Department of General Surgery (Hepatobiliary Surgery), The Affiliated Hospital of Southwest Medical University, Sichuan Province, Luzhou City, China.
School of Pharmacy, Southwest Medical University, Sichuan Province, Luzhou City, China.
Invest New Drugs. 2022 Oct;40(5):1146-1152. doi: 10.1007/s10637-022-01261-3. Epub 2022 Jun 20.
Patients with hepatocellular carcinoma (HCC) outside Milan criteria (MC) may be candidates for curative therapy after successful downstaging. We aimed to identify the predictors of successful downstaging of unresectable HCC in patient by transarterial chemoembolization (TACE) outside MC. We performed a retrospective study on patients with unresectable HCC outside MC who received downstaging with TACE. Clinical and laboratory variables were recorded. We identified 101 patients with unresectable HCC who underwent initial TACE, who formed the derivation set of this study. Thirty patients who treated by TACE with the same selection criteria served as an external validation set. We performed univariate and multivariate logistic regression analyses to identify variables associated with successful downstaging. Then we did the predictive model to predict the efficiency of TACE. Of the 101 patients in the study, 26 patients (25.7%) were successfully downstaging and 75 patients (74.3%) failed downstaging. Multivariate analysis of factors to predict successful downstaging of HCC outside MC the number of tumor (P = 0.01), portal vein tumor thrombosis (PVTT)(p < 0.01), the size of tumor (P = 0.02), hepatitis B surface antigen (HBsAg) (P = 0.01), α-fetoprotein (AFP) (P = 0.02) as significant predictors of successful downstaging. Then we constructed the predictive model. The area under the ROC curve (AUROC) of the predictive equation was 0.90 (95% confidence interval, 0.83-0.95). We found in our study that the number and size of tumors, PVTT, HBsAg, and AFP are good predictors of successful downstaging of unresectable HCC in patients by TACE outside the MC.
不符合米兰标准（MC）的肝细胞癌（HCC）患者在成功降期后可能有机会接受治愈性治疗。我们旨在确定经动脉化疗栓塞（TACE）治疗不符合 MC 的不可切除 HCC 患者成功降期的预测因素。我们对接受 TACE 降期治疗的不符合 MC 的不可切除 HCC 患者进行了回顾性研究。记录了临床和实验室变量。我们确定了 101 名接受初始 TACE 治疗的不符合 MC 的不可切除 HCC 患者，他们构成了本研究的推导集。30 名接受相同选择标准的 TACE 治疗的患者作为外部验证集。我们进行了单变量和多变量逻辑回归分析，以确定与成功降期相关的变量。然后，我们建立了预测模型来预测 TACE 的效率。在研究中的 101 名患者中，有 26 名（25.7%）患者成功降期，75 名（74.3%）患者降期失败。多变量分析预测不符合 MC 的 HCC 患者 TACE 成功降期的因素有肿瘤数量（P=0.01）、门静脉癌栓（PVTT）（p<0.01）、肿瘤大小（P=0.02）、乙型肝炎表面抗原（HBsAg）（P=0.01）、甲胎蛋白（AFP）（P=0.02）。这些是成功降期的显著预测因素。然后我们构建了预测模型。预测方程的 ROC 曲线下面积（AUROC）为 0.90（95%置信区间，0.83-0.95）。我们在研究中发现，肿瘤的数量和大小、PVTT、HBsAg 和 AFP 是 TACE 治疗不符合 MC 的不可切除 HCC 患者成功降期的良好预测因素。
