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Purpose Selective internal radiation therapy or radioembolization (RE) shows efficacy in unresectable hepatocellular carcinoma (HCC) limited to the liver. This study compared the safety and efficacy of RE and sorafenib in patients with locally advanced HCC. Patients and Methods SIRveNIB (selective internal radiation therapy v sorafenib), an open-label, investigator-initiated, phase III trial, compared yttrium-90 (90Y) resin microspheres RE with sorafenib 800 mg/d in patients with locally advanced HCC in a two-tailed study designed for superiority/detriment. Patients were randomly assigned 1:1 and stratified by center and presence of portal vein thrombosis. Primary end point was overall survival (OS). Efficacy analyses were performed in the intention-to-treat population and safety analyses in the treated population. Results A total of 360 patients were randomly assigned (RE, 182; sorafenib, 178) from 11 countries in the Asia-Pacific region. In the RE and sorafenib groups, 28.6% and 9.0%, respectively, failed to receive assigned therapy without significant cross-over to either group. Median OS was 8.8 and 10.0 months with RE and sorafenib, respectively (hazard ratio, 1.1; 95% CI, 0.9 to 1.4; P = .36). A total of 1,468 treatment-emergent adverse events (AEs) were reported (RE, 437; sorafenib, 1,031). Significantly fewer patients in the RE than sorafenib group had grade ≥ 3 AEs (36 of 130 [27.7%]) v 82 of 162 [50.6%]; P < .001). The most common grade ≥ 3 AEs were ascites (five of 130 [3.8%] v four of 162 [2.5%] patients), abdominal pain (three [2.3%] v two [1.2%] patients), anemia (zero v four [2.5%] patients), and radiation hepatitis (two [1.5%] v zero [0%] patients). Fewer patients in the RE group (27 of 130 [20.8%]) than in the sorafenib group (57 of 162 [35.2%]) had serious AEs. Conclusion In patients with locally advanced HCC, OS did not differ significantly between RE and sorafenib. The improved toxicity profile of RE may inform treatment choice in selected patients.

e15102 Background: Yttrium-90 microsphere (Y90) is currently used to treat locally advanced hepatocellular carcinoma (HCC) including those where resection is precluded because of inadequate future remnant liver. Hypertrophy of the contralateral lobe after Y90 treatment has been reported. This study aims to quantify this hypertrophy and identify factors predictive of this response. Methods: Radiological review of patients undergoing Y-90 with treatment delivered via right hepatic artery for advanced HCC between January 2008 – January 2012 was performed. Diagnosis of HCC was by AASLD criteria and patients must have at least one follow-up scan in our institution. Excluded were: tumour in the contralateral lobe, concomitant other treatment for HCC, patients enrolled in clinical trials. Pre- and post-treatment images were reviewed and volumes were measured using 3D software. Statistical analysis was conducted using SPSS version 16.0. Results: During this period 50 patients treated with Y90 for HCC had follow-up imaging at our institution. Of 37 patients with right-sided Y90 treatment, 11 had concomitant left-sided disease treated with TACE and RFA, 7 had follow-up scans of inadequate quality to perform accurate volumetric assessment, 2 had pre-treatment scans performed at another institution which were not accessible for study purposes. Seventeen (17) patients thus fulfilled criteria. Mean and median left-lobe hypertrophy were 34.2% (SD±35.9%) and 31.7% (range -19.0 – 106.5%) respectively at a median of 5 months post-treatment. Univariate analysis identified no specific pre-treatment factor predictive of the degree of left lobe hypertrophy. There were no cases of acute liver failure after administration of SIRT in this study and none of the patients developed disease in the contralateral lobe over the study period. Conclusions: In patients with HCC receiving SIRT to the right lobe via the right hepatic artery, a significant degree of left lobe hypertrophy results. This opens the possibility of the utilisation of SIRT as neoadjuvant therapy for borderline resectable HCC, thus increasing the pool of potentially operable and curable patients.