This trial is registered with, number NCT01524783.īetween April 3, 2012, and Aug 23, 2013, a total of 302 patients were enrolled, of whom 205 were allocated to everolimus 10 mg per day and 97 to placebo. Overall survival was a key secondary endpoint. The primary endpoint was progression-free survival assessed by central radiology review, analysed by intention to treat. Patients, investigators, and the study sponsor were masked to treatment assignment.
Patients were stratified by tumour origin, performance status, and previous somatostatin analogue treatment. Eligible patients were randomly assigned in a 2:1 ratio by an interactive voice response system to receive everolimus 10 mg per day orally or identical placebo, both with supportive care. In the randomised, double-blind, placebo-controlled, phase 3 RADIANT-4 trial, adult patients (aged ≥18 years) with advanced, progressive, well-differentiated, non-functional neuroendocrine tumours of lung or gastrointestinal origin were enrolled from 97 centres in 25 countries worldwide. We aimed to assess the efficacy and safety of everolimus compared with placebo in this patient population. 20 Charité Universitätsmedizin Berlin, Campus Virchow-Klinikum, Berlin, Germany.Įffective systemic therapies for patients with advanced, progressive neuroendocrine tumours of the lung or gastrointestinal tract are scarce.19 Dana Farber Cancer Institute, Boston, MA, USA.18 Moffitt Cancer Center, Tampa, FL, USA.17 Seoul National University Hospital, Seoul, South Korea.16 National Cancer Center Hospital, Tokyo, Japan.15 Nederlands Kanker Instituut, Antoni van Leeuwenhoek, Amsterdam, Netherlands.14 University Hospitals Gasthuisberg/Leuven and KU Leuven, Leuven, Belgium.13 Azienda Ospedaliera Sant'Andrea, Università La Sapienza, Rome, Italy.12 Institute of Cancer Studies, University of Manchester, The Christie Hospital, Manchester, UK.11 Novartis Pharma AG, Basel, Switzerland.10 Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.9 Universitaetsklinikum Essen, Zentrum f.7 Masaryk Memorial Cancer Institute, Faculty of Medicine, Masaryk University, Brno, Czech Republic.6 Markey Cancer Center, University of Kentucky, Lexington, KY, USA.5 IRCCS Istituto Clinico Humanitas, Rozzano, Italy.4 Fondazione IRCCS, Istituto Nazionale dei Tumori, Milan, Italy.3 Sunnybrook Health Sciences Centre, Toronto, ON, Canada.Electronic address: 2 Istituto Europeo di Oncologia, IRCCS, Milan, Italy. 1 University of Texas MD Anderson Cancer Center, Houston, TX, USA.
0 kommentar(er)
