Mc Laughlin, Anna M. ORCID: 0000-0002-5936-1877, Schmulenson, Eduard ORCID: 0000-0002-8026-609X, Teplytska, Olga, Zimmermann, Sebastian ORCID: 0000-0002-6282-297X, Opitz, Patrick, Groenland, Stefanie L., Huitema, Alwin D. R., Steeghs, Neeltje, Mueller, Lothar, Fuxius, Stefan, Illerhaus, Gerald, Joerger, Markus ORCID: 0000-0001-6602-6287, Mayer, Frank, Fuhr, Uwe, Holdenrieder, Stefan, Hempel, Georg ORCID: 0000-0002-5790-6423, Scherf-Clavel, Oliver ORCID: 0000-0002-1967-9231, Jaehde, Ulrich and Kloft, Charlotte (2021). Developing a Nationwide Infrastructure for Therapeutic Drug Monitoring of Targeted Oral Anticancer Drugs: The ON-TARGET Study Protocol. Cancers, 13 (24). BASEL: MDPI. ISSN 2072-6694

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Abstract

Simple Summary Relationships between drug concentrations in blood and efficacy and/or toxicity have been reported for up to 80% of oral anticancer drugs (OADs). Most OADs exhibit highly variable drug concentrations at the approved dose. This may result in a significant proportion of patients with suboptimal drug concentrations. Therapeutic Drug Monitoring (TDM), which is dose optimization based on measured drug concentrations, can be used to personalize drug dosing with the overall goal to improve the benefit-risk ratio of anticancer drug treatment. The ON-TARGET study aims to investigate the feasibility of TDM in patients receiving either axitinib or cabozantinib for the treatment of renal-cell carcinoma with the main objective to improve severe tyrosine kinase inhibitor associated toxicity. Additionally, the feasibility of volumetric absorptive microsampling (VAMS), a novel minimally invasive and easy to handle blood sampling technique, for TDM sample collection is investigated. Exposure-efficacy and/or exposure-toxicity relationships have been identified for up to 80% of oral anticancer drugs (OADs). Usually, OADs are administered at fixed doses despite their high interindividual pharmacokinetic variability resulting in large differences in drug exposure. Consequently, a substantial proportion of patients receive a suboptimal dose. Therapeutic Drug Monitoring (TDM), i.e., dosing based on measured drug concentrations, may be used to improve treatment outcomes. The prospective, multicenter, non-interventional ON-TARGET study (DRKS00025325) aims to investigate the potential of routine TDM to reduce adverse drug reactions in renal cell carcinoma patients receiving axitinib or cabozantinib. Furthermore, the feasibility of using volumetric absorptive microsampling (VAMS), a minimally invasive and easy to handle blood sampling technique, for sample collection is examined. During routine visits, blood samples are collected and sent to bioanalytical laboratories. Venous and VAMS blood samples are collected in the first study phase to facilitate home-based capillary blood sampling in the second study phase. Within one week, the drug plasma concentrations are measured, interpreted, and reported back to the physician. Patients report their drug intake and toxicity using PRO-CTCAE-based questionnaires in dedicated diaries. Ultimately, the ON-TARGET study aims to develop a nationwide infrastructure for TDM for oral anticancer drugs.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Mc Laughlin, Anna M.UNSPECIFIEDorcid.org/0000-0002-5936-1877UNSPECIFIED
Schmulenson, EduardUNSPECIFIEDorcid.org/0000-0002-8026-609XUNSPECIFIED
Teplytska, OlgaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Zimmermann, SebastianUNSPECIFIEDorcid.org/0000-0002-6282-297XUNSPECIFIED
Opitz, PatrickUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Groenland, Stefanie L.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Huitema, Alwin D. R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Steeghs, NeeltjeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mueller, LotharUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fuxius, StefanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Illerhaus, GeraldUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Joerger, MarkusUNSPECIFIEDorcid.org/0000-0001-6602-6287UNSPECIFIED
Mayer, FrankUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fuhr, UweUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Holdenrieder, StefanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hempel, GeorgUNSPECIFIEDorcid.org/0000-0002-5790-6423UNSPECIFIED
Scherf-Clavel, OliverUNSPECIFIEDorcid.org/0000-0002-1967-9231UNSPECIFIED
Jaehde, UlrichUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kloft, CharlotteUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-602204
DOI: 10.3390/cancers13246281
Journal or Publication Title: Cancers
Volume: 13
Number: 24
Date: 2021
Publisher: MDPI
Place of Publication: BASEL
ISSN: 2072-6694
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
DRIED BLOOD SPOTS; KINASE INHIBITORS; PHASE-I; ADHERENCE; IMATINIB; QUANTIFICATION; FEASIBILITY; VALIDATION; PLASMA; INDIVIDUALIZATIONMultiple languages
OncologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/60220

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