Comparative evaluation of the My5-FU™ immunoassay and LC-MS/MS in monitoring the 5-fluorouracil plasma levels in cancer patients

Büchel, Barbara; Sistonen, Johanna; Joerger, Markus; Aebi, Yolanda; Schürch, Stefan; Largiadèr, Carlo R.

doi:10.1515/cclm-2012-0641

Cited by 11 publications

(19 citation statements)

References 22 publications

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“…Outlier results > 50 mg × hour/l are assumed to indicate that the blood sample has been taken too close to the infusion port and these results are disregarded. The My5-FU assay has been validated against liquid chromatography-mass spectrometry (LC-MS) 89,95 and high-performance liquid chromatography (HPLC) laboratory techniques commonly used in PK studies.…”

Section: My5-fu Assaymentioning

confidence: 99%

“…[97][98][99][100] Response to 5-FU treatment is inconsistent with approximately 10-30% of patients displaying serious toxicity partly explained by reduced activity of DPD. 95 In the following section the key principles of the My5-FU assay procedure are provided; the majority of this information has been taken from the Saladax kit instructions. 90 …”

Section: My5-fu Assaymentioning

confidence: 99%

“…Two research papers 89,95 and two abstracts, 128,129 were found to include information relevant to whether or not My5-FU can be considered equivalent to LC-MS/MS and HPLC. However, one of the abstracts was considered part of the same study as one of the papers.…”

Section: Identificationmentioning

confidence: 99%

“…However, one of the abstracts was considered part of the same study as one of the papers. 95,128 Therefore there were three unique studies. Three studies provided Bland-Altman plots, but only one 95 provided the upper and lower limits of agreement and the 95%CI of the mean difference.…”

Section: Identificationmentioning

confidence: 99%

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Fluorouracil plasma monitoring: systematic review and economic evaluation of the My5-FU assay for guiding dose adjustment in patients receiving fluorouracil chemotherapy by continuous infusion

Freeman

Connock

Cummins³

et al. 2015

Health Technol Assess

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Background5-Fluorouracil (5-FU) is a chemotherapy used in colorectal, head and neck (H&N) and other cancers. Dose adjustment is based on body surface area (BSA) but wide variations occur. Pharmacokinetic (PK) dosing is suggested to bring plasma levels into the therapeutic range to promote fewer side effects and better patient outcomes. We investigated the clinical effectiveness and cost-effectiveness of the My5-FU assay for PK dose adjustment to 5-FU therapy.ObjectivesTo systematically review the evidence on the accuracy of the My5-FU assay compared with gold standard methods [high-performance liquid chromatography (HPLC) and liquid chromatography-mass spectrometry (LC-MS)]; the effectiveness of My5-FU PK dosing compared with BSA; the effectiveness of HPLC and/or LC-MS compared with BSA; the generalisability of published My5-FU and PK studies; costs of using My5-FU; to develop a cost-effectiveness model.Data sourcesWe searched MEDLINE, EMBASE, Science Citation Index and other databases between January and April 2014.MethodsTwo reviewers independently screened titles and abstracts with arbitration and consensus agreement. We undertook quality assessment. We reconstructed Kaplan–Meier plots for progression-free survival (PFS) and overall survival (OS) for comparison of BSA and PK dosing. We developed a Markov model to compare My5-FU with BSA dosing which modelled PFS, OS and adverse events, using a 2-week cycle over a 20 year time horizon with a 3.5% discount rate. Health impacts were evaluated from the patient perspective, while costs were evaluated from the NHS and Personal Social Services perspective.ResultsA total of 8341 records were identified through electronic searches and 35 and 54 studies were included in the clinical effectiveness and cost-effectiveness reviews respectively. There was a high apparent correlation between My5-FU, HPLC and LC-MS/mass spectrometer but upper and lower limits of agreement were –18% to 30%. Median OS were estimated as 19.6 [95% confidence interval (CI) 17.0 to 21.0] months for PK versus 14.6 (95% CI 14.1 to 15.3) months for BSA for 5-FU + folinic acid (FA); and 27.4 (95% CI 23.2 to 38.8) months for PK versus 20.6 (95% CI 18.4 to 22.9) months for BSA for FOLFOX6 in metastatic colorectal cancer (mCRC). PK versus BSA studies were generalisable to the relevant populations. We developed cost-effectiveness models for mCRC and H&N cancer. The base case assumed a cost per My5-FU assay of £61.03. For mCRC for 12 cycles of a oxaliplatin in combination with 5-fluorouracil and FA (FOLFOX) regimen, there was a quality-adjusted life-year (QALY) gain of 0.599 with an incremental cost-effectiveness ratio of £4148 per QALY. Probabilistic and scenario analyses gave similar results. The cost-effectiveness acceptability curve showed My5-FU to be 100% cost-effective at a threshold of £20,000 per QALY. For H&N cancer, again, given caveats about the poor evidence base, we also estimated that My5-FU is likely to be cost-effective at a threshold of £20,000 per QALY.LimitationsQuality and quantity of evidence were very weak for PK versus BSA dosing for all cancers with no randomised controlled trials (RCTs) using current regimens. For H&N cancer, two studies of regimens no longer in use were identified.ConclusionsUsing a linked evidence approach, My5-FU appears to be cost-effective at a willingness to pay of £20,000 per QALY for both mCRC and H&N cancer. Considerable uncertainties remain about evidence quality and practical implementation. RCTs are needed of PK versus BSA dosing in relevant cancers.FundingThe National Institute for Health Research Health Technology Assessment programme.

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Section: My5-fu Assaymentioning

confidence: 99%

Section: My5-fu Assaymentioning

confidence: 99%

Section: Identificationmentioning

confidence: 99%

Section: Identificationmentioning

confidence: 99%

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Fluorouracil plasma monitoring: systematic review and economic evaluation of the My5-FU assay for guiding dose adjustment in patients receiving fluorouracil chemotherapy by continuous infusion

Freeman

Connock

Cummins³

et al. 2015

Health Technol Assess

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“…The developed method combined the analysis of 5-FU pharmacokinetics and DPD activity into a single assay [56]. These assays were found to be suitable for monitoring 5-FU plasma levels in routine clinical practice and may contribute to improved efficacy and safety of 5-FU-based chemotherapies for therapeutic drug monitoring and toxicity prediction in cancer patients [57].…”

Section: Hybrid Instrumental Techniques For 5-fu Analysis In Biologicmentioning

confidence: 99%

A Critical Review on Clinical Application of Separation Techniques for Selective Recognition of Uracil and 5-Fluorouracil

2015

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The most important objectives that are frequently found in bio-analytical chemistry involve applying tools to relevant medical/biological problems and refining these applications. Developing a reliable sample preparation step, for the medical and biological fields is another primary objective in analytical chemistry, in order to extract and isolate the analytes of interest from complex biological matrices. Since, main inborn errors of metabolism (IEM) diagnosable through uracil analysis and the therapeutic monitoring of toxic 5-fluoruracil (an important anticancerous drug) in dihydropyrimidine dehydrogenase deficient patients, require an ultra-sensitive, reproducible, selective, and accurate analytical techniques for their measurements. Therefore, keeping in view, the diagnostic value of uracil and 5-fluoruracil measurements, this article refines several analytical techniques involved in selective recognition and quantification of uracil and 5-fluoruracil from biological and pharmaceutical samples. The prospective study revealed that implementation of molecularly imprinted polymer as a solid-phase material for sample preparation and preconcentration of uracil and 5-fluoruracil had proven to be effective as it could obviates problems related to tedious separation techniques, owing to protein binding and drastic interferences, from the complex matrices in real samples such as blood plasma, serum samples.

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Dose and therapy individualization in cancer chemotherapy

Hempel

2020

Handbook of Analytical Separations

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Comparative evaluation of the My5-FU™ immunoassay and LC-MS/MS in monitoring the 5-fluorouracil plasma levels in cancer patients

Cited by 11 publications

References 22 publications

Fluorouracil plasma monitoring: systematic review and economic evaluation of the My5-FU assay for guiding dose adjustment in patients receiving fluorouracil chemotherapy by continuous infusion

Fluorouracil plasma monitoring: systematic review and economic evaluation of the My5-FU assay for guiding dose adjustment in patients receiving fluorouracil chemotherapy by continuous infusion

A Critical Review on Clinical Application of Separation Techniques for Selective Recognition of Uracil and 5-Fluorouracil

Dose and therapy individualization in cancer chemotherapy

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