Dataset related to article "Immunotherapy in Hepatocellular Cancer Patients with Mild to Severe Liver Dysfunction: Adjunctive Role of the ALBI Grade"

This report contains raw data related to article "<em>Immunotherapy in Hepatocellular Cancer Patients with Mild to Severe Liver Dysfunction: Adjunctive Role of the ALBI Grade".</em> Immune checkpoint inhibitors (ICI) have shown positive results in patients with hepatocellular carcinoma (HCC). As liver function contributes to prognosis, its precise assessment is necessary for the safe prescribing and clinical development of ICI in HCC. We tested the accuracy of the albumin-bilirubin (ALBI) grade as an alternative prognostic biomarker to the Child-Turcotte-Pugh (CTP). In a prospectively maintained multi-centre dataset of HCC patients, we assessed safety and efficacy of ICI across varying levels of liver dysfunction described by CTP (A to C) and ALBI grade and evaluated uni- and multi-variable predictors of overall (OS) and post-immunotherapy survival (PIOS). We studied 341 patients treated with programmed-death pathway inhibitors (<em>n</em> = 290, 85%). Pre-treatment ALBI independently predicted for OS, with median OS of 22.5, 9.6, and 4.6 months across grades (<em>p</em> &lt; 0.001). ALBI was superior to CTP in predicting 90-days mortality with area under the curve values of 0.65 (95% CI 0.57-0.74) versus 0.63 (95% CI 0.54-0.72). ALBI grade at ICI cessation independently predicted for PIOS (<em>p</em> &lt; 0.001). Following adjustment for ICI regimen, neither ALBI nor CTP predicted for overall response rates or treatment-emerging adverse events (<em>p</em> &gt; 0.05). ALBI grade identifies a subset of patients with prolonged survival prior to and after ICI therapy, lending itself as an optimal stratifying biomarker to optimise sequencing of systemic therapies in advanced HCC.本报告包含与论文<em>《伴轻至重度肝功能不全的肝细胞癌患者的免疫治疗：ALBI分级的辅助应用价值》</em>相关的原始数据。免疫检查点抑制剂（Immune checkpoint inhibitors, ICI）在肝细胞癌（hepatocellular carcinoma, HCC）患者中已展现出积极临床疗效。鉴于肝功能状态与预后密切相关，精准评估肝功能对于肝细胞癌患者安全使用免疫检查点抑制剂及开展相关临床研发工作至关重要。本研究旨在验证白蛋白-胆红素（albumin-bilirubin, ALBI）分级作为Child-Turcotte-Pugh（CTP）评分替代预后生物标志物的准确性。我们基于一项前瞻性维护的多中心肝细胞癌患者数据集，针对Child-Turcotte-Pugh评分（A至C级）及ALBI分级所划分的不同肝功能不全程度，评估了免疫检查点抑制剂治疗的安全性与有效性，并分析了总生存期（overall survival, OS）及免疫治疗后生存期（post-immunotherapy survival, PIOS）的单变量与多变量预测因素。本研究共纳入341例接受程序性死亡通路抑制剂治疗的患者（n=290，占比85%）。治疗前ALBI分级可独立预测总生存期，不同分级患者的中位总生存期分别为22.5个月、9.6个月及4.6个月（p < 0.001）。在预测90天死亡率方面，ALBI分级的曲线下面积（area under the curve, AUC）为0.65（95%置信区间：0.57-0.74），优于CTP评分的0.63（95%置信区间：0.54-0.72）。免疫检查点抑制剂停药时的ALBI分级可独立预测免疫治疗后生存期（p < 0.001）。在校正免疫检查点抑制剂治疗方案后，ALBI分级与CTP评分均无法预测总体应答率或治疗相关不良事件（p > 0.05）。综上，ALBI分级可识别出免疫治疗前后生存期更长的患者亚群，可作为最优分层生物标志物，用于优化晚期肝细胞癌患者全身治疗的序贯方案。