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[Comment] Lenvatinib: can a non-inferiority trial change clinical practice?

The study by Masatoshi Kudo and colleagues1 in The Lancet is the first multicentre, randomised, first-line phase 3 trial in hepatocellular carcinoma to be positive since the 2007 sorafenib success.2,3 This trial1 recruited 954 patients who were stratified according to region (Asia-Pacific [defined as China, Hong Kong, Japan, Korea, Malaysia, Philippines, Singapore, Taiwan, and Thailand] or western [defined as Belgium, the UK, Spain, Germany, Italy, Poland, France, the USA, Canada, Israel, and Russia]), macroscopic portal vein invasion, extrahepatic spread, or both (yes or no), Eastern Cooperative Oncology Group performance status (0 or 1), and bodyweight (<60 kg or ≥60 kg), and then randomly assigned to sorafenib (as the established systemic therapy) or lenvatinib at a weight-adjusted dose in an open-label administration (lenvatinib [n=478] and sorafenib [n=476]).

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