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Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial

Phase 3N = 226NCT00492752

Population
Patients from the Asia-Pacific region with advanced (unresectable or metastatic) hepatocellular carcinoma, Child-Pugh class A, no previous systemic therapy
Design
Multinational double-blind, placebo-controlled phase 3 trial at 23 centres in China, South Korea and Taiwan; randomisation 2:1 to oral sorafenib 400 mg or placebo twice daily in 6-week cycles, stratified by macroscopic vascular invasion or extrahepatic spread, ECOG performance status and region. No predefined primary endpoint; overall survival, time to progression, time to symptomatic progression, disease control rate and safety were assessed; efficacy analyses were by intention to treat.
Arms
  • Sorafenib (experimental, n = 150): Sorafenib 400 mg twice daily
  • Placebo (control, n = 76): Placebo twice daily
People
Cheng AL
OSHR 0.68 (95% CI 0.50–0.93)Δ median OS+2.3 monthsTTPHR 0.57 (95% CI 0.42–0.79)Δ median TTP+1.4 months
Show the numbers
Results reported for Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial
EndpointAnalysisSorafenibPlaceboEffect
OSprimaryCheng 2009median 6.5 months (5.56–7.56)median 4.2 months (3.75–5.46)HR 0.68 (95% CI 0.50–0.93)P=0.014The trial had no predefined primary endpoint; overall survival is reported as one of the assessed outcomes.
TTPprimaryCheng 2009median 2.8 months (2.63–3.58)median 1.4 months (1.35–1.55)HR 0.57 (95% CI 0.42–0.79)P=0.0005
Results reported for Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial
EndpointAnalysisSorafenibPlaceboEffect
OSprimaryCheng 2009median 6.5 months (5.56–7.56)median 4.2 months (3.75–5.46)HR 0.68 (95% CI 0.50–0.93)P=0.014The trial had no predefined primary endpoint; overall survival is reported as one of the assessed outcomes.
TTPprimaryCheng 2009median 2.8 months (2.63–3.58)median 1.4 months (1.35–1.55)HR 0.57 (95% CI 0.42–0.79)P=0.0005
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OSTTP0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.680.5–0.93
TTP0.570.42–0.79
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%051015Months (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%
465.3%51.7%
842.6%26.7%
1227.8%13.8%
1618.2%7.1%
Illustrative — modelled from reported values, not trial data. TTP, primary.
0%25%50%75%100%01234567Months (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%
261.0%37.1%
437.1%13.8%
529.0%8.4%
717.7%3.1%
Primary publication: Cheng AL, Kang YK, Chen Z, Tsao CJ, Qin S, Kim JS, et al. Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2009;10(1):25-34. PubMedDOI

Appears in

Sources

  1. Cheng AL, Kang YK, Chen Z, Tsao CJ, Qin S, Kim JS, et al. Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2009;10(1):25-34.

    PubMedDOI