Skip to content
Bending the Curve Trial by Trial
?

Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial

N = 387

Population
Patients with advanced colorectal cancer previously untreated with chemotherapy (other than adjuvant)
Design
Open-label multicentre randomised trial. Irinotecan plus fluorouracil and calcium folinate versus fluorouracil and calcium folinate alone, given as weekly or every-2-weeks infusional schedules chosen by each centre. Response rate and time to progression were assessed, with duration of response, survival and quality of life; analyses were done in the intention-to-treat population and in evaluable patients.
Arms
  • Fluorouracil and folinate alone (control, n = 188): Fluorouracil and calcium folinate (infusional schedules chosen by each centre)
  • Irinotecan plus fluorouracil and folinate (experimental, n = 199): Irinotecan plus fluorouracil and calcium folinate (infusional schedules chosen by each centre)
People
Douillard JY
Δ ORR+13 pointsΔ ORR+18 pointsΔ median TTP+2.3 monthsΔ median OS+3.3 months
Show the numbers
Results reported for Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial
EndpointAnalysisIrinotecan plus fluorouracil and folinateFluorouracil and folinate aloneEffect
ORRprimaryDouillard 200035%22%P<0.005Response rate in the intention-to-treat population.
ORREvaluable patientsprimaryDouillard 200049%31%P<0.001
TTPAll randomised patients (analysis population not stated in the abstract)primaryDouillard 2000median 6.7 monthsmedian 4.4 monthsP<0.001
OSAll randomised patients (analysis population not stated in the abstract)primaryDouillard 2000median 17.4 monthsmedian 14.1 monthsP=0.031The abstract does not state which population the survival comparison uses.
Results reported for Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial
EndpointAnalysisIrinotecan plus fluorouracil and folinateFluorouracil and folinate aloneEffect
ORRprimaryDouillard 200035%22%P<0.005Response rate in the intention-to-treat population.
ORREvaluable patientsprimaryDouillard 200049%31%P<0.001
TTPAll randomised patients (analysis population not stated in the abstract)primaryDouillard 2000median 6.7 monthsmedian 4.4 monthsP<0.001
OSAll randomised patients (analysis population not stated in the abstract)primaryDouillard 2000median 17.4 monthsmedian 14.1 monthsP=0.031The abstract does not state which population the survival comparison uses.
Illustrative — modelled from reported values, not trial data. TTP, primary.
0%25%50%75%100%051015Months (modelled)
  • Fluorouracil and folinate alone (control)
  • Irinotecan plus fluorouracil and folinate (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsFluorouracil and folinate aloneIrinotecan plus fluorouracil and folinate
0100.0%100.0%
453.3%66.1%
828.4%43.7%
1312.9%26.1%
176.9%17.2%
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%010203040Months (modelled)
  • Fluorouracil and folinate alone (control)
  • Irinotecan plus fluorouracil and folinate (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsFluorouracil and folinate aloneIrinotecan plus fluorouracil and folinate
0100.0%100.0%
1158.2%64.5%
2233.9%41.6%
3319.7%26.9%
4411.5%17.3%
Primary publication: Douillard JY, Cunningham D, Roth AD, Navarro M, James RD, Karasek P, et al. Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. Lancet. 2000;355(9209):1041-7. PubMedDOI

Appears in

Sources

  1. Douillard JY, Cunningham D, Roth AD, Navarro M, James RD, Karasek P, et al. Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. Lancet. 2000;355(9209):1041-7.

    PubMedDOI