SAN FRANCISCO, CA—A new analysis of a phase III trial of patients with neuroendocrine tumors that began in the gastrointestinal (GI) tract or at an unknown primary location found that progression-free survival was improved with everolimus by 6 to 8 months compared with placebo. The study was presented at the 2016 Gastrointestinal Cancers Symposium.
“Everolimus has the potential to stop the cancer from growing for a prolonged period of time,” said Simron Singh, MD, MPH, FRCP(C), a medical oncologist at Sunnybrook’s Odette Cancer Centre in Toronto, Canada, and lead author of the study.
Neuroendocrine tumors begin in hormone-producing cells of various organs in the body, with most neuroendocrine tumors beginning in the GI tract. Although neuroendocrine tumors are diagnosed in only an estimated 8,000 people in the United States each year, incidence is increasing.
This analysis of the RADIANT study included 175 patients with previously treated, advanced GI neuroendocrine tumors and 36 patients with neuroendocrine tumors of unknown primary origin. The tumors were nonfunctional (caused few or no symptoms initially).
The patients in the study were randomly assigned to receive everolimus or placebo plus best supportive care. All the patients had tumors that had progressed on other therapies, such as somatostatin analog, a standard hormone therapy for neuroendocrine tumors; surgery; or chemotherapy.
The risk of disease progression overall was reduced approximately 40% by everolimus vs placebo. Median progression-free survival was 13.1 months with everolimus vs 5.4 months with placebo for patients with GI neuroendocrine tumors, and 13.6 months with everolimus vs 7.5 months with placebo for patients with tumors of unknown primary origin.
The most common adverse events reported by the patients treated with everolimus were stomatitis, infections, diarrhea, peripheral edema, and fatigue. This safety profile is consistent with previous reports for everolimus.
“While everolimus is already approved to treat pancreatic neuroendocrine tumors, these results demonstrate that it may also be effective for a broader group of patients with neuroendocrine cancer,” said Smitha Krishnamurthi, MD, ASCO spokesperson. “The findings may add a new treatment option for patients whose tumors have worsened despite other treatments.”
This study received funding from Novartis Pharmaceuticals.