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Bending the Curve Trial by Trial
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RESORCE

Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib treatment (RESORCE): a randomised, double-blind, placebo-controlled, phase 3 trial

Phase 3N = 573NCT01774344

Population
Adults with hepatocellular carcinoma who tolerated sorafenib (at least 400 mg/day for at least 20 of the last 28 days of treatment), progressed on sorafenib, and had Child-Pugh A liver function
Design
Randomised (2:1), double-blind, parallel-group phase 3 trial at 152 sites in 21 countries; best supportive care plus regorafenib 160 mg or placebo once daily in weeks 1 to 3 of each 4-week cycle; stratified by region, ECOG performance status, macrovascular invasion, extrahepatic disease and alpha-fetoprotein. Primary endpoint overall survival, analysed by intention to treat.
Primary endpoint
OS
Arms
  • Regorafenib plus best supportive care (experimental, n = 379): Regorafenib 160 mg once daily, weeks 1 to 3 of each 4-week cycle
  • Placebo plus best supportive care (control, n = 194): Placebo once daily, weeks 1 to 3 of each 4-week cycle
People
Bruix J, RESORCE Investigators
OSHR 0.63 (95% CI 0.50–0.79)Δ median OS+2.8 months
Show the numbers
Results reported for RESORCE
EndpointAnalysisRegorafenib plus best supportive carePlacebo plus best supportive careEffect
OSprimaryBruix 2017median 10.6 months (9.1–12.1)median 7.8 months (6.3–8.8)HR 0.63 (95% CI 0.50–0.79)P<0.0001 (one-sided)
Results reported for RESORCE
EndpointAnalysisRegorafenib plus best supportive carePlacebo plus best supportive careEffect
OSprimaryBruix 2017median 10.6 months (9.1–12.1)median 7.8 months (6.3–8.8)HR 0.63 (95% CI 0.50–0.79)P<0.0001 (one-sided)
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.630.5–0.79
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%0510152025Months (modelled)
  • Regorafenib plus best supportive care (experimental)
  • Placebo plus 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 plus best supportive carePlacebo plus best supportive care
0100.0%100.0%
763.3%53.7%
1342.7%31.5%
2027.0%16.9%
2717.1%9.1%
Primary publication: Bruix J, Qin S, Merle P, Granito A, Huang YH, Bodoky G, et al. Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib treatment (RESORCE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017;389(10064):56-66. PubMedDOI

Appears in

Sources

  1. Bruix J, Qin S, Merle P, Granito A, Huang YH, Bodoky G, et al. Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib treatment (RESORCE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017;389(10064):56-66.

    PubMedDOI