Adjuvant chemotherapy in resected bile duct cancer: A systematic review and meta-analysis of randomized trials

Background: The role of adjuvant chemotherapy (ACT) for resected biliary tract cancer (BTC) is still unclear and there is no specific recommendation by international guidelines.

Aim: To perform a meta-analysis of randomized clinical trials (RCTs) to better define the clinical benefit and risks of ACT or observation in resected BTC.

Method: A systematic literature search of Pubmed, Embase, and the Cochrane Library was performed up to April 2019. A meta-analysis was carried out using the random effects model.

Results: ACT provided a mild improvement in recurrence free survival (RFS) (HR:0.83, 95%CI 0.69-0.99) and no effect on overall survival (OS) (HR:0.91, 95%CI 0.75-1.09). Similarly, ACT showed no effect on OS in lymph-node positive subgroup (HR:0.84, 95% CI 0.65-1.08) and surgical margin positive subgroup (HR:0.95, 95%CI 0.69-1.31). Moreover, ACT led to a substantial increase of chemotherapy-associated adverse events (RR:3.03, 95%CI 2.22-4.15).

Conclusion: ACT for resected BTC patients modestly improved RFS with no effect on OS and a substantial increase in chemotherapy associated AEs.