Postoperative chemotherapy with capecitabine for biliary tract cancer? Quality and risk assessment of the BILCAP-study

Author(s): Giulia Manzini, Ursula Klotz, Ian N Hines, Doris Henne-Bruns, Michael Kremer, Marietta Kirchner

According to the ASCO guidelines, patients with resected biliary tract cancer should be offered adjuvant capecitabine chemotherapy based on the results of the BILCAP trial. The aim of this evaluation is to assess quality of the BILCAP study. The BILCAP study was analyzed according to the Delphi and the CONSORT checklists. Risk of bias was assessed using the Cochrane Risk of Bias Tool. On average, one patient was included every year by each center. The analysis was not adjusted for center. Treatment allocation by minimization was adopted but mode of application is poorly reported and the choice of variables not justified. No blinding was present. For the observed HR=0.81 with 234 events statistical power is only around 37%. Four of 9 items of the Delphi list and 6 of 35 items of the CONSORT checklist were not properly addressed. According to the Cochrane Risk of Bias Tool, the overall risk-of-bias judgement for the outcome overall survival of the BILCAP study was “some concerns”. Finally, the funding source had an advisory role in the study design. Based on the results of this study there is insufficient evidence for the administration of adjuvant chemotherapy with capecitabine in patients with biliary tract cancer.