Safety and toxicity of radioembolization plus Sorafenib in advanced hepatocellular carcinoma: analysis of the European multicentre trial SORAMIC

Background & AimsThe benefits of combined systemic and liver-directed treatments in inoperable intermediate- or advanced-stage hepatocellular carcinoma (HCC) have yet to be defined. This article presents the planned safety analyses for the first 40 patients randomized to radioembolization with yttrium-90 (Y-90) resin microspheres followed by sorafenib (n=20) or sorafenib only (n=20) in the SORAMIC study. MethodsPatients identified for palliative treatment who were poor candidates for transarterial (chemo)embolization (including those failing TACE) with preserved liver function (Child-Pugh B7) and ECOG performance status <2 were screened. Radioembolization was administered using a sequential lobar approach. On day 3 after the last radioembolization procedure, sorafenib 200mg twice daily was initiated escalating to 400mg twice daily 1week later; a matching sorafenib dose schedule was initiated in the control arm. ResultsPatients were followed up for a median of 8.3months. Median total implanted activity of Y-90 was 1.87 (range: 0.54-2.35) GBq. Patients received a similar intensity and duration of sorafenib in the combination-treatment arm (median daily dose 614mg over 8.5months) and control arm (557mg over 9.6months). The incidence of total (196 vs. 222) and grade 3 (43 vs. 47) adverse events was similar in combination-treatment arm and control arm respectively (P>0.05). No significant differences in the number of total or grade 3/4 toxicities were recorded for: total bilirubin, albumin, liver enzymes, ascites, Child-Pugh, fatigue, hand-foot skin reaction, blood pressure or diarrhoea. ConclusionsRadioembolization followed by sorafenib appears to be as well tolerated as sorafenib alone.