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Study · Randomized controlled trial · 2019

2 results

Tumor growth rate as a metric of progression, response, and prognosis in pancreatic and intestinal neuroendocrine tumors.

Dromain C, Pavel ME, Ruszniewski P, Langley A, Massien C, Baudin E, Caplin ME

BMC cancer14 Jan 2019Cited by 54 (Europe PMC)

Summary

BackgroundLanreotide depot/autogel antitumor activity in intestinal/pancreatic neuroendocrine tumors (NETs) was demonstrated in the phase-3 CLARINET study (NCT00353496), based on significantly prolonged progression-free survival (PFS) versus placebo.MethodsDuring CLARINET, patients with metastatic intestinal/pancreatic NETs received lanreotide depot/autogel 120 mg or placebo every 4 weeks for 96 weeks. Imaging data (response evaluation criteria in solid tumors [RECIST] v1.0, centrally reviewed) were re-evaluated in this post hoc analysis of tumor growth rate (TGR) in NETs. TGR (%/month) was calculated from two imaging scans during relevant periods: pre-treatment (TGR0); 12-24 weeks before randomization versus baseline; each treatment visit versus baseline (TGRTx-0); between consecutive treatment visits (TGRTx-Tx). To assess TGR as a measure of prognosis, PFS was compared for TGR0 subgroups stratified by optimum TGR0 cut-off; a multivariate analysis was conducted to identify prognostic factors for PFS.ResultsTGR0 revealed tumors growing during pre-treatment (median [interquartile range] TGR0: lanreotide 2.1%/month [0.2; 6.1]; placebo 2.7%/month [0.15; 6.8]), contrary to RECIST status. TGR was significantly reduced by 12 weeks with lanreotide versus placebo (difference in least-square mean TGR0-12 of - 2.9 [- 5.1, - 0.8], p = 0.008), a difference that was maintained at most subsequent visits. TGR0 > 4%/month had greater risk of progression/death than ≤4%/month (hazard ratio 4.1; [95% CI 2.5-6.5]; p < 0.001); multivariate analysis revealed lanreotide treatment, progression at baseline, TGR0, hepatic tumor load, and primary tumor type were independently associated with PFS.ConclusionsTGR provides valuable information on tumor activity and prognosis in patients with metastatic intestinal/pancreatic NETs, and identifies early lanreotide depot/autogel antitumor activity.Trial registrationRetrospective registration, 18 July 2006; EudraCT: 2005-004904-35; ClinicalTrials.gov: NCT00353496 .
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study2

2 results from studies that gave the peptide. 2 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In metastatic intestinal or pancreatic NETs, lanreotide reduced tumor growth rate versus placebo at 12 weeks (difference -2.9, interval -5.1 to -0.8, p = 0.008), maintained at most later visits.

    In plain wordsIn patients with metastatic intestinal or pancreatic NETs, lanreotide reduced tumor growth rate versus placebo by 12 weeks.

    Peptide
    Lanreotide
    Outcome
    DecreaseTumor growth rate
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Tumor growth · Cancer
    Studied dose
    120 mg every 4 weeks · Assessed at 12 weeks, within a 96-week treatment periodAs given in this study (human).

    Measurements

    Difference in least-square mean TGR0-12, lanreotide versus placebo
    −2.9 %/month
    12 weeks
    95% CI of difference in TGR0-12
    −5.1 to −0.8 %/month
    12 weeks
    P value for TGR0-12 difference
    0.008
    12 weeks

    Source sentences

    Summary
    TGR was significantly reduced by 12 weeks with lanreotide versus placebo (difference in least-square mean TGR0-12 of - 2.9 [- 5.1, - 0.8], p = 0.008), a difference that was maintained at most subsequent visits.
    2 context sentences
    Summary · context
    During CLARINET, patients with metastatic intestinal/pancreatic NETs received lanreotide depot/autogel 120 mg or placebo every 4 weeks for 96 weeks.
    Summary · context
    Imaging data (response evaluation criteria in solid tumors [RECIST] v1.0, centrally reviewed) were re-evaluated in this post hoc analysis of tumor growth rate (TGR) in NETs.
  2. 02HumanObservational studyEfficacy outcome

    In patients with metastatic intestinal or pancreatic NETs, lanreotide treatment was independently associated with PFS in multivariate analysis.

    In plain wordsIn patients with metastatic intestinal or pancreatic NETs, lanreotide treatment was independently linked to survival without progression.

    Peptide
    Lanreotide
    Outcome
    Direction not reportedTreatment association with PFS
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Tumor growth · Cancer
    Studied dose
    120 mg every 4 weeks · 96 weeksAs given in this study (human).

    Source sentences

    Summary
    multivariate analysis revealed lanreotide treatment, progression at baseline, TGR0, hepatic tumor load, and primary tumor type were independently associated with PFS.
    2 context sentences
    Summary · context
    During CLARINET, patients with metastatic intestinal/pancreatic NETs received lanreotide depot/autogel 120 mg or placebo every 4 weeks for 96 weeks.
    Summary · context
    Imaging data (response evaluation criteria in solid tumors [RECIST] v1.0, centrally reviewed) were re-evaluated in this post hoc analysis of tumor growth rate (TGR) in NETs.

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Version history

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  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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