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    Fulvestrant revisited: efficacy and safety of the 500-mg dose.

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    Authors
    Howell, Anthony
    Sapunar, F
    Affiliation
    CRUK Department of Medical Oncology, University of Manchester, Christie Hospital NHS Trust, Wilmslow Road, Manchester, UK.
    Issue Date
    2011-08
    
    Metadata
    Show full item record
    Abstract
    Postmenopausal women with hormone receptor-positive advanced breast cancer are candidates for endocrine therapy. As the disease will eventually progress in most patients, it is important to investigate agents with novel modes of action to reduce the likelihood of treatment cross-resistance. Fulvestrant is an estrogen receptor antagonist with no known agonist effects that has been shown to be as effective as anastrozole following failure on tamoxifen, at the approved dose of 250 mg/mo. However, pharmacokinetic modelling and evidence of clinical efficacy in early trials, together with the favorable tolerability profile of fulvestrant 250 mg, led to suggestions that increasing the fulvestrant dose would lead to an improved benefit-risk profile. This review describes the rationale behind the development of a 500 mg/mo higher dose of fulvestrant and details relevant clinical trials, including the pivotal phase III COmparisoN of Faslodex In Recurrent or Metastatic breast cancer (CONFIRM) study. CONFIRM demonstrated a significant improvement in progression-free survival for fulvestrant 500 mg versus 250 mg in postmenopausal patients who had progressed on previous endocrine therapy. Here, we present and discuss a pooled safety analysis of CONFIRM and three further clinical studies demonstrating fulvestrant 500 mg to be well-tolerated with no evidence of dose-related adverse events. Overall, these data indicate an improved benefit-risk profile for fulvestrant 500 mg versus 250 mg following failure on prior endocrine therapy, and suggest that fulvestrant 500 mg may be considered in future as initial endocrine treatment for advanced breast cancer.
    Citation
    Fulvestrant revisited: efficacy and safety of the 500-mg dose. 2011, 11 (4):204-10 Clin. Breast Cancer
    Journal
    Clinical Breast Cancer
    URI
    http://hdl.handle.net/10541/229167
    DOI
    10.1016/j.clbc.2011.02.002
    PubMed ID
    21729658
    Type
    Article
    Language
    en
    ISSN
    1938-0666
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.clbc.2011.02.002
    Scopus Count
    Collections
    All Christie Publications
    Medical Oncology

    entitlement

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