Evidence map›Paper›PMID 31290566›Full record

ArticleBritish journal of clinical pharmacology2019

The effect of gastrectomy on regorafenib exposure and progression-free survival in patients with advanced gastrointestinal stromal tumours.

Floor J E Lubberman, Winette T A van der Graaf, Lei Xu, Adriaan Cleton, George D Demetri, Hans Gelderblom, Nielka P van Erp

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Article 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 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.5field-weighted citation impact, top 33% 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

4 citing papers in PubMed, 6 citations in OpenAlex.

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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 5 institutions in 3 countries.

Floor J E LubbermanDepartment of pharmacy, Radboud University Medical Center, Nijmegen, The Netherlands.ORCID 0000-0002-5537-0784
Winette T A van der GraafDepartment of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands.
Lei XuBayer HealthCare Pharmaceuticals, Whippany, NJ, USA.
Adriaan CletonBayer AG, Berlin, Germany.
George D DemetriDana-Farber Cancer Institute, Harvard Medical School, Department of Oncology, Boston, MA, USA.
Hans GelderblomDepartment of Medical Oncology, Leiden University Medical Center, Leiden, The Netherlands.
Nielka P van ErpDepartment of pharmacy, Radboud University Medical Center, Nijmegen, The Netherlands.ORCID 0000-0003-1553-178X
Radboud University Nijmegen · NLBayer (Germany) · DEBayer (United States) · USHarvard University · USLeiden University Medical Center · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsWe investigated whether major gastrectomy influences the plasma exposure of regorafenib and treatment outcome.

methodsEfficacy and pharmacokinetic data from 133 gastrointestinal stromal tumour patients included in a phase III trial were analysed. Patients were subdivided into 2 groups according to the extent of the gastrectomy (no/nonsignificant gastrectomy and major gastrectomy). Progression-free survival (PFS) on regorafenib was measured and regorafenib and its pharmacological active metabolites plasma exposure were measured.

resultsA total of 133 patient were included, of whom 27 underwent major gastrectomy. In patients with no/nonsignificant gastrectomy the median PFS was 145 (interquartile range 43-281) days. The PFS in patients with a major gastrectomy was 172 (interquartile range 57-280) days. Regorafenib pharmacokinetic samples were collected in 80 patients of which 19 patients with a major gastrectomy and 61 patients with no/nonsignificant gastric surgery. The average ± standard deviation total concentration of regorafenib including the metabolites M-2 and M-5 was 6.9 ± 1.53 μmol/L and 6.7 ± 1.56 μmol/L in patient with major gastrectomy and no/nonsignificant gastrectomy respectively.

conclusionOur study shows that major gastrectomy did not influence plasma exposure of regorafenib and metabolites. In addition, no difference in PFS between the subgroups was seen.

Indexed as

AdolescentAdultAgedAntineoplastic AgentsClinical Trials, Phase III as TopicFemaleGastrectomyGastrointestinal NeoplasmsGastrointestinal Stromal TumorsHumansMaleMiddle AgedPhenylurea CompoundsProgression-Free SurvivalPyridinesRandomized Controlled Trials as TopicAntineoplastic AgentsPhenylurea CompoundsPyridinesregorafenibgastrectomygastrointestinal stromal tumourpharmacokineticsregorafenib

Identifiers

PMID31290566
PMCPMC6783594
OpenAlexW2960727045

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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.