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Bending the Curve Trial by Trial
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RECOURSE

Randomized, Double-blind, Phase 3 Study of TAS-102 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies

Phase 3N = 800NCT01607957

Population
Refractory metastatic colorectal cancer
Design
Double-blind, randomised phase 3 trial; 800 patients were randomised 2:1 to TAS-102 (trifluridine plus tipiracil) or placebo. The abstract does not describe best supportive care beyond the registry title.
Primary endpoint
OS
Arms
  • Placebo (control): Placebo
  • TAS-102 (experimental): TAS-102 (trifluridine plus tipiracil)
People
Mayer RJ
OSHR 0.68 (95% CI 0.58–0.81)Δ median OS+1.8 months
Show the numbers
Results reported for RECOURSE
EndpointAnalysisTAS-102PlaceboEffect
OSAll randomised patients (analysis population not stated in the abstract)Overall survival (primary endpoint)primaryMayer 2015median 7.1 monthsmedian 5.3 monthsHR 0.68 (95% CI 0.58–0.81)P<0.001
Results reported for RECOURSE
EndpointAnalysisTAS-102PlaceboEffect
OSAll randomised patients (analysis population not stated in the abstract)Overall survival (primary endpoint)primaryMayer 2015median 7.1 monthsmedian 5.3 monthsHR 0.68 (95% CI 0.58–0.81)P<0.001
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.680.58–0.81
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%051015Months (modelled)
  • TAS-102 (experimental)
  • Placebo (control)

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

Data table (modelled values)
MonthsTAS-102Placebo
0100.0%100.0%
467.7%59.3%
941.5%30.8%
1328.1%18.3%
1817.3%9.5%
Primary publication: Mayer RJ, Van Cutsem E, Falcone A, Yoshino T, Garcia-Carbonero R, Mizunuma N, et al. Randomized trial of TAS-102 for refractory metastatic colorectal cancer. N Engl J Med. 2015;372(20):1909-19. PubMedDOI

Appears in

Sources

  1. Mayer RJ, Van Cutsem E, Falcone A, Yoshino T, Garcia-Carbonero R, Mizunuma N, et al. Randomized trial of TAS-102 for refractory metastatic colorectal cancer. N Engl J Med. 2015;372(20):1909-19.

    PubMedDOI