Study · Non-randomized trial · n = 30 · 2013

8 results

Antiproliferative effects of lanreotide autogel in patients with progressive, well-differentiated neuroendocrine tumours: a Spanish, multicentre, open-label, single arm phase II study.

Martín-Richard M, Massutí B, Pineda E, Alonso V, Marmol M, Castellano D, Fonseca E, Galán A, Llanos M, Sala MA, Pericay C, Rivera F and 4 more

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Sastre J, Segura A, Quindós M, Maisonobe P

BMC cancer20 Sept 2013Cited by 55 (Europe PMC)

PMID24053191PMCIDPMC3853091DOI10.1186/1471-2407-13-427PepBankPUB-24053191

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Summary

BackgroundSomatostatin analogues (SSAs) are indicated to relieve carcinoid syndrome but seem to have antiproliferative effects on neuroendocrine tumours (NETs). This is the first prospective study investigating tumour stabilisation with the long-acting SSA lanreotide Autogel in patients with progressive NETs.MethodsThis was a multicentre, open-label, phase II trial conducted in 17 Spanish specialist centres. Patients with well-differentiated NETs and radiologically confirmed progression within the previous 6 months received lanreotide Autogel, 120 mg every 28 days over ≤92 weeks. The primary endpoint was progression-free survival (PFS). Secondary endpoints were response rate, tumour biomarkers, symptom control, quality of life (QoL), and safety. Radiographic imaging was assessed by a blinded central radiologist.ResultsOf 30 patients included in the efficacy and safety analyses, 40% had midgut tumours and 27% pancreatic tumours; 63% of tumours were functioning. Median PFS time was 12.9 (95% CI: 7.9, 16.5) months, and most patients achieved disease stabilisation (89%) or partial response (4%). No deterioration in QoL was observed. Nineteen patients (63%) experienced treatment-related adverse events, most frequently diarrhoea and asthenia; only one treatment-related adverse event (aerophagia) was severe.ConclusionLanreotide Autogel provided effective tumour stabilisation and PFS >12 months in patients with progressive NETs ineligible for surgery or chemotherapy, with a safety profile consistent with the pharmacology of the class.Trial registrationClinicalTrials.gov Identifier NCT00326469; EU Clinical Trial Register EudraCT no 2004-002871-18.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study8

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

01HumanNon-randomized trialEfficacy outcome
In progressive NETs, median progression-free survival with lanreotide was 12.9 months (95% CI 7.9, 16.5).
In plain wordsIn progressive NETs, median time without progression with lanreotide was 12.9 months.
Peptide
Lanreotide
Outcome
Not applicableProgression-free survival
Study
n = 30
Analysis
Primary
Outcome group
Tumor growth · Cancer
Studied dose
120 mg every 28 days · ≤92 weeksAs given in this study (human).
Measurements
Median progression-free survival
12.9 months
30 patients
95% CI of median progression-free survival
7.9 to 16.5 months
30 patients
Source sentences
Summary
Median PFS time was 12.9 (95% CI: 7.9, 16.5) months, and most patients achieved disease stabilisation (89%) or partial response (4%).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients with well-differentiated NETs and radiologically confirmed progression within the previous 6 months received lanreotide Autogel, 120 mg every 28 days over ≤92 weeks.
Show in the study text Report a problemFND-2405319101
02HumanNon-randomized trialEfficacy outcome
In progressive NETs, 4% achieved partial response with lanreotide.
In plain wordsIn progressive NETs, 4% achieved a partial response with lanreotide.
Peptide
Lanreotide
Outcome
Not applicablePartial response
Study
n = 30
Analysis
Secondary
Outcome group
Tumor growth · Cancer
Studied dose
120 mg every 28 days · ≤92 weeksAs given in this study (human).
Measurements
Partial response
4%
30 patients
Source sentences
Summary
Median PFS time was 12.9 (95% CI: 7.9, 16.5) months, and most patients achieved disease stabilisation (89%) or partial response (4%).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients with well-differentiated NETs and radiologically confirmed progression within the previous 6 months received lanreotide Autogel, 120 mg every 28 days over ≤92 weeks.
Show in the study text Report a problemFND-2405319103
03HumanNon-randomized trialEfficacy outcome
In progressive NETs, quality of life did not deteriorate during lanreotide treatment.
In plain wordsIn progressive NETs, quality of life did not worsen during lanreotide treatment.
Peptide
Lanreotide
Outcome
Direction not reportedQuality of life
Study
n = 30
Analysis
Secondary
Outcome group
Quality of life · Whole body
Studied dose
120 mg every 28 days · ≤92 weeksAs given in this study (human).
Source sentences
Summary
No deterioration in QoL was observed.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients with well-differentiated NETs and radiologically confirmed progression within the previous 6 months received lanreotide Autogel, 120 mg every 28 days over ≤92 weeks.
Show in the study text Report a problemFND-2405319104
04HumanNon-randomized trialSafety outcome
In progressive NETs, 19 patients (63%) experienced treatment-related adverse events with lanreotide.
In plain wordsIn progressive NETs, 19 patients (63%) experienced treatment-related adverse events with lanreotide.
Peptide
Lanreotide
Outcome
Not applicableTreatment-related adverse events
Study
n = 30
Analysis
Secondary
Outcome group
Adverse events · Whole body
Studied dose
120 mg every 28 days · ≤92 weeksAs given in this study (human).
Measurements
Patients with treatment-related adverse events
19 patients
30 patients
Patients with treatment-related adverse events
63%
30 patients
Source sentences
Summary
Nineteen patients (63%) experienced treatment-related adverse events, most frequently diarrhoea and asthenia; only one treatment-related adverse event (aerophagia) was severe.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients with well-differentiated NETs and radiologically confirmed progression within the previous 6 months received lanreotide Autogel, 120 mg every 28 days over ≤92 weeks.
Show in the study text Report a problemFND-2405319105
05HumanNon-randomized trialSafety outcome
In progressive NETs, diarrhoea was among the most frequent treatment-related adverse events with lanreotide.
In plain wordsIn progressive NETs, diarrhea was among the most frequent treatment-related adverse events with lanreotide.
Peptide
Lanreotide
Outcome
Not applicableDiarrhoea
Study
n = 30
Analysis
Secondary
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
120 mg every 28 days · ≤92 weeksAs given in this study (human).
Source sentences
Summary
Nineteen patients (63%) experienced treatment-related adverse events, most frequently diarrhoea and asthenia; only one treatment-related adverse event (aerophagia) was severe.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients with well-differentiated NETs and radiologically confirmed progression within the previous 6 months received lanreotide Autogel, 120 mg every 28 days over ≤92 weeks.
Show in the study text Report a problemFND-2405319106
06HumanNon-randomized trialSafety outcome
In progressive NETs, asthenia was among the most frequent treatment-related adverse events with lanreotide.
In plain wordsIn progressive NETs, weakness was among the most frequent treatment-related adverse events with lanreotide.
Peptide
Lanreotide
Outcome
Not applicableAsthenia
Study
n = 30
Analysis
Secondary
Outcome group
Adverse events · Whole body
Studied dose
120 mg every 28 days · ≤92 weeksAs given in this study (human).
Source sentences
Summary
Nineteen patients (63%) experienced treatment-related adverse events, most frequently diarrhoea and asthenia; only one treatment-related adverse event (aerophagia) was severe.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients with well-differentiated NETs and radiologically confirmed progression within the previous 6 months received lanreotide Autogel, 120 mg every 28 days over ≤92 weeks.
Show in the study text Report a problemFND-2405319107
07HumanNon-randomized trialSafety outcome
In progressive NETs, one treatment-related aerophagia event with lanreotide was severe, the only severe treatment-related event.
In plain wordsIn progressive NETs, one air-swallowing event with lanreotide was severe, the only severe treatment-related event.
Peptide
Lanreotide
Outcome
Not applicableSevere aerophagia
Study
n = 30
Analysis
Secondary
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
120 mg every 28 days · ≤92 weeksAs given in this study (human).
Measurements
Severe treatment-related aerophagia events
1 events
30 patients
Source sentences
Summary
Nineteen patients (63%) experienced treatment-related adverse events, most frequently diarrhoea and asthenia; only one treatment-related adverse event (aerophagia) was severe.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients with well-differentiated NETs and radiologically confirmed progression within the previous 6 months received lanreotide Autogel, 120 mg every 28 days over ≤92 weeks.
Show in the study text Report a problemFND-2405319108
08HumanNon-randomized trialEfficacy outcome
In progressive NETs, 89% achieved disease stabilization with lanreotide.
In plain wordsIn progressive NETs, 89% achieved stable disease with lanreotide.
Peptide
Lanreotide
Outcome
Not applicableDisease stabilization
Study
n = 30
Outcome group
Tumor growth · Cancer
Studied dose
120 mg every 28 days · ≤92 weeksAs given in this study (human).
Measurements
Disease stabilisation
89%
30 patients
Source sentences
Summary
Median PFS time was 12.9 (95% CI: 7.9, 16.5) months, and most patients achieved disease stabilisation (89%) or partial response (4%).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients with well-differentiated NETs and radiologically confirmed progression within the previous 6 months received lanreotide Autogel, 120 mg every 28 days over ≤92 weeks.
Show in the study text Report a problemFND-2405319102

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Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 1 completed · source ClinicalTrials.gov (opens in a new tab)

Status unknownEarly phase 1NCT02823691

The MetNET-2 Trial

Fondazione IRCCS Istituto Nazionale dei Tumori, Milanon = 20Apr 2016 to est. Dec 2021

Neuroendocrine Tumors

Trial page ClinicalTrials.govUpdated 7 Jun 2021

CompletedPhase 2NCT00326469

Efficacy and Safety of Lanreotide Autogel in Tumour Stabilization of Patients With Progressive Neuroendocrine Tumours

Ipsenn = 30May 2006 to Nov 2009

Neuroendocrine Tumours

Trial page ClinicalTrials.govUpdated 5 Nov 2020

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

Subjects

Terms as the source lists them.

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