Authors
Josep M Llovet, Maria Isabel Real, Xavier Montaña, Ramon Planas, Susana Coll, John Aponte, Carmen Ayuso, Margarita Sala, Jordi Muchart, Ricard Solà, Joan Rodés, Jordi Bruix
Publication date
2002/5/18
Journal
The Lancet
Volume
359
Issue
9319
Pages
1734-1739
Publisher
Elsevier
Description
Background
There is no standard treatment for unresectable hepatocellular carcinoma. Arterial embolisation is widely used, but evidence of survival benefits is lacking.
Methods
We did a randomised controlled trial in patients with unresectable hepatocellular carcinoma not suitable for curative treatment, of Child-Pugh class A or B and Okuda stage I or II, to assess the survival benefits of regularly repeated arterial embolisation (gelatin sponge) or chemoembolisation (gelatin sponge plus doxorubicin) compared with conservative treatment. 903 patients were assessed, and 112 (12%) patients were finally included in the study. The primary endpoint was survival. Analyses were by intention to treat.
Findings
The trial was stopped when the ninth sequential inspection showed that chemoembolisation had survival benefits compared with conservative treatment (hazard ratio of death 0·47 [95% CI 0·25–0·91], p=0·025). 25 of …
Total citations
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