The results of a large Phase-III clinical trial have shown that the drug everolimus (Afinitor, Novartis) delays tumor progression in patients with a hard-to-treat group of rare cancers that affect particular hormone-producing cells.

At the 35th Congress of the European Society for Medical Oncology (ESMO), Dr Marianne Pavel from Charit? University in Berlin, Germany reported that everolimus improved progression-free survival by 5.1 months in patients with advanced neuroendocrine tumors.

Neuroendocrine tumors (NET) are slow-growing malignancies that originate from cells of the body?s neuroendocrine system, regulating many of the body’s functions. [1] These cells are found throughout the body in organs such as the gastrointestinal tract (GI), pancreas and the lungs [3, 4]. Because NET are relatively rare, there is no routine screening and patients often experience delays of five to seven years before receiving an accurate diagnosis. As a result of this, patients with NET often have advanced disease when diagnosed. The tumors are mostly non-responsive to chemotherapy drugs. They affect less than five people in 100,000, and until now there have been few treatment options for inhibition of tumor growth. Although considered a rare cancer, the incidence of NET is increasing dramatically, having more than quadrupled in the past 30 years[5],[6].

Trial Results
In the new RADIANT-2 trial, a Phase III randomized, double-blind, placebo-controlled, multicenter study, researchers in several European countries and the USA treated 429 patients with progressing, well- or moderately-differentiated advanced neuroendocrine tumors with either everolimus plus a somatostatin analog called octreotide LAR (Sandostatin ?, LAR ?, Novartis/octreotide acetate for injectable suspension) or placebo plus octreotide LAR.Ospedali Riuniti di Bergamo, Italy, commented: “This large Phase III trial in a rare tumor shows that everolimus is able to increase the efficacy of octreotide LAR, at the present time the standard treatment for advanced neuroendocrine tumors.?

?This trial should be considered a practice-changing achievement but it is essential that selection criteria are refined in order to identify the population more likely to respond to this approach,? Dr Labianca said. ?Further trials in this field are needed, preferably in the frame of a large cooperative collaboration.?

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More Information:
[1] Pavel et al. A randomized, double-blind, placebo-controlled, multicenter phase III trial of everolimus + octreotide LAR vs placebo + octreotide LAR in patients with advanced neuroendocrine tumors (NET) (RADIANT-2). 35th European Society for Medical Oncology Congress. October 9, 2010.
[2] Sandostatin? LAR? (octreotide acetate) Basic Prescribing Information. Basel, Switzerland: Novartis International AG; November 2007.
[3] Memorial Sloan-Kettering Cancer Center.
Gastrointestinal Carcinoid Tumors. Accessed September 29, 2010.
[4] Caring for Carcinoid Foundation.
What is Carcinoid Cancer? Accessed September 29, 2010.
[5] Modlin, et al. Priorities for Improving the Management of Gasteroenteropancreatic Neuroendocrine Tumors. J Natl Cancer Inst 2008;100:1282-1289.
[6] Yao, et al. One Hundred Years After “Carcinoid:” Epidemiology of and Prognostic Factors for Neuroendocrine Tumors in 35,825 Cases in the United States. Journal of Clinical Oncology. June 20 2009; vol. 26, number 18.
[7] Yao et al. A randomized, double-blind, placebo-controlled, multicenter phase III trial of everolimus in patients with advanced pancreatic neuroendocrine tumors (pNET) (RADIANT-3). 35th European Society for Medical Oncology Congress. October 9, 2010.
[8] National Library of Medicine and the National Institutes of Health.
Neuroendocrine Tumor (NET). Accessed September 29, 2010.
[9] American Cancer Society Detailed Guides. What are the key statistics about
gastrointestinal carcinoid tumors? Accessed September 29, 2010.

[10] Everolimus (Afinitor?, Novartis) Basic Prescribing Information for Healthcare Professionals Outside The USA.

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