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New treatment linked to reduced progression risk in advanced cancer

January 20, 2016

Sunnybrook researchers report that for patients with advanced GI (gastrointestinal) neuroendocrine tumours, treatment with a novel biologic therapy was associated with reduced risk of disease progression by about 40 per cent compared to placebo, as presented at the annual Gastrointestinal Cancers Symposium.

Neuroendocrine tumours or NETs are an often poorly understood type of cancer that can develop in the hormone-producing cells of the body. This group of cancers is difficult to diagnose and treat. The most common site of NETs is the gastrointestinal tract, known as GI NETs or carcinoid tumours. There has been a five-fold increase in global incidence of NETs over the last five decades, and in Ontario alone, the increase in NETs has more than doubled, over the last 15 years.

This newly released analysis is part a global phase III randomized trial, the RADIANT4 study which looked at everolimus treatment in 302 patients with advanced GI NETs, lung NETs or NETs of unknown origin. Tumours were identified as non-functional, or tumours that were asymptomatic or caused few symptoms initially. Everolimus is a targeted therapy that inhibits the mTOR enzyme, which when over-active or causing mutation, has been linked to cancers of the kidney and breast.

“These patients with advanced disease have limited treatment options. It is our hope that this approach offers a new way to help stop progression for a prolonged period of time,” says Dr. Simron Singh, medical oncologist and co-head of the Susan Leslie Clinic for Neuroendocrine Tumours at Sunnybrook Odette Cancer Centre, the largest clinic of its kind in Canada. Dr. Singh is the global lead of the GI NETs portion of the trial that included patients from across Canada and the world.

The analysis reports on the effects of everolimus treatment in 175 patients with advanced GI NETs and 36 patients with advanced NETs of unknown origin. Median progression free survival for patients with advanced GI NETs was 13.1 months with everolimus, compared to 5.4 months with placebo, and 13.6 months vs 7.5 for patients with advanced NETs of unknown origin. Overall risk of disease progression was reduced by 44 percent for patient groups.

The most frequent severe adverse effects included diarrhea, high blood pressure, inflammation of the mouth, abdominal pain, fatigue, and acute kidney failure.

It is estimated that over 2,000 Canadians are diagnosed annually with neuroendocrine tumours.

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Neuroendocrine tumours

What are they?

  • Develop in the body's hormone producing cells
  • Commonly begins in the gastrointestinal tract (carcinoid tumours)
  • Can also begin in the lungs, or unknown areas of origin
  • Groups of cancers that are difficult to diagnose & treat

In this analysis:

Analysis is part of a global Phase III randomized clinical trial, RADIANT-4 conducted with 302 patients with advanced GI NETs, lung NETs or NETs of unknown origin.

Researchers looked at treatment using a novel biologic therapy with 175 patients with advanced gastrointestinal (GI) NETs.

  • An estimated 2,000 Canadians are diagnosed annually with neuroendocrine tumours
  • Incidence in Ontario has more than doubled over the last 15 years
  • 40% biologic therapy, everolimus, reduced risk of disease progression, compared to placebo
  • NETS on the rise: 5-fold increase globally over the last 5 decades