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GRID

Efficacy and safety of regorafenib for advanced gastrointestinal stromal tumours after failure of imatinib and sunitinib (GRID): an international, multicentre, randomised, placebo-controlled, phase 3 trial

Phase 3N = 199NCT01271712

Population
Patients with histologically confirmed metastatic or unresectable GIST with failure of at least imatinib and sunitinib
Design
Randomised (2:1), double-blind, placebo-controlled phase 3 trial at 57 hospitals in 17 countries: regorafenib 160 mg daily (first 3 weeks of each 4-week cycle) or matching placebo, plus best supportive care in both groups. Placebo patients could cross over to open-label regorafenib at progression. Analyses by intention to treat.
Primary endpoint
PFS
Arms
  • Regorafenib (experimental, n = 133): Regorafenib 160 mg daily, 3 weeks on / 1 week off, plus best supportive care
  • Placebo (control, n = 66): Placebo plus best supportive care
People
Demetri GD, Bayer
PFSHR 0.27 (95% CI 0.19–0.39)Δ median PFS+3.9 months
Show the numbers
Results reported for GRID
EndpointAnalysisRegorafenibPlaceboEffect
PFSPer independent blinded central reviewprimaryDemetri 2013median 4.8 monthsmedian 0.9 monthsHR 0.27 (95% CI 0.19–0.39)P<0.0001Interquartile ranges as published: 1.4 to 9.2 months (regorafenib) and 0.9 to 1.8 months (placebo); the abstract gives no confidence intervals for the medians. After progression, 56 patients (85%) assigned placebo crossed over to regorafenib.
Results reported for GRID
EndpointAnalysisRegorafenibPlaceboEffect
PFSPer independent blinded central reviewprimaryDemetri 2013median 4.8 monthsmedian 0.9 monthsHR 0.27 (95% CI 0.19–0.39)P<0.0001Interquartile ranges as published: 1.4 to 9.2 months (regorafenib) and 0.9 to 1.8 months (placebo); the abstract gives no confidence intervals for the medians. After progression, 56 patients (85%) assigned placebo crossed over to regorafenib.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.270.19–0.39
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%024681012Months (modelled)
  • Regorafenib (experimental)
  • Placebo (control)

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

Data table (modelled values)
MonthsRegorafenibPlacebo
0100.0%100.0%
364.8%9.9%
642.0%1.0%
927.3%0.1%
1217.7%0.0%
Primary publication: Demetri GD, Reichardt P, Kang YK, Blay JY, Rutkowski P, Gelderblom H, et al. Efficacy and safety of regorafenib for advanced gastrointestinal stromal tumours after failure of imatinib and sunitinib (GRID): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet. 2013;381(9863):295-302. PubMedDOI

Appears in

Sources

  1. Demetri GD, Reichardt P, Kang YK, Blay JY, Rutkowski P, Gelderblom H, et al. Efficacy and safety of regorafenib for advanced gastrointestinal stromal tumours after failure of imatinib and sunitinib (GRID): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet. 2013;381(9863):295-302.

    PubMedDOI