Evidence map›Paper›PMID 32594200›Full record

Trial reportCancer chemotherapy and pharmacology2020

Wide variation in tissue, systemic, and drain fluid exposure after oxaliplatin-based HIPEC: results of the GUTOX study.

Loek A W de Jong, Fortuné M K Elekonawo, Marie Lambert, Jan Marie de Gooyer, Henk M W Verheul, David M Burger, Johannes H W de Wilt, Etienne Chatelut, Rob Ter Heine, Philip R de Reuver and 2 more

Erratum issued Registry-linked trialOpen access · hybridAbstract readClinical Trial
In one paragraph

Trial report in Cancer chemotherapy and pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03364907 (Clinical pharmacoloGy of platinUm-based hyperThermic Intraperitoneal Chemotherapy), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.8field-weighted citation impact, top 27% 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.

NCT03364907 completednot on this map

Clinical pharmacoloGy of platinUm-based hyperThermic Intraperitoneal Chemotherapy: Exploration of the Impact of Flushing on tumOur, Systemic and Personnel eXposure (GUTOX)

TypeobservationalSponsorRadboud University Medical CenterRan2018 to 2019Enrolled20ConditionsPeritoneal CarcinomatosisArmsHIPEC with flushing afterwards, HIPEC without flushing afterwards
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 6 citations in OpenAlex.

  1. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 2 institutions in 2 countries.

Loek A W de JongDepartment of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center (RUMC), P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands. Loek.dejong@radboudumc.nl.ORCID http://orcid.org/0000-0002-3989-8386
Fortuné M K ElekonawoDepartment of Radiology and Nuclear Medicine, Radboud Institute for Health Sciences, Radboud University Medical Center (RUMC), P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands.
Marie LambertInstitut Claudius‑Regaud, IUCT‑Oncopole, and CRCT, Université de Toulouse, Inserm, 1, avenue Irène Joliot‑Curie, Toulouse, France.
Jan Marie de GooyerDepartment of Radiology and Nuclear Medicine, Radboud Institute for Health Sciences, Radboud University Medical Center (RUMC), P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands.
Henk M W VerheulDepartment of Medical Oncology, Radboud Institute for Health Sciences, Radboud University Medical Center (RUMC), P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands.
David M BurgerDepartment of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center (RUMC), P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands.
Johannes H W de WiltDepartment of Surgery, Radboud Institute for Health Sciences, Radboud University Medical Center (RUMC), P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands.
Etienne ChatelutInstitut Claudius‑Regaud, IUCT‑Oncopole, and CRCT, Université de Toulouse, Inserm, 1, avenue Irène Joliot‑Curie, Toulouse, France.
Rob Ter HeineDepartment of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center (RUMC), P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands.
Philip R de ReuverDepartment of Surgery, Radboud Institute for Health Sciences, Radboud University Medical Center (RUMC), P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands.
Andre J A BremersDepartment of Surgery, Radboud Institute for Health Sciences, Radboud University Medical Center (RUMC), P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands.
Nielka P van ErpDepartment of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center (RUMC), P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands.
Radboud University Nijmegen · NLInserm · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeIn this exploratory study, the effect of postprocedural flushing with crystalloids after oxaliplatin-based hyperthermic intraperitoneal chemotherapy (HIPEC) on platinum concentrations in peritoneal tissue, blood, and drain fluid was studied. Interpatient variability in oxaliplatin pharmacokinetics and the relation between platinum concentration in peritoneal fluid and platinum exposure in tissue and blood was explored.

methodsTen patients with peritoneal carcinomatosis of colorectal origin were treated with HIPEC including postprocedural flushing, followed by ten patients without flushing afterwards. Tissue, peritoneal fluid, blood, and drain fluid samples were collected for measurement of total and ultrafiltered platinum concentrations.

resultsPeritoneal tissue concentration and systemic ultrafiltered platinum exposure showed large inter individual variability, ranging from 65 to 1640 µg/g dry weight and 10.5 to 28.0 µg*h/ml, respectively. No effect of flushing was found on geometric mean platinum concentration in peritoneal tissue (348 vs. 356 µg/g dry weight), blood (14.8 vs. 18.1 µg*h/ml), or drain fluid (day 1: 7.6 vs. 7.7 µg/ml; day 2: 1.7 vs. 1.9 µg/ml). The platinum concentration in peritoneal fluid at the start of HIPEC differed twofold between patients and was positively correlated with systemic exposure (p = .04) and peak plasma concentration (p = .04).

conclusionIn this exploratory study, no effect was found for postprocedural flushing on platinum concentrations in peritoneal tissue, blood, or drain fluid. BSA-based HIPEC procedure leads to large interpatient variability in platinum exposure in all compartments. The study was registered at ClinicalTrials.gov on 7 December 2017 under registration number NCT03364907.

Indexed as

AgedAged, 80 and overAscitic FluidDrainageFemaleHumansHyperthermic Intraperitoneal ChemotherapyMaleMiddle AgedOxaliplatinPeritoneal NeoplasmsSodium ChlorideTissue DistributionOxaliplatinSodium ChlorideColorectal peritoneal metastasisHIPECHyperthermic intraperitoneal chemotherapyOxaliplatinPeritoneal carcinomatosisPharmacokinetics

Identifiers

PMID32594200
PMCPMC7338818
OpenAlexW3037814103

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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.