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  • 1
    Online Resource
    Online Resource
    Framework for Implementing Individualised Dosing of Anti-Cancer Drugs in Routine Care: Overcoming the Logistical Challenges
    MDPI AG ; 2023
    In:  Cancers Vol. 15, No. 13 ( 2023-06-22), p. 3293-
    Details
    In: Cancers, MDPI AG, Vol. 15, No. 13 ( 2023-06-22), p. 3293-
    Abstract: Precision medicine in oncology involves identifying the ‘right drug’, at the ‘right dose’, for the right person. Currently, many orally administered anti-cancer drugs, particularly kinase inhibitors (KIs), are prescribed at a standard fixed dose. Identifying the right dose remains one of the biggest challenges to optimal patient care. Recently the Precision Dosing Group established the Accurate Dosing of Anti-cancer Patient-centred Therapies (ADAPT) Program to address individualised dosing; thus, use existing anti-cancer drugs more safely and efficiently. In this paper, we outline our framework, based on the Medical Research Council (MRC) framework, with a simple 6-step process and strategies which have led to the successful implementation of the ADAPT program in South Australia. Implementation strategies in our 6-step process involve: (1) Evaluate the evidence and identify the cancer drugs: Literature review, shadowing other experts, establishing academic partnerships, adaptability/flexibility; (2) Establishment of analytical equipment for drug assays for clinical purposes: assessment for readiness, accreditation, feasibility, obtaining formal commitments, quality assurance to all stakeholders; (3) Clinical preparation and education: educational material, conducted educational meetings, involve opinion leaders, use of mass media, promote network weaving, conduct ongoing training; (4) Blood collection, sample preparation and analyses: goods received procedures, critical control points (transport time); (5) Interpret and release results with recommendations: facilitate the relay of clinical data to providers; (6) Clinical application: providing ongoing consultation, identify early adopters, identify, and prepare champions. These strategies were selected from the 73 implementation strategies outlined in the Expert Recommendations for Implementing Change (ERIC) study. The ADAPT program currently provides routine plasma concentrations for patients on several orally administered drugs in South Australia and is currently in its evaluation phase soon to be published. Our newly established framework could provide great potential and opportunities to advance individualised dosing of oral anti-cancer drugs in routine clinical care.
    Type of Medium: Online Resource
    ISSN: 2072-6694
    URL: Article
    DOI: 10.3390/cancers15133293
    Language: English
    Publisher: MDPI AG
    Publication Date: 2023
    detail.hit.zdb_id: 2527080-1
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  • 2
    Online Resource
    Online Resource
    Efficacy and Safety of NSAIDs in Infants: A Comprehensive Review of the Literature of the Past 20 Years
    Springer Science and Business Media LLC ; 2022
    In:  Pediatric Drugs Vol. 24, No. 6 ( 2022-11), p. 603-655
    Details
    In: Pediatric Drugs, Springer Science and Business Media LLC, Vol. 24, No. 6 ( 2022-11), p. 603-655
    Type of Medium: Online Resource
    ISSN: 1174-5878 , 1179-2019
    URL: Article
    DOI: 10.1007/s40272-022-00514-1
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
    detail.hit.zdb_id: 2043681-6
    SSG: 15,3
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  • 3
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    Plasma concentration guided dosing of drugs used for the treatment of childhood leukaemias: protocol for a systematic review
    BMJ ; 2022
    In:  BMJ Open Vol. 12, No. 1 ( 2022-01), p. e053308-
    Details
    In: BMJ Open, BMJ, Vol. 12, No. 1 ( 2022-01), p. e053308-
    Abstract: Childhood leukaemia is the most common type of cancer in children and represents among 25% of the diagnoses in children 〈 15 years old. Childhood survival rates have significantly improved within the last 40 years due to a rapid advancement in therapeutic interventions. However, in high-risk groups, survival rates remain poor. Pharmacokinetic (PK) data of cancer medications in children are limited and thus current dosing regimens are based on studies with small sample sizes. In adults, large variability in PK is observed and dose individualisation (plasma concentration guided dosing) has been associated with improved clinical outcomes; whether this is true for children is still unknown. This provides an opportunity to explore this strategy in children to potentially reduce toxicities and ensure optimal dosing. This paper will provide a protocol to systematically review studies that have used dose individualisation of drugs used in the treatment of childhood leukaemias. Methods and analysis Systematic review methodology will be applied to identify, select and extract data from published plasma guided dosing studies conducted in a paediatric leukaemia cohort. Databases (eg, Ovid Embase, Ovid MEDLINE, Ovid Cochrane) and clinical trial registries (CENTRAL, ClinicalTrials.gov and ISRCTN) will be used to perform the systematic literature search (up until February 2021). Only full empirical studies will be included, with primary clinical outcomes (progression-free survival, toxicities, minimal residual disease status, complete cytogenetic response, partial cytogenetic response and major molecular response) being used to decide whether the study will be included. The quality of included studies will be undertaken, with a subgroup analysis where appropriate. Ethics and dissemination This systematic review will not require ethics approval as there will not be collection of primary data. Findings of this review will be made available through publications in peer-reviewed journals and conference presentations. Gaps will be identified in current literature to inform future-related research. PROSPERO registration number CRD42021225045.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2021-053308
    Language: English
    Publisher: BMJ
    Publication Date: 2022
    detail.hit.zdb_id: 2599832-8
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  • 4
    Online Resource
    Online Resource
    Cost-effectiveness of oral anticancer drugs and associated individualised dosing approaches in patients with cancer: protocol for a systematic review
    BMJ ; 2021
    In:  BMJ Open Vol. 11, No. 8 ( 2021-08), p. e047173-
    Details
    In: BMJ Open, BMJ, Vol. 11, No. 8 ( 2021-08), p. e047173-
    Abstract: Oral anticancer drugs (OADs) have rapidly expanded with more than 70 OADs targeting several molecular targets. Many of the OADs exert an exposure–response relationship but still, a ‘one-size fits-all’ dose is used, ignoring interindividual variability. Several of these OADs share similar mechanisms of actions and thus target the same cancer and has resulted in a substantial research focus on comparing the health benefit of each. However, significantly less is known about the cost–benefit associated with OADs. This paper will provide a protocol to systematically review studies that have evaluated the cost-effectiveness of OADs and their associated individualised dosing interventions. Methods and analysis Systematic review methodology will be applied to identify, select and extract data from published economic evaluation (costs and outcomes/benefits) studies of OADs and their associated individualised dosing interventions. Bibliographic databases (eg, Ovid EMBASE, Ovid MEDLINE) will be used to perform the systematic literature search (between 1 January 2000 and October 2020). Only full economic evaluations will be included, but no restrictions on study outcomes will be applied. The quality of included primary studies will be assessed using the Consolidated Health Economic Evaluation Reporting Standards checklist for reporting economic evaluations. Studies with low-quality evidence will be excluded. A narrative synthesis of the results from the included studies will be undertaken, with a subgroup analysis where appropriate. Ethics and dissemination This systematic review will not require ethics approval as there will not be any collection of primary data. Findings of this review will be disseminated through publications in peer-reviewed journals, presentations at workshops or conferences and sharing through a media release. Findings from this review will provide evidence to direct and inform policy-makers where cost-neutral strategies may be effective or where dose individualising strategies may be economically beneficial. Additionally, gaps will be identified in the current literature to inform future-related research. PROSPERO registration number CRD42020218170. Electronic supplemental material The online version of this article contains supplemental material, which is available to authorised users.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2020-047173
    Language: English
    Publisher: BMJ
    Publication Date: 2021
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  • 5
    Online Resource
    Online Resource
    Simulation-Based Assessment of the Impact of Non-Adherence on Endoxifen Target Attainment in Different Tamoxifen Dosing Strategies
    MDPI AG ; 2021
    In:  Pharmaceuticals Vol. 14, No. 2 ( 2021-02-03), p. 115-
    Details
    In: Pharmaceuticals, MDPI AG, Vol. 14, No. 2 ( 2021-02-03), p. 115-
    Abstract: Tamoxifen is widely used in breast cancer treatment and minimum steady-state concentrations of its active metabolite endoxifen (CSS,min ENDX) above 5.97 ng/mL have been associated with favourable disease outcome. Yet, about 20% of patients do not reach target CSS,min ENDX applying conventional tamoxifen dosing. Moreover, 4–75% of patients are non-adherent, resulting in worse disease outcomes. Assuming complete adherence, we previously showed model-informed precision dosing (MIPD) to be superior to conventional and CYP2D6-guided dosing in minimising the proportion of patients with subtarget CSS,min ENDX. Given the high non-adherence rate in long-term tamoxifen therapy, this study investigated the impact of non-adherence on CSS,min ENDX target attainment in different dosing strategies. We show that MIPD allows to account for the expected level of non-adherence (here: up to 2 missed doses/week): increasing the MIPD target threshold from 5.97 ng/mL to 9 ng/mL (the lowest reported CSS,min ENDX in CYP2D6 normal metabolisers) as a safeguard resulted in the lowest interindividual variability and proportion of patients with subtarget CSS,min ENDX even in non-adherent patients. This is a significant improvement to conventional and CYP2D6-guided dosing. Adding a fixed increment to the originally selected dose is not recommended, since it inflates interindividual variability.
    Type of Medium: Online Resource
    ISSN: 1424-8247
    URL: Article
    DOI: 10.3390/ph14020115
    Language: English
    Publisher: MDPI AG
    Publication Date: 2021
    detail.hit.zdb_id: 2193542-7
    SSG: 15,3
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  • 6
    Online Resource
    Online Resource
    Combining Therapeutic Drug Monitoring and Pharmacokinetic Modelling Deconvolutes Physiological and Environmental Sources of Variability in Clozapine Exposure
    MDPI AG ; 2021
    In:  Pharmaceutics Vol. 14, No. 1 ( 2021-12-27), p. 47-
    Details
    In: Pharmaceutics, MDPI AG, Vol. 14, No. 1 ( 2021-12-27), p. 47-
    Abstract: Background: Clozapine is a key antipsychotic drug for treatment-resistant schizophrenia but exhibits highly variable pharmacokinetics and a propensity for serious adverse effects. Currently, these challenges are addressed using therapeutic drug monitoring (TDM). This study primarily sought to (i) verify the importance of covariates identified in a prior clozapine population pharmacokinetic (popPK) model in the absence of environmental covariates using physiologically based pharmacokinetic (PBPK) modelling, and then to (ii) evaluate the performance of the popPK model as an adjunct or alternative to TDM-guided dosing in an active TDM population. Methods: A popPK model incorporating age, metabolic activity, sex, smoking status and weight was applied to predict clozapine trough concentrations (Cmin) in a PBPK-simulated population and an active TDM population comprising 142 patients dosed to steady state at Flinders Medical Centre in Adelaide, South Australia. Post hoc analyses were performed to deconvolute the impact of physiological and environmental covariates in the TDM population. Results: Analysis of PBPK simulations confirmed age, cytochrome P450 1A2 activity, sex and weight as physiological covariates associated with variability in clozapine Cmin (R2 = 0.7698; p = 0.0002). Prediction of clozapine Cmin using a popPK model based on these covariates accounted for 〈 5% of inter-individual variability in the TDM population. Post hoc analyses confirmed that environmental covariates accounted for a greater proportion of the variability in clozapine Cmin in the TDM population. Conclusions: Variability in clozapine exposure was primarily driven by environmental covariates in an active TDM population. Pharmacokinetic modelling can be used as an adjunct to TDM to deconvolute sources of variability in clozapine exposure.
    Type of Medium: Online Resource
    ISSN: 1999-4923
    URL: Article
    DOI: 10.3390/pharmaceutics14010047
    Language: English
    Publisher: MDPI AG
    Publication Date: 2021
    detail.hit.zdb_id: 2527217-2
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  • 7
    Online Resource
    Online Resource
    Physiologically Based Pharmacokinetic Modeling to Identify Physiological and Molecular Characteristics Driving Variability in Drug Exposure
    Wiley ; 2018
    In:  Clinical Pharmacology & Therapeutics Vol. 104, No. 6 ( 2018-12), p. 1219-1228
    Details
    In: Clinical Pharmacology & Therapeutics, Wiley, Vol. 104, No. 6 ( 2018-12), p. 1219-1228
    Abstract: Prospectively defining the physiological and molecular characteristics most likely driving between‐subject variability (BSV) in drug exposure provides the opportunity to inform the assessment of biomarkers to account for this variability. A physiologically based pharmacokinetic (PBPK) model was constructed and verified for dabrafenib. This model was then used to evaluate the physiological and molecular characteristics driving BSV in dabrafenib exposure. The capacity to discriminate a steady‐state dabrafenib trough concentration 〉 48 ng/mL was also evaluated. The mean simulated/observed ratios for the parameters describing dabrafenib exposure in single‐dose, multiple‐dose, and drug–drug interaction studies were between 0.78 and 1.23. Multivariable analysis indicated that consideration of baseline weight, body mass index, and CYP2C8, CYP3A4, and P‐gp abundance strongly predicts steady‐state dabrafenib trough concentration above 48 ng/mL (ROC AUC = 0.94; accuracy = 86%). This is the first study to use a verified PBPK model to identify baseline physiological and molecular characteristics driving BSV in drug exposure.
    Type of Medium: Online Resource
    ISSN: 0009-9236 , 1532-6535
    URL: Issue
    URL: Article
    DOI: 10.1002/cpt.2018.104.issue-6
    DOI: 10.1002/cpt.1076
    RVK:
    XA 36900
    Language: English
    Publisher: Wiley
    Publication Date: 2018
    detail.hit.zdb_id: 2040184-X
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  • 8
    Online Resource
    Online Resource
    Plasma extracellular nanovesicle (exosome)‐derived biomarkers for drug metabolism pathways: a novel approach to characterize variability in drug exposure
    Wiley ; 2019
    In:  British Journal of Clinical Pharmacology Vol. 85, No. 1 ( 2019-01), p. 216-226
    Details
    In: British Journal of Clinical Pharmacology, Wiley, Vol. 85, No. 1 ( 2019-01), p. 216-226
    Abstract: Demonstrate the presence of cytochrome P450 (CYP) and UDP‐glucuronosyltransferase (UGT) proteins and mRNAs in isolated human plasma exosomes and evaluate the capacity for exosome‐derived biomarkers to characterize variability in CYP3A4 activity. Methods The presence of CYP and UGT protein and mRNA in exosomes isolated from human plasma and HepaRG cell culture medium was determined by mass spectrometry and reverse transcription–polymerase chain reaction, respectively. The concordance between exosome‐derived CYP3A4 biomarkers and midazolam apparent oral clearance (CL/F) was evaluated in a small proof‐of‐concept study involving six genotyped (CYP3A4 *1/*1 and CYP3A5 *3/*3) Caucasian males. Results Exosomes isolated from human plasma contained peptides and mRNA originating from CYP 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 2 J2, 3A4 and 3A5, UGT 1A1, 1A3, 1A4, 1A6, 1A9, 2B4, 2B7, 2B10 and 2B15, and NADPH‐cytochrome P450 reductase. Mean (95% confidence interval) exosome‐derived CYP3A4 protein expression pre‐ and post‐rifampicin dosing was 0.24 (0.2–0.28) and 0.42 (0.21–0.65) ng ml –1 exosome concentrate. Mean (95% confidence interval) exosome CYP3A4 mRNA expression pre‐ and post‐rifampicin dosing was 6.0 (1.1–32.7) and 48.3 (11.3–104) × 10 –11 2 ‐ΔΔCt , respectively. R 2 values for correlations of exosome‐derived CYP3A4 protein expression, CYP3A4 mRNA expression, and ex vivo CYP3A4 activity with midazolam CL/F were 0.905, 0.787 and 0.832, respectively. Conclusions Consistent strong concordance was observed between exosome‐derived CYP3A4 biomarkers and midazolam CL/F. The significance of these results is that CYP3A4 is the drug‐metabolizing enzyme of greatest clinical importance and variability in CYP3A4 activity is poorly described by existing precision dosing strategies.
    Type of Medium: Online Resource
    ISSN: 0306-5251 , 1365-2125
    URL: Issue
    URL: Article
    DOI: 10.1111/bcp.v85.1
    DOI: 10.1111/bcp.13793
    RVK:
    XA 33650
    Language: English
    Publisher: Wiley
    Publication Date: 2019
    detail.hit.zdb_id: 1498142-7
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  • 9
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    Online Resource
    A novel approach for the simultaneous quantification of 18 small molecule kinase inhibitors in human plasma: A platform for optimised KI dosing
    Elsevier BV ; 2016
    In:  Journal of Chromatography B Vol. 1033-1034 ( 2016-10), p. 17-26
    Details
    In: Journal of Chromatography B, Elsevier BV, Vol. 1033-1034 ( 2016-10), p. 17-26
    Type of Medium: Online Resource
    ISSN: 1570-0232
    URL: Article
    DOI: 10.1016/j.jchromb.2016.07.046
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2016
    detail.hit.zdb_id: 1491259-4
    SSG: 11
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  • 10
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    Correction to: Therapeutic drug monitoring of oral targeted antineoplastic drugs
    Springer Science and Business Media LLC ; 2021
    In:  European Journal of Clinical Pharmacology Vol. 77, No. 4 ( 2021-04), p. 465-465
    Details
    In: European Journal of Clinical Pharmacology, Springer Science and Business Media LLC, Vol. 77, No. 4 ( 2021-04), p. 465-465
    Type of Medium: Online Resource
    ISSN: 0031-6970 , 1432-1041
    URL: Article
    DOI: 10.1007/s00228-020-03067-9
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2021
    detail.hit.zdb_id: 1459058-X
    SSG: 15,3
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