Evidence map›Paper›PMID 38528813›Full record

Trial reportCPT: pharmacometrics & systems pharmacology2024

Population pharmacokinetic-pharmacodynamic modeling of serum biomarkers as predictors of tumor dynamics following lenvatinib treatment in patients with radioiodine-refractory differentiated thyroid cancer (RR-DTC).

Oneeb Majid, Seiichi Hayato, Sree Harsha Sreerama Reddy, Bojan Lalovic, Taro Hihara, Taisuke Hoshi, Yasuhiro Funahashi, Jagadeesh Aluri, Osamu Takenaka, Sanae Yasuda and 1 more

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in CPT: pharmacometrics & systems pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 22% 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

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 3 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. 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

11 authors at 3 institutions in 3 countries.

Oneeb MajidEisai Ltd., Hatfield, UK.ORCID 0000-0003-3481-1138
Seiichi HayatoEisai Co., Ltd., Tokyo, Japan.ORCID 0000-0003-2691-2545
Sree Harsha Sreerama ReddyEisai Inc., Nutley, New Jersey, USA.
Bojan LalovicEisai Inc., Nutley, New Jersey, USA.
Taro HiharaEisai Co., Ltd., Tokyo, Japan.
Taisuke HoshiEisai Co., Ltd., Tokyo, Japan.
Yasuhiro FunahashiEisai Co., Ltd., Tokyo, Japan.
Jagadeesh AluriEisai Inc., Nutley, New Jersey, USA.
Osamu TakenakaEisai Co., Ltd., Tokyo, Japan.
Sanae YasudaEisai Co., Ltd., Tokyo, Japan.
Ziad HusseinEisai Ltd., Hatfield, UK.
Eisai (Japan) · JPEisai (United States) · USEisai (United Kingdom) · GB

Funding

Eisai Co.Eisai IncEisai Ltd.
6 · The paper itself

Abstract

Lenvatinib is a receptor tyrosine kinase (RTK) inhibitor targeting vascular endothelial growth factor (VEGF) receptors 1-3, fibroblast growth factor (FGF) receptors 1-4, platelet-derived growth factor receptor-α (PDGFRα), KIT, and RET that have been implicated in pathogenic angiogenesis, tumor growth, and cancer. The primary objective of this work was to evaluate, by establishing quantitative relationships, whether lenvatinib exposure and longitudinal serum biomarker data (VEGF, Ang-2, Tie-2, and FGF-23) are predictors for change in longitudinal tumor size which was assessed based on data from 558 patients with radioiodine-refractory differentiated thyroid cancer (RR-DTC) receiving either lenvatinib or placebo treatment. Lenvatinib PK was best described by a 3-compartment model with simultaneous first- and zero-order absorption and linear elimination from the central compartment with significant covariates (body weight, albumin <30 g/dL, ALP>ULN, RR-DTC, RCC, HCC subjects, and concomitant CYP3A inhibitors). Except for body weight, none of the covariates have any clinically meaningful effect on exposure to lenvatinib. Longitudinal biomarker measurements over time were reasonably well defined by a PK/PD model with common EC

Indexed as

Iodine RadioisotopesPhenylurea CompoundsQuinolinesThyroid NeoplasmsAdultAgedAngiopoietin-2Antineoplastic AgentsBiomarkers, TumorFemaleHumansMaleMiddle AgedModels, BiologicalProtein Kinase InhibitorsReceptor, TIE-2Angiopoietin-2Antineoplastic AgentsBiomarkers, TumorIodine RadioisotopeslenvatinibPhenylurea CompoundsProtein Kinase InhibitorsQuinolinesReceptor, TIE-2Vascular Endothelial Growth Factor A

Identifiers

PMID38528813
PMCPMC11179699
OpenAlexW4393195795

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.