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


RESULTS
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 37 patients assigned embolisation, 21 of 40 assigned chemoembolisation, and 25 of 35 assigned conservative treatment died. Survival probabilities at 1 year and 2 years were 75% and 50% for embolisation; 82% and 63% for chemoembolisation, and 63% and 27% for control (chemoembolisation vs control p=0.009). Chemoembolisation induced objective responses sustained for at least 6 months in 35% (14)of cases, and was associated with a significantly lower rate of portal-vein invasion than conservative treatment. Treatment allocation was the only variable independently related to survival (odds ratio 0.45 [95% CI 0.25-0.81], p=0.02).


CONCLUSIONS
Chemoembolisation improved survival of stringently selected patients with unresectable hepatocellular carcinoma.
Llovet
Josep M
JM
Liver Unit, Digestive Disease Institute, Hospital Clínic, University of Barcelona, Barcelona, Spain.
Real
Maria Isabel
MI
Montaña
Xavier
X
Planas
Ramon
R
Coll
Susana
S
Aponte
John
J
Ayuso
Carmen
C
Sala
Margarita
M
Muchart
Jordi
J
Solà
Ricard
R
Rodés
Joan
J
Bruix
Jordi
J
D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D006528:Carcinoma, Hepatocellular / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D002423:Cause of Death; D016461:Chemoembolization, Therapeutic / Q000379:methods*; D004317:Doxorubicin / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis
D000970:Antineoplastic Agents; D004317:Doxorubicin