Too little too late.
The Study: Thus far the role of adjuvant therapy has been questionable at best. Back at ASCO 2017, initial results from the BILCAP trial showed that capecitabine may be beneficial compared to observation. The “may” comes from the fact that there was only a trend toward improved survival overall. PRODIGE-12 was a similar trial that randomized patients to gemcitabine and oxaliplatin (aka GEMOX) versus observation after gross total resection. Unfortunately, there was no improvement in the primary endpoint of recurrence-free survival nor in overall survival with the addition of chemo. There were also no differences in patterns of recurrence, with a dismal three-quarters of each arm experiencing distant recurrence. This is in line with another randomized trial that failed to show a benefit with adjuvant gemcitabine monotherapy in this population. With these results, we cautiously await the final publication of BILCAP to better understand adjuvant therapy options for resected biliary tract cancer.
Bottom Line: We're still waiting on adjuvant chemo to prove itself after resection of biliary tract cancer. | Edeline, J Clin Oncol 2019