Multicenter phase 3 trial of first-line sorafenib versus stereotactic body radiotherapy and sorafenib for locally advanced hepatocellular carcinoma

Most patients with locally advanced hepatocellular carcinoma (LA HCC) recur within the liver following systemic therapy. The NRG Oncology/RTOG 1112 phase 3 trial, at 23 centers in Australia, Canada, Hong Kong and the United States, randomized patients with LA HCC (75% with macrovascular invasion) to stereotactic body radiation therapy followed by sorafenib or sorafenib alone. The trial found that the use of SBRT prior to sorafenib was associated with clinically important but not statistically improved overall survival (median 15.8 months versus 12.3 months; HR 0.77; p=0.06) and statistically significant improved progression-free survival (9.2 months versus 5.5 months; HR 0.55; p<0.001). Treatment-related grade 3 or higher adverse events were seen in 47% of patients in the SBRT-sorafenib group and 42% of patients in the sorafenib alone group. The authors conclude that SBRT should be considered for selected patients with LA HCC (visual abstract).