According to a new study published in the Journal of Clinical Oncology, researchers have found that the addition of erlotinib to sorafenib does not improve survival in patients with advanced hepatocellular carcinoma.
For the international, double-blind, placebo-controlled phase 3 study, researchers sought to determine whether adding erlotinib to sorafenib would improve clinical outcomes for patients with advanced hepatocellular carcinoma.
Researchers enrolled 720 patients with advanced hepatocellular carcinoma and underlying Child-Pugh class A liver cirrhosis and randomly assigned them to receive sorafenib plus either placebo or erlotinib. All patients had not received systemic treatment prior to the study.
Results showed that the median overall survivals were similar across both arms (9.5 months in the sorafenib plus erlotinib group versus 8.5 months in the sorafenib plus placebo group; HR = 0.929; P = 0.408). The median time to progression was also similar in both arms (3.2 months versus 4.0 months; HR = 1.135; P = 0.18).
The overall response rate was slightly higher in the sorafenib plus erlotinib arm (P = 0.102), but the disease control rate was significantly lower in that arm (P = 0.021). In regard to safety, adverse events were similar in both arms.
The authors aimed to compare the clinical outcomes of sorafenib plus either erlotinib or placebo in patients with advanced hepatocellular carcinoma (HCC) in a multicenter, multinational, randomized, phase III trial. Adding erlotinib to sorafenib did not improve survival in patients with advanced HCC.