Biliary tract cancer: cautious support for adjuvant capecitabine

  • Lancet Oncol

  • curated by Jim Kling
  • Univadis Clinical Summaries
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Takeaway

  • 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

Study design

  • 447 patients across 44 centers in the United Kingdom were randomly assigned to capecitabine or observation.
  • Funding: Cancer Research UK, Roche.

Key results

  • 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.

Limitations

  • Primary endpoint failed.

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