OnCo
trialsTrialPositive

PARADIGM

Proved that for RAS-normal tumours starting on the left side of the colon, an EGFR antibody beats the VEGF antibody as first partner for chemotherapy.

Left-sided primaries: OS 37.9 vs 34.3 months (HR 0.82), the longest median OS in a first-line phase 3 at the time; no benefit in right-sided tumours. Confirmed the sidedness principle from FIRE-3 and CALGB 80405 subgroup analyses and made 'left-sided, RAS/BRAF wild-type' the anti-EGFR population in guidelines.

Setting
First-line RAS wild-type metastatic colorectal cancer: panitumumab + mFOLFOX6 vs bevacizumab + mFOLFOX6
Phase
Phase 3
Sponsor
Takeda (Japan)
Registry
Headline result
OS 37.9 vs 34.3 months (HR 0.82) in left-sided RAS wild-type disease.
Reported
2022
Enrolled
823
Replication
Replicates FIRE-3 (cetuximab vs bevacizumab with FOLFIRI, OS benefit) and the CALGB/SWOG 80405 sidedness analysis.

Outcomes

1top
In plain words
What these results mean for people, not percentages
823 people took part
Overall survival, left-sidedprimarysurvival endpoint
  • Median 37.9 vs 34.3 months with Panitumumab + mFOLFOX6 compared with Bevacizumab + mFOLFOX6; 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 18 percent lower chance of the event at any given time (hazard ratio 0.82, likely range 0.68 to 0.99).
  • 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: First-line RAS wild-type metastatic colorectal cancer: panitumumab + mFOLFOX6 vs bevacizumab + mFOLFOX6. 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.

823 participants enrolled.

Overall survival, left-sidedprimary
HR 0.82 (0.68–0.99) · p = 0.031
Panitumumab + mFOLFOX6
37.9 mo
Bevacizumab + mFOLFOX6
34.3 mo
Source
EndpointArmnValueHR (95% CI)pSource
Overall survival, left-sidedprimaryPanitumumab + mFOLFOX637.9 months0.82 (0.68–0.99)0.031link
Bevacizumab + mFOLFOX634.3 months
Replication
Replicates FIRE-3 (cetuximab vs bevacizumab with FOLFIRI, OS benefit) and the CALGB/SWOG 80405 sidedness analysis.

Connected

9top