%0 Journal Article
%T Adjuvant Therapy for Biliary Tract Cancers: New Evidence to Resolve Old Questions
%A Jordan M. Cloyd
%A Timothy M. Pawlik
%J General Information | Journal of Oncology Practice
%D 2018
%R https://doi.org/10.1200/JOP.18.00682
%X Biliary tract cancers are a diverse set of neoplasms arising from the biliary tract epithelium and include intrahepatic cholangiocarcinoma, perihilar cholangiocarcinoma, distal extrahepatic cholangiocarcinoma, and gallbladder cancer. Although anatomically related, they are heterogeneous cancers with distinct genetic and molecular underpinnings. Although technical factors may influence the exact approach, the underlying surgical principle for all localized biliary tract cancers is consistent: performance of a margin-negative resection with regional lymphadenectomy. Unfortunately, recurrence is common, even among patients with localized disease who undergo curative-intent resection. As in other cancers, there has long been interest in the development of effective adjuvant therapy strategies to reduce the risk of both locoregional and distant recurrence. However, considerable controversy over the optimal adjuvant therapy regimen has existed, largely due to the relative rarity of biliary tract cancers and the paucity, until recently, of well-designed prospective clinical trials. In this issue of Journal of Oncology Practice, Horgan and Knox1 nicely review the relevant literature on adjuvant therapies for biliary tract cancers. Although population-based cohort studies have largely supported the use of adjuvant chemotherapy,2 the results of three recent randomized controlled trials have demonstrated somewhat conflicting results. The French PRODIGE 12¨CACCORD 18 trial (adjuvant gemcitabine-oxaliplatin v observation)3 and the Japanese BCAT (Bile Duct Cancer Adjuvant Trial; adjuvant gemcitabine v observation)4 found no difference in recurrence-free survival, whereas the UK BILCAP trial (adjuvant capecitabine v observation)5 reported improved overall survival but only in the per-protocol analysis. Whether these discordant findings are related to differences in sample size (n = 196, 225, and 447, respectively), proportion of high-risk patients with margin positivity (approximately 13%, 11%, and 38%, respectively) or lymph node metastasis (approximately 37%, 35%, and 54%, respectively), other methodological issues (the BCAT trial excluded gallbladder cancer and was terminated early for poor accrual), or the chemotherapy regimens themselves is unknown. Although acknowledging that phase III randomized controlled trials are not available to guide the use of adjuvant radiation or chemoradiation approaches, Horgan and Knox1 highlight the registry-based studies that frequently demonstrate an association between adjuvant chemoradiation and improved overall survival,
%U http://ascopubs.org/doi/full/10.1200/JOP.18.00682