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For patients with metastatic or unresectable hepatocellular cancer (HCC), the multitargeted tyrosine-kinase inhibitor sorafenib is the only therapy shown to improve survival. However, no known treatment is effective for patients with disease progression after sorafenib. Investigators now report the results of an industry-sponsored, international, phase III, randomized, double-blind, placebo-controlled trial (EVOLVE-1) evaluating the mTOR inhibitor everolimus in patients progressing on first-line sorafenib.
A total of 546 patients were randomized 2:1 to receive everolimus (7.5 mg daily) or placebo. Most patients were white (53%–60%), were treated in non-Asian countries (83%–84%), and had extrahepatic disease (73%–74%). Most discontinued soraf…