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Background: The 'Prediction Of Survival in Advanced Sorafenib‐treated HCC' (PROSASH) model addressed the heterogeneous survival of patients with hepatocellular carcinoma (HCC) treated with sorafenib in clinical trials but requires validation in daily clinical practice. This study aimed to validate, compare and optimize this model for survival prediction. Methods: Patients treated with sorafenib for HCC at five tertiary European centres were retrospectively staged according to the PROSASH model. In addition, the optimized PROSASH‐II model was developed using the data of four centres (training set) and tested in an independent dataset. These models for overall survival (OS) were then compared with existing prognostic models. Results: The PROSASH model was validated in 445 patients, showing clear differences between the four risk groups (OS 16.9‐4.6 months). A total of 920 patients (n = 615 in training set, n = 305 in validation set) were available to develop PROSASH‐II. This optimized model incorporated fewer and less subjective parameters: the serum albumin, bilirubin and alpha‐foetoprotein, and macrovascular invasion, extrahepatic spread and largest tumour size on imaging. Both PROSASH and PROSASH‐II showed improved discrimination (C‐index 0.62 and 0.63, respectively) compared with existing prognostic scores (C‐index ≤0.59). Conclusions: In HCC patients treated with sorafenib, individualized prediction of survival and risk group stratification using baseline prognostic and predictive parameters with the PROSASH model was validated. The refined PROSASH‐II model performed at least as good with fewer and more objective parameters. PROSASH‐II can be used as a tool for tailored treatment of HCC in daily practice and to define pre‐planned subgroups for future studies. [ABSTRACT FROM AUTHOR]

Background & Aims: It remains controversial whether the eradication of hepatitis C virus (HCV) by interferon (IFN)‐free anti‐HCV therapy using direct‐acting antivirals (DAAs) suppresses or promotes hepatocellular carcinoma (HCC) development. We investigated the influence of HCV eradication by DAA therapy on HCC development, by observing changes of non‐hypervascular hypointense nodules (NHHNs) by gadolinium‐ethoxybenzyl‐diethylenetriamine pentaacetic acid‐enhanced magnetic resonance imaging (EOB‐MRI). Methods: A total of 401 patients treated with DAA therapy who did not have a history of HCC were enrolled in this prospective cohort study. All patients underwent EOB‐MRI prior to the start of DAA therapy and were followed up periodically after therapy. The progression of NHHNs detected at baseline to typical HCC, as indicated by hypervascularization and the incidence of newly emergent NHHNs, was analyzed. Results: In comparison of patients who achieved sustained virologic response (SVR) with propensity score‐matched patients with persistent HCV infection, there was no difference in the incidence of hypervascularization of NHHNs to typical HCC among patients who had NHHNs at baseline. Among patients who did not have NHHNs at baseline, the incidence of the new emergence of NHHNs did not differ between study patients and propensity score–matched patients with persistent HCV infection. Conclusions: During a 2‐year observation period after SVR, the eradication of HCV by IFN‐free DAA therapy did not suppress or enhance HCC development. (UMIN000017020). See Editorial on Page 446 [ABSTRACT FROM AUTHOR]