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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Greaves, Ronda / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter


IMPACT FACTOR 2018: 3.638

CiteScore 2018: 2.44

SCImago Journal Rank (SJR) 2018: 1.191
Source Normalized Impact per Paper (SNIP) 2018: 1.205

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1437-4331
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Volume 57, Issue 7

Issues

Therapeutic drug monitoring (TDM) of 5-fluorouracil (5-FU): new preanalytic aspects

Sonani Mindt
  • Corresponding author
  • Institute for Clinical Chemistry, Mannheim Medical Faculty of Heidelberg University, University Hospital Mannheim, Mannheim, Germany
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/ Sihem Aida
  • Institute for Clinical Chemistry, Mannheim Medical Faculty of Heidelberg University, University Hospital Mannheim, Mannheim, Germany
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/ Kirsten Merx
  • Day Treatment Center (TTZ), Interdisciplinary Tumor Center Mannheim (ITM) & III Medical Clinic, Mannheim, Germany
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/ Annette Müller
  • Day Treatment Center (TTZ), Interdisciplinary Tumor Center Mannheim (ITM) & III Medical Clinic, Mannheim, Germany
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/ Tobias Gutting
  • Day Treatment Center (TTZ), Interdisciplinary Tumor Center Mannheim (ITM) & III Medical Clinic, Mannheim, Germany
  • Department of Medicine II, Mannheim Medical Faculty of Heidelberg University, University Hospital Mannheim, Mannheim, Germany
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/ Maren Hedtke
  • Institute for Clinical Chemistry, Mannheim Medical Faculty of Heidelberg University, University Hospital Mannheim, Mannheim, Germany
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/ Michael Neumaier
  • Institute for Clinical Chemistry, Mannheim Medical Faculty of Heidelberg University, University Hospital Mannheim, Mannheim, Germany
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/ Ralf-Dieter Hofheinz
  • Day Treatment Center (TTZ), Interdisciplinary Tumor Center Mannheim (ITM) & III Medical Clinic, Mannheim, Germany
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Published Online: 2019-01-30 | DOI: https://doi.org/10.1515/cclm-2018-1177

Abstract

Background

5-Fluorouracil (5-FU) is frequently used for the treatment of gastrointestinal tumors. The pharmacological effect of 5-FU is influenced by genetic polymorphisms as well as differently dosed regimens. Currently, 5-FU is generally administered as a continuous infusion via an implanted port system using a body surface area (BSA)-based dose calculation. In order to optimize treatment, the area under the curve (AUC) can be estimated to allow for individual dose adjustment. A 5-FU AUC range between 20 and 30 [mg×h×L] is recommended. The aim of the current study was to assess if blood for AUC analysis could also be drawn at the side where the port system had been placed.

Methods

We collected EDTA blood samples of patients receiving infusional 5-FU simultaneously from different sampling points (right/left cubital vein). 5-FU concentrations were measured in a steady-state equilibrium based on nanoparticle immunoassay (My5-FU; Saladax).

Results

A total of 39 patients took part in this study. About half of the patients did not reach the target 5-FU concentration window (37% were under- and 16% of the patients were overdosed). Calculated median AUC was 23.3 for the right arm (range 5.8–59.4) and a median of 23.4 for the left arm (range 5.3–61.0). AUC values showed no difference between right compared to left arms (p=0.99).

Conclusions

In all, these results confirm that a high percentage of patients are not treated with 5-FU doses reaching suggested AUC levels of 20–30. The location of venepuncture, however, had no impact on the results of plasma 5-FU concentration.

Keywords: colorectal carcinoma; 5-fluorouracil; preanalytic; therapeutic drug monitoring

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About the article

Corresponding author: Sonani Mindt, MSc, Institute for Clinical Chemistry, Mannheim Medical Faculty of Heidelberg University, University Hospital Mannheim, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany, Phone: 0049-621-383-2624, Fax: 0049-621-383-3819


Received: 2018-11-02

Accepted: 2018-12-16

Published Online: 2019-01-30

Published in Print: 2019-06-26


Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

Research funding: Ralf-Dieter Hofheinz: Consulting fee: Saladax.

Employment or leadership: None declared.

Honorarium: None declared.

Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.


Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), Volume 57, Issue 7, Pages 1012–1016, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2018-1177.

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