Abstract
Background and Aims In this pilot study, we assessed the safety and tolerability of combining sorafenib with Y-90 radioembolization for the treatment of unresectable hepatocellular carcinoma (HCC).
Methods The study, conducted prospectively during 2009-2012, included eligible patients with unresectable HCC and a life expectancy of at least 12 weeks. Each patient received sorafenib (400 mg twice daily) for 6-8 weeks before Y-90 treatment. Safety and tolerability were assessed.
Results Of the 40 patients enrolled, 29 completed treatment (combined therapy). In the initial cohort, the most common cause of HCC was hepatitis C (32.5%), and most patients were staged Child A (82.5%). The 29 patients who completed the study had similar baseline characteristics. Grades 1 and 2 toxicities accounted for 77.8% of all adverse events reported. The most common toxicities reported were fatigue (19.0%), alteration in liver function (7.9%), and diarrhea (6.3%). There were 12 grade 3 and 2 grade 4 toxicity events reported. One patient died of liver failure within 30 days after treatment. During the study, the sorafenib dose was reduced in 6 patients (20.7%), and sorafenib had to be interrupted in 4 patients (13.8%) and discontinued in 4 patients (13.8%). The disease control rate was 72.4% per the modified Response Evaluation Criteria in Solid Tumors, and tumour necrosis was observed in 82.8% of patients. Overall survival in patients undergoing combined therapy was 12.4 months.
Conclusions Preliminary results demonstrate the safety and tolerability of combining Y-90 radioembolization and sorafenib for advanced HCC. A larger prospective study is needed to determine the extent of the survival benefit.