A pharmacometrics model to define docetaxel target in early breast cancer.


Journal

British journal of clinical pharmacology
ISSN: 1365-2125
Titre abrégé: Br J Clin Pharmacol
Pays: England
ID NLM: 7503323

Informations de publication

Date de publication:
02 2023
Historique:
revised: 23 08 2022
received: 21 03 2022
accepted: 01 09 2022
pubmed: 14 9 2022
medline: 18 1 2023
entrez: 13 9 2022
Statut: ppublish

Résumé

We aimed to study the relation between pharmacokinetics (PK) and pharmacodynamics (PD) of docetaxel in early breast cancer and recommend a target exposure. A PK/PD study was performed in 27 early breast cancer patients treated with doxorubicin and cyclophosphamide for 4 cycles followed by 4 cycles of docetaxel 75-100 mg/m Docetaxel clearance showed no change over the 4 treatment cycles, but a gradual increase in the volume of distribution was observed. One third of the patients had at least 1 dose reduction of docetaxel due to toxicity. The mean AUC, AUCcum and Cmax in patients showing docetaxel-associated adverse events were significantly higher than in patients free of toxicity (P < .05). Fatigue and decrease in haemoglobin and haematocrit levels were related to docetaxel AUC and Cmax and pain to AUC. AUC and Cmax >4.5 mg*h/L and 3.5 mg/L, respectively, were risk factors for docetaxel toxicity, while an AUC <4.5 mg*h/L was associated with tumour recurrence. We report for the first time a relation between docetaxel exposure and toxicity and recommend specific targets of drug exposure with implications for the clinical management of early breast cancer patients.

Identifiants

pubmed: 36098504
doi: 10.1111/bcp.15526
pmc: PMC10087179
doi:

Substances chimiques

Docetaxel 15H5577CQD
Taxoids 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

727-736

Informations de copyright

© 2022 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.

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Auteurs

Azucena Aldaz (A)

Pharmacy Service, Clínica Universidad de Navarra, Pamplona, Navarra, Spain.

Paula Schaiquevich (P)

National Scientific and Technical Research Council (CONICET), Buenos Aires, Argentina.

José Manuel Aramendía (JM)

Breast Cancer Unit, Medical Oncology Department, Clínica Universidad de Navarra, Pamplona, Navarra, Spain.
IdiSNA, Navarra Institute for Health Research, Pamplona, Spain.

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Classifications MeSH