This article is more than 5 years old. Information may no longer be current.
Sorafenib increased overall survival in hepatocellular carcinoma
Click Here to Manage Email Alerts
Compared with placebo, sorafenib may increase time to radiologic progression in patients with hepatocellular carcinoma.
The Sorafenib Hepatocellular Assessment Randomized Protocol (SHARP) Investigators Study Group conducted a multicenter, phase-3, placebo-controlled, double-blind trial to determine the efficacy of sorafenib (Nexavar, Bayer) in hepatocellular carcinoma. The study included 602 patients with advanced disease who had not previously received systemic treatment.
Patients were randomly assigned to sorafenib 400 mg twice daily or placebo.
The study was stopped after the second interim analysis, at which time 321 deaths had occurred.
Median overall survival was longer in the sorafenib group (7.9 months in the placebo group vs. 10.7 months; P<.001).
The researchers reported no significant difference between the two groups for median time to symptomatic progression (4.1 months for sorafenib vs. 4.9 months for placebo; P=.77).
Time to radiologic progression was greater in the sorafenib group, compared with placebo (5.5 months vs. 2.8 months; P<.001). Partial response occurred in both the sorafenib (2%) and placebo (1%) groups, though no patients in either group had a complete response.
According to the researchers, the most common side effects in the sorafenib group were diarrhea, weight loss, hand-foot skin reaction and hypophosphatemia. – by Stacey L. Adams
N Engl J Med. 2008;359:378-390.