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Higher levels of hepatocytes positive for pERK immunostaining and greater microvascular invasion have emerged as independent prognostic factors of recurrence in patients following sorafenib (Nexavar) treatment for hepatocellular carcinoma (HCC), researchers reported at the 2017 International Liver Congress in Amsterdam. “The is an unmet need for adjuvant treatment for HCC since HCC recurrence after resection or ablation occurs in 70% of patients within 5 years,” said Roser Pinyol, PhD, a senior post-doctoral fellow, Liver Cancer Translational Research Laboratory, BCLC-IDIBAPS, Liver Unit, Universitat de Barcelona.
The analysis was based on data from the phase III randomized STORM trial that compared adjuvant sorafenib to placebo in patients who had undergone surgical resection or local ablation with curative intent and had an intermediate or high risk of recurrence. The STORM trial randomized 1114 patients to sorafenib or placebo; however, no differences in recurrence-free survival (RFS; P = .26), time to recurrence (TTR; P = .12), or overall survival (OS; P = .48) between treatment arms were observed.
“We conducted BIOSTORM, a biomarker companion study using the STORM study population, to identify biomarkers that independently associated with HCC recurrence and also to identify predictors of recurrence prevention following sorafenib treatment of HCC,” explained Pinyol.
BIOSTORM included samples obtained from HCC patients after resection; of these, 83 patients were on sorafenib and 105 received placebo. Recurrence occurred in 70 cases.