Treatment of advanced hepatocellular carcinoma with long-acting octreotide: a phase III multicentre, randomised, double blind placebo-controlled study.
BACKGROUND
A previous study reported a significant survival benefit for octreotide compared with no treatment in patients with advanced hepatocellular carcinoma (HCC). This was investigated further in this multicentre study.


METHODS
Two hundred and seventy two patients with HCC who were ineligible for curative treatments or had relapsed following potentially curative therapies were randomised to receive long-acting octreotide, 30 mg as an intramuscular injection once every 4 weeks for up to 2 years, or placebo.


RESULTS
At the time of the final analysis, median overall survival (OS) was 6.53 months (95% confidence interval [CI], 4.8-8.3) for octreotide versus 7.03 months (95% CI, 5.43-8.53) for placebo (p=0.34). Progression-free survival (p=0.26) also did not differ significantly between the two treatment groups. No objective responses were achieved in the octreotide group but 33% of patients achieved disease stabilisation for a mean time of 5.5 months (95% CI, 1.1-9.9). The median time until definitive global health score deterioration (according to QLQ-C30) was 2.3 months (95% CI, 1.4-3.7) in the octreotide and 4 months (95% CI, 2.2-5.7) in the placebo group (p=0.09). There were four objective responses in the placebo group. Octreotide was well tolerated; seven patients reported severe adverse events possibly related to octreotide and there were no cases of haematoma or cholecystitis.


CONCLUSIONS
In patients with advanced HCC, octreotide has a favourable safety profile but does not improve OS and could have a negative impact on quality of life.
Barbare
Jean-Claude
JC
Fédération Francophone de Cancérologie Digestive, Association Nationale des Hépato-Gastroentérologues des Hôpitaux Généraux, France. barbare.jeanclaude@chu-amiens.fr
Bouché
Olivier
O
Bonnetain
Franck
F
Dahan
Laetitia
L
Lombard-Bohas
Catherine
C
Faroux
Roger
R
Raoul
Jean-Luc
JL
Cattan
Stéphane
S
Lemoine
Alain
A
Blanc
Jean-Frédéric
JF
Bronowicki
Jean-Pierre
JP
Zarski
Jean-Pierre
JP
Cazorla
Sophie
S
Gargot
Dany
D
Thevenot
Thierry
T
Diaz
Emmanuel
E
Bastie
Anne
A
Aparicio
Thomas
T
Bedenne
Laurent
L
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018931:Antineoplastic Agents, Hormonal / Q000009:adverse effects / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D015282:Octreotide / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D016019:Survival Analysis; D016896:Treatment Outcome
D018931:Antineoplastic Agents, Hormonal; D015282:Octreotide