The Study: And, as promised, the BILCAP trial is now out in final form. Unfortunately, the study was beset by statistical misfortunes. Despite a clearly visible and clinically meaningful difference in median overall survival of 36 months with observation versus 51 months with capecitabine and a >6 month improvement in median progression free survival, there were insufficient events to meet the primary endpoint unless looking strictly at a per-protocol analysis. The editorial brings up the point (which you can maybe see in the curves) that adjuvant capecitabine reduced recurrences in the first 24 months but not so much thereafter. Looking at patient characteristics, nearly 40% had R1 resections and adjuvant radiation was not part of protocol therapy. With the forest plot favoring those with R0 resections, perhaps adjuvant radiation—as proposed in the ASCO guidelines—further reduces recurrence after R1 resections. Despite the limitations, the expert takeaway is that adjuvant capecitabine should be routinely offered to this population.
Bottom Line: Adjuvant capecitabine for resected biliary tract cancer provides a meaningful improvement in overall and progression free survival, despite our best statistical impediments. | Primrose, Lancet Oncol 2019