Patients with resected biliary tract cancer can benefit from a 5-fluorouracil (5-FU) regimen, a study published in Clinics and Research in Hepatology and Gastroenterology concluded. This is regardless of whether they had cholangiocarcinoma or gallbladder carcinoma.

“High-risk patients are more likely to benefit from it, such as node-positive or vascular invasion disease,” Shaoming Song, MD, and the coauthors of the study wrote.

In patients with biliary tract cancer, the risk of disease recurrence after surgery is 60% to 70%, and adjuvant therapy following surgery is controversial. 5-FU is widely used for digestive system tumors. However, there has been no meta-analysis to investigate the benefits of 5-FU or any other adjuvant therapy on survival.

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In the present study, the researchers investigated the safety and efficacy of the 5-FU regimen in patients with resected biliary tract cancer by conducting a literature review and meta-analysis of 9 clinical trials involving 1339 patients.

They found that patients with resected biliary tract carcinoma could significantly benefit from a 5-FU regimen, independent of cholangiocarcinoma or gallbladder carcinoma diagnosis.

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They also found that survival was significantly improved in patients treated with adjuvant chemotherapy or chemoradiotherapy after surgery compared to those who only had surgery.

When they analyzed subgroups of patients, the researchers found that patients with node-positive or vascular invasion disease were more likely to benefit from adjuvant therapy following surgery.

“This study provides the latest evidence to support 5-FU regimens for [biliary tract cancer] patients after surgery,” the researchers concluded. However, they added that more prospective trials are necessary to verify this conclusion. 

Biliary tract cancer is a highly malignant type of digestive system tumor that includes gallbladder cancer and cholangiocarcinoma, the incidence of which has been increasing in recent years.


Song S, Yang W, Tian H, et al. The efficacy and safety of 5-fluorouracil based adjuvant therapy in resected biliary tract cancer: a systematic review and meta-analysis. Clin Res Hepatol Gastroenterol. Published online August 10, 2021. doi:10.1016/j.clinre.2021.101788