Equivalent single-dose pharmacokinetics of two different dosing methods of prolonged-release fulvestrant ('Faslodex') in postmenopausal women with advanced breast cancer View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2003-10

AUTHORS

John F. R. Robertson, M. P. Harrison

ABSTRACT

PURPOSE: To compare the pharmacokinetics of two different dosing methods of fulvestrant ('Faslodex'), an estrogen receptor antagonist with no known agonist activity, for the treatment of advanced breast cancer. METHODS: Postmenopausal women with advanced breast cancer were randomly assigned to receive a single 5-ml intramuscular injection of 250 mg fulvestrant, or two 2.5-ml intramuscular injections with a total of 250 mg fulvestrant. Blood samples were taken for pharmacokinetic analysis up to 28 days after injection. RESULTS: Plasma concentrations of fulvestrant were measurable up to 28 days after both dosing methods. The concentration-time profiles were relatively shallow, spanning an approximate threefold range from 3 h after dosing to Cmin measured on day 28. Peak plasma concentrations (Cmax) of fulvestrant occurred between 1 and 11 days after dosing, with mean Cmax values of 6.0 and 6.2 ng/ml following one 5-ml injection and two 2.5-ml injections, respectively. The plasma concentration-time profiles were very similar in terms of duration and concentration, and overall exposure to fulvestrant was similar in both dosing groups (the ratio of the AUC(0-28) of the single-injection group to that of the double-injection group was 1.01; 95% confidence interval 0.68-1.51). CONCLUSION: This study found no evidence of any pharmacokinetic difference between one 5-ml injection and two 2.5-ml injections. The two methods can be used interchangeably, depending on which is more convenient in any particular clinical setting. More... »

PAGES

346-348

References to SciGraph publications

  • 1993-01. The future of new pure antiestrogens in clinical breast cancer in BREAST CANCER RESEARCH AND TREATMENT
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1007/s00280-003-0643-7

    DOI

    http://dx.doi.org/10.1007/s00280-003-0643-7

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1028515801

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/12879276


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