Administering capecitabine after surgery extends survival by a median of 17 months compared with surgery alone for patients with biliary tract cancer, according to research that will be presented at the 2017 ASCO Annual Meeting (June 2-6, 2017; Chicago, IL).
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Only some patients with biliary tract cancer are able to have their tumors surgically removed (20%), and fewer than 10% of these patients survive 5 years. There is currently no standard of care for adjuvant therapy for this disease.
“Biliary tract cancer is a disease of decidedly unmet need as until recently there has been little research on treating the disease,” said John N Primrose, MD, professor of surgery, University of Southampton (United Kingdom).
Dr Primrose and colleagues designed the BILCAP trial to assess the use of adjuvant therapy in biliary tract cancer. A total of 447 patients were randomly assigned to receive either the chemotherapy agent capecitabine for 6 months or observation for recurrence of cancer. Most patients were followed for a median of 3 years with clinical exams, CT imaging, and blood tests to be used for determining biomarkers for tumors.
Results of the study showed that patients who received capecitabine lived a median of 51 months after surgery, whereas those who received observation lived a median of 36 months. Capecitabine was associated with a 25% lower chance of death than observation in a subgroup of 430 patients that received treatment per study protocol.
Median time to recurrence was 25 months for patients who received capecitabine and 18 months for patients who received observation.
The most notable adverse events resulting from capecitabine treatment included rash on the hands and feet, which is a common occurrence after capecitabine. Researchers reported no deaths due to the use of capecitabine.
Authors of the study are testing a subgroup analysis of the 4 distinct types of biliary tract cancer – three of which involve the liver and one involves the gallbladder. Authors believe that this analysis will help indicate which patients could benefit most from adjuvant chemotherapy.
“One of the major benefits of our trial is the fact that we now have a tumor tissue collection associated with very robust clinical data which will be used for genomic exploration. Since we started planning this trial at the start of this century, a number of new agents have become available, including several that treat cancer based on its genetic profile. This is where our tumor tissue repository will play an important role,” said Dr Primrose. — Zachary Bessette
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