To analyze safety and efficacy of patterns of sorafenib and TACE therapy under real-life clinical practice conditions. A total of 338 Chinese patients with unresectable hepatocellular carcinoma (HCC) from the international database of the GIDEON non-interventional trial were included in this analysis. Endpoints were overall survival (OS), progression-free survival (PFS), time to progression (TTP) and safety. Two major patterns in the use of sorafenib observed in current Chinese clinical practice were: sorafenib administration subsequent to transarterial chemoembolization (TACE) treatment (n = 226, 66.9%) and sorafenib administration concomitant to TACE (n = 80, 35.4%). Patients receiving TACE prior to sorafenib had worse liver function (43.8% BCLC stage Cat diagnosis and 62.1% BCLC stage C at study entry) than those receiving TACE concomitant to sorefenib (35.0% BCLC stage C at diagnosis and 51.3% BCLC stage three at study entry). For patients undergoing prior TACE and concomitant TACE treatment, median OS time was 354 days vs. 608 days, PFS time was 168 days vs. 201 days, and TTP was 214 days vs. 205 days; and the percentage of patients who experienced drug-related adverse effects after sorafenib therapy in these two groups were 33.3 and 50.0%, respectively. Sorafenib treatment is usually administered in cases of tumor progression or poor liver function status after TACE treatment in China. Under such conditions, patients still gained a relatively satisfactory survival outcome. In addition, the present study suggests that concomitant sorafenib and TACE treatments may lead to a better prognosis, although differences in baseline characteristics may have contributed in part to the better outcomes.
Keywords: Advanced; Hepatocellular carcinoma; Observational studies; Sorafenib; Survival, neoplasm staging; TACE, transarterial chemoembolization; Unresectable.