NEW YORK (Reuters Health) – Sorafenib improves survival and disease control consistently in patients with advanced hepatocellular carcinoma (HCC) of different etiologies, according to a new report.
“The data from the study demonstrate the safety of sorafenib for all types of patients with liver cancer,” lead author Dr. Jordi Bruix, of the University of Barcelona in Spain, told Reuters Health by email.
The study, published online June 19 in the Journal of Hepatology, was funded by Onyx Pharmaceuticals and Bayer Healthcare, which markets sorafenib.
Dr. Bruix and colleagues note that the Sorafenib Hepatocellular Carcinoma Assessment Randomized Protocol (SHARP) trial showed that in patients with well-preserved liver function and advanced disease, the drug improves overall survival and is safe. An Asia-Pacific trial confirmed those findings.
However, the researchers note, “Because HCC is a heterogeneous disease, baseline patient characteristics may affect individual responses to treatment.”
To determine if this might be the case in the SHARP trial, the researchers examined data on the 602 participants, who had been randomized to sorafenib or placebo. The hazard ratio for improved median overall survival was 0.69 with sorafenib.
When analyzed according to disease etiology, tumor burden, performance status, tumor stage, and prior therapy, the overall survival findings were similar to those in the complete cohort.
The hazard ratio ranged from 0.50 in patients positive for anti-hepatitis C virus antibody to 0.85 in those with extrahepatic spread. Eight out of 15 comparisons achieved statistical significance.
Sorafenib also consistently improved median time to progression (HR, 0.40 to 0.64), except in patients positive for hepatitis B virus (HBV) (HR, 1.03). The disease control rate was consistently improved as well.
The most common grade 3 and 4 adverse events included diarrhea and fatigue and did not differ appreciably among subgroups
The researchers note that the results are limited by small patient numbers in some subgroups. For example, there were only 60 HBV-positive patients.
Nevertheless, they conclude that “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.”
“All together,” added Dr. Bruix, “the information provided by the SHARP trial and the Asian-Pacific trial with sorafenib has represented a major breakthrough for patients diagnosed with this disease.”
J Hepatol 2012.