Lenvatinib: can a non-inferiority trial change clinical practice?
Mené dans 20 pays en Asie, en Europe et en Amérique du Nord sur 954 patients atteints d'un carcinome hépatocellulaire non résécable, cet essai de phase III compare l'efficacité, du point de vue de la survie globale, et la toxicité du lenvatinib et du sorafénib, en traitement de première ligne
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]).
The Lancet , commentaire, 2017