Background: The standard therapy in advanced hepatocellular carcinoma (HCC) is sorafenib (SOR), which has the inconvenience of toxicity and discontinuation. Patient selection and the use of early markers are critical for optimizing the potential benefit of SOR. Alpha-fetoprotein (AFP) has an established role in HCC prognosis. The objective was to evaluate whether AFP variation during SOR treatment reflects the lack of progression to SOR and can be used as a prognostic factor. Methods: AFP levels were prospectively analyzed in 114 patients to determine whether the time to progression of AFP (TPA) at 3 months had a prognostic value for survival. Results: Between July 2007 and October 2012, 114 patients were included (mean age 64 years, 97 male, 96 with cirrhosis). Etiology was alcohol 47 (41%) and hepatitis C virus (HCV) 31 (27%). According to the Barcelona Clinic Liver Cancer (BCLC) staging system: A (one case), B (24 cases) and C (89 cases). The Child-Pugh was Class A in 89 cases. The general condition of the patient according to ECOG-PS was 0 in 73 cases. The median duration of treatment was 5 months (3.47 - 6.53, 95% CI). The median overall survival (OS) was 9.23 months. The standard dose was maintained in 26 patients (22.8%). Sixty-seven percent of patients experienced at least one adverse event grade 3-4. The time to progression of AFP lower or higher than 3 months was an independent prognostic factor of OS (univariate and multivariate analysis): 8.10 vs. 18.85 months, P < 0.001. Conclusion: HCC treated with SOR with TPA > 3 months had longer OS, and TPA was an independent prognostic factor.
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