Evidence map›Paper›PMID 24053191›Full record

Trial reportBMC cancer2013

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

Marta Martín-Richard, Bartomeu Massutí, Eva Pineda, Vicente Alonso, Maribel Marmol, Daniel Castellano, Emilio Fonseca, Antonio Galán, Marta Llanos, Maria Angeles Sala and 7 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in BMC cancer, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 35 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 2 pooled it
6.3field-weighted citation impact, top 3% 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.

NCT00326469 phase2completednot on this map

Phase II, Open, Single Group, Multicentre Study to Evaluate the Efficacy and Safety of Lanreotide Autogel Administered Every 4 Weeks by Deep Subcutaneous Injection in the Tumour's Growth Stabilization of Patients With Progressive Neuroendocrine Tumours Who Are Not Eligible to be Treated With Either Surgery or Chemotherapy

TypeinterventionalSponsorIpsenRan2006 to 2009Enrolled30ConditionsNeuroendocrine TumoursArmslanreotide (Autogel formulation)
NCT02823691 early_phase1unknown statusnot on this mapstarted 2016, after this paper: background citation

Safety of Lanreotide 120 mg ATG in Combination With Metformin in Patients With Progressive Advanced Well-differentiated Gastro-intestinal (GI) or Lung Carcinoids: A Pilot, One-arm, Open-label, Prospective Study: the MetNET-2 Trial

TypeinterventionalSponsorFondazione IRCCS Istituto Nazionale dei Tumori, MilanoRan2016 to 2021Enrolled20ConditionsNeuroendocrine TumorsArmsLanreotide and Metformin
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 2 syntheses or guidelines pooled it, 70 citations in OpenAlex.

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  18. Sex differences in carcinoid syndrome: A gap to be closed.Reviews in endocrine & metabolic disorders · 2022
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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

17 authors at 13 institutions in 2 countries.

Marta Martín-RichardMedical Oncology Department, Hospital de la Santa Creu y Sant Pau, Av, Sant Antoni Mª Claret, 167, Barcelona 08025, Spain. MMartinRi@santpau.cat.
Bartomeu Massutí
Eva Pineda
Vicente Alonso
Maribel Marmol
Daniel Castellano
Emilio Fonseca
Antonio Galán
Marta Llanos
Maria Angeles Sala
Carlos Pericay
Fernando Rivera
Javier Sastre
Angel Segura
Maria Quindós
Pascal Maisonobe
TTD (Tumores del Tracto Digestivo) Study Group
Hospital Clínic de Barcelona · ESHospital Clínico San Carlos · ESHospital de Basurto · ESHospital de Sagunto · ESHospital de Sant Pau · ESHospital General Universitario de Alicante Doctor Balmis · ESHospital Universitari i Politècnic La Fe · ESHospital Universitario de Canarias · ESHospital Universitario Miguel Servet · ESIpsen (France) · FRIpsen (Spain) · ESMarqués de Valdecilla University Hospital · ESResearch Institute Hospital 12 de Octubre · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

AdultAgedAntineoplastic AgentsCell ProliferationCombined Modality TherapyDisease ProgressionFemaleHumansMaleMiddle AgedNeoplasm GradingNeuroendocrine TumorsPeptides, CyclicSomatostatinSpainTreatment OutcomeAntineoplastic AgentslanreotidePeptides, CyclicSomatostatin

Identifiers

PMID24053191
PMCPMC3853091
OpenAlexW2001025514

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.