Treatment of advanced hepatocellular carcinoma with long-acting octreotide: a phase III multicentre, randomised, double blind placebo-controlled study.

Barbare JC, Bouché O, Bonnetain F, Dahan L, Lombard-Bohas C, Faroux R, Raoul JL, Cattan S, Lemoine A, Blanc JF, Bronowicki JP, Zarski JP and 7 more

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Cazorla S, Gargot D, Thevenot T, Diaz E, Bastie A, Aparicio T, Bedenne L

European journal of cancer (Oxford, England : 1990)19 Mar 2009Cited by 51 (Europe PMC)

PMID19303768DOI10.1016/j.ejca.2009.02.018PepBankPUB-19303768

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

01HumanRandomized controlled trialEfficacy outcome
In advanced HCC, median survival was 6.53 months with octreotide versus 7.03 months with placebo, without significance (p=0.34).
In plain wordsIn advanced liver cancer, survival was numerically shorter with octreotide than placebo, without a significant difference.
Peptide
Octreotide
Outcome
DecreaseOverall survival
Study
n = 272
Comparator
placebo
Outcome group
Mortality · Cancer
Studied dose
30 mg once every 4 weeks · intramuscular · up to 2 yearsAs given in this study (human).
Measurements
Median overall survival
6.53 months
octreotide group
Median overall survival
7.03 months
placebo group
95% CI of median overall survival
4.8 to 8.3 months
octreotide group
95% CI of median overall survival
5.43 to 8.53 months
placebo group
P value
0.34 P
octreotide versus placebo
Source sentences
Summary
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).
1 context sentence(design, population, supporting numbers)
Summary · context
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.
Report a problemFND-1930376801
02HumanRandomized controlled trialEfficacy outcome
In advanced HCC, octreotide did not significantly change progression-free survival versus placebo (p=0.26).
In plain wordsIn advanced liver cancer, octreotide did not significantly change time without progression versus placebo.
Peptide
Octreotide
Outcome
No significant changeProgression-free survival
Study
n = 272
Comparator
placebo
Outcome group
Tumor growth · Cancer
Studied dose
30 mg once every 4 weeks · intramuscular · up to 2 yearsAs given in this study (human).
Measurements
P value
0.26 P
progression-free survival, octreotide versus placebo
Source sentences
Summary
Progression-free survival (p=0.26) also did not differ significantly between the two treatment groups.
1 context sentence(design, population, supporting numbers)
Summary · context
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.
Report a problemFND-1930376802
03HumanRandomized controlled trialEfficacy outcome
In advanced HCC, no objective responses occurred with octreotide, compared with four objective responses with placebo.
In plain wordsIn advanced liver cancer, no objective tumor responses occurred with octreotide, compared with four with placebo.
Peptide
Octreotide
Outcome
DecreaseObjective responses
Study
n = 272
Comparator
placebo
Outcome group
Tumor growth · Cancer
Studied dose
30 mg once every 4 weeks · intramuscular · up to 2 yearsAs given in this study (human).
Measurements
Objective responses
4 responses
placebo group
Source sentences
Summary
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).
2 context sentences(design, population, supporting numbers)
Summary · context
There were four objective responses in the placebo group.
Summary · context
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.
Report a problemFND-1930376803
04HumanRandomized controlled trialEfficacy outcome
In advanced HCC, global health deterioration occurred at median 2.3 months with octreotide versus 4 months with placebo, without significance (p=0.09).
In plain wordsIn advanced liver cancer, global health deteriorated numerically sooner with octreotide than placebo, without a significant difference.
Peptide
Octreotide
Outcome
DecreaseTime to global health deterioration
Study
n = 272
Comparator
placebo
Outcome group
Quality of life · Cancer
Studied dose
30 mg once every 4 weeks · intramuscular · up to 2 yearsAs given in this study (human).
Measurements
Median time to global health score deterioration
2.3 months
octreotide group
Median time to global health score deterioration
4 months
placebo group
95% CI of median time to deterioration
1.4 to 3.7 months
octreotide group
95% CI of median time to deterioration
2.2 to 5.7 months
placebo group
P value
0.09 P
octreotide versus placebo
Source sentences
Summary
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).
1 context sentence(design, population, supporting numbers)
Summary · context
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.
Report a problemFND-1930376805
05HumanNon-randomized trialEfficacy outcome
In advanced HCC, 33% of octreotide patients achieved disease stabilization for a mean 5.5 months (95% CI 1.1-9.9).
In plain wordsIn advanced liver cancer, one-third of octreotide patients achieved stable disease for an average of 5.5 months.
Peptide
Octreotide
Outcome
Not applicableDisease stabilization
Study
n: not reported in source
Outcome group
Tumor growth · Cancer
Studied dose
30 mg once every 4 weeks · intramuscular · up to 2 yearsAs given in this study (human).
Measurements
Patients with disease stabilisation
33%
octreotide group
Mean time of disease stabilisation
5.5 months
octreotide group
95% CI of mean time of disease stabilisation
1.1 to 9.9 months
octreotide group
Source sentences
Summary
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).
1 context sentence(design, population, supporting numbers)
Summary · context
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.
Report a problemFND-1930376804
06HumanNon-randomized trialSafety outcome
In advanced HCC, seven octreotide patients reported severe adverse events possibly related to treatment.
In plain wordsIn advanced liver cancer, seven octreotide patients reported severe adverse events possibly related to treatment.
Peptide
Octreotide
Outcome
Not applicableSevere adverse events possibly related to octreotide
Study
n: not reported in source
Outcome group
Adverse events · Cancer
Studied dose
30 mg once every 4 weeks · intramuscular · up to 2 yearsAs given in this study (human).
Measurements
Patients with severe adverse events possibly related to octreotide
7 patients
octreotide group
Source sentences
Summary
Octreotide was well tolerated; seven patients reported severe adverse events possibly related to octreotide and there were no cases of haematoma or cholecystitis.
1 context sentence(design, population, supporting numbers)
Summary · context
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.
Report a problemFND-1930376806
07HumanNon-randomized trialSafety outcome
In advanced HCC, no haematoma cases occurred with octreotide.
In plain wordsIn advanced liver cancer, no haematoma cases occurred with octreotide.
Peptide
Octreotide
Outcome
Not applicableHaematoma
Study
n: not reported in source
Outcome group
Adverse events · Cancer
Studied dose
30 mg once every 4 weeks · intramuscular · up to 2 yearsAs given in this study (human).
Source sentences
Summary
Octreotide was well tolerated; seven patients reported severe adverse events possibly related to octreotide and there were no cases of haematoma or cholecystitis.
1 context sentence(design, population, supporting numbers)
Summary · context
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.
Report a problemFND-1930376807
08HumanNon-randomized trialSafety outcome
In advanced HCC, no cholecystitis cases occurred with octreotide.
In plain wordsIn advanced liver cancer, no gallbladder inflammation cases occurred with octreotide.
Peptide
Octreotide
Outcome
Not applicableCholecystitis
Study
n: not reported in source
Outcome group
Adverse events · Cancer
Studied dose
30 mg once every 4 weeks · intramuscular · up to 2 yearsAs given in this study (human).
Source sentences
Summary
Octreotide was well tolerated; seven patients reported severe adverse events possibly related to octreotide and there were no cases of haematoma or cholecystitis.
1 context sentence(design, population, supporting numbers)
Summary · context
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.
Report a problemFND-1930376808

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Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:36 UTC
First added · source update from Europe PMC

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