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STORM

Adjuvant sorafenib for hepatocellular carcinoma after resection or ablation (STORM): a phase 3, randomised, double-blind, placebo-controlled trial

Phase 3N = 1,114NCT00692770

Population
HCC with a complete radiological response after surgical resection or local ablation
Design
Phase 3, randomised (1:1), double-blind, placebo-controlled trial at 202 sites in 28 countries: sorafenib 400 mg orally twice daily or placebo for a maximum of 4 years in patients with a complete radiological response after surgical resection (n=900) or local ablation (n=214); stratified by curative treatment, geography, Child-Pugh status and recurrence risk. The final analysis is reported.
Primary endpoint
RFS
Arms
  • Sorafenib (experimental, n = 556): Sorafenib 400 mg orally twice daily for a maximum of 4 years
  • Placebo (control, n = 558): Placebo orally twice daily for a maximum of 4 years
People
Bruix J
RFSHR 0.940 (95% CI 0.780–1.134)Δ median RFS−0.4 months
Show the numbers
Results reported for STORM
EndpointAnalysisSorafenibPlaceboEffect
RFSRecurrence-free survival (primary outcome)finalBruix 2015median 33.3 monthsmedian 33.7 monthsHR 0.940 (95% CI 0.780–1.134)P=0.26One-sided p. 464 recurrence-free survival events had occurred (194 in the sorafenib group, 270 in the placebo group). Median follow-up for recurrence-free survival was 8.5 months (IQR 2.9-19.5) in the sorafenib group and 8.4 months (2.9-19.8) in the placebo group.
Results reported for STORM
EndpointAnalysisSorafenibPlaceboEffect
RFSRecurrence-free survival (primary outcome)finalBruix 2015median 33.3 monthsmedian 33.7 monthsHR 0.940 (95% CI 0.780–1.134)P=0.26One-sided p. 464 recurrence-free survival events had occurred (194 in the sorafenib group, 270 in the placebo group). Median follow-up for recurrence-free survival was 8.5 months (IQR 2.9-19.5) in the sorafenib group and 8.4 months (2.9-19.8) in the placebo group.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
RFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
RFS0.940.78–1.134
Illustrative — modelled from reported values, not trial data. RFS, final.
0%25%50%75%100%020406080Months (modelled)
  • Sorafenib (experimental)
  • Placebo (control)

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

Data table (modelled values)
MonthsSorafenibPlacebo
0100.0%100.0%
2164.6%64.9%
4241.7%42.2%
6326.9%27.4%
8417.4%17.8%
Primary publication: Bruix J, Takayama T, Mazzaferro V, Chau GY, Yang J, Kudo M, et al. Adjuvant sorafenib for hepatocellular carcinoma after resection or ablation (STORM): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2015;16(13):1344-54. PubMedDOI

Appears in

Sources

  1. Bruix J, Takayama T, Mazzaferro V, Chau GY, Yang J, Kudo M, et al. Adjuvant sorafenib for hepatocellular carcinoma after resection or ablation (STORM): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2015;16(13):1344-54.

    PubMedDOI