In the literature: June 2019

Abstract

Biliary tract cancer (BTC) includes cholangiocarcinoma and gallbladder cancer. BTCs are known to have a poor prognosis, with a 5-year overall survival below 20%.1 Unfortunately, majority of patients are diagnosed with advanced stage, being palliative chemotherapy with cisplatin and gemcitabine the current standard of care.2 Poor prognosis is due to the fact that only 20% of patients are diagnosed in early stages3 and the high risk of relapse following curative surgery. Unfortunately, the lack of randomised studies has made the role of adjuvant treatment in BTC following surgery an unresolved matter for many years.4 5 Adjuvant therapy (either in the form of chemotherapy or chemoradiotherapy) was supported by a meta-analysis published in 2012, which showed that tumours with lymph node metastases and microscopic invasion of resection margins were the ones benefiting the most.5 However, this meta-analysis consisted of retrospective studies that employed different chemotherapy schedules; thus, adjuvant strategies were not widely adopted and practice varied significantly between countries worldwide.\n\nFruit of a huge effort and investment from the BTC scientific community, three phase III randomised trials were recently reported.6–8 All these three prospective studies randomised patients with resected BTC to chemotherapy or observation alone. The chemotherapy arm consisted of gemcitabine in the bile duct cancer adjuvant trial (BCAT), which included patients diagnosed with extrahepatic cholangiocarcinoma only,6 gemcitabine and oxaliplatin (GemOx) in the PRODIGE-12 (Gemcitabine and Oxaliplatin Chemotherapy or Surveillance in Resected BTC) study7 and capecitabine in the resected biliary tract cancer (BILCAP) study.8 BCAT and PRODIGE-12 randomised 225 and 186 patients, respectively. Unfortunately, none of these studies showed a significant benefit from adjuvant therapy (BCAT: primary endpoint was overall survival (OS) (HR 1.01 (95% CI 0.70 to 1.45); p value 0.964); PRODIGE-12: primary endpoint was relapse-free survival (RFS) (HR 1.28 (95% …