Long-term safety and efficacy of lanreotide autogel in Japanese patients with neuroendocrine tumors: Final results of a phase II open-label extension study.

Ito T, Fujimori N, Honma Y, Kudo A, Hijioka S, Katsushima S, Kimura Y, Fukutomi A, Hisamatsu S, Nakajima A, Shimatsu A

Asia-Pacific journal of clinical oncology5 Aug 2020Cited by 10 (Europe PMC)

PMID32757459PMCIDPMC8596629DOI10.1111/ajco.13371PepBankPUB-32757459

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Summary

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Text rights: CC BY-NC. Results still quote short attributed sentences.

Results from this study11

11 results from studies that gave the peptide. 11 results from people.

01HumanNon-randomized trialEfficacy outcome
With lanreotide, two Japanese NET patients (7.1%) had partial responses at 60 and 108 weeks.
In plain wordsWith lanreotide, two Japanese NET patients had partial tumor responses at 60 and 108 weeks.
Peptide
Lanreotide
Outcome
Not applicablePartial tumor response
Study
n = 28
Outcome group
Tumor growth · Cancer
Studied dose
120 mg every 4 weeks · subcutaneous · median 52.7 weeks (range 12-181), efficacy analysis setAs given in this study (human).
Measurements
Patients with partial response
2 patients
efficacy analysis set
Patients with partial response
7.1%
efficacy analysis set
Time of partial response
60 weeks
one reported response
Time of partial response
108 weeks
other reported response
Source sentences
Summary
Partial response was observed in 2 patients (7.1%; at 60 and 108 weeks), stable disease in 20 (71.4%) and progressive disease in 6 (21.4%).
2 context sentences(design, population, supporting numbers)
Summary · context
The final analyses of a 48-week open-label phase II study (n = 32) and its extension study (n = 17) were conducted. Patients received 4-weekly subcutaneous injections of lanreotide autogel 120 mg.
Summary · context
The median (range) of lanreotide exposure in the safety analysis set (n = 17) and efficacy analysis set (n = 28) were 151.4 (52-181) and 52.7 (12-181) weeks, respectively.
Report a problemFND-3275745907
02HumanNon-randomized trialEfficacy outcome
With lanreotide, 20 Japanese NET patients (71.4%) had stable disease.
In plain wordsWith lanreotide, 20 Japanese NET patients had stable disease.
Peptide
Lanreotide
Outcome
Not applicableStable disease
Study
n = 28
Outcome group
Tumor growth · Cancer
Studied dose
120 mg every 4 weeks · subcutaneous · median 52.7 weeks (range 12-181), efficacy analysis setAs given in this study (human).
Measurements
Patients with stable disease
20 patients
efficacy analysis set
Patients with stable disease
71.4%
efficacy analysis set
Source sentences
Summary
Partial response was observed in 2 patients (7.1%; at 60 and 108 weeks), stable disease in 20 (71.4%) and progressive disease in 6 (21.4%).
2 context sentences(design, population, supporting numbers)
Summary · context
The final analyses of a 48-week open-label phase II study (n = 32) and its extension study (n = 17) were conducted. Patients received 4-weekly subcutaneous injections of lanreotide autogel 120 mg.
Summary · context
The median (range) of lanreotide exposure in the safety analysis set (n = 17) and efficacy analysis set (n = 28) were 151.4 (52-181) and 52.7 (12-181) weeks, respectively.
Report a problemFND-3275745908
03HumanNon-randomized trialEfficacy outcome
With lanreotide, six Japanese NET patients (21.4%) had progressive disease.
In plain wordsWith lanreotide, six Japanese NET patients had progressive disease.
Peptide
Lanreotide
Outcome
Not applicableProgressive disease
Study
n = 28
Outcome group
Tumor growth · Cancer
Studied dose
120 mg every 4 weeks · subcutaneous · median 52.7 weeks (range 12-181), efficacy analysis setAs given in this study (human).
Measurements
Patients with progressive disease
6 patients
efficacy analysis set
Patients with progressive disease
21.4%
efficacy analysis set
Source sentences
Summary
Partial response was observed in 2 patients (7.1%; at 60 and 108 weeks), stable disease in 20 (71.4%) and progressive disease in 6 (21.4%).
2 context sentences(design, population, supporting numbers)
Summary · context
The final analyses of a 48-week open-label phase II study (n = 32) and its extension study (n = 17) were conducted. Patients received 4-weekly subcutaneous injections of lanreotide autogel 120 mg.
Summary · context
The median (range) of lanreotide exposure in the safety analysis set (n = 17) and efficacy analysis set (n = 28) were 151.4 (52-181) and 52.7 (12-181) weeks, respectively.
Report a problemFND-3275745909
04HumanNon-randomized trialEfficacy outcome
In Japanese NET patients receiving lanreotide, mean greatest change in summed target lesion diameters was -5.5% from baseline.
In plain wordsIn Japanese NET patients receiving lanreotide, summed target lesion diameters decreased by a mean greatest change of 5.5%.
Peptide
Lanreotide
Outcome
DecreaseGreatest target lesion diameter change
Study
n = 28
Outcome group
Tumor growth · Cancer
Studied dose
120 mg every 4 weeks · subcutaneous · median 52.7 weeks (range 12-181), efficacy analysis setAs given in this study (human).
Measurements
Mean greatest change in sum of target lesion diameters
−5.5%
change from baseline, efficacy analysis set
Source sentences
Summary
The mean of the greatest change from baseline in the sum of diameters of target lesions was -5.5%.
2 context sentences(design, population, supporting numbers)
Summary · context
The final analyses of a 48-week open-label phase II study (n = 32) and its extension study (n = 17) were conducted. Patients received 4-weekly subcutaneous injections of lanreotide autogel 120 mg.
Summary · context
The median (range) of lanreotide exposure in the safety analysis set (n = 17) and efficacy analysis set (n = 28) were 151.4 (52-181) and 52.7 (12-181) weeks, respectively.
Report a problemFND-3275745910
05HumanNon-randomized trialSafety outcome
During prolonged lanreotide treatment in Japanese NET patients, 16 patients developed adverse drug reactions.
In plain wordsDuring prolonged lanreotide treatment, 16 Japanese NET patients developed drug reactions.
Peptide
Lanreotide
Outcome
Not applicableAdverse drug reactions
Study
n = 17
Outcome group
Adverse events · Whole body
Studied dose
120 mg every 4 weeks · subcutaneous · median 151.4 weeks (range 52-181), safety analysis setAs given in this study (human).
Measurements
Patients with adverse drug reaction
16 patients
safety analysis set
Source sentences
Summary
Sixteen patients developed adverse drug reaction; of these, upper abdominal pain and urticaria were not reported before 48 weeks.
2 context sentences(design, population, supporting numbers)
Summary · context
The final analyses of a 48-week open-label phase II study (n = 32) and its extension study (n = 17) were conducted. Patients received 4-weekly subcutaneous injections of lanreotide autogel 120 mg.
Summary · context
The median (range) of lanreotide exposure in the safety analysis set (n = 17) and efficacy analysis set (n = 28) were 151.4 (52-181) and 52.7 (12-181) weeks, respectively.
Report a problemFND-3275745901
06HumanNon-randomized trialSafety outcome
Upper abdominal pain emerged as a lanreotide adverse drug reaction not reported before 48 weeks in Japanese NET patients.
In plain wordsJapanese NET patients had upper abdominal pain during lanreotide treatment that was not reported before 48 weeks.
Peptide
Lanreotide
Outcome
Not applicableUpper abdominal pain after 48 weeks
Study
n = 17
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
120 mg every 4 weeks · subcutaneous · median 151.4 weeks (range 52-181), safety analysis setAs given in this study (human).
Source sentences
Summary
Sixteen patients developed adverse drug reaction; of these, upper abdominal pain and urticaria were not reported before 48 weeks.
2 context sentences(design, population, supporting numbers)
Summary · context
The final analyses of a 48-week open-label phase II study (n = 32) and its extension study (n = 17) were conducted. Patients received 4-weekly subcutaneous injections of lanreotide autogel 120 mg.
Summary · context
The median (range) of lanreotide exposure in the safety analysis set (n = 17) and efficacy analysis set (n = 28) were 151.4 (52-181) and 52.7 (12-181) weeks, respectively.
Report a problemFND-3275745902
07HumanNon-randomized trialSafety outcome
Urticaria emerged as a lanreotide adverse drug reaction not reported before 48 weeks in Japanese NET patients.
In plain wordsJapanese NET patients had urticaria during lanreotide treatment that was not reported before 48 weeks.
Peptide
Lanreotide
Outcome
Not applicableUrticaria after 48 weeks
Study
n = 17
Outcome group
Adverse events · Skin and wound
Studied dose
120 mg every 4 weeks · subcutaneous · median 151.4 weeks (range 52-181), safety analysis setAs given in this study (human).
Source sentences
Summary
Sixteen patients developed adverse drug reaction; of these, upper abdominal pain and urticaria were not reported before 48 weeks.
2 context sentences(design, population, supporting numbers)
Summary · context
The final analyses of a 48-week open-label phase II study (n = 32) and its extension study (n = 17) were conducted. Patients received 4-weekly subcutaneous injections of lanreotide autogel 120 mg.
Summary · context
The median (range) of lanreotide exposure in the safety analysis set (n = 17) and efficacy analysis set (n = 28) were 151.4 (52-181) and 52.7 (12-181) weeks, respectively.
Report a problemFND-3275745903
08HumanNon-randomized trialSafety outcome
No Japanese NET patient discontinued lanreotide because of an adverse event.
In plain wordsNo Japanese NET patient stopped lanreotide because of an adverse event.
Peptide
Lanreotide
Outcome
Not applicableDiscontinuation due to adverse events
Study
n = 17
Outcome group
Adverse events · Whole body
Studied dose
120 mg every 4 weeks · subcutaneous · median 151.4 weeks (range 52-181), safety analysis setAs given in this study (human).
Source sentences
Summary
No patient discontinued lanreotide or died from an adverse event.
2 context sentences(design, population, supporting numbers)
Summary · context
The final analyses of a 48-week open-label phase II study (n = 32) and its extension study (n = 17) were conducted. Patients received 4-weekly subcutaneous injections of lanreotide autogel 120 mg.
Summary · context
The median (range) of lanreotide exposure in the safety analysis set (n = 17) and efficacy analysis set (n = 28) were 151.4 (52-181) and 52.7 (12-181) weeks, respectively.
Report a problemFND-3275745904
09HumanNon-randomized trialSafety outcome
No Japanese NET patient died from an adverse event during lanreotide treatment.
In plain wordsNo Japanese NET patient died from an adverse event during lanreotide treatment.
Peptide
Lanreotide
Outcome
Not applicableDeath from adverse events
Study
n = 17
Outcome group
Mortality · Whole body
Studied dose
120 mg every 4 weeks · subcutaneous · median 151.4 weeks (range 52-181), safety analysis setAs given in this study (human).
Source sentences
Summary
No patient discontinued lanreotide or died from an adverse event.
2 context sentences(design, population, supporting numbers)
Summary · context
The final analyses of a 48-week open-label phase II study (n = 32) and its extension study (n = 17) were conducted. Patients received 4-weekly subcutaneous injections of lanreotide autogel 120 mg.
Summary · context
The median (range) of lanreotide exposure in the safety analysis set (n = 17) and efficacy analysis set (n = 28) were 151.4 (52-181) and 52.7 (12-181) weeks, respectively.
Report a problemFND-3275745905
10HumanNon-randomized trialSafety outcome
One Japanese NET patient had two serious bile duct stone events related to lanreotide.
In plain wordsOne Japanese NET patient had two serious bile duct stone events related to lanreotide.
Peptide
Lanreotide
Outcome
Not applicableSerious bile duct stones
Study
n = 17
Outcome group
Adverse events · Gastrointestinal
Studied dose
120 mg every 4 weeks · subcutaneous · median 151.4 weeks (range 52-181), safety analysis setAs given in this study (human).
Measurements
Serious drug-related bile duct stone events
2 events
one patient
Patients with serious drug-related bile duct stones
1 patients
safety analysis set
Source sentences
Summary
Two serious events of bile duct stones in one patient were drug-related.
2 context sentences(design, population, supporting numbers)
Summary · context
The final analyses of a 48-week open-label phase II study (n = 32) and its extension study (n = 17) were conducted. Patients received 4-weekly subcutaneous injections of lanreotide autogel 120 mg.
Summary · context
The median (range) of lanreotide exposure in the safety analysis set (n = 17) and efficacy analysis set (n = 28) were 151.4 (52-181) and 52.7 (12-181) weeks, respectively.
Report a problemFND-3275745906
11HumanNon-randomized trialEfficacy outcome
In Japanese NET patients, mean tumor growth rate was 25.3%/month before lanreotide and 6.4%/month during treatment.
In plain wordsIn Japanese NET patients, mean tumor growth rate decreased from 25.3%/month before lanreotide to 6.4%/month during treatment.
Peptide
Lanreotide
Outcome
DecreaseTumor growth rate
Study
n: not reported in source
Comparator
pre-treatment tumor growth rate
Outcome group
Tumor growth · Cancer
Studied dose
120 mg every 4 weeks · subcutaneousAs given in this study (human).
Measurements
Mean tumor growth rate
25.3 %/month
before treatment
SD of tumor growth rate
35.7 %/month
before treatment
Mean tumor growth rate
6.4 %/month
baseline to last observation on lanreotide
SD of tumor growth rate
9.6 %/month
baseline to last observation on lanreotide
Source sentences
Summary
The mean (standard deviation) tumor growth rate before treatment and from baseline to last observation was 25.3% (35.7%)/month and 6.4% (9.6%)/month, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
The final analyses of a 48-week open-label phase II study (n = 32) and its extension study (n = 17) were conducted. Patients received 4-weekly subcutaneous injections of lanreotide autogel 120 mg.
Report a problemFND-3275745911

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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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