Supplementary Material for: Reassessing Hepatocellular Carcinoma Staging in a Changing Patient Population

<b><i>Objective:</i></b> Hepatocellular carcinoma (HCC) staging systems were developed using data predominantly from patients who had hepatitis and cirrhosis. Given the recent change in prevalence of viral hepatitis and cirrhosis at oncology centers, which has altered the natural history of HCC, we aimed at comparing the accuracy of HCC staging systems in patients with or without hepatitis and cirrhosis. <b><i>Methods:</i></b> A total of 438 patients were enrolled. Baseline clinicopathologic parameters, Barcelona Clinic Liver Cancer stage, Cancer of the Liver Italian Program score, TNM (6th edition) stage, Okuda stage, and Chinese University Prognostic Index score were prospectively obtained for all patients, and retrospectively analyzed. Kaplan-Meier analysis was used to determine overall survival (OS), Cox regression analyses were performed, and Harrell's Correspondence Index compared the staging systems' ability to predict OS duration. Subgroup analyses of patients with or without hepatitis or cirrhosis were performed. <b><i>Results:</i></b> Median patient OS was 13.9 months; 165 patients (37.7%) had no cirrhosis and 256 patients (58.4%) had no hepatitis. Overall, all staging systems were significantly less predictive of OS in patients who did not have cirrhosis or hepatitis. <b><i>Conclusion:</i></b> Our results advocate the need to further stratify HCC based on cirrhosis and hepatitis status, which may change patient risk-stratification and, ultimately, treatment decisions.

研究目的：肝细胞癌（Hepatocellular carcinoma）分期系统多基于合并病毒性肝炎与肝硬化的患者数据构建而成。鉴于近年来肿瘤中心内病毒性肝炎与肝硬化的流行态势发生变化，进而改变了肝细胞癌的自然病程，本研究旨在对比各类肝细胞癌分期系统在合并与未合并肝炎、肝硬化的患者中的预测准确性。研究方法：本研究共纳入438例患者。收集所有患者的基线临床病理参数、巴塞罗那临床肝癌分期、意大利肝癌项目评分、TNM分期（第6版）、奥田分期以及中国大学预后指数（Chinese University Prognostic Index）评分，所有数据均通过前瞻性方式采集并进行回顾性分析。采用Kaplan-Meier分析法计算总生存期（OS），开展Cox回归分析，并通过哈雷尔对应指数（Harrell's Correspondence Index）对比各分期系统预测OS时长的能力。此外，针对合并与未合并肝炎、肝硬化的患者亚组开展了分析。研究结果：所有患者的中位OS为13.9个月，其中165例（37.7%）无肝硬化，256例（58.4%）无肝炎。总体而言，在未合并肝硬化或肝炎的患者中，所有分期系统对OS的预测准确性均显著下降。研究结论：本研究结果提示，需基于肝硬化与肝炎状态对肝细胞癌进行进一步分层，这或将改变患者的风险分层策略，并最终影响临床治疗决策。