Objective : This phase 2, single-arm trial aimed to evaluate the efficacy and safety of gemcitabine in the adjuvant setting for patients with biliary tract carcinoma (BTC).
Method : Patients undergoing surgery subsequently received 6 cycles of adjuvant gemcitabine (1000mg/m2) intravenously over 30 minutes on days 1, 8, and 15 every 4 weeks. The primary end point was a two-year disease-free survival (DFS) rate and secondary end points were a two-year overall survival (OS) rate, tolerability, and the frequency of grade 3 or 4 toxicity.
Results : A total of 55 patients were enrolled. Primary tumor sites were intrahepatic bile duct in 14, extrahepatic bile duct in 34, gallbladder in 3, and ampulla of Vater in 4. During median follow-up of 40 months, 34 patients developed disease recurrence. Two-year DFS and OS rates were 47.7% and 78.2%, and median DFS and OS were 23 months and 46 months, respectively. The long-term outcomes in patients with extrahepatic bile duct carcinoma were similar compared with a historical cohort who underwent surgery alone. The completion rate and total dose intensity were 61.8% and 70.3%, respectively. Twenty-six patients (47.3%) had grade 3 or 4 toxicity, none of which culminated in a fatal event.
Conclusion : The present study failed to show significant benefits of gemcitabine in the adjuvant setting for patients with resected BTC, although the regimen was well tolerated.
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