Learning from 7 Years of Experience with Sorafenib in Advanced HCC: Sorafenib Better than Sorafenib?
Sorafenib approval in patients with advanced hepatocellular carcinoma (HCC) was based on two randomized, placebo-controlled, phase III trials. In those studies, sorafenib treatment resulted in a median overall survival (mOS) of 10.7 months versus 7.9 months with placebo in the Sorafenib HCC Assessment Randomized Protocol (SHARP) trial including Western patients  and 6.5 months versus 4.2 months in the Asian-Pacific study . Since then, results of large randomized trials using sunitinib, brivanib and linifanib have been reported showing no OS benefit (and sometimes deleterious effects) over sorafenib as first-line therapy in patients with advanced HCC [3, 4, 5]. Cynically, a total of more than 3000 patients were randomized in phase III trials for the merit of strengthening sorafenib as a stand-alone standard of care in advanced HCC . Shall we contemplate these disheartening trials or surpass disappointments to move forward learning from failures to continue developing novel...
KeywordsSorafenib Sunitinib Overall Response Rate Sorafenib Treatment Adverse Event Management
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Conflict of Interest
Sandrine Faivre, Armand de Gramont and Eric Raymond declare no conflicts of interest.
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