Abstract
BACKGROUND: Prediction of the life expectancy of a patient with unresectable hepatocellular carcinoma (HCC) remains difficult. The aims of the study were to construct a new staging scheme for patients with unresectable HCC and to compare the discriminatory ability of the staging scheme with the Okuda and CLIP score and TNM staging system in a cohort of patients with unresectable HCC. METHODS: A retrospective analysis of unresectable HCC cases from 1999 to 2003 was performed. The Cox model was used for multivariate analyses. The final model was derived from 10 randomly chosen training samples and the prognostic validity of the new staging scheme was assessed on the corresponding testing samples. Moreover, 54 cases with unresectable HCC were enrolled and prospectively followed up. The new staging, named the China integrated score (CIS), Okuda, TNM and CLIP systems were determined for each case. Comparisons of the survival rate between each stage were performed to evaluate their discriminatory ability. RESULTS: A simple scoring system was constructed, assigning linear scores (0/1/2) to the three covariates (TNM, alpha-fetoprotein and Child-Pugh) of the final model. The CIS system was more discriminant than the Okuda or TNM staging system, as confirmed by the Kaplan-Meier comparison of survival curves and by the Cox's regression analysis, with a median survival rate of 9.0, 2.3, 2.1 and 0.6 months in patients with CIS 2, 3, 4 and 5, respectively. The CIS system was performed as well as the CLIP score. CONCLUSION: The new staging system, accounting for both liver function and tumor characteristics, can accurately identify patients with different prognoses, particularly in the advanced phases of HCC. It should be useful as the only tool that can be applied for patients with unresectable HCC.