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Bending the Curve Trial by Trial
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CORRECT

A Randomized, Double-blind, Placebo-controlled Phase III Study of Regorafenib Plus BSC Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy

Phase 3N = 760NCT01103323

Population
Metastatic colorectal cancer with progression during or within 3 months after the last standard therapy
Design
International, multicentre, randomised, placebo-controlled phase 3 trial at 114 centres in 16 countries. Randomisation was 2:1 to best supportive care plus regorafenib 160 mg or placebo once daily for the first 3 weeks of each 4-week cycle. Efficacy analyses were by intention to treat; the primary endpoint was met at a preplanned interim analysis.
Primary endpoint
OS
Arms
  • Placebo + best supportive care (control, n = 255): Placebo plus best supportive care
  • Regorafenib + best supportive care (experimental, n = 505): Regorafenib 160 mg once daily, 3 weeks on and 1 week off, plus best supportive care
People
Grothey A
OSHR 0.77 (95% CI 0.64–0.94)Δ median OS+1.4 months
Show the numbers
Results reported for CORRECT
EndpointAnalysisRegorafenib + best supportive carePlacebo + best supportive careEffect
OSOverall survival (primary endpoint), preplanned interim analysisinterimGrothey 2013median 6.4 monthsmedian 5 monthsHR 0.77 (95% CI 0.64–0.94)P=0.0052 (one-sided)The abstract states that the primary endpoint was met at a preplanned interim analysis.
Results reported for CORRECT
EndpointAnalysisRegorafenib + best supportive carePlacebo + best supportive careEffect
OSOverall survival (primary endpoint), preplanned interim analysisinterimGrothey 2013median 6.4 monthsmedian 5 monthsHR 0.77 (95% CI 0.64–0.94)P=0.0052 (one-sided)The abstract states that the primary endpoint was met at a preplanned interim analysis.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.770.64–0.94
Illustrative — modelled from reported values, not trial data. OS, interim.
0%25%50%75%100%051015Months (modelled)
  • Regorafenib + best supportive care (experimental)
  • Placebo + best supportive care (control)

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

Data table (modelled values)
MonthsRegorafenib + best supportive carePlacebo + best supportive care
0100.0%100.0%
464.8%57.4%
842.0%33.0%
1227.3%18.9%
1617.7%10.9%
Primary publication: Grothey A, Van Cutsem E, Sobrero A, Siena S, Falcone A, Ychou M, et al. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet. 2013;381(9863):303-12. PubMedDOI

Appears in

Sources

  1. Grothey A, Van Cutsem E, Sobrero A, Siena S, Falcone A, Ychou M, et al. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet. 2013;381(9863):303-12.

    PubMedDOI