Long-Term Outcomes and Exploratory Analyses of the Randomized Phase III BILCAP Study

Area of Science:

• Oncology
• Surgical Oncology
• Gastroenterology

Background:

• Biliary tract cancer (BTC) is a group of rare and aggressive gastrointestinal malignancies.
• Adjuvant chemotherapy plays a crucial role in improving outcomes for resected BTC.
• Capecitabine has emerged as a potential standard of care in the adjuvant setting for BTC.

Purpose of the Study:

• To present long-term overall survival (OS) data from the BILCAP study.
• To conduct exploratory subgroup analyses of capecitabine's efficacy in resected BTC.
• To reinforce the role of capecitabine as adjuvant therapy for curatively resected BTC.

Main Methods:

• Phase III, randomized, controlled, multicenter trial comparing capecitabine to observation in resected BTC.
• Patients received oral capecitabine or observation for eight cycles.
• Primary endpoint was overall survival (OS); secondary endpoints included prognostic factor analysis.

Main Results:

• Median OS was 49.6 months with capecitabine versus 36.1 months with observation (adjusted HR 0.84).
• Sensitivity analysis adjusting for key factors showed a significant OS benefit (HR 0.74).
• Exploratory analyses investigated the prognostic impact of R status, grade, nodal status, and sex.

Conclusions:

• Long-term data support capecitabine as an effective adjuvant chemotherapy for resected BTC.
• Capecitabine improves overall survival and should be considered the standard of care.
• Further analysis provides insights into prognostic factors influencing outcomes in BTC.