Evidence map›Paper›PMID 29222715›Full record

Observational studyEuropean journal of clinical pharmacology2018

Clinical validation study of dried blood spot for determining everolimus concentration in patients with cancer.

A E C A B Willemsen, L M Knapen, Y M de Beer, R J M Brüggemann, S Croes, C M L van Herpen, N P van Erp

Open access · hybridAbstract readComparative StudyObservational StudyValidation Study
In one paragraph

Observational study in European journal of clinical pharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 14% 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

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.

  1. Pooled it
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  4. Article
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  9. Observational
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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

7 authors at 3 institutions in 1 country.

A E C A B WillemsenDepartment of Medical Oncology, Radboud university medical center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, the Netherlands. annelieke.willemsen@radboudumc.nl.
L M KnapenDepartment of Clinical Pharmacy & Toxicology, Maastricht University Medical Center+, Maastricht, the Netherlands.
Y M de BeerDepartment of Clinical Pharmacy & Toxicology, Maastricht University Medical Center+, Maastricht, the Netherlands.
R J M BrüggemannDepartment of Pharmacy, Radboud university medical center, Nijmegen, the Netherlands.
S CroesDepartment of Clinical Pharmacy & Toxicology, Maastricht University Medical Center+, Maastricht, the Netherlands.
C M L van HerpenDepartment of Medical Oncology, Radboud university medical center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, the Netherlands.
N P van ErpDepartment of Pharmacy, Radboud university medical center, Nijmegen, the Netherlands.
Maastricht University · NLRadboud University Medical Center · NLRadboud University Nijmegen · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeEverolimus treatment is seriously hampered by its toxicity profile. As a relationship between everolimus exposure and effectiveness and toxicity has been established, early and ongoing concentration measurement can be key to individualize the dose and optimize treatment outcomes. Dried blood spot (DBS) facilitates sampling at a patients' home and thereby eases dose individualization. The aim of this study is to determine the agreement and predictive performance of DBS compared to whole blood (WB) to measure everolimus concentrations in cancer patients.

methodsPaired DBS and WB samples were collected in 22 cancer patients treated with everolimus and analyzed using UPLC-MS/MS. Bland-Altman and Passing-Bablok analysis were used to determine method agreement. Limits of clinical relevance were set at a difference of ± 25%, as this would lead to a different dosing advice. Using DBS concentration and Passing-Bablok regression analysis, WB concentrations were predicted.

resultsSamples of 20 patients were suitable for analysis. Bland-Altman analysis showed a mean ratio of everolimus WB to DBS concentrations of 0.90, with 95% of data points within limits of clinical relevance. Passing-Bablok regression of DBS compared to WB revealed no constant bias (intercept 0.02; 95% CI 0.93-1.35) and a small proportional bias (slope 0.89; 95% CI 0.76-0.99). Predicted concentrations showed low bias and imprecision and 90% of samples had an absolute percentage prediction error of < 20%.

conclusionsDBS is a valid method to determine everolimus concentrations in cancer patients. This can especially be of value for early recognition of over- or underexposure to enable dose adaptations.

Indexed as

Dried Blood Spot TestingAdultAgedAntineoplastic AgentsChromatography, LiquidDrug Dosage CalculationsDrug MonitoringEverolimusFemaleHumansMaleMiddle AgedNeoplasmsPredictive Value of TestsReproducibility of ResultsTandem Mass SpectrometryAntineoplastic AgentsEverolimusCancerDried blood spotEverolimusMethod agreementPharmacokineticsTherapeutic drug monitoring

Identifiers

PMID29222715
PMCPMC5849667
OpenAlexW2771413423

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.