Adjuvant therapy for surgically resected ampullary tumors does not confer a survival benefit, even in patients with aggressive disease, according to new retrospective findings presented at the Society of Surgical Oncology Annual Cancer Symposium in Chicago, Illinois.
In a large historic cohort of more than 5000 patients, 29% (n = 1513) of patients who underwent surgical resection for their ampullary tumors received adjuvant therapy. Most patients receiving adjuvant therapy had stage III disease, lymph node metastasis, and positive surgical margins. However, the authors found no significant differences in stage-specific overall survival between patients who received adjuvant therapy and those who didn’t.
Additionally, no survival benefit was observed in patients with positive resection margins or node-positive disease receiving adjuvant therapy (both P > .05).
Currently, there is no real standard of care as it pertains to adjuvant therapy in this setting. “Due to a lack of high-quality evidence, including clinical trials, current consensus guidelines make no specific recommendations regarding the role of adjuvant therapy for ampullary cancers,” said first author, Vikrom Dhar, MD, a surgical resident at the University of Cincinnati College of Medicine in Ohio.
“As a result, utilization of adjuvant therapy for these cancers varies and is likely institution-specific,” he told Medscape Medical News.
Their study highlights the ongoing need for randomized clinical trials to truly assess whether adjuvant therapy offers any benefit to patients with ampullary cancers, especially those with advanced-stage disease, Dhar explained. “It’s important to note that although the current study included a large sample size and data from centers across the nation, it is limited by the fact that we did not know specific types of chemotherapy regimens patients received.”
Ampullary tumors are neoplasms that arise in the vicinity of the ampulla of Vater. They can originate from the pancreas, duodenum, distal common bile duct, or structures of the ampullary complex. Surgical resection with pancreaticoduodenectomy remains the gold standard for treatment, while local excision remains an alternative option for patients who may not be candidates for this procedure. Even though certain features, such as positive surgical margins, may lead to a worse prognosis, overall survival is generally better than seen with pancreatic cancer.
Dhar pointed out that histologic subtypes, including pancreaticobiliary or intestinal, may play a significant role in determining whether patients should receive adjuvant therapy and what kind. “Because ampullary cancers are rare and clinical trials are difficult to perform, it is likely that our decision regarding what therapies to use will be based on data from studies examining more prevalent diseases, including pancreas, biliary tract, and colorectal cancers,” he said.
No Survival Benefit
In this study, Dhar and colleagues sought to better define the role of adjuvant therapy in the treatment of patients with resected ampullary tumors. Using the American College of Surgeons National Cancer Database, they identified 5298 patients with ampullary tumors, stage I through III, that had been surgically removed between 1998 and 2006.
Outcomes for patients who underwent surgery alone (n = 3785), surgery with adjuvant chemotherapy (n = 316), and surgery with adjuvant chemotherapy and radiation therapy (ACR; n = 1197) were compared.
Adjuvant therapy was more commonly used in patients with stage III disease (22.5% for surgery alone, 42.1% for surgery with adjuvant chemotherapy, 47.1% for ACR), positive lymph nodes (33.1% for surgery alone, 70.7% for adjuvant chemotherapy, and 70.9% for ACR), and positive surgical margins (1.9% for surgery alone, 2.8% for adjuvant chemotherapy, and 4.3% for ACR) (all P < .01).
Upon multivariate analysis, the authors found no significant differences in stage-specific overall survival rates among patients who were receiving any type of adjuvant therapy for pathologic stage I, II, or III disease (all P > .05).
Further studies evaluating subtypes of the cancer, as well as those evaluating the effect of newer systemic therapies, are needed, Dhar explained. “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,” he said.
The researchers have disclosed no relevant financial relationships.
Society of Surgical Oncology Annual Cancer Symposium. Abstract QS50. Presented March 24, 2018.
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