BILCAP
Six months of oral chemotherapy after surgery became the standard for bile duct cancer despite a technically negative primary result.
Intention-to-treat OS 51.1 vs 36.4 months (HR 0.81, not significant); per-protocol HR 0.75 (significant). Adopted by ASCO and ESMO guidelines as standard adjuvant therapy.
Setting
Adjuvant capecitabine for 6 months vs observation after resection of biliary tract cancer
Phase
Phase 3
Sponsor
Cancer Research UK
Headline result
OS 51.1 vs 36.4 months; ITT HR 0.81 (p=0.097), per-protocol HR 0.75.
Reported
2017
Enrolled
447
In plain words
What these results mean for people, not percentages
Overall survival (ITT)primarysurvival endpoint
- Median 51.1 vs 36.4 months with Capecitabine compared with Observation; about 14.7 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 19 percent lower chance of the event at any given time (hazard ratio 0.81, likely range 0.63 to 1.04).
- The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: Adjuvant capecitabine for 6 months vs observation after resection of biliary tract cancer. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
447 participants enrolled.
Overall survival (ITT)primary
HR 0.81 (0.63–1.04) · p = 0.097
Capecitabine
51.1 mo
Observation
36.4 mo
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival (ITT)primary | Capecitabine | 223 | 51.1 months | 0.81 (0.63–1.04) | 0.097 | — |
| Observation | 224 | 36.4 months |