Efficacy and safety of everolimus in advanced low- to intermediate-grade neuroendocrine tumors.

e15198 Background: Most patients with neuroendocrine tumors (NET) have advanced disease at the time of diagnosis, and 65% die within the first 5 years after diagnosis. The benefits associated with cytotoxic chemotherapy in advanced neuroendocrine tumors appear to be modest. Everolimus, an oral inhibitor of the mammalian target of rapamycin (mTOR), has shown antitumor activity in patients with advanced pancreatic neuroendocrine tumors. It has also shown beneficial activity in neuroendocrine tumors of pulmonary or gastrointestinal origin Here it is presented an evaluation of the agent in a retrospective study in patients with low-grade or intermediate-grade neuroendocrine tumours. Methods: This is a retrospective study of the registries of 10 patients diagnosed with neuroendocrine tumors, in whom it was administrated everolimus during the course of their management, as monotherapy or in combination with somatostatin analogues. Everolimus was administrated in a dose of 10 mg once daily. The primary endpoint was the evaluation of the activity through estimation of the progression-free survival, as well as the safety of the drug through identification of the adverse events of all grades. The findings were compared with the recent published data of randomized, double-blind, placebo controlled studies. Results: Median progression-free survival was 10.5 months, a result comparable with recent published data. The benefit from everolimus with respect to progression-free survival was seen primarily in the stabilization of disease or minor tumor shrinkage. It was not recorded a case of partial or complete response. The noted adverse events were usually of grade 1 or 2 and rarely led to drug discontinuation. It was not recorded deadly outcome during the drug administration. Conclusions: Everolimus, offers long term progression free survival, usually by achieving stable disease, in patients with advanced neuroendocrine tumors and it is associated with a low rate of severe adverse events. The findings of this study, although underpowered, were similar with the results of the RADIANT-2 and RADIANT-3 studies.