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Bending the Curve Trial by Trial
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FRESCO

A Randomized, Double-blind and Placebo-controlled Phase III Trial Comparing Fruquintinib Efficacy and Safety vs Best Support Care (BSC) in Advanced Colorectal Cancer Patients Who Have Failed at Least Second Lines of Chemotherapies

Phase 3N = 416NCT02314819

Population
Metastatic colorectal cancer in patients aged 18 to 75 years who progressed after at least two lines of chemotherapy and had not received VEGFR inhibitor therapy (China only)
Design
Randomised, double-blind, placebo-controlled phase 3 trial at 28 hospitals in China; 2:1 randomisation (stratified by prior anti-VEGF therapy and K-ras status) to fruquintinib 5 mg or placebo once daily on days 1 to 21 of 28-day cycles. The primary endpoint was overall survival; progression-free survival was a key secondary endpoint.
Primary endpoint
OS
Arms
  • Placebo (control, n = 138): Placebo once daily for 21 days, then 7 days off
  • Fruquintinib (experimental, n = 278): Fruquintinib 5 mg once daily for 21 days, then 7 days off
People
Li J
OSHR 0.65 (95% CI 0.51–0.83)Δ median OS+2.7 monthsPFSHR 0.26 (95% CI 0.21–0.34)Δ median PFS+1.9 months
Show the numbers
Results reported for FRESCO
EndpointAnalysisFruquintinibPlaceboEffect
OSAll randomised patients (analysis population not stated in the abstract)Overall survival (primary endpoint)primaryLi 2018median 9.3 months (8.2–10.5)median 6.6 months (5.9–8.1)HR 0.65 (95% CI 0.51–0.83)P<0.001
PFSAll randomised patients (analysis population not stated in the abstract)Progression-free survival (key secondary endpoint)primaryLi 2018median 3.7 months (3.7–4.6)median 1.8 months (1.8–1.8)HR 0.26 (95% CI 0.21–0.34)P<0.001
Results reported for FRESCO
EndpointAnalysisFruquintinibPlaceboEffect
OSAll randomised patients (analysis population not stated in the abstract)Overall survival (primary endpoint)primaryLi 2018median 9.3 months (8.2–10.5)median 6.6 months (5.9–8.1)HR 0.65 (95% CI 0.51–0.83)P<0.001
PFSAll randomised patients (analysis population not stated in the abstract)Progression-free survival (key secondary endpoint)primaryLi 2018median 3.7 months (3.7–4.6)median 1.8 months (1.8–1.8)HR 0.26 (95% CI 0.21–0.34)P<0.001
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OSPFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.650.51–0.83
PFS0.260.21–0.34
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%05101520Months (modelled)
  • Fruquintinib (experimental)
  • Placebo (control)

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

Data table (modelled values)
MonthsFruquintinibPlacebo
0100.0%100.0%
663.9%53.3%
1240.9%28.4%
1728.2%16.8%
2318.0%8.9%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%02468Months (modelled)
  • Fruquintinib (experimental)
  • Placebo (control)

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

Data table (modelled values)
MonthsFruquintinibPlacebo
0100.0%100.0%
268.8%46.3%
539.2%14.6%
726.9%6.8%
918.5%3.1%
Primary publication: Li J, Qin S, Xu RH, Shen L, Xu J, Bai Y, et al. Effect of Fruquintinib vs Placebo on Overall Survival in Patients With Previously Treated Metastatic Colorectal Cancer: The FRESCO Randomized Clinical Trial. JAMA. 2018;319(24):2486-2496. PubMedDOI

Appears in

Sources

  1. Li J, Qin S, Xu RH, Shen L, Xu J, Bai Y, et al. Effect of Fruquintinib vs Placebo on Overall Survival in Patients With Previously Treated Metastatic Colorectal Cancer: The FRESCO Randomized Clinical Trial. JAMA. 2018;319(24):2486-2496.

    PubMedDOI