In a recent Phase III trial, the targeted therapy Afinitor® (everolimus) more than doubled progression-free survival time among patients with advanced pancreatic neuroendocrine tumors (NET). Results of this study were presented at the 12th World Congress on Gastrointestinal Cancer.

Neuroendocrine tumors form from cells that release hormones in response to a signal from the nervous system. These tumors include carcinoid tumors, islet cell tumors, medullary thyroid carcinomas, pheochromocytomas, and Merkel cell carcinomas. Although they can occur in many different parts of the body, neuroendocrine tumors often develop in the digestive system.

Afinitor is an oral targeted therapy that works by inhibiting a protein known as the mammalian target of rapamycin (mTOR). The mTOR protein plays an important role in regulating cancer cell division and blood vessel growth. It was approved in 2009 for the treatment of selected patients with advanced renal cell (kidney) cancer.

This recent trial of Afinitor in pancreatic NET, the RADIANT-3 (RAD001 In Advanced Neuroendocrine Tumors) study, involved 410 patients and compared outcomes and safety of Afinitor versus placebo.

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  • Median progression-free survival among patients receiving Afinitor was extended to 11 months from five months among those receiving placebo.
  • Afinitor reduced the risk of cancer progression by 65% compared with placebo.
  • Side effects of Afinitor were consistent with previous studies and primarily included stomatitis (inflammation in the mouth), diarrhea, and fatigue.

Based on these findings, Afinitor appears to be a promising treatment option for patients with advanced pancreatic cancer. Researcher James Yao, MD, concluded, “These results further validate earlier trials and demonstrate the potential benefit [Afinitor] can provide to these patients.”

Reference: Yao, et al. Everolimus versus placebo in patients with advanced pancreatic neuroendocrine tumors (pNET) (RADIANT-3). 12th World Congress on Gastrointestinal Cancer, Barcelona. July 1, 2010.