James C Yao, Manisha H Shah, Tetsuhide Ito, Catherine Lombard Bohas, Edward M Wolin, Eric Van Cutsem, Timothy J Hobday, Takuji Okusaka, Jaume Capdevila, Elisabeth G E de Vries, Paola Tomassetti, Marianne E Pavel, Sakina Hoosen, Tomas Haas, Jeremie Lincy, David Lebwohl, Kjell Öberg
BACKGROUND: Everolimus, an oral inhibitor of mammalian target of rapamycin (mTOR), has shown antitumor activity in patients with advanced pancreatic neuroendocrine tumors, in two phase 2 studies. We evaluated the agent in a prospective, randomized, phase 3 study. METHODS: We randomly assigned 410 patients who had advanced, low-grade or intermediate-grade pancreatic neuroendocrine tumors with radiologic progression within the previous 12 months to receive everolimus, at a dose of 10 mg once daily (207 patients), or placebo (203 patients), both in conjunction with best supportive care...
February 10, 2011: New England Journal of Medicine