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Study · Non-randomized trial · n = 99 · 2021

7 results

Efficacy and safety of high-dose lanreotide autogel in patients with progressive pancreatic or midgut neuroendocrine tumours: CLARINET FORTE phase 2 study results.

Pavel M, Ćwikła JB, Lombard-Bohas C, Borbath I, Shah T, Pape UF, Capdevila J, Panzuto F, Truong Thanh XM, Houchard A, Ruszniewski P

European journal of cancer (Oxford, England : 1990)28 Sept 2021Cited by 68 (Europe PMC)

PMID34597974 (opens in a new tab)DOI10.1016/j.ejca.2021.06.056 (opens in a new tab)PepBankPUB-34597974
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Summary

IntroductionThis prospective, single-arm, phase 2 study assessed the efficacy and safety of lanreotide autogel (LAN) administered at a reduced dosing interval in patients with progressive neuroendocrine tumours (NETs) after LAN standard regimen.MethodsPatients had metastatic or locally advanced, grade 1 or 2 midgut NETs or pancreatic NETs (panNETs) and centrally assessed disease progression on LAN 120 mg every 28 days. They were treated with LAN 120 mg every 14 days for up to 96 weeks (midgut cohort) or 48 weeks (panNET cohort). The primary end-point was centrally assessed progression-free survival (PFS). PFS by Ki-67 categories was analysed post hoc. Secondary end-points included quality of life (QoL) and safety.ResultsNinety-nine patients were enrolled (midgut, N = 51; panNET, N = 48). Median (95% CI) PFS was 8.3 (5.6-11.1) and 5.6 (5.5-8.3) months, respectively. In patients with Ki-67 ≤ 10%, median (95% CI) PFS was 8.6 (5.6-13.8) and 8.0 (5.6-8.3) months in the midgut and panNET cohorts, respectively. Patients' QoL did not deteriorate during the study. There were no treatment-related serious adverse events and only two withdrawals for treatment-related adverse events (both in the panNET cohort).ConclusionsIn patients with progressive NETs following standard-regimen LAN, reducing the dosing interval to every 14 days provided encouraging PFS, particularly in patients with a Ki-67 ≤ 10% (post hoc); no safety concerns and no deterioration in QoL were observed. Increasing LAN dosing frequency could therefore be considered before escalation to less well-tolerated therapies.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

  1. 01HumanNon-randomized trialEfficacy outcome

    In progressive midgut NET patients receiving intensified lanreotide, median progression-free survival was 8.3 months (95% CI 5.6-11.1).

    In plain wordsIn progressive midgut NET patients receiving intensified lanreotide, median progression-free survival was 8.3 months.

    Peptide
    Lanreotide
    Outcome
    Not applicableMidgut NET progression-free survival
    Study

    n = 51

    Analysis
    Primary
    Outcome group
    Tumor growth · Cancer
    Studied dose
    120 mg every 14 days · up to 96 weeksAs given in this study (human).

    Measurements

    Median progression-free survival
    8.3 months
    midgut cohort
    95% CI of median progression-free survival
    5.6 to 11.1 months
    midgut cohort

    Source sentences

    Summary
    Median (95% CI) PFS was 8.3 (5.6-11.1) and 5.6 (5.5-8.3) months, respectively.
    2 context sentences
    Summary · context
    Ninety-nine patients were enrolled (midgut, N = 51; panNET, N = 48).
    Summary · context
    Patients had metastatic or locally advanced, grade 1 or 2 midgut NETs or pancreatic NETs (panNETs) and centrally assessed disease progression on LAN 120 mg every 28 days. They were treated with LAN 120 mg every 14 days for up to 96 weeks (midgut cohort) or 48 weeks (panNET cohort).
  2. 02HumanNon-randomized trialEfficacy outcome

    In progressive pancreatic NET patients receiving intensified lanreotide, median progression-free survival was 5.6 months (95% CI 5.5-8.3).

    In plain wordsIn progressive pancreatic NET patients receiving intensified lanreotide, median progression-free survival was 5.6 months.

    Peptide
    Lanreotide
    Outcome
    Not applicablePancreatic NET progression-free survival
    Study

    n = 48

    Analysis
    Primary
    Outcome group
    Tumor growth · Cancer
    Studied dose
    120 mg every 14 days · up to 48 weeksAs given in this study (human).

    Measurements

    Median progression-free survival
    5.6 months
    panNET cohort
    95% CI of median progression-free survival
    5.5 to 8.3 months
    panNET cohort

    Source sentences

    Summary
    Median (95% CI) PFS was 8.3 (5.6-11.1) and 5.6 (5.5-8.3) months, respectively.
    2 context sentences
    Summary · context
    Ninety-nine patients were enrolled (midgut, N = 51; panNET, N = 48).
    Summary · context
    Patients had metastatic or locally advanced, grade 1 or 2 midgut NETs or pancreatic NETs (panNETs) and centrally assessed disease progression on LAN 120 mg every 28 days. They were treated with LAN 120 mg every 14 days for up to 96 weeks (midgut cohort) or 48 weeks (panNET cohort).
  3. 03HumanNon-randomized trialEfficacy outcome

    Quality of life did not deteriorate during intensified lanreotide treatment in progressive NET patients.

    In plain wordsQuality of life did not deteriorate during intensified lanreotide treatment in progressive NET patients.

    Peptide
    Lanreotide
    Outcome
    Direction not reportedQuality of life
    Study

    n = 99

    Analysis
    Secondary
    Outcome group
    Quality of life · Whole body
    Studied dose
    120 mg every 14 daysAs given in this study (human).

    Source sentences

    Summary
    Patients' QoL did not deteriorate during the study.
    1 context sentence
    Summary · context
    Patients had metastatic or locally advanced, grade 1 or 2 midgut NETs or pancreatic NETs (panNETs) and centrally assessed disease progression on LAN 120 mg every 28 days. They were treated with LAN 120 mg every 14 days for up to 96 weeks (midgut cohort) or 48 weeks (panNET cohort).
  4. 04HumanNon-randomized trialSafety outcome

    No treatment-related serious adverse events occurred during intensified lanreotide treatment in progressive NET patients.

    In plain wordsNo treatment-related serious adverse events occurred during intensified lanreotide treatment in progressive NET patients.

    Peptide
    Lanreotide
    Outcome
    Not applicableTreatment-related serious adverse events
    Study

    n = 99

    Analysis
    Secondary
    Outcome group
    Adverse events · Whole body
    Studied dose
    120 mg every 14 daysAs given in this study (human).

    Source sentences

    Summary
    There were no treatment-related serious adverse events and only two withdrawals for treatment-related adverse events (both in the panNET cohort).
    1 context sentence
    Summary · context
    Patients had metastatic or locally advanced, grade 1 or 2 midgut NETs or pancreatic NETs (panNETs) and centrally assessed disease progression on LAN 120 mg every 28 days. They were treated with LAN 120 mg every 14 days for up to 96 weeks (midgut cohort) or 48 weeks (panNET cohort).
  5. 05HumanNon-randomized trialSafety outcome

    Two patients withdrew for treatment-related adverse events during intensified lanreotide treatment, both in the pancreatic NET cohort.

    In plain wordsTwo patients stopped intensified lanreotide because of treatment-related adverse events, both in the pancreatic NET cohort.

    Peptide
    Lanreotide
    Outcome
    Not applicableWithdrawal for treatment-related adverse events
    Study

    n = 48

    Analysis
    Secondary
    Outcome group
    Adverse events · Whole body
    Studied dose
    120 mg every 14 days · up to 48 weeksAs given in this study (human).

    Measurements

    Withdrawals for treatment-related adverse events
    2 patients
    panNET cohort

    Source sentences

    Summary
    There were no treatment-related serious adverse events and only two withdrawals for treatment-related adverse events (both in the panNET cohort).
    1 context sentence
    Summary · context
    Patients had metastatic or locally advanced, grade 1 or 2 midgut NETs or pancreatic NETs (panNETs) and centrally assessed disease progression on LAN 120 mg every 28 days. They were treated with LAN 120 mg every 14 days for up to 96 weeks (midgut cohort) or 48 weeks (panNET cohort).
  6. 06HumanNon-randomized trialEfficacy outcome

    In a post hoc analysis of midgut NET patients with Ki-67 ≤10% receiving intensified lanreotide, median progression-free survival was 8.6 months (95% CI 5.6-13.8).

    In plain wordsIn a post hoc analysis of midgut NET patients with Ki-67 ≤10% receiving intensified lanreotide, median progression-free survival was 8.6 months.

    Peptide
    Lanreotide
    Outcome
    Not applicableMidgut NET PFS with Ki-67 ≤10%
    Study

    n: not reported in source

    Outcome group
    Tumor growth · Cancer
    Studied dose
    120 mg every 14 days · up to 96 weeksAs given in this study (human).

    Measurements

    Median progression-free survival
    8.6 months
    midgut cohort, Ki-67 <=10%
    95% CI of median progression-free survival
    5.6 to 13.8 months
    midgut cohort, Ki-67 <=10%

    Source sentences

    Summary
    In patients with Ki-67 ≤ 10%, median (95% CI) PFS was 8.6 (5.6-13.8) and 8.0 (5.6-8.3) months in the midgut and panNET cohorts, respectively.
    1 context sentence
    Summary · context
    Patients had metastatic or locally advanced, grade 1 or 2 midgut NETs or pancreatic NETs (panNETs) and centrally assessed disease progression on LAN 120 mg every 28 days. They were treated with LAN 120 mg every 14 days for up to 96 weeks (midgut cohort) or 48 weeks (panNET cohort).
  7. 07HumanNon-randomized trialEfficacy outcome

    In a post hoc analysis of pancreatic NET patients with Ki-67 ≤10% receiving intensified lanreotide, median progression-free survival was 8.0 months (95% CI 5.6-8.3).

    In plain wordsIn a post hoc analysis of pancreatic NET patients with Ki-67 ≤10% receiving intensified lanreotide, median progression-free survival was 8.0 months.

    Peptide
    Lanreotide
    Outcome
    Not applicablePancreatic NET PFS with Ki-67 ≤10%
    Study

    n: not reported in source

    Outcome group
    Tumor growth · Cancer
    Studied dose
    120 mg every 14 days · up to 48 weeksAs given in this study (human).

    Measurements

    Median progression-free survival
    8 months
    panNET cohort, Ki-67 <=10%
    95% CI of median progression-free survival
    5.6 to 8.3 months
    panNET cohort, Ki-67 <=10%

    Source sentences

    Summary
    In patients with Ki-67 ≤ 10%, median (95% CI) PFS was 8.6 (5.6-13.8) and 8.0 (5.6-8.3) months in the midgut and panNET cohorts, respectively.
    1 context sentence
    Summary · context
    Patients had metastatic or locally advanced, grade 1 or 2 midgut NETs or pancreatic NETs (panNETs) and centrally assessed disease progression on LAN 120 mg every 28 days. They were treated with LAN 120 mg every 14 days for up to 96 weeks (midgut cohort) or 48 weeks (panNET cohort).

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

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.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. 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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