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Alessandro D Santin, Stefania Bellone, Natalia Buza, Peter E Schwartz
BACKGROUND: The management of uterine-serous-carcinoma (USC) no longer amenable to treatment with surgery, radiation and/or chemotherapy remains dismal. Alternative therapeutic options are desperately needed. CASE: We describe the case of a heavily pretreated 74-year-old patient with a recurrent USC overexpressing HER2/neu at 3 + level by IHC treated with the anti-HER2/neu antibody-drug-conjugate (ADC) trastuzumab-emtansine (TDM-1-Kadcyla-Genentech/Roche). She experienced a remarkable clinical response to TDM-1 with a complete resolution of a large metastatic, radiation/chemotherapy resistant tumor deposit in her abdominal wall muscle confirmed by multiple CAT scans and a prolonged systemic control of her disease...
February 2017: Gynecologic Oncology Reports
Ranjana Arora, Lisa Armitige, Audrey Wanger, Robert L Hunter, Shen-An Hwang
Trehalose 6,6'dimycolate (TDM) is a glycolipid found in nearly pure form on the surface of virulent Mycobacterium tuberculosis (MTB). This manuscript investigated the production of TDM, growth rate and colony morphology of multiple strains of MTB, each of which had been isolated from both pulmonary (sputum) and extrapulmonary sites of multiple patients. Since sputum contains MTB primarily from cavities and extrapulmonary biopsies are typically granulomas, this provided an opportunity to compare the behavior of single strains of MTB that had been isolated from cavities and granulomas...
December 2016: Tuberculosis
S S Göksu, H Bozcuk, L Koral, B Çakar, S Gündüz, A M Tatlı, D Arslan, M Uysal, M Koçer, M Artaç, B Karabulut, H S Coşkun, M Özdoğan, B Savaş
CONTEXT: Introduction of trastuzumab, a recombinant monoclonal antibody against the extracellular domain of HER-2, is a cornerstone in the treatment of HER-2+ breast carcinoma. However, many cancers that have an initial response to trastuzumab will progress some time later. After progression on trastuzumab-based first-line treatment, there are several options. Although TDM-1 (Trastuzumab emtansine) has prolonged progression-free survival (PFS) and overall survival in patients previously treated with trastuzumab and taxane, it is still not available in Turkey...
October 2015: Indian Journal of Cancer
Julia Tonini, Sébastien Bailly, Elodie Gautier-Veyret, Clémentine Wambergue, Hervé Pelloux, Anne Thiébaut-Bertrand, Muriel Cornet, Françoise Stanke-Labesque, Danièle Maubon
BACKGROUND: With the constantly growing incidence of invasive fungal infections, any failure of antifungal treatment is worrying. Azole antifungals present high variability of their plasma trough concentrations (Cmin), justifying their therapeutic drug monitoring (TDM). The authors aimed to develop a simple bioassay to determine the in vitro growth inhibition diameter (ID) and to correlate this ID with Cmin in patients treated with voriconazole or posaconazole. METHODS: The bioassay determined the ID for Candida parapsilosis using a disk diffusion method...
October 2015: Therapeutic Drug Monitoring
Ariel Hammerman, Sari Greenberg-Dotan, Ilan Feldhamer, Haim Bitterman, Rinat Yerushalmi
BACKGROUND: The relative efficacy of lapatinib vs. continuing trastuzumab beyond progression (TBP) in HER2-positive metastatic breast cancer (MBC) patients, who progressed on first-line trastuzumab, is still unclear. The objective of this population based cohort study was to compare outcomes of lapatinib vs. TBP in daily practice. METHODS: All HER2-positive MBC patients who began second-line anti HER2 therapy between 1st January 2010 and 30th August 2013 were selected from Clalit Health Services' (CHS) electronic database...
2015: PloS One
Lisbeth Patteet, Kristof E Maudens, Manuel Morrens, Bernard Sabbe, Geert Dom, Hugo Neels
BACKGROUND: Oral fluid (OF) is an interesting alternative for conventional blood testing in therapeutic drug monitoring. OF can be used for screening but its value for quantification has to be established. METHODS: To evaluate the value of OF for quantification of 11 commonly used antipsychotics (APs) and 5 metabolites, an ultra-high performance liquid chromatography-tandem mass spectrometric method was validated. OF was obtained from psychiatric patients using a Quantisal collection device...
February 2016: Therapeutic Drug Monitoring
Lewis Couchman, Krithika Subramaniam, Danielle S Fisher, Sarah L Belsey, Simon A Handley, Robert J Flanagan
BACKGROUND: Analysis of plasma clozapine and N-desmethylclozapine (norclozapine) for therapeutic drug monitoring purposes is well established. To minimize analysis times and facilitate rapid reporting of results, we have fully automated sample preparation using novel AC Extraction Plates and a Tecan Freedom EVO 100 liquid handling platform, and minimized extract analysis times using flow-injection tandem mass spectrometry (FIA-MS/MS). METHODS: Analytes and deuterium-labeled internal standards were extracted from plasma (100 μL) at pH 10...
February 2016: Therapeutic Drug Monitoring
D Neofytos, D Ostrander, S Shoham, M Laverdiere, J Hiemenz, H Nguyen, W Clarke, L Brass, N Lu, K A Marr
BACKGROUND: Voriconazole (VOR) levels are highly variable, with potential implications to both efficacy and safety. We hypothesized that VOR therapeutic drug monitoring (TDM) will decrease the incidence of treatment failures and adverse events (AEs). METHODS: We initiated a prospective, randomized, non-blinded multicenter study to compare clinical outcomes in adult patients randomized to standard dosing (clinician-driven) vs. TDM (doses adjusted based on levels)...
December 2015: Transplant Infectious Disease: An Official Journal of the Transplantation Society
Massimiliano Fabbiani, Simona Di Giambenedetto, Antonella Cingolani, Iuri Fanti, Manuela Colafigli, Enrica Tamburrini, Roberto Cauda, Pierluigi Navarra, Andrea De Luca, Rita Murri
BACKGROUND: The aim of the study was to explore relationships between self-reported adherence, antiretroviral drug concentration measurement (TDM) and self-reported symptoms. METHODS: We systematically administered to human immunodeficiency (HIV)-infected outpatients a questionnaire evaluating measures of self-reported adherence (missing doses during last week, deviations from the prescribed timing of therapy, self-initiated discontinuations for > 24 or 48 h, exhausting drugs and present sense of how patients are taking therapy) and a panel of referred symptoms (a symptom score was built summing self-reported scores for each listed symptom)...
2016: Infectious Diseases
Samer K Khaled, Joycelynne M Palmer, Josef Herzog, Tracey Stiller, Ni-Chun Tsai, David Senitzer, Xueli Liu, Sandra H Thomas, Sepideh Shayani, Jeffrey Weitzel, Stephen J Forman, Ryotaro Nakamura
Allelic variants of genes implicated in drug absorption, distribution, metabolism, and excretion (ADME) determine the pharmacokinetic variability of many medications and are increasingly recognized as important factors determining the success or failure of medical treatments. Both tacrolimus and sirolimus have narrow therapeutic ranges maintained by therapeutic drug monitoring (TDM). Using an ADME panel that covers >99% of the PharmaADME working group core list (188 single nucleotide polymorphism [SNP] and 12 copy number variant [CNV] assays in 36 pharmacogenetically relevant genes), we studied 177 patients who underwent allogeneic hematopoietic cell transplantation (HCT) using tacrolimus/sirolimus-based graft-versus-host disease (GVHD) prophylaxis...
February 2016: Biology of Blood and Marrow Transplantation
Hyojin Chae, Sung-Yeon Cho, Haein Yu, Kyoungho Cha, Seongok Lee, Myungshin Kim, Yonggoo Kim, Yoo-Jin Kim, Hee-Je Kim, Dong-Gun Lee
BACKGROUND: Posaconazole has an important role in the prophylaxis of invasive fungal infections (IFIs), however oral suspension formulation is associated with variable bioavailability. The relationship between posaconazole concentrations achieved with the oral suspension and the IFI occurrence were analyzed along with demographic and clinical covariates (mucositis, diarrhea, liver enzymes, co-medications, and food intake). METHODS: One hundred twenty-two adult patients with AML/MDS undergoing remission induction chemotherapy were enrolled...
October 23, 2015: Clinica Chimica Acta; International Journal of Clinical Chemistry
Uwe Christians, Alexander A Vinks, Loralie J Langman, William Clarke, Pierre Wallemacq, Teun van Gelder, Varun Renjen, Pierre Marquet, Eric J Meyer
The immunosuppressants cyclosporine, tacrolimus, sirolimus, everolimus, and probably also mycophenolic acid require therapeutic drug monitoring (TDM)-guided dosing to ensure that blood concentrations are kept within the target range in transplant patients. Reliable, accurate, and precise test methods are therefore essential to effectively monitor levels and to make proper dose adjustments. Data from proficiency testing programs have shown substantial interlaboratory variability. Only few attempts have been made to study the underlying causes...
December 2015: Therapeutic Drug Monitoring
Yusuke Tanigawara
Efficacy of cancer pharmacotherapy depends upon drug exposure to the body and responsiveness of the tumor to the drug treatment. Drug exposure is determined by pharmacokinetics and dose, whereas responsiveness is intrinsically variable by tumor heterogeneity. Molecular targeting drugs are used as promising therapy for cancers, and most of them are coupled with particular diagnostics which can predict responders and non-responders before treatment. On the other hand, lower drug exposure to the body can lead to insufficient efficacy...
August 2015: Nihon Rinsho. Japanese Journal of Clinical Medicine
Junmei Li, Qingwen Shi, Ye Jiang, Yan Liu
A novel and practical sample pretreatment method based on hollow fiber centrifugal ultrafiltration (HFCF-UF) was developed to determine plasma protein binding by using HPLC. The samples for analyzing unbound and total concentrations could be prepared in parallel simultaneously by the same device. It only required centrifugation for a short time and the filtrate could be injected directly for HPLC analysis without further treatment. Coumarins were selected as the model drugs. Acetone was chosen as the releasing agent to free the binding drug from the drug-protein complex for the total drug concentration determination...
September 15, 2015: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
S Unholzer, E Haen
INTRODUCTION: Lamotrigine is licensed for treatment of epilepsy and prevention or at least delay of depressive episodes in bipolar disorder. The accepted therapeutic reference range (TRR) of lamotrigine for anticonvulsant treatment is 3 000-14 000 ng/ml. This TRR is often used for the therapy of bipolar disorders as well. This work presents serious doubts about this approach. METHODS: KONBEST, a large TDM database containing patients' characteristics including diagnoses, doses, comedication and serum concentrations, was analyzed...
September 2015: Pharmacopsychiatry
A Smits, R F W De Cock, K Allegaert, S Vanhaesebrouck, M Danhof, C A J Knibbe
Based on a previously derived population pharmacokinetic model, a novel neonatal amikacin dosing regimen was developed. The aim of the current study was to prospectively evaluate this dosing regimen. First, early (before and after second dose) therapeutic drug monitoring (TDM) observations were evaluated for achieving target trough (<3 mg/liter) and peak (>24 mg/liter) levels. Second, all observed TDM concentrations were compared with model-predicted concentrations, whereby the results of a normalized prediction distribution error (NPDE) were considered...
October 2015: Antimicrobial Agents and Chemotherapy
Nuggehally R Srinivas
There is an ongoing debate on the use of a single concentration time point C2 for therapeutic drug monitoring (TDM) and exposure prediction for cyclosporine. The objective of the present work was to evaluate the relationship between the peak concentration (Cmax ) versus area under the curve (AUC) for cyclosporine. Using published data from renal transplant patients from an 8-12 week study with two formulations, a simple linear regression model represented by AUC - cyclosporine = Cmax - Cyclosporine × 3...
December 2015: Biopharmaceutics & Drug Disposition
Zoubir Djerada, Françoise Daviet, Pierre-Michel Llorca, Alain Eschalier, Franck Saint-Marcoux, Danièle Bentué-Ferrer, Fréderic Libert
Clozapine is a prototypical atypical antipsychotic used to treat severe schizophrenia and for which a therapeutic drug monitoring (TDM) is quite commonly proposed. Clozapine is rapidly absorbed (maximum concentration reached within 1 to 4 hours), and is extensively metabolized in the liver by CYP1A2 to an active metabolite (and to a lesser extent, to inactive metabolites via other enzymes). Its half-life is 8 to 16 h. A therapeutic range has been proposed for clozapine as some studies have reported both a relationship between low plasmatic concentrations and resistance to treatment (threshold level is likely between 250 and 400 µg/L), and a relationship between high plasmatic concentrations and an increase in the occurrence of toxicity (alert level=1 000µg/L)...
July 28, 2015: Thérapie
I Hahirwa, C Charlier, C Karangwa, R Denooz
OBJECTIVES: In Rwanda, no therapeutic monitoring of psychotropic drugs is done. This results in difficult treatment optimisation and exposition to a high risk of toxicity and drug ineffectiveness for patients under treatment. This study aimed to determine blood concentration levels of psychotropic drugs in Rwandan patients and identify problems associated with the lack of therapeutic drug monitoring (TDM) of these drugs. METHODS: The analysis was performed on 1 ml of serum sample using prazepam as internal standard...
December 2015: Acta Clinica Belgica
Anthony P Cardile, Christopher Tan, Michael B Lustik, Amy N Stratton, Cristian S Madar, Jun Elegino, Günther Hsue
BACKGROUND: Outcomes data for the efficacy of interventions designed to decrease the time to initial target vancomycin troughs are sparse. OBJECTIVE: A vancomycin therapeutic drug monitoring (TDM) program was initiated to reduce the time to initial target troughs and to examine the impact on clinical outcomes. METHODS: Single-center, pre- and post-intervention observational study in a 250 bed teaching facility. Adult inpatients treated with physician-guided, vancomycin therapy (historical control, CTRL) were compared to high trough, pharmacist-guided vancomycin therapy (TDM)...
2015: SpringerPlus
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