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Arterial embolisation or chemoembolisation versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomised controlled trial

N = 112

Population
Unresectable HCC not suitable for curative treatment; Child-Pugh class A or B and Okuda stage I or II
Design
Randomised controlled trial of regularly repeated arterial embolisation (gelatin sponge) or chemoembolisation (gelatin sponge plus doxorubicin) versus conservative treatment; patients with unresectable HCC not suitable for curative treatment. 903 patients were assessed and 112 (12%) included; stopped at the ninth sequential inspection; intention-to-treat analyses.
Primary endpoint
OS
Arms
  • Embolisation (experimental, n = 37): Regularly repeated arterial embolisation with gelatin sponge
  • Chemoembolisation (experimental, n = 40): Regularly repeated arterial chemoembolisation with gelatin sponge plus doxorubicin
  • Conservative treatment (control, n = 35): Conservative treatment
People
Llovet JM
OSHR 0.47 (95% CI 0.25–0.91)Δ 12-month OS+12 points
Show the numbers
Results reported for Arterial embolisation or chemoembolisation versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomised controlled trial
EndpointAnalysisEmbolisation / ChemoembolisationConservative treatmentEffect
OSSurvival (primary endpoint); probabilities at 1 and 2 yearsprimaryLlovet 200275% at 12 mo; 50% at 2 y63% at 12 mo; 27% at 2 yHR 0.47 (95% CI 0.25–0.91)P=0.025The hazard ratio of death is for chemoembolisation versus conservative treatment; the trial was stopped when the ninth sequential inspection showed a survival benefit for chemoembolisation. The comparison of survival probabilities for chemoembolisation versus control gave p = 0.009.
Results reported for Arterial embolisation or chemoembolisation versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomised controlled trial
EndpointAnalysisEmbolisation / ChemoembolisationConservative treatmentEffect
OSSurvival (primary endpoint); probabilities at 1 and 2 yearsprimaryLlovet 200275% at 12 mo; 50% at 2 y63% at 12 mo; 27% at 2 yHR 0.47 (95% CI 0.25–0.91)P=0.025The hazard ratio of death is for chemoembolisation versus conservative treatment; the trial was stopped when the ninth sequential inspection showed a survival benefit for chemoembolisation. The comparison of survival probabilities for chemoembolisation versus control gave p = 0.009.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.470.25–0.91
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%0510152025Months (modelled)
  • Embolisation (experimental)
  • Chemoembolisation (experimental)
  • Conservative treatment (control)
Data table (modelled values)
MonthsEmbolisationChemoembolisationConservative treatment
0100.0%100.0%100.0%
687.5%91.1%81.4%
1372.9%80.5%60.0%
1960.4%71.0%41.9%
2650.0%63.0%27.0%
Primary publication: Llovet JM, Real MI, Montaña X, Planas R, Coll S, Aponte J, et al. Arterial embolisation or chemoembolisation versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomised controlled trial. Lancet. 2002;359(9319):1734-9. PubMedDOI

Appears in

Sources

  1. Llovet JM, Real MI, Montaña X, Planas R, Coll S, Aponte J, et al. Arterial embolisation or chemoembolisation versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomised controlled trial. Lancet. 2002;359(9319):1734-9.

    PubMedDOI