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Study · Randomized controlled trial · 2024

1 result

Combined Lanreotide Autogel and Temozolomide Treatment of Progressive Pancreatic and Intestinal Neuroendocrine Tumors: The Phase II SONNET Study.

Pavel M, Lahner H, Hörsch D, Rinke A, Denecke T, Koch A, Regnault B, Helbig D, Hoffmanns P, Raderer M

The oncologist1 May 2024Cited by 9 (Europe PMC)

PMID38206830 (opens in a new tab)PMCIDPMC11067796 (opens in a new tab)DOI10.1093/oncolo/oyad325 (opens in a new tab)PepBankPUB-38206830
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Summary

BackgroundIn advanced neuroendocrine tumors (NET), antiproliferative treatment options beyond somatostatin analogs remain limited. Temozolomide (TMZ) has shown efficacy in NET alone or combined with other drugs.Materials and methodsSONNET (NCT02231762) was an open, multicenter, prospective, phase II study to evaluate lanreotide autogel 120 mg (LAN) plus TMZ in patients with progressive advanced/metastatic grade 1/2 gastroenteropancreatic (GEP) NET or of unknown primary. Patients could be enrolled at first-line or higher therapy line. The primary endpoint was disease control rate ([DCR], rate of stable disease [SD], partial [PR], and complete response [CR]) at 6 months of LAN and TMZ. Patients with nonfunctioning (NF) NET without progression at 6 months were randomized to 6-month LAN maintenance or watch and wait, patients with functioning (F)-NET with clinical benefit (PR, SD) continued on LAN.ResultsFifty-seven patients were recruited. The majority of patients received the study drug at second or higher treatment line and had an NET G2. DCR at 6 months LAN and TMZ was 73.5%. After 6 months of further LAN maintenance, 54.5% of patients with F-NET and 71.4% with NF-NET had SD or PR vs 41.7% with NF-NET on observation only. LAN and TMZ were effective in all subgroups analyzed. At 12 months of follow-up, median progression-free survival was 11.1 months. Median serum chromogranin A decreased except in NF-NET on observation. O6-methylguanine DNA methyltransferase promoter methylation appeared to better reflect TMZ response than loss of gene expression. During combination therapy, the most frequent treatment-emergent adverse events grade 3/4 reported were nausea (14%), thrombocytopenia (12.3%), and neutropenia (8.8%). Four deaths were reported resulting from severe adverse events not considered related to study medication.ConclusionsLAN plus TMZ is a treatment option for patients with progressive GEP-NET with more aggressive biological profile showing a manageable safety profile.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study1

1 result from studies that gave the peptide. 1 result from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with nonfunctioning NET without progression at 6 months, randomized lanreotide maintenance had stable disease or partial response in 71.4% versus 41.7% with observation only after 6 further months.

    In plain wordsWith no progression at 6 months, stable disease or partial response occurred in 71.4% on lanreotide maintenance versus 41.7% under observation.

    Peptide
    Lanreotide
    Outcome
    IncreaseStable disease or partial response in nonfunctioning NET maintenance
    Study

    n: not reported in source

    Comparator
    observation only
    Outcome group
    Tumor growth · Cancer
    Studied dose
    120 mg · 6 monthsAs given in this study (human).

    Measurements

    Stable disease or partial response
    71.4%
    nonfunctioning NET, lanreotide maintenance for 6 months
    Stable disease or partial response
    41.7%
    nonfunctioning NET, observation only

    Source sentences

    Summary
    After 6 months of further LAN maintenance, 54.5% of patients with F-NET and 71.4% with NF-NET had SD or PR vs 41.7% with NF-NET on observation only.
    1 context sentence
    Summary · context
    Patients with nonfunctioning (NF) NET without progression at 6 months were randomized to 6-month LAN maintenance or watch and wait, patients with functioning (F)-NET with clinical benefit (PR, SD) continued on LAN.

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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