依据。