Objective: After progression on platinum-gemcitabine, patients with advanced biliary tract cancer (aBTC) have limited treatment options. The objective of the present study was to evaluate the outcomes and adverse events of FOLFOX4 as a second-line chemotherapy.
Materials and Methods: This was a retrospective study included aBTC patients who previously treated with platinum/gemcitabine and received the FOLFOX4 regimen as a second-line treatment in Srinagarind Hospital between June 2014 and June 2018. Survival analysis was done using the Kaplan-Meier method and the log-rank test.
Results: A total of 19 patients of biliary tract cancer were included, the median age was 59 years (42 to 75), and 14 patients (73.6%) were male. Most patients had ECOG 1 and were intrahepatic subtype in primary. Two patients achieved partial response and 8 patients had stable disease. The median progression-free survival and overall survival (OS) were 2.6 and 6.2 months respectively. The 6- and 12-month survival rate was 52.6% and 11.8%. The median OS in patients who achieved disease control was significantly longer than who progressed on FOLFOX (9.1 vs. 4.7 months), hazard ratio 0.11 (95% CI 0.12 to 0.73, p=0.02). Grade 3 or higher adverse events were observed in seven patients (36.8%), with no patient discontinue the treatment from toxicity.
Conclusion: In patients with aBTC who progressed after platinum-gemcitabine, FOLFOX4 is effective with manageable toxicity.

Keywords: Advanced biliary tract cancer; Second-line chemotherapy; FOLFOX; Cholangiocarcinoma