Effect of Sorafenib and Hepatitis Status in Advanced Hepatocellular Carcinoma


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In a meta-analysis reported in the Journal of Clinical Oncology, Jackson et al found that overall survival with sorafenib (Nexavar) in advanced hepatocellular carcinoma was significantly improved vs comparator treatments among patients who were both hepatitis B virus (HBV)-negative and hepatitis C virus (HCV)-positive but not in other viral status subgroups. Philip Johnson, MD, of the University of Liverpool, is the corresponding author of the Journal of Clinical Oncology article.

The individual patient data meta-analysis involved 3,256 patients with advanced unresectable disease from 3 phase III trials in which sorafenib was the control treatment, with 1,643 patients (50%) receiving sorafenib.

Outcome by Viral Subgroup

Hazard ratios (HRs) showed significantly improved overall survival with sorafenib vs other treatment only among the 628 patients who were both HBV-negative and HCV-positive (log HR = –0.26; 95% confidence interval [CI] = –0.46 to –0.04). Median unadjusted overall survival was 12.6 months with sorafenib vs 10.2 months with other treatments in this subgroup.

No significant effect of sorafenib on overall survival was observed among other viral status subgroups; log hazard ratios were –0.11 (95% CI = –0.28 to 0.09) among 689 HBV-negative/HCV-negative patients, 0.05 (95% CI = –0.1 to 0.21) among 1,474 HBV-positive/HCV-negative patients, and –0.11 (95% CI = –0.45 to 0.25) among 72 HBV-positive/HCV-positive patients. Results were consistent across all trials, with no evidence of heterogeneity (P = .362).

The investigators concluded: “There is consistent evidence that the effect of sorafenib on [overall survival] is dependent on patients’ hepatitis status. There is an improved [overall survival] for patients negative for HBV and positive for HCV when treated with sorafenib. There was no evidence of any improvement in [overall survival] attributable to sorafenib for patients positive for HBV and negative for HCV.”

Jackson R, et al: J Clin Oncol. January 3, 2017 (early release online).



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