OnCo
trialsTrialPositive

ABC-02

The 2010 UK trial that gave bile duct cancer its first standard chemotherapy.

OS 11.7 vs 8.1 months (HR 0.64); PFS 8.0 vs 5.0 months. Remained the control arm for every subsequent first-line trial for over a decade.

Setting
Locally advanced or metastatic biliary tract cancer: gemcitabine + cisplatin vs gemcitabine
Phase
Phase 3
Sponsor
Cancer Research UK
Headline result
OS 11.7 vs 8.1 months, HR 0.64.
Reported
2010
Enrolled
410
Replication
Confirmed by the Japanese BT22 trial and a decade of use as control arm.

Outcomes

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In plain words
What these results mean for people, not percentages
410 people took part
Overall survivalprimarysurvival endpoint
  • Median 11.7 vs 8.1 months with Gemcitabine + cisplatin compared with Gemcitabine; about 3.6 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 36 percent lower chance of the event at any given time (hazard ratio 0.64, likely range 0.52 to 0.8).
  • 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: Locally advanced or metastatic biliary tract cancer: gemcitabine + cisplatin vs gemcitabine. 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.

410 participants enrolled.

Overall survivalprimary
HR 0.64 (0.52–0.8) · p <0.001
Gemcitabine + cisplatin
11.7 mo
Gemcitabine
8.1 mo
EndpointArmnValueHR (95% CI)pSource
Overall survivalprimaryGemcitabine + cisplatin20411.7 months0.64 (0.52–0.8)<0.001
Gemcitabine2068.1 months
Replication
Confirmed by the Japanese BT22 trial and a decade of use as control arm.

Connected

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