BILCAP
Trial question
What is the role of capecitabine in patients with resected biliary tract cancer?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
50.0% female
50.0% male
N = 447
447 patients (223 female, 224 male).
Inclusion criteria: patients with biliary tract cancer resected with curative intent.
Key exclusion criteria: pancreatic or ampullary cancer; mucosal gallbladder or unresolved biliary tree obstruction; not full recovery from previous surgery; previous chemotherapy or radiotherapy for biliary tract cancer.
Interventions
N=223 capecitabine (oral dose of 1,250 mg/m² BID on days 1-14 of a 21-day cycle for 8 cycles).
N=224 observation (monitoring commenced within 16 weeks of surgery).
Primary outcome
Median overall survival
51.1 months
36.4 months
51.1 months
38.3 months
25.6 months
12.8 months
0.0 months
Capecitabine
Observation
No significant
difference ↔
No significant difference in median overall survival (51.1 months vs. 36.4 months; HR 1.23, 95% CI 0.96 to 1.58).
Secondary outcomes
Significant increase in median recurrence-free survival (24.4 months vs. 17.5 months; HR 1.33, 95% CI 1.02 to 1.72).
No significant difference in global health status of EORTC Core QoL questionnaire functioning scale (67.9 points vs. 70.8 points; AD -2.9 points, 95% CI -7.13 to 1.33).
Significant decrease in social EORTC Core QoL questionnaire functioning scale (76.2 vs. 83.3; AD -7.1 , 95% CI -12.16 to -2.04).
Conclusion
In patients with biliary tract cancer resected with curative intent, capecitabine was not superior to observation with respect to median overall survival.
Reference
John N Primrose, Richard P Fox, Daniel H Palmer et al. Capecitabine compared with observation in resected biliary tract cancer (BILCAP): a randomised, controlled, multicentre, phase 3 study. Lancet Oncol. 2019 May;20(5):663-673.
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