Sorafenib improved OS among patients with hepatocellular carcinoma who were hepatitis C positive but hepatitis B negative, suggesting that the beneficial effects of sorafenib may be based on hepatitis status, according to results of a meta-analysis.
“Irrespective of the mechanism, our data suggest that in future trials in HCC, particularly where sorafenib is the control arm, there should be stratification according to etiology,” Richard Jackson, BSc, MSc, from the Liverpool Cancer Trials Unit of University of Liverpool in United Kingdom, and colleagues wrote. “Etiological differences have already been considered as factors in the interpretation of clinical trials.”
The analysis included 3,256 patients with HCC treated in three randomized phase 3 clinical trials that compared sorafenib (Nexavar, Bayer) with brivanib (BMS-540215, Bristol-Myers Squibb; n = 1,155), sunitinib (Sutent, Pfizer; n = 1,070) or linifanib (ABT-869, Abbott; n = 1,031).
HealthDay News — For patients with advanced unresectable hepatocellular carcinoma, the effect of sorafenib on overall survival (OS) is dependent on patients’ hepatitis status, according to a meta-analysis published online in the Journal of Clinical Oncology.
Richard Jackson, from the Liverpool Cancer Trials Unit in the United Kingdom, and colleagues undertook an individual patient data meta-analysis of three prospective randomized trials in which sorafenib was the control arm. Data were included for 1,643 patients with advanced unresectable hepatocellular carcinoma who received sorafenib.
The researchers found that patients who were both hepatitis B virus (HBV) negative and hepatitis C virus (HCV) positive had improved OS for sorafenib (log [hazard ratio], −0.27). In this subgroup, the median unadjusted survival was 12.6 and 10.2 months for sorafenib and other treatments, respectively. Other patient subgroups defined by HBV and HCV did not have improvement in OS. Consistent results were seen across all trials.