@article{JustSchollBoehmeetal.2021,
  author    = {Just, Katja S. and Scholl, Catharina and Boehme, Miriam and Kastenm{\"u}ller, Kathrin and Just, Johannes M. and Bleckwenn, Markus and Holdenrieder, Stefan and Meier, Florian and Weckbecker, Klaus and Stingl, Julia C.},
  title     = {Individualized versus standardized risk assessment in patients at high risk for adverse drug reactions (the IDrug randomized controlled trial) - never change a running system?},
  series = {Pharmaceuticals},
  volume    = {14},
  journal   = {Pharmaceuticals},
  number    = {10},
  issn      = {1424-8247},
  doi       = {10.3390/ph14101056},
  url       = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-248557},
  year      = {2021},
  abstract  = {The aim of this study was to compare effects of an individualized with a standardized risk assessment for adverse drug reactions to improve drug treatment with antithrombotic drugs in older adults. A randomized controlled trial was conducted in general practitioner (GP) offices. Patients aged 60 years and older, multi-morbid, taking antithrombotic drugs and at least one additional drug continuously were randomized to individualized and standardized risk assessment groups. Patients were followed up for nine months. A composite endpoint defined as at least one bleeding, thromboembolic event or death reported via a trigger list was used. Odds ratios (OR) and 95\% confidence intervals (CI) were calculated. In total, N = 340 patients were enrolled from 43 GP offices. Patients in the individualized risk assessment group met the composite endpoint more often than in the standardized group (OR 1.63 [95\%CI 1.02-2.63]) with multiple adjustments. The OR was higher in patients on phenprocoumon treatment (OR 1.99 [95\%CI 1.05-3.76]), and not significant on DOAC treatment (OR 1.52 [95\%CI 0.63-3.69]). Pharmacogenenetic variants of CYP2C9, 2C19 and VKORC1 were not observed to be associated with the composite endpoint. The results of this study may indicate that the time point for implementing individualized risk assessments is of importance.},
  language  = {en}
}
@article{McLaughlinSchmulensonTeplytskaetal.2021,
  author    = {Mc Laughlin, Anna M. and Schmulenson, Eduard and Teplytska, Olga and Zimmermann, Sebastian and Opitz, Patrick and Groenland, Stefanie L. and Huitema, Alwin D. R. and Steeghs, Neeltje and M{\"u}ller, Lothar and Fuxius, Stefan and Illerhaus, Gerald and Joerger, Markus and Mayer, Frank and Fuhr, Uwe and Holdenrieder, Stefan and Hempel, Georg and Scherf-Clavel, Oliver and Jaehde, Ulrich and Kloft, Charlotte},
  title     = {Developing a nationwide infrastructure for therapeutic drug monitoring of targeted oral anticancer drugs: the ON-TARGET study protocol},
  series = {Cancers},
  volume    = {13},
  journal   = {Cancers},
  number    = {24},
  issn      = {2072-6694},
  doi       = {10.3390/cancers13246281},
  url       = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-252196},
  year      = {2021},
  abstract  = {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.},
  language  = {en}
}