Evidence map›Paper›PMID 36969063›Full record

ArticleFrontiers in oncology2023

Therapeutic drug monitoring guided dosing versus standard dosing of alectinib in advanced ALK positive non-small cell lung cancer patients: Study protocol for an international, multicenter phase IV randomized controlled trial (ADAPT ALEC).

Marinda Meertens, M Benthe Muntinghe-Wagenaar, Barend J Sikkema, Marta Lopez-Yurda, Valesca P Retèl, Marthe S Paats, Rob Ter Heine, Ed Schuuring, Wim Timens, Daan J Touw and 12 more

Registry-linked trialOpen access · goldFull text read
In one paragraph

Article in Frontiers in oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05525338 (Standard Dosed Alectinib Versus Therapeutic Drug Monitoring Guided Alectinib Dosing), which is not on this map. Cited by 9 papers.

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

NCT05525338 phase4recruitingnot on this map

Standard Dosed Alectinib Versus Therapeutic Drug Monitoring Guided Alectinib Dosing

TypeinterventionalSponsorUniversity Medical Center GroningenRan2022 to 2026Enrolled196ConditionsDrug Monitoring, Carcinoma, Non-Small-Cell Lung, Lung Cancer, Anaplastic Lymphoma Kinase Gene MutationArmsAlectinib
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
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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

22 authors at 8 institutions in 1 country.

Marinda MeertensDepartment of Pharmacy and Pharmacology, Netherlands Cancer Institute, Amsterdam, Netherlands.
M Benthe Muntinghe-WagenaarDepartment of Pulmonology and Tuberculosis, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.
Barend J SikkemaDepartment of Medical Oncology, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Rotterdam, Netherlands.
Marta Lopez-YurdaDepartment of Biometrics, The Netherlands Cancer Institute, Amsterdam, Netherlands.
Valesca P RetèlDivision of Psychosocial Research and Epidemiology, Netherlands Cancer Institute, Amsterdam, Netherlands.
Marthe S PaatsDepartment of Pulmonary Medicine, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Rotterdam, Netherlands.
Rob Ter HeineDepartment of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center Nijmegen, Nijmegen, Netherlands.
Ed SchuuringDepartment of Pathology and Medical Biology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.
Wim TimensDepartment of Pathology and Medical Biology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.
Daan J TouwDepartment of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.
Job F M van BovenDepartment of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.
Adrianus J de LangenDepartment of Thoracic Oncology, Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands.
Sayed M S HashemiDepartment of Pulmonary Medicine, Amsterdam University Medical Center, VU University Medical Center, Amsterdam, Netherlands.
Lizza E L HendriksDepartment of Respiratory Medicine, Maastricht University Medical Center, GROW School for Oncology and Reproduction, Maastricht, Netherlands.
Sander CroesDepartment of Clinical Pharmacy and Toxicology, Maastricht University Medical Center, CARIM School for Cardiovascular disease, Maastricht, Netherlands.
Michel M van den HeuvelDepartment of Pulmonary Diseases, Radboud University Medical Center, Nijmegen, Netherlands.
Anne-Marie C DingemansDepartment of Pulmonary Medicine, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Rotterdam, Netherlands.
Ron H J MathijssenDepartment of Medical Oncology, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Rotterdam, Netherlands.
Egbert F SmitDepartment of Pulmonology, Leiden University Medical Center, Leiden, Netherlands.
Alwin D R HuitemaDepartment of Pharmacy and Pharmacology, Netherlands Cancer Institute, Amsterdam, Netherlands.
Neeltje SteeghsDepartment of Clinical Pharmacology, Division of Medical Oncology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands.
Anthonie J van der WekkenDepartment of Pulmonology and Tuberculosis, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.
The Netherlands Cancer Institute · NLErasmus MC Cancer Institute · NLUniversity Medical Center Groningen · NLMaastricht University · NLRadboud University Nijmegen · NLUniversity of Groningen · NLLeiden University Medical Center · NLOncode Institute · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Alectinib is first-line therapy in patients with stage IV non-small cell lung carcinoma (NSCLC) and an anaplastic lymphoma kinase (ALK) fusion. A shorter median progression-free survival (mPFS) was observed when alectinib minimum plasma concentrations during steady state (C Methods: ADAPT ALEC is a multicenter, phase IV RCT, in which patients aged ≥ 18 years with advanced ALK positive (+) NSCLC eligible for alectinib in daily care are enrolled. Participants will be randomized (1:1 ratio) into intervention arm A (TDM) or B (control), stratified by brain metastases and prior ALK treatments. Starting dose in both arms is the approved flat fixed dose of alectinib 600 mg taken twice daily with food. In case of alectinib C Discussion: The ADAPT ALEC will show whether treatment outcomes of patients with advanced ALK+ NSCLC improve when using TDM-guided dosing of alectinib instead of fixed dosing. The results will provide high quality evidence for deciding whether TDM should be implemented as standard of care and this will have important consequences for the prescribing of alectinib. Clinical trial registration: ClinicalTrials.gov, identifier NCT05525338.

Indexed as

anaplastic lymphoma kinasecost-effectivenessnon-small cell lung cancerpersonalized dosingpharmacokineticsprotein kinase inhibitorsrandomized controlled trialtherapeutic drug monitoring

Identifiers

PMID36969063
PMCPMC10035072
OpenAlexW4323661663

What OpenQuestion holds

Textfull text, public
LicenceCC BY
measurements read32
Read underepoch 390

Registered trials

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.