Highlighted study from the 2016 Gastrointestinal Cancers Symposium, which AGA is co-sponsoring.

Contact: Rachel Shubert

Alise Fisher

Bethesda, MD (Jan. 15, 2016) — 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 was associated with a six- to eight-month longer time period before the cancer worsened. The study will be presented at the upcoming 2016 Gastrointestinal Cancers Symposium in San Francisco.

“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 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.

Overall, everolimus reduced the risk of disease progression by about 40 percent 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 (inflammation of the mouth), infections, diarrhea, peripheral edema and fatigue.

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 GI tract. While they are uncommon (each year only about 8,000 people in the U.S. are diagnosed with a neuroendocrine tumor of the GI tract[1]), the incidence of neuroendocrine tumors is on the rise.

“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,” says Dr. Singh.

Everolimus has previously been approved for the treatment of pancreatic neuroendocrine cancer.

This study received funding from Novartis Pharmaceuticals.

[1] http://www.cancer.org/cancer/gastrointestinalcarcinoidtumor/detailedguide/gastrointestinal-carcinoid-tumors-key-statistics Accessed Jan. 13, 2016.

View the full abstract.

2016 Gastrointestinal Cancers Symposium News Planning Team
William Grady, MD, AGA Institute; Smitha Krishnamurthi, MD, American Society of Clinical Oncology (ASCO); Karyn Goodman, MD, MS, American Society for Radiation Oncology (ASTRO); and Jennifer Tseng, MD, MPH, Society of Surgical Oncology (SSO). 
View the disclosures for the News Planning Team


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