Nexavar in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer. Cardiac ischemia and/or myocardial infarction may occur. Temporary or permanent discontinuation of Nexavar should be considered in patients who develop cardiac ischemia and/or myocardial infarction. An increased risk of bleeding may occur following Nexavar administration. If bleeding necessitates medical intervention, consider permanent discontinuation of Nexavar. continue reading below »
44% increase in overall survival vs placebo (P<.001; HR: 0.69; 95% CI, 0.55-0.87)¹CI=confidence interval; HR=hazard ratio.
44% 1-Year survival rate (n=299) vs 33% for placebo (n=303); P=.009¹
The SHARP Trial was stopped early for efficacy following a prespecified second interim analysis for survival showing a statistically significant advantage for Nexavar over placebothis advantage was consistent across all subsets analyzed.
Reference: 1. Llovet JM, Ricci S, Mazzaferro V, et al; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008;359(4):378-390.