Patients with hepatocellular carcinomas had higher survival and disease control rates when treated with sorafenib compared with placebo, regardless of pretreatment disease characteristics, in a recent study.
Researchers performed subgroup analyses on 602 participants in the Sorafenib Hepatocellular Carcinoma Assessment Randomized Protocol trial. These patients randomly received 400 mg sorafenib (n=299) or placebo (n=303) twice daily, and analysis was conducted to determine whether patients’ baseline characteristics influenced drug efficacy and safety or survival rates.
Patients were split into subgroups based on disease etiology, tumor burden and stage, performance status and previous treatment, and then further divided into subsets. Survival rates were greater among treated patients compared with placebo patients, with HRs ranging from 0.50 to 0.85 (95% CI for all) across all subsets, compared with an HR of 0.69 (95% CI, 0.55-0.87) for the entire cohort. Median time to progression also was likely to be higher among treated patients (HR range 0.40-0.64 across all subsets), excluding those who tested positive for HBsAg antigen (HR=1.03) (95% CI for all). Among all subgroups, sorafenib improved disease control rates, including treated patients (34.4%-54.4%) compared with placebo patients (26.0%-43.1%).
The incidence rate of adverse events, which did not differ significantly, included diarrhea, hand-foot skin reaction and fatigue. Treatment-related events occurred in 71.9% to 84.9% in subgroups of sorafenib patients and 43.2% to 60.7% of those receiving placebo. Serious events occurred in 9.4% to 14.6% of treated patients and 5% to 25% of placebo patients.
“The efficacy and safety of sorafenib, relative to placebo, in patients with advanced HCC and well-preserved liver function do not appear to be affected by baseline health status, disease etiology, tumor burden, tumor stage or prior therapy,” the researchers concluded.
Disclosure: See the study for a full list of relevant disclosures.