Strategies for the development of tdm for targeted anticancer agents
Détails
Etat: Public
Version: de l'auteur⸱e
ID Serval
serval:BIB_6D59B5CC6719
Type
Actes de conférence (partie): contribution originale à la littérature scientifique, publiée à l'occasion de conférences scientifiques, dans un ouvrage de compte-rendu (proceedings), ou dans l'édition spéciale d'un journal reconnu (conference proceedings).
Sous-type
Abstract (résumé de présentation): article court qui reprend les éléments essentiels présentés à l'occasion d'une conférence scientifique dans un poster ou lors d'une intervention orale.
Collection
Publications
Institution
Titre
Strategies for the development of tdm for targeted anticancer agents
Titre de la conférence
11th Conference of the European Association for Clinical Pharmacology and Therapeutics
Adresse
Geneva, Switzerland, August 28-31, 2013
ISBN
0149-2918
Statut éditorial
Publié
Date de publication
2013
Volume
35
Série
Clinical Therapeutics
Pages
e113-e114
Langue
anglais
Résumé
Most of the novel targeted anticancer agents share classical
characteristics that define drugs as candidates for blood concentration
monitoring: long-term therapy; high interindividual but
restricted intraindividual variability; significant drug-drug and drug-
food interactions; correlations between concentration and efficacy/
toxicity with rather narrow therapeutic index; reversibility of effects;
and absence of early markers of response. Surprisingly though, therapeutic
concentration monitoring has received little attention for these
drugs despite reiterated suggestions from clinical pharmacologists.
Several issues explain the lack of clinical research and development
in this field: global tradition of empiricism regarding treatment
monitoring, lack of formal conceptual framework, ethical difficulties
in the elaboration of controlled clinical trials, disregard from
both drug manufacturers and public funders, limited encouragement
from regulatory authorities, and practical hurdles making dosage
adjustment based on concentration monitoring a difficult task for
prescribers. However, new technologies are soon to help us overcome
these obstacles, with the advent of miniaturized measurement devices
able to quantify circulating drug concentrations at the point-of-care,
to evaluate their plausibility given actual dosage and sampling time,
to determine their appropriateness with reference to therapeutic targets,
and to advise on suitable dosage adjustment. Such evolutions
could bring conceptual changes into the clinical development of drugs
such as anticancer agents, while increasing the therapeutic impact of
population PK-PD studies and systematic reviews. Research efforts
in that direction from the clinical pharmacology community will
be essential for patients to receive the greatest benefits and the least
harm from new anticancer treatments. The example of imatinib, the
first commercialized tyrosine kinase inhibitor, will be outlined to
illustrate a potential research agenda for the rational development
of therapeutic concentration monitoring.
characteristics that define drugs as candidates for blood concentration
monitoring: long-term therapy; high interindividual but
restricted intraindividual variability; significant drug-drug and drug-
food interactions; correlations between concentration and efficacy/
toxicity with rather narrow therapeutic index; reversibility of effects;
and absence of early markers of response. Surprisingly though, therapeutic
concentration monitoring has received little attention for these
drugs despite reiterated suggestions from clinical pharmacologists.
Several issues explain the lack of clinical research and development
in this field: global tradition of empiricism regarding treatment
monitoring, lack of formal conceptual framework, ethical difficulties
in the elaboration of controlled clinical trials, disregard from
both drug manufacturers and public funders, limited encouragement
from regulatory authorities, and practical hurdles making dosage
adjustment based on concentration monitoring a difficult task for
prescribers. However, new technologies are soon to help us overcome
these obstacles, with the advent of miniaturized measurement devices
able to quantify circulating drug concentrations at the point-of-care,
to evaluate their plausibility given actual dosage and sampling time,
to determine their appropriateness with reference to therapeutic targets,
and to advise on suitable dosage adjustment. Such evolutions
could bring conceptual changes into the clinical development of drugs
such as anticancer agents, while increasing the therapeutic impact of
population PK-PD studies and systematic reviews. Research efforts
in that direction from the clinical pharmacology community will
be essential for patients to receive the greatest benefits and the least
harm from new anticancer treatments. The example of imatinib, the
first commercialized tyrosine kinase inhibitor, will be outlined to
illustrate a potential research agenda for the rational development
of therapeutic concentration monitoring.
Création de la notice
17/02/2014 14:36
Dernière modification de la notice
20/08/2019 15:27