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TDM oncology

Stefanie L Groenland, Merel van Nuland, Remy B Verheijen, Jan H M Schellens, Jos H Beijnen, Alwin D R Huitema, Neeltje Steeghs
Oral anti-hormonal drugs are essential in the treatment of breast and prostate cancer. It is well known that the interpatient variability in pharmacokinetic exposure is high for these agents and exposure-response relationships exist for many oral anti-hormonal drugs. Yet, they are still administered at fixed doses. This could lead to underdosing and thus suboptimal efficacy in some patients, while other patients could be overdosed resulting in unnecessary side effects. Therapeutic drug monitoring (TDM), individualized dosing based on measured blood concentrations of the drug, could therefore be a valid option to further optimize treatment...
June 4, 2018: Clinical Pharmacokinetics
Maria Domenica Alvau, Stefano Tartaggia, Anna Meneghello, Bruno Casetta, Giammario Calia, Pier Andrea Serra, Federico Polo, Giuseppe Toffoli
Therapeutic drug monitoring (TDM) is the clinical practice of measuring pharmaceutical drug concentrations in patients' biofluids at designated intervals, thus allowing a close and timely control of their dosage. To date, TDM in oncology can only be performed by trained personnel in centralized laboratories and core facilities employing conventional analytical techniques (e.g., MS). CPT-11 is an antineoplastic drug that inhibits topoisomerase type I, causing cell death, and is widely used in the treatment of colorectal cancer...
May 15, 2018: Analytical Chemistry
Brett Fleisher, Sihem Ait-Oudhia
Background: Biologics have gained traction for use in oncology, but have demonstrate clinical variability for efficacy and safety. Therapeutic drug monitoring (TDM) can benefit patients' outcomes from a biologic therapy when the latter has a defined therapeutic window. A clinically relevant therapeutic window may exist for biologics with established exposure-response (E-R) relationships for efficacy and/or safety and a documented maximum tolerated dose (MTD). Additionally, the inter-individual variability (IIV) on the clearance (CL) parameter could determine risks for patients falling outside the proposed therapeutic window...
2018: OncoTargets and Therapy
Sibylle C Mellinghoff, Jens Panse, Nael Alakel, Gerhard Behre, Dieter Buchheidt, Maximilian Christopeit, Justin Hasenkamp, Michael Kiehl, Michael Koldehoff, Stefan W Krause, Nicola Lehners, Marie von Lilienfeld-Toal, Annika Y Löhnert, Georg Maschmeyer, Daniel Teschner, Andrew J Ullmann, Olaf Penack, Markus Ruhnke, Karin Mayer, Helmut Ostermann, Hans-H Wolf, Oliver A Cornely
Immunocompromised patients are at high risk of invasive fungal infections (IFI), in particular those with haematological malignancies undergoing remission-induction chemotherapy for acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS) and recipients of allogeneic haematopoietic stem cell transplants (HSCT). Despite the development of new treatment options in the past decades, IFI remains a concern due to substantial morbidity and mortality in these patient populations. In addition, the increasing use of new immune modulating drugs in cancer therapy has opened an entirely new spectrum of at risk periods...
February 2018: Annals of Hematology
Lotte M Knapen, Yvo de Beer, Roger J M Brüggemann, Leo M Stolk, Frank de Vries, Vivianne C G Tjan-Heijnen, Nielka P van Erp, Sander Croes
While the therapeutic drug monitoring (TDM) of everolimus has been routinely performed for over 10 years in solid organ transplantation medicine, in order to optimize the balance between effectiveness and toxicity, it is yet uncommon in the treatment of malignancies. The aim of this study was to develop and validate a bioanalytical method to quantify everolimus in dried blood spots (DBS) to facilitate TDM for the oncology outpatient setting. The hematocrit effect of everolimus was investigated. An 7.5mm disk from the central part of the DBS was punched, followed by the extraction of everolimus from the DBS by methanol/acetonitrile (80/20%) spiked with deuterium-labelled everolimus as internal standard...
February 5, 2018: Journal of Pharmaceutical and Biomedical Analysis
Markus Joerger, Stefanie Kraff, Ulrich Jaehde, Ralf A Hilger, Jodi B Courtney, Daniel J Cline, Sonali Jog, Irina Baburina, M Craig Miller, Salvatore J Salamone
BACKGROUND: The value of therapeutic drug monitoring (TDM) for paclitaxel (PTX) was recently demonstrated in the largest TDM trial ever conducted in oncology. The trial demonstrated significant reduction in neuropathy when using TDM. Dose adjustment for PTX was based on time above a threshold concentration (Tc>0.05). Tc>0.05 must be calculated with a pharmacokinetic model and complex nonlinear mixed-effects software. The use of the software and chromatographic methods to measure PTX requires specialized expertise...
December 2017: Therapeutic Drug Monitoring
Robin Q H Kloos, Carin A Uyl-de Groot, Raphaële R L van Litsenburg, Gertjan J L Kaspers, Rob Pieters, Inge M van der Sluis
BACKGROUND: Therapeutic drug monitoring (TDM) of asparaginase is necessary to respond to variability in asparaginase activity levels, detect silent inactivation, and distinguish between real allergies and allergic-like reactions with and without asparaginase neutralization, respectively. In this study, the costs of an individualized and fixed asparaginase dosing schedule were compared. PROCEDURE: Patients, treated according to the Dutch Childhood Oncology Group ALL-11 protocol (individualized PEGasparaginase treatment, starting dose: 1,500 IU/m2 ) or ALL-10 protocol (native Escherichia coli asparaginase followed by 2,500 IU/m2 PEGasparaginase), were included...
December 2017: Pediatric Blood & Cancer
Anna Meneghello, Stefano Tartaggia, Maria Domenica Alvau, Federico Polo, Giuseppe Toffoli
Therapeutic drug monitoring (TDM) is the clinical practice of measuring pharmaceutical drug concentrations in patients' biofluids at designated intervals to allow a close and timely control of their dosage. This practice allows for rapid medical intervention in case of toxicity-related issues and/or adjustment of dosage to better fit the therapeutic demand. Currently, TDM is performed in centralized laboratories employing instruments, such as immunoassay analyzers and mass spectrometers that can be run only by trained personnel...
July 20, 2017: Current Medicinal Chemistry
Evelina Cardoso, Chantal Csajka, Marie P Schneider, Nicolas Widmer
The emergence of oral targeted anticancer agents transformed several cancers into chronic conditions with a need for long-term oral treatment. Although cancer is a life-threatening condition, oncology medication adherence-the extent to which a patient follows the drug regimen that is intended by the prescriber-can be suboptimal in the long term, as in any other chronic disease. Poor adherence can impact negatively on clinical outcomes, notably because most of these drugs are given as a standard non-individualized dosage despite marked inter-individual variabilities that can lead to toxic or inefficacious drug concentrations...
January 2018: Clinical Pharmacokinetics
C C Llanos-Paez, C E Staatz, R Lawson, S Hennig
To ensure the safe and effective dosing of gentamicin in children, therapeutic drug monitoring (TDM) is recommended. TDM utilizing Bayesian forecasting software is recommended but is unavailable, as no population model that describes the pharmacokinetics of gentamicin in pediatric oncology patients exists. This study aimed to develop and externally evaluate a population pharmacokinetic model of gentamicin to support personalized dosing in pediatric oncology patients. A nonlinear mixed-effect population pharmacokinetic model was developed from retrospective data...
August 2017: Antimicrobial Agents and Chemotherapy
Berrie Meijer, Abraham J Wilhelm, Chris J J Mulder, Gerd Bouma, Adriaan A van Bodegraven, Nanne K H de Boer
BACKGROUND: Thiopurines are the prerequisite for immunomodulation in inflammatory bowel disease (IBD) therapy. When administered in high (oncological) dose, thiopurine metabolites act as purine antagonists, causing DNA-strand breakage and myelotoxicity. In lower IBD dosages, the mode of action is primarily restricted to anti-inflammatory effects. Then, myelosuppression and hepatotoxicity are the most common adverse events of thiopurines. The aim of this study was to assess the effect of thiopurine metabolites on hematologic and hepatic parameters and to determine which patient characteristics are related to generation of thiopurine metabolites...
August 2017: Therapeutic Drug Monitoring
Marine Deppenweiler, Sabrina Falkowski, Franck Saint-Marcoux, Caroline Monchaud, Nicolas Picard, Marie-Laure Laroche, Nicole Tubiana-Mathieu, Laurence Venat-Bouvet, Pierre Marquet, Jean-Baptiste Woillard
INTRODUCTION: Therapeutic drug monitoring (TDM) of everolimus is not performed in oncology and no trough level (C0 ) target has been yet defined. The aim of this study was to determine everolimus C0 target for toxicity and efficacy. MATERIALS AND METHODS: Clinical, biological and radiologic data from 54 patients were collected. Toxicity event was defined by termination, temporary interruption and/or dose reduction of everolimus while efficacy was defined as progression-free survival...
July 2017: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
Pauline Herviou, Emilie Thivat, Damien Richard, Lucie Roche, Joyce Dohou, Mélanie Pouget, Alain Eschalier, Xavier Durando, Nicolas Authier
The therapeutic activity of drugs can be optimized by establishing an individualized dosage, based on the measurement of the drug concentration in the serum, particularly if the drugs are characterized by an inter-individual variation in pharmacokinetics that results in an under- or overexposure to treatment. In recent years, several tyrosine kinase inhibitors (TKIs) have been developed to block intracellular signaling pathways in tumor cells. These oral drugs are candidates for therapeutic drug monitoring (TDM) due to their high inter-individual variability for therapeutic and toxic effects...
August 2016: Oncology Letters
Jitka Rychlíčková, Jan Šaloun, Jana Gregorová
STUDY OBJECTIVES: To determine the frequency of interventions, categorized by type of intervention and therapeutic class, made by a team of four clinical pharmacists over a 1-year period, and to assess the potential economic impact of these interventions. DESIGN: Prospective analysis. SETTING: Large medical center in Prague, Czech Republic. PATIENTS: A total of 9153 adults who were admitted to the general surgery, infectious diseases, oncology, orthopedics, and thoracic surgery and respiratory medicine services between January 1, 2014, and December 31, 2014...
July 2016: Pharmacotherapy
James J Lee, Jan H Beumer, Edward Chu
PURPOSE: For over 50 years, 5-FU has played a critical role in the systemic chemotherapy of cancer patients. 5-FU serves as the main backbone of combination chemotherapy for patients with colorectal cancer in both the adjuvant and metastatic disease settings. Herein, we review the current status of 5-FU therapeutic drug monitoring (TDM) and discuss its potential role in the clinical practice setting. METHOD: PubMed and abstracts from the American Society of Clinical Oncology were searched up through September 2015 for clinical data relating to 5-FU TDM...
September 2016: Cancer Chemotherapy and Pharmacology
Susan M Abdel-Rahman, Matthew L Breitkreutz, Charlie Bi, Brett J Matzuka, Jignesh Dalal, K Leigh Casey, Uttam Garg, Sara Winkle, J Steven Leeder, JeanAnn Breedlove, Brian Rivera
BACKGROUND: Busulfan demonstrates a narrow therapeutic index for which clinicians routinely employ therapeutic drug monitoring (TDM). However, operationalizing TDM can be fraught with inefficiency. We developed and tested software encoding a clinical decision support tool (DST) that is embedded into our electronic health record (EHR) and designed to streamline the TDM process for our oncology partners. METHODS: Our development strategy was modeled based on the features associated with successful DSTs...
2016: Frontiers in Pharmacology
Stefano Fornasaro, Silvia Dalla Marta, Marco Rabusin, Alois Bonifacio, Valter Sergo
To date, in spite of their toxicity, the plasmatic concentration of most chemotherapeutic drugs is difficult to monitor in oncological patients, because their quantitative determination is expensive and time consuming. This contribution reports a first attempt for the direct quantitative determination of a chemotherapeutic drug in human serum samples by means of Surface Enhanced Raman Spectroscopy (SERS). In this study, SERS substrates constituted by Au nanoparticles deposited on paper by a simple dipping method have been used for rapid (few minutes) analysis of diluted human serum spiked with different concentrations of methotrexate, MTX...
June 23, 2016: Faraday Discussions
Hyun Mi Kang, Hoan Jong Lee, Eun Young Cho, Kyung-Sang Yu, Hyunju Lee, Ji Won Lee, Hyoung Jin Kang, Kyung Duk Park, Hee Young Shin, Eun Hwa Choi
Voriconazole is an antifungal drug used to treat fungal infections. This was a retrospective study of 61 children with hemato-oncologic diseases or solid organ transplantation who were administered voriconazole for invasive fungal infections. Of the 61 patients, 31 (50.8%) were in the therapeutic drug monitoring (TDM) group, and 30 (49.2%) were in the non-TDM group. At 12 weeks, treatment failure rate in the non-TDM group was higher than the TDM group (78.6% versus 40.0%, p = 0.038). Drug discontinuation due to adverse events was less frequent in the TDM group than the non-TDM group (26...
2015: Pediatric Hematology and Oncology
T H Oude Munnink, M J Henstra, L I Segerink, K L L Movig, P Brummelhuis-Visser
Lack of response to monoclonal antibodies (mAbs) has been associated with inadequate mAb serum concentrations. Therapeutic drug monitoring (TDM) of mAbs has the potential to guide to more effective dosing in individual patients. This review discusses the mechanisms responsible for interpatient variability of mAb pharmacokinetics, summarizes exposure-response data of mAbs used in inflammatory and malignant disease, presents current evidence of mAb-TDM in inflammatory disease, and provides hurdles and required future steps for further implementing mAb-TDM...
April 2016: Clinical Pharmacology and Therapeutics
S Boissonneau, R Faguer, C Joubert, S Fuentes, P Metellus
Breast cancer, after lung cancer, is the second major cause of brain metastases. In breast cancer, the prognosis is closely linked to the molecular subtype of the primary tumor. Targeted therapies, with or without cytotoxic treatment, have significantly modified overall survival in these patients. We report, the case of a patient suffering from breast cancer with brain metastasis in whom the biological documentation of the metastatic disease permitted to tailor the systemic treatment. Analysis of the surgical specimen revealed an immunohistochemical HER2 positive staining, which was not found in the primary tumor and therefore warranted trastuzumab administration...
August 2015: Neuro-Chirurgie
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