Background: Patients with hepatocellular carcinoma (HCC) outside the Milan criteria (MC) may be candidates for curative therapy after successful downstaging. However, there have been no studies that have examined the factors affecting the e cacy of transarterial chemoembolization (TACE) on downstaging. We aimed to identify the predictors of successful downstaging of unresectable HCC in patients by TACE outside the MC.Methods: We performed a retrospective study on patients with unresectable HCC outside the MC who received downstaging with TACE. Clinical and laboratory variables were recorded. We identi ed 101 patients with unresectable HCC who underwent initial TACE, and they formed the derivation set of this study. Thirty patients who received TACE treatment with the same selection criteria served as an external validation set. We performed multivariate logistic regression analyses to identify the variables associated with successful downstaging. Then, we created a predictive model and determined its accuracy in predicting the e ciency of TACE.Results: Of the 101 patients in the study, 26 patients (25.7%) were successfully downstaged. Multivariate analysis was performed on the number of tumors (P=0.018), portal vein tumor thrombi (PVTT) ( 0.001), the size of tumors (P=0.021), hepatitis B surface antigen (HBsAg) (P=0.014), and a-fetoprotein (AFP, P=0.027), which were considered as signi cant predictors of successful downstaging of HCC outside the MC. Then, we constructed the predictive model. The area under the ROC curve (AUROC) for the predictive equation was 0.908 (95% con dence interval, 0.832-0.957).Conclusions: 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.
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