DRAFT: RAMSETE trial of everolimus (RAD001) in the treatment of silent (nonfunctioning) advanced neuroendocrine tumors.

TPS208 Background: Nonfunctioning (nf) neuroendocrine tumors (NETs) do not hypersecrete biogenic amines and peptidic hormones in the blood, ie, they are nonsyndromic. Nf NETS represent at least 50% of gastroenteropancreatic NETs. Nf NETs may have symptoms due to tumor mass effect, such as abdominal pain and jaundice. Surgery is the only curative option but is limited to early well-differentiated disease. For inoperable advanced disease, there are currently no standard tumor control therapies. Everolimus is an oral inhibitor of the mammalian target of rapamycin (mTOR; a central regulator of cell growth and proliferation, cellular metabolism, and angiogenesis) and interrupts insulin-like growth factor/phosphatidylinositol 3-kinase signaling that is integral to NETs growth. Everolimus plus octreotide LAR showed promising efficacy in a phase II study in pts with pancreatic NETs (Yao 2009). Few studies have specifically focused on nf NETs at other primary sites (eg, bronchial, rectal, etc). The RAMSETE (RAD001...