Evidence map›Paper›PMID 35867144›Full record

ArticleCancer chemotherapy and pharmacology2022

Revisiting metronomic vinorelbine with mathematical modelling: a Phase I trial in lung cancer.

Fabrice Barlesi, Laure Deyme, Diane-Charlotte Imbs, Elissa Cousin, Mathieu Barbolosi, Sylvanie Bonnet, Pascale Tomasini, Laurent Greillier, Melissa Galloux, Albane Testot-Ferry and 4 more

Abstract readClinical Trial, Phase I
PubMed Publisher
In one paragraph

Article in Cancer chemotherapy and pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.9field-weighted citation impact, top 25% 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

5 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  2. Article
  3. Treatment of evolving cancers will require dynamic decision support.Annals of oncology : official journal of the European Society for Medical Oncology · 2023
    Review
  4. Mathematical Modeling Support for Lung Cancer Therapy-A Short Review.International journal of molecular sciences · 2023
    Review
  5. Article
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 2 institutions in 2 countries.

Fabrice BarlesiMarseille Early Phases Cancer Trials Center CLIP, Aix Marseille University, APHM, Marseille, France.
Laure DeymeSMARTc Unit Centre de Recherche en Cancérologie de Marseille Inserm U1068, Aix Marseille University, Marseille, France.
Diane-Charlotte ImbsSMARTc Unit Centre de Recherche en Cancérologie de Marseille Inserm U1068, Aix Marseille University, Marseille, France.
Elissa CousinSMARTc Unit Centre de Recherche en Cancérologie de Marseille Inserm U1068, Aix Marseille University, Marseille, France.
Mathieu BarbolosiMarseille Early Phases Cancer Trials Center CLIP, Aix Marseille University, APHM, Marseille, France.
Sylvanie BonnetSMARTc Unit Centre de Recherche en Cancérologie de Marseille Inserm U1068, Aix Marseille University, Marseille, France.
Pascale TomasiniMarseille Early Phases Cancer Trials Center CLIP, Aix Marseille University, APHM, Marseille, France.
Laurent GreillierMarseille Early Phases Cancer Trials Center CLIP, Aix Marseille University, APHM, Marseille, France.
Melissa GallouxMarseille Early Phases Cancer Trials Center CLIP, Aix Marseille University, APHM, Marseille, France.
Albane Testot-FerryMarseille Early Phases Cancer Trials Center CLIP, Aix Marseille University, APHM, Marseille, France.
Annick PelletierMarseille Early Phases Cancer Trials Center CLIP, Aix Marseille University, APHM, Marseille, France.
Nicolas AndréMarseille Early Phases Cancer Trials Center CLIP, Aix Marseille University, APHM, Marseille, France. nicolas.andre@ap-hm.fr.ORCID 0000-0002-6786-4968
Joseph CiccoliniSMARTc Unit Centre de Recherche en Cancérologie de Marseille Inserm U1068, Aix Marseille University, Marseille, France.
Dominique BarbolosiSMARTc Unit Centre de Recherche en Cancérologie de Marseille Inserm U1068, Aix Marseille University, Marseille, France.
Inserm · FRAix-Marseille Université · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA phase Ia/Ib trial of metronomic oral vinorelbine (MOV) driven by a mathematical model was performed in heavily pretreated metastatic Non-Small Cell Lung Cancer or Pleural Mesothelioma patients. Disease Control Rate, progression free survival, toxicity and PK/PD were the main endpoints.

methodsBest MOV scheduling was selected using a simplified phenomenological, semi-mechanistic model with a total weekly dose of 150-mg vinorelbine. Computation of individual PK parameters was performed using population approach.

resultsThe mathematical model proposed the following metronomic schedule for a 150-mg weekly dose of vinorelbine: 60 mg D1, 30 mg D2, 60 mg D4. A total of 37 heavily pre-treated patients (30 evaluable) were enrolled. Grade III/IV neutropenia was observed in 30% patients. Median PFS was 11 weeks. Disease Control Rate was 73% (i.e.; 13% partial response and 60% stable disease). A large variability in drug exposure (AUC

conclusionsMOV was characterized by important variability in drug exposure among patients. However, and despite being all heavily pre-treated, 73% of disease control rate and 11 weeks PFS were achieved with manageable toxicities. PK/PD relationships yielded conflicting results depending on the initial tumor burden and BSA, suggesting that patients should be carefully selected prior to be scheduled for metronomic regimen. Possible role NLR could play as a predictive marker suggests immunomodulating features with MOV.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsNeutropeniaAdministration, MetronomicAntineoplastic Combined Chemotherapy ProtocolsHumansModels, TheoreticalVinblastineVinorelbineVinblastineVinorelbineLung cancerMathematical modellingMesotheliomaMetronomicVinorelbine

Identifiers

PMID35867144
OpenAlexW4286488469

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.