Positive results of everolimus in neuroendocrine tumors18 Jan 2016
Researchers report the results of a new analysis from a phase 3 trial of patients with neuroendocrine tumors that begin in the gastrointestinal (GI) tract or have an unknown origin. Compared to placebo, everolimus was associated with a 6 to 8 month longer time period before the cancer worsened.
“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.
Neuroendocrine tumors are a group of cancers that begin in hormone-producing (neuroendocrine) cells of various organs in the body. Most neuroendocrine tumors begin in the gastrointestinal tract. While they are uncommon, the incidence of neuroendocrine tumors is on the rise.
All patients had tumors that progressed on other therapies
The analysis included 175 patients with previously treated, advanced gastrointestinal neuroendocrine tumors and 36 patients with neuroendocrine tumors of an unknown site of origin. All patients had non-functional tumors, meaning that the tumor 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 somatostatin analog (a standard hormone therapy for neuroendocrine tumors), surgery, or chemotherapy.
A possible new treatment in a disease with limited treatment options
Overall, everolimus reduced the risk of disease progression by about 40% compared to placebo. In particular:
- Among patients with gastrointestinal 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 (inflammation of the mouth), infections, diarrhea, peripheral edema, and fatigue.
“Currently there are limited treatment options for patients with gastrointestinal neuroendocrine tumors, so this study is a welcome advancement in the field, opening the door to a new exciting treatment,” says Dr Singh. Everolimus has previously been approved for the treatment of pancreatic neuroendocrine cancer.Source: eCancer News