Efficacy of the combination of long-acting release octreotide and tamoxifen in patients with advanced hepatocellular carcinoma: a randomised multicentre phase III study

Br J Cancer. 2007 Sep 3;97(5):582-8. doi: 10.1038/sj.bjc.6603901. Epub 2007 Aug 7.


To assess the efficacy of the combination of long-acting release (LAR) octreotide and tamoxifen (TMX) for the treatment of advanced hepatocellular carcinoma (HCC). A total of 109 patients with advanced HCC were randomised to receive octreotide LAR combined with TMX (n=56) (experimental treatment group) or TMX alone (n=53; control group). The clinical, biological and tumoural parameters were recorded every 3 months until death. Primary end point was patient survival; secondary end points were the impact of therapy on tumour response, quality of life and variceal bleeding episodes. Univariate and multivariate analyses were performed for assessment of specific prognostic factors. The median survival was 3 months (95% CI 1.4-4.6) for the experimental treatment group and 6 months (CI 95% 2-10) for the control group (P=0.609). There was no difference in terms of alpha-foetoprotein (alpha-FP) decrease, tumour regression, improvement of quality of life and prevention of variceal bleeding between the two groups. Variables associated with a better survival in the multivariate analysis were: presence of cirrhosis, alpha-FP level <400 ng ml(-1) and Okuda stage I. The combination of octreotide LAR and TMX does not influence survival, tumour progression or quality of life in patients with advanced HCC.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Carcinoma, Hepatocellular / drug therapy*
  • Carcinoma, Hepatocellular / metabolism
  • Carcinoma, Hepatocellular / pathology
  • Diarrhea / chemically induced
  • Female
  • Humans
  • Liver Neoplasms / drug therapy*
  • Liver Neoplasms / metabolism
  • Liver Neoplasms / pathology
  • Male
  • Middle Aged
  • Multivariate Analysis
  • Nausea / chemically induced
  • Neoplasm Staging
  • Octreotide / administration & dosage
  • Octreotide / adverse effects
  • Patient Compliance / statistics & numerical data
  • Prognosis
  • Quality of Life
  • Survival Analysis
  • Tamoxifen / administration & dosage
  • Tamoxifen / adverse effects
  • Treatment Outcome
  • alpha-Fetoproteins / metabolism


  • alpha-Fetoproteins
  • Tamoxifen
  • Octreotide