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Bending the Curve Trial by Trial
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Randomized controlled trial of transarterial lipiodol chemoembolization for unresectable hepatocellular carcinoma

N = 80

Population
Asian patients with newly diagnosed unresectable HCC who fulfilled the entry criteria
Design
Randomised controlled trial in Asian patients with newly diagnosed unresectable HCC (80 of 279 fulfilled the entry criteria, March 1996 to October 1997): chemoembolisation with an emulsion of cisplatin in Lipiodol and gelatin-sponge particles via the hepatic artery, repeated every 2 to 3 months unless contraindicated or progressive, versus symptomatic treatment. Survival was the main end point.
Primary endpoint
OS
Arms
  • Chemoembolisation (experimental, n = 40): Transarterial chemoembolisation: cisplatin in Lipiodol emulsion plus gelatin-sponge particles, repeated every 2 to 3 months unless contraindicated or progressive
  • Symptomatic treatment (control, n = 40): Symptomatic treatment
People
Lo CM
Δ 12-month OS+25 points
Show the numbers
Results reported for Randomized controlled trial of transarterial lipiodol chemoembolization for unresectable hepatocellular carcinoma
EndpointAnalysisChemoembolisationSymptomatic treatmentEffect
OSRandomised patients; one control patient was excluded after randomisation because of unrecognised systemic metastasis (the abstract does not use the term ITT)Actuarial survival (main end point) at 1, 2 and 3 yearsprimaryLo 200257% at 12 mo; 31% at 2 y; 26% at 3 y32% at 12 mo; 11% at 2 y; 3% at 3 yP=0.002P value for the comparison of actuarial survival between the groups. After adjustment for baseline prognostic variables in a multivariate Cox model, the abstract reports a relative risk of death of 0.49 (95% CI 0.29-0.81; P = 0.006); it is published as a relative risk and is not entered as a hazard ratio here.
Results reported for Randomized controlled trial of transarterial lipiodol chemoembolization for unresectable hepatocellular carcinoma
EndpointAnalysisChemoembolisationSymptomatic treatmentEffect
OSRandomised patients; one control patient was excluded after randomisation because of unrecognised systemic metastasis (the abstract does not use the term ITT)Actuarial survival (main end point) at 1, 2 and 3 yearsprimaryLo 200257% at 12 mo; 31% at 2 y; 26% at 3 y32% at 12 mo; 11% at 2 y; 3% at 3 yP=0.002P value for the comparison of actuarial survival between the groups. After adjustment for baseline prognostic variables in a multivariate Cox model, the abstract reports a relative risk of death of 0.49 (95% CI 0.29-0.81; P = 0.006); it is published as a relative risk and is not entered as a hazard ratio here.
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%0102030Months (modelled)
  • Chemoembolisation (experimental)
  • Symptomatic treatment (control)
Data table (modelled values)
MonthsChemoembolisationSymptomatic treatment
0100.0%100.0%
1063.2%40.6%
1939.3%16.4%
2927.6%6.7%
3926.0%3.0%
Primary publication: Lo CM, Ngan H, Tso WK, Liu CL, Lam CM, Poon RT, et al. Randomized controlled trial of transarterial lipiodol chemoembolization for unresectable hepatocellular carcinoma. Hepatology. 2002;35(5):1164-71. PubMedDOI

Appears in

Sources

  1. Lo CM, Ngan H, Tso WK, Liu CL, Lam CM, Poon RT, et al. Randomized controlled trial of transarterial lipiodol chemoembolization for unresectable hepatocellular carcinoma. Hepatology. 2002;35(5):1164-71.

    PubMedDOI