The combination of Afinitor® (everolimus) and Temodar® (temozolomide) appears to be active against advanced pancreatic neuroendocrine tumors. The details of this Phase I/II study were presented at the 2010 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium.
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.
The combination of Afinitor and the chemotherapy drug Temodar was evaluated in 24 patients with advanced pancreatic neuroendocrine tumors. Of 17 patients with treatment response information available, six had a partial response and nine had stable disease; overall benefit was 88%. The most common serious side effects involved low blood cell counts.
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The results of this Phase I/II study suggest that the combination of Temodar and Afinitor is well tolerated and reasonably effective in patients with pancreatic neuroendocrine tumors.
 Kulke M, Plaszkowsky LS, Zhu AX, et al. Phase I/II study of everolimus (RAD001) in combination with temozolomide (TMZ) in patients (pts) with advanced pancreatic neuroendocrine tumors (NET). ASCO 2010 Gastrointestinal Cancers Symposium. Abstract 223.