Validation and modification of a proposed substaging system for patients with intermediate hepatocellular carcinoma

Background and Aim Based on up‐to‐seven criteria and C hild‐ P ugh score, four substages of B arcelona C linic L iver C ancer ( BCLC ) intermediate hepatocellular carcinoma ( HCC ) were proposed. The purpose of this study was to validate and modify this proposal. Methods Between J anuary 2002 and F ebruary 2011, newly diagnosed intermediate HCC patients underwent transarterial embolization ( TAE ) were enrolled. Patients were stratified into four ( B 1– B 4) substages and followed up until death or end of 2012. Patients' survivals and discriminatory ability of substaging systems were compared. Results Five‐hundred and eighty patients were enrolled. There were 56.6%, 33.8%, 7.4%, and 2.2% in substage B 1, B 2, B 3, and B 4. The 5‐year survival rate was 21.4%, 13.9%, 7.4%, and 7.7% with median survival time of 2.4, 1.3, 0.5, and 0.8 years ( P  < 0.001). In addition to substage B 1– B 4, α‐fetoprotein ( AFP ) level was an independent factor associated with survival in multivariate analysis. According to AFP < or > 200 ng/mL, B 1 was classified into B 1a and B 1b, and B 2 into B 2a and B 2b. There were no differences in survivals between B 1b and B 2a ( P  = 0.174), and B 2b and B 3 ( P  = 0.785). Patients were re‐classified into modified (m) B 1 ( B 1a), mB2 ( B 1b +  B 2a), m B 3 ( B 2b +  B 3). The modified substages (m B 1–m B 3) showed a more desirable substaging system. Conclusions For BCLC intermediate HCC patients, substages B 1– B 4 were useful in predicting survival after TAE . However, modified substaging system provided better prognostic prediction.