- Adjuvant capecitabine showed no survival advantage over observation in resected biliary tract cancer, but the study may have been underpowered.
- Prespecified sensitivity and per protocol analyses suggest OS benefit.
Why this matters
- Given its relatively low cost, tolerability, and the failure of other approaches, adjuvant capecitabine should be proposed to patients after curative-intent resection of biliary tract cancer, according to an accompanying editorial.
- Incremental cost per quality-adjusted life-year was
- 447 patients across 44 centers in the United Kingdom were randomly assigned to capecitabine or observation.
- Funding: Cancer Research UK, Roche.
- 2-year survival in the observation group was 60%, higher than the projected 20%, which may have led to study being underpowered.
- Intention-to-treat analysis showed no significant difference in median survival (capecitabine, 51.1 vs observation, 36.4 months; HR, 0.81; P=.097).
- Adjustment for prognostic factors and minimization factors showed a survival benefit for capecitabine (HR, 0.71; P=.010).
- The per protocol analysis found a benefit in median OS for capecitabine (53 vs 36 months; aHR, 0.75; P=.028).
- Between-group survival differed over time, with capecitabine associated with an advantage in months 0-24 (HR, 0.70; P=.0093), but not beyond 24 months.
- Primary endpoint failed.