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Bending the Curve Trial by Trial
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Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group

N = 683

Population
Previously untreated metastatic colorectal cancer
Design
Multicentre randomised three-arm trial: weekly irinotecan 125 mg per square metre with bolus fluorouracil 500 mg per square metre and leucovorin 20 mg per square metre for four weeks every six weeks (IFL); bolus fluorouracil 425 mg per square metre and leucovorin 20 mg per square metre daily for five consecutive days every four weeks; or weekly irinotecan 125 mg per square metre alone for four weeks every six weeks. End points included progression-free survival and overall survival.
Arms
  • Fluorouracil and leucovorin (control, n = 226): Bolus fluorouracil 425 mg per square metre and leucovorin 20 mg per square metre daily for five consecutive days every four weeks
  • Irinotecan, fluorouracil and leucovorin (IFL) (experimental, n = 231): Irinotecan 125 mg per square metre, bolus fluorouracil 500 mg per square metre and leucovorin 20 mg per square metre weekly for four weeks every six weeks
  • Irinotecan alone (experimental, n = 226): Irinotecan 125 mg per square metre weekly for four weeks every six weeks
People
Saltz LB, Irinotecan Study Group
Δ median OS+2.2 monthsΔ median PFS+2.7 monthsΔ ORR+18 points
Show the numbers
Results reported for Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group
EndpointAnalysisIrinotecan, fluorouracil and leucovorin (IFL) / Irinotecan aloneFluorouracil and leucovorinEffect
OSprimarySaltz 2000median 14.8 monthsmedian 12.6 monthsP=0.04Comparison of IFL with fluorouracil and leucovorin. Results for irinotecan alone were reported as similar to those for fluorouracil and leucovorin; no values are given in the abstract.
PFSprimarySaltz 2000median 7 monthsmedian 4.3 monthsP=0.004
ORRConfirmed response rateprimarySaltz 200039%21%P<0.001
Results reported for Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group
EndpointAnalysisIrinotecan, fluorouracil and leucovorin (IFL) / Irinotecan aloneFluorouracil and leucovorinEffect
OSprimarySaltz 2000median 14.8 monthsmedian 12.6 monthsP=0.04Comparison of IFL with fluorouracil and leucovorin. Results for irinotecan alone were reported as similar to those for fluorouracil and leucovorin; no values are given in the abstract.
PFSprimarySaltz 2000median 7 monthsmedian 4.3 monthsP=0.004
ORRConfirmed response rateprimarySaltz 200039%21%P<0.001
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%0102030Months (modelled)
  • Fluorouracil and leucovorin (control)
  • Irinotecan, fluorouracil and leucovorin (IFL) (experimental)

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

Data table (modelled values)
MonthsFluorouracil and leucovorinIrinotecan, fluorouracil and leucovorin (IFL)
0100.0%100.0%
961.0%65.6%
1935.2%41.1%
2821.4%26.9%
3713.1%17.7%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%051015Months (modelled)
  • Fluorouracil and leucovorin (control)
  • Irinotecan, fluorouracil and leucovorin (IFL) (experimental)

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

Data table (modelled values)
MonthsFluorouracil and leucovorinIrinotecan, fluorouracil and leucovorin (IFL)
0100.0%100.0%
452.5%67.3%
923.4%41.0%
1312.3%27.6%
185.5%16.8%
Primary publication: Saltz LB, Cox JV, Blanke C, Rosen LS, Fehrenbacher L, Moore MJ, et al. Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group. N Engl J Med. 2000;343(13):905-14. PubMedDOI

Appears in

Sources

  1. Saltz LB, Cox JV, Blanke C, Rosen LS, Fehrenbacher L, Moore MJ, et al. Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group. N Engl J Med. 2000;343(13):905-14.

    PubMedDOI