Evidence map›Paper›PMID 30811063›Full record

Trial reportBritish journal of clinical pharmacology2019

Cetuximab pharmacokinetic/pharmacodynamics relationships in advanced head and neck carcinoma patients.

Félicien Le Louedec, Catherine Alix-Panabières, Thierry Lafont, Ben C Allal, Renaud Garrel, Laurence Digue, Joël Guigay, Didier Cupissol, Jean-Pierre Delord, Benjamin Lallemant and 7 more

Open access · bronzeAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in British journal of clinical pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
2.3field-weighted citation impact, top 11% 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

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

  1. Pooled it
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  6. Antibody Drug Clearance: An Underexplored Marker of Outcomes with Checkpoint Inhibitors.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
    Review
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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 11 institutions in 1 country.

Félicien Le LouedecLaboratory of Pharmacology, Institut Claudius Regaud, IUCT-Oncopole, Toulouse, France.
Catherine Alix-PanabièresLaboratory of Rare Human Circulating Cells, University Medical Centre of Montpellier, Montpellier, France.
Thierry LafontLaboratory of Pharmacology, Institut Claudius Regaud, IUCT-Oncopole, Toulouse, France.
Ben C AllalLaboratory of Pharmacology, Institut Claudius Regaud, IUCT-Oncopole, Toulouse, France.
Renaud GarrelDepartment of Head Neck Cancer and Laryngology, University Medical Centre of Montpellier, France.
Laurence DigueMedical Oncology Department, CHU Saint André, Bordeaux, France.
Joël GuigayDepartment of Head and Neck Oncology, Gustave Roussy, Villejuif, France.
Didier CupissolMedical Oncology Department, Institute of Cancer of Montpellier, France.
Jean-Pierre DelordCRCT, University of Toulouse, Inserm, Toulouse, France.
Benjamin LallemantDepartment of Head and Neck Surgery, University Hospital Center of Nîmes, France.
Marc AlfonsiDepartment of Radiation Oncology, Clinique Sainte Catherine, Avignon, France.
Karine AubryDepartment of Head and Neck Oncology and Surgery, Hôpital Dupuytren CHU, Limoges, France.
Martine MazelLaboratory of Rare Human Circulating Cells, University Medical Centre of Montpellier, Montpellier, France.
François BecherService de Pharmacologie et Immunoanalyse, Laboratoire d'Etude du Métabolisme des Médicaments, Commissariat à l'Énergie Atomique et aux Énergies Alternatives, Institut National de la Recherche Agronomique, Université Paris Saclay, Gif-sur-Yvette, France.
Françoise PerriardDepartment of Biostatistics, UPRES EA2415, Clinical Research University Institute, Montpellier, France.
Etienne ChatelutLaboratory of Pharmacology, Institut Claudius Regaud, IUCT-Oncopole, Toulouse, France.
Fabienne ThomasLaboratory of Pharmacology, Institut Claudius Regaud, IUCT-Oncopole, Toulouse, France.ORCID 0000-0001-9886-412X
Inserm · FRCentre Occitanie-Montpellier · FRCentre Hospitalier Universitaire de Montpellier · FRCommissariat à l'Énergie Atomique et aux Énergies Alternatives · FRHôpital Dupuytren · FRHôpital Saint-André · FRInstitut de Recherche en Cancérologie de Montpellier · FRInstitut Gustave Roussy · FRInstitut Sainte Catherine · FRUniversité de Montpellier · FRUniversité de Nîmes · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsCetuximab associated with cisplatin and 5-fluorouracil is used to treat patients with inoperable or metastatic head and neck squamous cell carcinomas (HNSCC) up until disease progression or unacceptable toxicities. To date, no biomarkers of efficacy are available to select patients who will benefit from treatment.

methodsAn ancillary pharmacokinetics (PK) exploration was performed in the context of a prospective study investigating circulating-tumour cells vs progression-free survival (PFS). Cetuximab plasma concentrations were analysed according to a population PK model. Individual exposure parameters were confronted with soluble epidermal growth factor receptor (sEGFR) concentrations, tumour response and PFS.

resultsPK data (28 patients, 203 observations) were best described by a two-compartment model with linear elimination. Performance status (PS) significantly correlated to both cetuximab clearance and central volume of distribution with both parameters increasing by 33.3% (95% CI 1-65.6) for each 1-point increase of PS compared to PS = 0. Univariate analysis showed that patients with higher trough cetuximab concentrations at Day 7 (C

conclusionsOur study prospectively indicates that PS is likely a confounding factor in the relationship between cetuximab PK and PFS, patients with a poor PS having lower cetuximab plasma exposure and lower PFS.

Indexed as

Models, BiologicalAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCetuximabCisplatinErbB ReceptorsFemaleFluorouracilHead and Neck NeoplasmsHumansMaleMiddle AgedNeoplastic Cells, CirculatingBiomarkers, TumorCetuximabCisplatinEGFR protein, humanErbB ReceptorsFluorouracilcetuximabconcentrationefficacyHNSCCpharmacokinetics

Identifiers

PMID30811063
PMCPMC6533440
OpenAlexW2917160309

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.