Evidence map›Paper›PMID 38206830›Full record

Trial reportThe oncologist2024

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

Marianne Pavel, Harald Lahner, Dieter Hörsch, Anja Rinke, Timm Denecke, Arend Koch, Benjamin Regnault, Dorit Helbig, Philipp Hoffmanns, Markus Raderer

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The oncologist, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02231762 (Phase II, Multicentre, Open Label Study to Evaluate the Efficacy of the Combination of Lanreotide Autogel 120mg and Temozolomide in Patients With Progressive Gastro-entero-pancreatic Neuroendocrine Tumours), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
2.3field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02231762 phase2completednot on this map

Phase II, Multicentre, Open Label Study to Evaluate the Efficacy of the Combination of Lanreotide Autogel 120mg and Temozolomide in Patients With Progressive Gastro-entero-pancreatic Neuroendocrine Tumours (GEP-NET) G1/G2 - A Pilot-Study

TypeinterventionalSponsorIpsenRan2014 to 2017Enrolled57ConditionsGastroenteropancreatic Neuroendocrine TumorsArmsLanreotide Autogel 120 mg, Temozolomide (TMZ)
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Review
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  6. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 9 institutions in 3 countries.

Marianne PavelDepartment of Hepatology and Gastroenterology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health (BIH), Berlin, Germany.
Harald LahnerDepartment of Endocrinology and Metabolism, University Hospital Essen, Essen, Germany.
Dieter HörschDepartment of Gastroenterology/Endocrinology, Zentralklinik Bad Berka, Bad Berka, Germany.ORCID 0000-0002-4872-4337
Anja RinkeDepartment of Gastroenterology, University Hospital Gießen and Marburg, Marburg and Philipps University Marburg, Germany.ORCID 0000-0002-8156-2915
Timm DeneckeDepartment of Radiology, Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin, Berlin, Germany.ORCID 0000-0003-3313-3208
Arend KochDepartment of Neuropathology, Charité-Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health (BIH), Berlin, Germany.ORCID 0000-0001-8589-4688
Benjamin RegnaultIpsen Pharma, Boulogne-Billancourt, France.
Dorit HelbigIpsen Pharma GmbH, München, Germany.
Philipp HoffmannsIpsen Pharma GmbH, München, Germany.
Markus RadererMedical University Vienna, Internal Medicine I, Division of Oncology, Vienna, Austria.ORCID 0000-0002-3248-5802
Ipsen (Germany) · DEEssen University Hospital · DEFriedrich-Alexander-Universität Erlangen-Nürnberg · DEHumboldt-Universität zu Berlin · DEIpsen (France) · FRMedical University of Vienna · ATUniversitätsklinikum Gießen und Marburg · DEUniversity Hospital Leipzig · DEZentralklinik Bad Berka · DE

Funding

Ipsen
6 · The paper itself

Abstract

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.

Indexed as

Intestinal NeoplasmsNeuroendocrine TumorsPancreatic NeoplasmsPeptides, CyclicSomatostatinTemozolomideAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansMaleMiddle AgedProspective StudieslanreotidePeptides, CyclicSomatostatinTemozolomidegastrointestinal neoplasmslanreotideneuroendocrine tumorsO(6)-methylguanine-DNA methyltransferasereceptorssomatostatintemozolomide

Identifiers

PMID38206830
PMCPMC11067796
OpenAlexW4390754390

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.