ASO Author Reflection: Trends and Impact of Adjuvant Chemotherapy in Resected Gallbladder Cancer: Going Beyond Trial Data

Excerpt

Over the last decade, at least three randomized phase III trials have examined the role of adjuvant chemotherapy following resection of non-metastatic gallbladder cancer. Unfortunately, due to the rarity of this disease, these series have included a heterogenous population of patients with a variety of other biliary tract malignancies. The strongest evidence supporting adjuvant chemotherapy in this disease stems from the BILCAP study published in 2019.1 In this trial, 447 patients with resected biliary tract cancer were randomized to either treatment with adjuvant capecitabine or observation. While there was no statistically significant difference in median overall survival between the treatment and observation arms on intention-to-treat analysis (36.4 months vs. 51.1 months; p = 0.097), a difference of 14.7 months in median overall survival between groups in a disease process with a notoriously poor prognosis could certainly be considered clinically relevant. With accumulating evidence from BILCAP and other studies supporting adjuvant therapy in resected biliary tract cancer, the American Society of Clinical Oncology guidelines were amended to recommend 6 months of adjuvant capecitabine therapy for all patients following resection with curative intent.2 Has this growing body of evidence supporting adjuvant therapy in resected gallbladder cancer been implemented in the community at large? Do all patients benefit from the addition of adjuvant chemotherapy or could the advantages be limited to those at highest risk? …