Long-term results after surgical resection of intrahepatic cholangiocarcinoma before and since the BILCAP era

Background Since the first data of the BILCAP trial was presented in 2017, capecitabine became standard adjuvant treatment for intrahepatic cholangiocarcinoma (ICC). For ICC, the efficacy of capecitabine on survival outcomes remains unresolved as the BILCAP trial included all entities of biliary tract cancer. The aim of this study was to evaluate the influence of adjuvant therapy with capecitabine on long-term outcome in a large German single-center cohort. Methods All patients who underwent surgical resection of ICC between January 2008 and December 2023 were divided into a pre-BILCAP (2008–2017) and a post-BILCAP group (2018–2023). For further homogenization both groups underwent a propensity score matching (PSM) in a 1:1 fashion. Survival analysis was conducted using Kaplan Meier model. Results In total 334 patients were included, 254 (76%) underwent resection while 80 (24%) were irresectable. After PSM two comparable groups of 75 patients were generated. Median overall survival was 20.5 months for the pre- and 29.1 months for the post-BILCAP group ( p = 0.351). Time to recurrence (TTR, median 10.8 versus 21.3 months, p = 0.019) and recurrence-free survival (RFS, median 8.6 and 10.7 months, p = 0.029) were significantly better for the post-BILCAP group. Conclusion Although there was a trend to longer survival, we could not demonstrate a significant effect of adjuvant therapy with capecitabine on an intention to treat basis after resection of intrahepatic cholangiocarcinoma. Nevertheless, a significant influence on time to recurrence and recurrence-free survival could be demonstrated. Further observation is necessary to detect the potential benefit of decreased RFS/TTR in the future.