- Biliary tract cancers usually present at an advanced stage, and only approximately 20% of tumors are considered resectable.
- Surgery is the primary curative treatment option for early-stage biliary tract cancer. However, due to the high rates of recurrence with resection alone, there remains a need for effective adjuvant therapy to improve rates of relapse-free and overall survival while maintaining health-related quality of life.
- Patients with resected biliary tract cancer should be offered adjuvant capecitabine chemotherapy for a duration of 6 months. (Moderate recommendation; EB-B-I)
- In the BILCAP phase III randomized controlled trial, capecitabine was delivered at a dose of 1250 mg/m2 twice/day on treatment day 1 to 14 of a 3-weekly cycle for 24 weeks (8 cycles).
- The Expert Panel agrees that the recommended dose of capecitabine may be determined by institutional and regional practices.
- Patients with extrahepatic cholangiocarcinoma or gallbladder cancer and a microscopically positive surgical margin resection (R1 resection) may be offered chemoradiation therapy (CRT). (Conditional recommendation; EB/CB-B-L)
- A shared decision-making approach is recommended, considering the risk of potential harm and potential for benefit associated with radiation therapy for patients with extrahepatic cholangiocarcinoma or gallbladder cancer.
- The Expert Panel notes that in the SWOG0809 prospective single-arm trial of CRT, radiation was delivered at a dose of 45 Gy to regional lymphatics and 54 to 59.4 Gy to the tumor bed. However, at this time, the evidence base is not sufficiently well-developed to make a recommendation for optimal dosing of radiation therapy in the context of CRT.