title: Treatment of advanced hepatocellular carcinoma with long-acting octreotide: a phase III multicentre, randomised, double blind placebo-controlled study.
abstract: 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.
authors.affiliation: Fédération Francophone de Cancérologie Digestive, Association Nationale des Hépato-Gastroentérologues des Hôpitaux Généraux, France. barbare.jeanclaude@chu-amiens.fr
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Barbare
authors.forename: Olivier
authors.initials: O
authors.lastname: Bouché
authors.forename: Franck
authors.initials: F
authors.lastname: Bonnetain
authors.forename: Laetitia
authors.initials: L
authors.lastname: Dahan
authors.forename: Catherine
authors.initials: C
authors.lastname: Lombard-Bohas
authors.forename: Roger
authors.initials: R
authors.lastname: Faroux
authors.forename: Jean-Luc
authors.initials: JL
authors.lastname: Raoul
authors.forename: Stéphane
authors.initials: S
authors.lastname: Cattan
authors.forename: Alain
authors.initials: A
authors.lastname: Lemoine
authors.forename: Jean-Frédéric
authors.initials: JF
authors.lastname: Blanc
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Bronowicki
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Zarski
authors.forename: Sophie
authors.initials: S
authors.lastname: Cazorla
authors.forename: Dany
authors.initials: D
authors.lastname: Gargot
authors.forename: Thierry
authors.initials: T
authors.lastname: Thevenot
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Diaz
authors.forename: Anne
authors.initials: A
authors.lastname: Bastie
authors.forename: Thomas
authors.initials: T
authors.lastname: Aparicio
authors.forename: Laurent
authors.initials: L
authors.lastname: Bedenne
mesh_terms: 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
chemical_list: D018931:Antineoplastic Agents, Hormonal; D015282:Octreotide