Evidence map›Paper›PMID 32358810›Full record

Observational studyBritish journal of clinical pharmacology2021

The relationship between sunitinib exposure and both efficacy and toxicity in real-world patients with renal cell carcinoma and gastrointestinal stromal tumour.

Kim Westerdijk, Stefanie D Krens, Winette T A van der Graaf, Sasja F Mulder, Carla M L van Herpen, Tineke Smilde, Nielka P van Erp, Ingrid M E Desar

Open access · hybridAbstract readObservational Study
In one paragraph

Observational study in British journal of clinical pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 pooled it
2.4field-weighted citation impact, top 9% 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

17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 29 citations in OpenAlex.

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  14. Precision Dosing of Targeted Therapies Is Ready for Prime Time.Clinical cancer research : an official journal of the American Association for Cancer Research · 2021
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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

8 authors at 2 institutions in 1 country.

Kim WesterdijkDepartment of Medical Oncology, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, Netherlands.ORCID 0000-0003-3512-4671
Stefanie D KrensDepartment of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, Netherlands.
Winette T A van der GraafDepartment of Medical Oncology, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, Netherlands.
Sasja F MulderDepartment of Medical Oncology, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, Netherlands.
Carla M L van HerpenDepartment of Medical Oncology, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, Netherlands.
Tineke SmildeDepartment of Medical Oncology, Jeroen Bosch Hospital, 's Hertogenbosch, Netherlands.
Nielka P van ErpDepartment of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, Netherlands.ORCID 0000-0003-1553-178X
Ingrid M E DesarDepartment of Medical Oncology, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, Netherlands.
Radboud University Nijmegen · NLJeroen Bosch Ziekenhuis · NL

Funding

KWF Kankerbestrijding 11575
6 · The paper itself

Abstract

aimSunitinib is an oral tyrosine kinase inhibitor approved for the treatment of renal cell carcinoma (RCC) and gastrointestinal stromal tumor (GIST). Because of the large interpatient pharmacokinetic variability and established exposure-response and exposure-toxicity relationships in clinical trial patients, therapeutic drug monitoring (TDM) seems promising for optimizing sunitinib exposure. We aimed to investigate the relationship between sunitinib exposure and treatment outcome in a real-world patient cohort.

methodsWe performed a retrospective observational cohort study in 53 patients with metastatic RCC and 18 patients with metastatic GIST treated with sunitinib and receiving TDM-guided dosing. Time on treatment - as a surrogate for progression-free survival - in patients who achieved adequate sunitinib exposure was compared with patients who did not. Additionaly, the median sunitinib exposure was compared in patients with or without sunitinib-induced toxicity leading to dose reduction.

resultsThe median time on treatment in patients with RCC who achieved adequate sunitinib exposure (n = 39) was 32 weeks, compared to 15 weeks in patients who did not achieve adequate sunitinib exposure (n = 12) (P = 0.244). In 29 patients (41%) with toxicity leading to dose reduction, sunitinib sum plasma trough concentration (C

conclusionIn our real-world patient cohort, patients with sunitinib-induced toxicity requiring dose reduction had significantly higher sunitinib exposure compared to patients without toxicity. The threshold for toxicity, however, was lower compared to that previously described in clinical trials.

Indexed as

Antineoplastic AgentsCarcinoma, Renal CellGastrointestinal Stromal TumorsKidney NeoplasmsHumansIndolesPyrrolesRetrospective StudiesSunitinibTreatment OutcomeAntineoplastic AgentsIndolesPyrrolesSunitinibpharmacodynamicspharmacokineticssunitinibtherapeutic drug monitoring

Identifiers

PMID32358810
PMCPMC9328649
OpenAlexW3023530971

What OpenQuestion holds

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LicenceCC BY-NC
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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.