Results of an analysis from the University of Cincinnati (UC) College of Medicine show that additional therapy, or adjuvant therapy, delivered after surgical removal of a rare type of gastrointestinal tumor does not increase survival rates for patients.
These findings provide insight on treatment plans for patients with these types of tumors possibly eliminating the need for prescribed adjuvant therapy, preserving quality of life and saving money.
“Due to a lack of randomized clinical trials, the role of adjuvant therapy in the treatment of patients with surgically removed ampullary tumors is poorly defined,” says Vikrom Dhar, MD, a surgical resident at UC and co-principal investigator on the study along with Syed Ahmad, MD, professor of surgery and director of the Division of Surgical Oncology for the UC College of Medicine. Ahmad is also a UC Health surgical oncologist and director of the UC Cancer Institute’s Pancreatic Disease Center.
Ampullary cancer is a cancer that arises from the ampulla of Vater, which is where the bile duct and pancreatic duct come together and empty into the small intestine. Ampullary cancers often block the bile duct while they’re still small and have not spread far. This blockage causes bile to build up in the body, which leads to yellowing of the skin and eyes (jaundice). Because of this, these cancers are usually found earlier than pancreatic cancers, and they usually have better outcomes.
For this study, researchers used the American College of Surgeons National Cancer Database to identify patients with ampullary tumors, stage I through III, which had been surgically removed between 1998 and 2006 (5,298 patients). Patients receiving surgery alone (3,785), surgery with additional chemotherapy (316), and surgery with additional chemotherapy and radiation therapy (1,197) were compared. Analyses taking into account one variable and/or many variables were used to determine overall survival rates for patients.
“Over the study period, 29 percent (1,513) of patients who had their ampullary tumors surgically removed received adjuvant therapy; adjuvant therapy was more often used in patients with stage III disease, cancer in their lymph nodes and positive surgical margins, meaning cancer in the tissues surrounding the removed tumor after surgery,” Dhar says. “However, no significant differences in stage-specific survival were noted between patients receiving any treatment for stages I, II or III of the disease. Similarly, no survival benefit was found for patients with positive resection margins or cancer in their lymph nodes who were receiving adjuvant therapy.
“This national analysis demonstrates that adjuvant therapy for surgically removed ampullary tumors, even when used in patients with aggressive disease, does not show any survival benefit,” he adds. “Further studies evaluating subtypes of the cancer, and how they differ on a cellular level, as well as evaluating the effect of newer systemic therapies are needed. However, these results could lead to a new standard of care for patients with this type of cancer, regardless of the stage of the disease.”
Researchers cite no conflicts of interest.