[Therapeutic decisions in the treatment of hepatocellular carcinoma and patterns of sorafenib use. Results of the international observational GIDEON trial in Spain]. / Decisiones terapéuticas en el tratamiento del carcinoma hepatocelular y patrones de uso de sorafenib. Resultados del estudio internacional observacional GIDEON en España.

INTRODUCTION: GIDEON is a non-interventional, prospective, international study that evaluated the safety of sorafenib in patients with unresectable hepatocellular carcinoma (HCC) in daily clinical practice, including Child-Pugh B patients. OBJECTIVES: To analyze data collected in Spain on the safety and efficacy of sorafenib and treatment patterns. METHODS: Data were collected during follow-up on demographic and disease characteristics, the initial dose used, treatment-emergent adverse events (AEs) and dose modifications. Overall survival was evaluated, as well as time to disease progression. Efficacy and safety were analyzed according to the Child-Pugh classification and the initial dose. RESULTS: We included 143 patients from 19 Spanish hospitals. A total of 24.5% of the patients were Child-Pugh B. An initial dose of 400 mg/12 h was used in 90.9% of patients. In Child-Pugh A patients, dose modifications occurred more frequently and the treatment duration was longer. The incidence of AEs and drug-related AEs were similar in Child-Pugh A and B patients, although serious AEs were more frequent in Child-Pugh B patients. The most common AEs were diarrhea, fatigue and hand-foot skin reactions. The median overall survival was 384 days and was higher in Child-Pugh A patients (593 vs. 211 days in Child-Pugh B). The median time to disease progression was 177 days, similar in both subgroups. CONCLUSION: The safety profile of sorafenib in Spanish patients with unresectable HCC is independent of liver function. Child-Pugh status does not seem to influence the approach to sorafenib dosage or time to progression but does seem to be a strong prognostic factor for survival.

[Treatment approach of hepatocellular carcinoma in Spain. Analysis of 705 patients from 62 centers]. / Tratamiento del carcinoma hepatocelular en España. Análisis de 705 casos en 62 centros.

BACKGROUND AND OBJECTIVE: Hepatocellular carcinoma (HCC) is the leading cause of death in patients with cirrhosis and its current situation in Spain is not well known. Therefore, a national registry was created to assess the characteristics of patients with de novo HCC. PATIENTS AND METHOD: Between 1/10/2008 and 31/1/2009, 62 centers reported the baseline demographic, clinical and tumor characteristics, the first choice of treatment and eligibility for transplantation (OLT) of HCC diagnosed during this time. RESULTS: There were 705 new cases of HCC, 78% men, mean age 65 years, 89% cirrhosis (58% Child-Pugh class A, 42% HCV, 30% alcohol). Only 334 cases (47%) were diagnosed by screening. The size of the main nodule and BCLC stage were significantly lower in the screening group than in the rest (p<0.001). The applicability of radical therapies (resection and percutaneous ablation) was significantly higher (47.5% versus 24.6%, p<0.001) as well as the evaluation for OLT (31% versus 12%, p<0.001). The screening did not differ according to gender (p=0.204) or age (<50 years, <65, <75, >75 years) (p=0.171). Chemoembolization was the most common treatment: initial tumors (46.4%), tumors >5 cm (15.7%), multifocal HCC (37.9%) and as a bridge to OLT (33%). CONCLUSION: The majority of HCC patients are diagnosed in Spain out of early detection programs, and this limits the chance for early diagnosis and effective therapy.