Real-world analysis of ctDNA and other biomarkers in patients with curatively resected stage I-III biliary tract cancer
In 167 people whose bile duct or gallbladder cancer had been removed, a blood test for tumour DNA in the weeks after surgery picked out those whose cancer would return far better than the standard blood markers.
Overview
Retrospective real-world analysis of 167 patients with stage I to III resectable biliary tract cancer tested with a personalised, tumour-informed 16-plex PCR next-generation sequencing assay (Signatera) between July 2020 and February 2024; 751 plasma samples were drawn before surgery, in a 2 to 12 week post-surgical window and during surveillance, and compared with CA 19-9 and CEA. Median follow-up was 21 months. ctDNA detection rates were 23 percent (19 of 82) in the residual disease window and 38 percent (31 of 82) in surveillance. Positivity in either window was associated with worse relapse-free and overall survival; in the residual disease window it was the strongest prognostic factor for relapse-free survival (hazard ratio 15.86, 95 percent CI 4.69 to 53.6), and ctDNA outperformed the conventional markers.
- ctDNA detected in 23 percent (19 of 82) in the 2 to 12 week residual disease window and 38 percent (31 of 82) during surveillance.
- Residual disease window positivity: relapse-free survival hazard ratio 15.86 (95 percent CI 4.69 to 53.6).
- ctDNA outperformed CA 19-9 and CEA for prognosis.
Together with the JCO Precision Oncology cohort this makes residual disease testing in biliary cancer prognostic to the same degree as in colon cancer. Nobody has yet shown that acting on it helps; that is the trial gap the ideas on this page name.
- Retrospective commercial testing cohort; testing was ordered selectively.
- Mixed biliary sites; gallbladder numbers are not given in the abstract.
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