Evidence map›Paper›PMID 34451893›Full record

ArticlePharmaceuticals (Basel, Switzerland)2021

Cross-Validation of a Multiplex LC-MS/MS Method for Assaying mAbs Plasma Levels in Patients with Cancer: A GPCO-UNICANCER Study.

Clémence Marin, Nihel Khoudour, Aurélien Millet, Dorothée Lebert, Pauline Bros, Fabienne Thomas, David Ternant, Bruno Lacarelle, Jérôme Guitton, Joseph Ciccolini and 1 more

Open access · goldAbstract read
In one paragraph

Article in Pharmaceuticals (Basel, Switzerland), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.8field-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.

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

9 citing papers in PubMed, 27 citations in OpenAlex.

  1. Trial
  2. Biologics in Kidney Transplantation: Why and How Should We Personalize Their Dosage?BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026
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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

11 authors at 7 institutions in 1 country.

Clémence MarinSMARTc, CRCM INSERM U1068, Aix-Marseille Universiteé, F-13009 Marseille, France.ORCID 0000-0003-2828-8790
Nihel KhoudourDepartment of Pharmacokinetics and Pharmacochemistry, Cochin Hospital, AP-HP, CARPEM, F-75014 Paris, France.ORCID 0000-0002-8269-9817
Aurélien MilletLaboratory of Biochemistry and Pharmacology-Toxicology, Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon, F-69495 Pierre Bénite, France.
Dorothée LebertPromise Proteomics, 7 Parvis Louis Néel, F-38040 Grenoble, France.
Pauline BrosPromise Proteomics, 7 Parvis Louis Néel, F-38040 Grenoble, France.
Fabienne ThomasInstitute Claude Regaud, Institut Universitaire du Cancer (IUCT)-Oncopole, F-31059 Toulouse, France.ORCID 0000-0001-9886-412X
David TernantEA 4245 "Transplantation, Immunology, Inflammation", Department of Clinical Pharmacology, University of Tours, F-37032 Tours, France.
Bruno LacarelleSMARTc, CRCM INSERM U1068, Aix-Marseille Universiteé, F-13009 Marseille, France.
Jérôme GuittonLaboratory of Biochemistry and Pharmacology-Toxicology, Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon, F-69495 Pierre Bénite, France.ORCID 0000-0001-6180-5708
Joseph CiccoliniSMARTc, CRCM INSERM U1068, Aix-Marseille Universiteé, F-13009 Marseille, France.ORCID 0000-0003-1733-3410
Benoit BlanchetDepartment of Pharmacokinetics and Pharmacochemistry, Cochin Hospital, AP-HP, CARPEM, F-75014 Paris, France.
Inserm · FRCentre National de la Recherche Scientifique · FRHôpital Cochin · FRHospices Civils de Lyon · FRUniversité Claude Bernard Lyon 1 · FRUniversité de Tours · FRUniversité Toulouse III - Paul Sabatier · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDifferent liquid chromatography tandem mass spectrometry (LC-MS/MS) methods have been published for quantification of monoclonal antibodies (mAbs) in plasma but thus far none allowed the simultaneous quantification of several mAbs, including immune checkpoint inhibitors. We developed and validated an original multiplex LC-MS/MS method using a ready-to-use kit to simultaneously assay 7 mAbs (i.e., bevacizumab, cetuximab, ipilimumab, nivolumab, pembrolizumab, rituximab and trastuzumab) in plasma. This method was next cross-validated with respective reference methods (ELISA or LC-MS/MS).

methodsThe mAbXmise kit was used for mAb extraction and full-length stable-isotope-labeled antibodies as internal standards. The LC-MS/MS method was fully validated following current EMA guidelines. Each cross validation between reference methods and ours included 16-28 plasma samples from cancer patients.

resultsThe method was linear from 2 to 100 µg/mL for all mAbs. Inter- and intra-assay precision was <14.6% and accuracy was 90.1-111.1%. The mean absolute bias of measured concentrations between multiplex and reference methods was 10.6% (range 3.0-19.9%).

conclusionsWe developed and cross-validated a simple, accurate and precise method that allows the assay of up to 7 mAbs. Furthermore, the present method is the first to offer a simultaneous quantification of three immune checkpoint inhibitors likely to be associated in patients.

Indexed as

biologicscross-validationimmunotherapyLC–MS/MStherapeutic drug monitoring

Identifiers

PMID34451893
PMCPMC8401780
OpenAlexW3190001839

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.