2016 GI Symposium: Everolimus Slows Growth of Neuroendocrine Tumors
Researchers report the results of a new analysis from a phase III trial of patients with neuroendocrine tumors that begin in the gastrointestinal (GI) tract or have an unknown origin. Compared to placebo, everolimus (Afinitor) was associated with a 6- to 8-month longer time period before the cancer worsened. The study was presented by Singh et al at the 2016 Gastrointestinal Cancers Symposium in San Francisco (Abstract 315).
“Everolimus has the potential to stop the cancer from growing for a prolonged period of time,” said lead study author Simron Singh, MD, MPH, FRCP(C), a medical oncologist at Sunnybrook’s Odette Cancer Centre in Toronto, Canada.
The analysis included 175 patients with previously treated, advanced GI neuroendocrine tumors and 36 patients with neuroendocrine tumors of an unknown site of origin. All patients had nonfunctional tumors, ie, tumors that caused few or no symptoms initially.
“In consultation with their oncologist, patients with neuroendocrine tumors may consider this as one of the new standard treatment options,” said Dr. Singh.
Study patients were randomly assigned to receive everolimus plus best supportive care, or placebo plus best supportive care. All patients had tumors that progressed on other therapies, which included a somatostatin analog, surgery, or chemotherapy.
Findings
Overall, everolimus reduced the risk of disease progression by about 40% compared to placebo. Among patients with GI neuroendocrine tumors, the median progression-free survival was 13.1 months with everolimus vs 5.4 months with placebo. In the group of patients with tumor of unknown origin, the median progression-free survival with everolimus and placebo was 13.6 and 7.5 months, respectively.
The most common adverse events in the everolimus arm were stomatitis, infections, diarrhea, peripheral edema, and fatigue.
“Currently there are limited treatment options for patients with GI neuroendocrine tumors, so this study is a welcome advancement in the field, opening the door to a new exciting treatment,” say Dr. Singh.
Everolimus has previously been approved for the treatment of pancreatic neuroendocrine cancer.
This study received funding from Novartis Pharmaceuticals.
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