IMPACT
International Multicentre Pooled Analysis of Colon Cancer Trials (IMPACT): fluorouracil and folinic acid after resection of Dukes' B and C colon cancer
Phase meta-analysisN = 1,526
- Population
- Patients with resected Dukes' B (56%) and C (44%) colon cancer; 1526 enrolled and 1493 confirmed as eligible (736 treatment group, 757 control group).
- Design
- Pooled analysis of three separately conducted randomised trials (GIVIO, NCIC-CTG and FFCD), analysed together under a previously agreed protocol when there were enough events to detect at least a 10% reduction in mortality with 80% power. Each trial was multicentre and used the same regimen: fluorouracil 370-400 mg/m2 plus folinic acid 200 mg/m2 daily for 5 days, every 28 days for 6 cycles. The abstract does not describe the control treatment or name a primary endpoint.
- Arms
- Control group (control, n = 757): Control group as labelled in the abstract (the abstract does not describe the control treatment)
- Fluorouracil plus folinic acid (experimental, n = 736): Fluorouracil 370-400 mg/m2 plus folinic acid 200 mg/m2 daily for 5 days, every 28 days for 6 cycles
- People
- International Multicentre Pooled Analysis of Colon Cancer Trials (IMPACT) investigators, IMPACT investigators (GIVIO, NCIC-CTG, FFCD)
Δ 36-month EFS+9 pointsΔ 36-month OS+5 points
Show the numbers
| Endpoint | Analysis | Fluorouracil plus folinic acid | Control group | Effect |
|---|---|---|---|---|
| EFSEligible patients with resected Dukes' B and C colon cancer (1493 of 1526 enrolled) | primaryInternational 1995 | 71% at 3 y | 62% at 3 y | P<0.0001Whole-number percentages as published. The abstract states that events were reduced by 35% (95% CI 22-46; p < 0.0001) and gives no hazard ratio. |
| OSEligible patients with resected Dukes' B and C colon cancer (1493 of 1526 enrolled) | primaryInternational 1995 | 83% at 3 y | 78% at 3 y | P=0.029Whole-number percentages as published. The abstract states that mortality was reduced by 22% (95% CI 3-38; p = 0.029) and gives no hazard ratio. |
| Endpoint | Analysis | Fluorouracil plus folinic acid | Control group | Effect |
|---|---|---|---|---|
| EFSEligible patients with resected Dukes' B and C colon cancer (1493 of 1526 enrolled) | primaryInternational 1995 | 71% at 3 y | 62% at 3 y | P<0.0001Whole-number percentages as published. The abstract states that events were reduced by 35% (95% CI 22-46; p < 0.0001) and gives no hazard ratio. |
| OSEligible patients with resected Dukes' B and C colon cancer (1493 of 1526 enrolled) | primaryInternational 1995 | 83% at 3 y | 78% at 3 y | P=0.029Whole-number percentages as published. The abstract states that mortality was reduced by 22% (95% CI 3-38; p = 0.029) and gives no hazard ratio. |