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

Everolimus has improved progression-free survival by 5.1 months in patients with advanced neuroendocrine tumors.

Neuroendocrine tumors are slow-growing malignancies that originate from cells of the body’s neuroendocrine system. These cells are found throughout the body in organs such as the gastrointestinal tract and the lungs. 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.

In the new RADIANT-2 trial, researchers treated 429 patients with progressing, well- or moderately-differentiated advanced neuroendocrine tumors with either Everolimus plus a somatostatin analog called Octreotide LAR ( Sandostatin LAR ), or placebo plus Octreotide LAR.

All patients had a history of carcinoid symptoms, meaning the tumors have been secreting excessive levels of amines, especially serotonin, leading to symptoms such as flushing and diarrhea. The tumor originated in the small intestine in about 50% of patients.

Overall, the median progression-free survival for patients given Everolimus plus Octreotide LAR was 16.4 months, significantly longer than the median 11.3 months for placebo plus Octreotide LAR.

This is the first Phase-III trial of the combination therapy with Octreotide LAR and everolimus and it is the largest trial that has ever been done in this type of neuroendocrine tumors. When researchers designed the study, they tested for an improvement of at least 4.5 months compared to Octreotide LAR and were pleased with the resulting 5.1 month difference.

Currently, treatment options for neuroendocrine tumors are limited. Chemotherapy is only effective in neuroendocrine tumors affecting the pancreas. For tumors that originate in other organs, treatments include Somatostatin analogs that control symptoms related to over-secretion of compounds such as serotonin. Interferon-alpha is also approved for these types of neuroendocrine tumors which are also referred to as carcinoid tumors. A placebo-controlled trial recently demonstrated that Octreotide LAR has anti-tumor effects in neuroendocrine tumors of the small intestine.

Source: ESMO Meeting, 2010

XagenaMedicine2010


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