Percutaneous ethanol instillation therapy for hepatocellular carcinoma - a randomized controlled trial.
OBJECTIVE
The aim of the study was to compare the clinical outcome of additional percutaneous ethanol instillation (PEI) against no further treatment in patients with hepatocellular carcinoma receiving hormonal treatment with long-acting octreotide.


METHODS
In a randomized controlled trial conducted in a tertiary care center, a total of 61 patients with inoperable hepatocellular carcinoma were treated with long-acting octreotide 30 mg i.m. once a month and randomly assigned to receive either PEI (31 patients) or no further treatment (30 patients).


RESULTS
Median survival time did not significantly differ between the long-acting octreotide plus PEI group (14 months; 95% CI: 9-28 months) and the long-acting octreotide alone group (22 months; 95% CI: 10-30 months) (logrank test P = 0.9). Similarly, an analysis stratifying for tumor diameter (< 5 cm or 5-8 cm) showed no significant survival differences between PEI or non-PEI treatment (logrank test P = 0.68). Progression-free survival according to RECIST was similar in the two groups (median: 3 months [3-6 months 95% CI] vs. 6 months [3-7 months 95% CI], logrank test P = 0.63). Time of local tumor control did not significantly differ between the two groups (6 months vs. 6 months). The course of alpha-fetoprotein levels and the reported quality of life were similar in the two groups.


CONCLUSIONS
The addition of PEI to treatment with long-acting octreotide in patients with hepatocellular carcinoma did not result in better overall survival, longer progression-free survival or longer time of local tumor control.
Müller
Christian
C
Universitätsklinik für Innere Medizin III, Klinische Abteilung für Gastroenterologie und Hepatologie, Medical University of Vienna, Austria. christian.j.mueller@meduniwien.ac.at
Schöniger-Hekele
Maximilian
M
Schernthaner
Rüdiger
R
Renner
Barbara
B
Peck-Radosavljevic
Markus
M
Brichta
Andrea
A
Wrba
Fritz
F
Posch
Martin
M
Bauer
Peter
P
Ferenci
Peter
P
Gangl
Alfred
A
D000368:Aged; D000369:Aged, 80 and over; D001317:Austria / Q000453:epidemiology; D006528:Carcinoma, Hepatocellular / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality*; D000431:Ethanol / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D015994:Incidence; D007279:Injections, Subcutaneous; D007322:Instillation, Drug; D008113:Liver Neoplasms / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality*; D008297:Male; D008875:Middle Aged; D018570:Risk Assessment; D012307:Risk Factors; D013534:Survival; D015996:Survival Rate; D016896:Treatment Outcome
D000431:Ethanol