Evidence map›Paper›PMID 37872405›Full record

Trial reportBritish journal of cancer2023

Phase II study of everolimus and temozolomide as first-line treatment in metastatic high-grade gastroenteropancreatic neuroendocrine neoplasms.

Siren Morken, Seppo W Langer, Anna Sundlöv, Lene Weber Vestermark, Morten Ladekarl, Geir Olav Hjortland, Johanna B Svensson, Elizaveta Mitkina Tabaksblat, Torjan Magne Haslerud, Jörg Assmus and 4 more

Open access · hybridAbstract readClinical Trial, Phase II
In one paragraph

Trial report in British journal of cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
3.0field-weighted citation impact, top 8% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Review
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  7. 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

14 authors at 11 institutions in 5 countries.

Siren MorkenDepartment of Oncology, Haukeland University Hospital, Bergen, Norway. siren.morken@helse-bergen.no.ORCID 0009-0003-8676-772X
Seppo W LangerDepartment of Oncology, Rigshospitalet, Copenhagen, Denmark.
Anna SundlövDivision of Oncology, Department of Clinical Sciences Lund, Lund University, Lund, Sweden.
Lene Weber VestermarkDepartment of Oncology, Odense University Hospital, Odense, Denmark.
Morten LadekarlDepartment of Oncology, Aarhus University Hospital, Aarhus, Denmark.ORCID 0000-0002-0182-1228
Geir Olav HjortlandDepartment of Oncology, Oslo University Hospital, Oslo, Norway.
Johanna B SvenssonDepartment of Oncology, Sahlgrenska University Hospital, Gothenburg, Sweden.
Elizaveta Mitkina TabaksblatDepartment of Oncology, Aarhus University Hospital, Aarhus, Denmark.
Torjan Magne HaslerudDepartment of Radiology and Nuclear Medicine, Haukeland University Hospital, Bergen, Norway.
Jörg AssmusCentre for Clinical Research, Haukeland University Hospital, Bergen, Norway.
Sönke DetlefsenDepartment of Pathology, Odense University Hospital, Odense, Denmark.
Anne CouvelardDepartment of Pathology, Bichat Hospital, Paris, France.
Aurel PerrenInstitute of Tissue medicine and Pathology, University of Bern, Bern, Switzerland.
Halfdan SorbyeDepartment of Oncology, Haukeland University Hospital, Bergen, Norway.
Haukeland University Hospital · NOAalborg University Hospital · DKAarhus University Hospital · DKHôpital Bichat-Claude-Bernard · FRLund University · SEOdense University Hospital · DKOslo University Hospital · NOSahlgrenska University Hospital · SEUniversity of Bern · CHUniversity of Copenhagen · DKUniversity of Southern Denmark · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe optimal treatment for metastatic high-grade gastroenteropancreatic (GEP) neuroendocrine neoplasms when Ki-67 ≤55% is unknown. A prospective multi-centre phase 2 study was performed to evaluate the efficacy and safety of everolimus and temozolomide as first-line treatment for these patients.

methodsPatients received everolimus 10 mg daily continuously and temozolomide 150 mg/m

resultsFor 37 eligible patients, the primary endpoint with 65% disease control rate (DCR) at 6 months (m) was reached. The response rate was 30%, the median progression-free survival (PFS) 10.2 months and the median overall survival (OS) 26.4 months. Considering 26 NET G3 patients, 6 months DCR was 77% vs. 22% among nine NEC patients (p = 0.006). PFS was superior for NET G3 vs. NEC (12.6 months vs. 3.4 months, Log-rank-test: p = 0.133, Breslow-test: p < 0.001). OS was significantly better for NET G3 (31.4 months vs. 7.8 months, p = 0.003). Grade 3 and 4 toxicities were reported in 43% and 38%. QoL remained stable during treatment.

conclusionEverolimus and temozolomide may be a treatment option for selected GEP-NET G3 patients including careful monitoring. Toxicity did not compromise QoL. CLINICAL

trial registrationClinicalTrials.gov (NTC02248012).

Indexed as

Neuroendocrine TumorsPancreatic NeoplasmsEverolimusHumansProspective StudiesQuality of LifeTemozolomideEverolimusTemozolomide

Identifiers

PMID37872405
PMCPMC10703888
OpenAlexW4387872762

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.