Research in context
Evidence before this study
We searched PubMed for articles published between Jan 1, 2000, and Jan 1, 2017, focusing solely on publications of large-scale randomised clinical trials for advanced hepatocellular carcinoma with the search terms “sorafenib” and “selective internal radiation therapy (SIRT)”. We identified three trials confirming the survival gain obtained with sorafenib in hepatocellular carcinoma compared with placebo. No previous large-scale randomised trials with SIRT were identified. Sorafenib is the reference treatment for advanced hepatocellular carcinoma, having increased median overall survival compared with placebo from 8 months to 11 months in the SHARP trial. However, sorafenib has a high level of toxicity (80% of patients had adverse events in the SHARP trial). Overall, the evidence of the effects of SIRT in unresectable hepatocellular carcinoma is from retrospective, non-comparative studies. Across 13 open-label, single-arm studies involving approximately 400 patients with advanced hepatocellular carcinoma, the combined estimate of the median overall survival after SIRT with yttrium-90 microspheres was 15 months (range 7–27). The present study was therefore designed to ascertain whether SIRT could increase median overall survival with fewer side-effects or a better quality of life (QOL), or both, compared with sorafenib.
Added value of this study
In patients with locally advanced or intermediate-stage hepatocellular carcinoma after unsuccessful transarterial chemoembolisation, when compared with sorafenib, SIRT did not improve overall or progression-free survival but it significantly increased tumour response, reduced the incidence of adverse events, and improved QOL.
Implications of all the available evidence
These results suggest that SIRT might be better tolerated than sorafenib in patients with locally advanced or intermediate-stage hepatocellular carcinoma, and these results might lead to changes in the recommended treatment algorithm for these patients.