A phase II study of nilutamide in men with prostate cancer after the failure of flutamide or bicalutamide therapy

Nancy B. Davis, Christopher Ryan, Walter M. Stadler, Nicholas J. Vogelzang

    Research output: Contribution to journalArticle

    12 Citations (Scopus)

    Abstract

    OBJECTIVE: To determine the prostate-specific antigen (PSA) response and time to PSA or radiographic progression in men with prostate cancer refractory to bicalutamide and/or flutamide therapy. PATIENTS AND METHODS: Men with historically confirmed prostate cancer not amenable to curative surgery or radiation therapy were eligible for the study if they had radiographic or PSA progression on at least one antiandrogen (not nilutamide) despite continued androgen suppression and standard antiandrogen withdrawal periods. All men received nilutamide 150 mg/day orally for ≥8 weeks unless there was unacceptable toxicity or disease progression. All men were evaluated for response, safety and toxicity. Baseline PSA levels, chest X-ray, bone scan and abdominopelvic computed tomography studies were obtained; the re-evaluation included PSA levels every 4 weeks and repeated imaging every 8 weeks in those with baseline abnormalities. The chest X-ray was repeated if there were pulmonary symptoms. Nineteen men were consented and 16 were evaluable for response. RESULTS: The median (range) Gleason score was 7 (6-9) and the median number of previous second-line therapies was 2 (1-4). Bicalutamide therapy had failed in all patients. At baseline, 13 (of 16 men) had radiographically evident disease, nine with diffuse osseous and four with radiographically measurable metastases. There was no grade 3/4 toxicity; the commonest grade 1/2 toxicities were constipation (three), sensory neuropathy (four), fatigue (six), and visual changes (two) involving transiently altered colour vision and sensitivity to light, respectively. Responses included three partial and 13 with progressive disease. CONCLUSIONS: The study was discontinued after a planned interim analysis because nilutamide had no apparent activity. Although well tolerated, nilutamide offers benefit to few men with prostate cancer in whom bicalutamide has failed.

    Original languageEnglish (US)
    Pages (from-to)787-790
    Number of pages4
    JournalBJU International
    Volume96
    Issue number6
    DOIs
    StatePublished - Oct 2005

    Fingerprint

    Flutamide
    Prostatic Neoplasms
    Prostate-Specific Antigen
    Androgen Antagonists
    Therapeutics
    Thorax
    Asthenopia
    X-Rays
    Photophobia
    Color Vision
    Neoplasm Grading
    Constipation
    bicalutamide
    nilutamide
    Androgens
    Reaction Time
    Disease Progression
    Radiotherapy
    Tomography
    Neoplasm Metastasis

    Keywords

    • Antiandrogen
    • Bicalutamide
    • Nilutamide
    • Prostate cancer
    • Response

    ASJC Scopus subject areas

    • Urology

    Cite this

    A phase II study of nilutamide in men with prostate cancer after the failure of flutamide or bicalutamide therapy. / Davis, Nancy B.; Ryan, Christopher; Stadler, Walter M.; Vogelzang, Nicholas J.

    In: BJU International, Vol. 96, No. 6, 10.2005, p. 787-790.

    Research output: Contribution to journalArticle

    Davis, Nancy B. ; Ryan, Christopher ; Stadler, Walter M. ; Vogelzang, Nicholas J. / A phase II study of nilutamide in men with prostate cancer after the failure of flutamide or bicalutamide therapy. In: BJU International. 2005 ; Vol. 96, No. 6. pp. 787-790.
    @article{ea75844ab1c44b248f9b5e7d5ecf8bde,
    title = "A phase II study of nilutamide in men with prostate cancer after the failure of flutamide or bicalutamide therapy",
    abstract = "OBJECTIVE: To determine the prostate-specific antigen (PSA) response and time to PSA or radiographic progression in men with prostate cancer refractory to bicalutamide and/or flutamide therapy. PATIENTS AND METHODS: Men with historically confirmed prostate cancer not amenable to curative surgery or radiation therapy were eligible for the study if they had radiographic or PSA progression on at least one antiandrogen (not nilutamide) despite continued androgen suppression and standard antiandrogen withdrawal periods. All men received nilutamide 150 mg/day orally for ≥8 weeks unless there was unacceptable toxicity or disease progression. All men were evaluated for response, safety and toxicity. Baseline PSA levels, chest X-ray, bone scan and abdominopelvic computed tomography studies were obtained; the re-evaluation included PSA levels every 4 weeks and repeated imaging every 8 weeks in those with baseline abnormalities. The chest X-ray was repeated if there were pulmonary symptoms. Nineteen men were consented and 16 were evaluable for response. RESULTS: The median (range) Gleason score was 7 (6-9) and the median number of previous second-line therapies was 2 (1-4). Bicalutamide therapy had failed in all patients. At baseline, 13 (of 16 men) had radiographically evident disease, nine with diffuse osseous and four with radiographically measurable metastases. There was no grade 3/4 toxicity; the commonest grade 1/2 toxicities were constipation (three), sensory neuropathy (four), fatigue (six), and visual changes (two) involving transiently altered colour vision and sensitivity to light, respectively. Responses included three partial and 13 with progressive disease. CONCLUSIONS: The study was discontinued after a planned interim analysis because nilutamide had no apparent activity. Although well tolerated, nilutamide offers benefit to few men with prostate cancer in whom bicalutamide has failed.",
    keywords = "Antiandrogen, Bicalutamide, Nilutamide, Prostate cancer, Response",
    author = "Davis, {Nancy B.} and Christopher Ryan and Stadler, {Walter M.} and Vogelzang, {Nicholas J.}",
    year = "2005",
    month = "10",
    doi = "10.1111/j.1464-410X.2005.05765.x",
    language = "English (US)",
    volume = "96",
    pages = "787--790",
    journal = "BJU International",
    issn = "1464-4096",
    publisher = "Wiley-Blackwell",
    number = "6",

    }

    TY - JOUR

    T1 - A phase II study of nilutamide in men with prostate cancer after the failure of flutamide or bicalutamide therapy

    AU - Davis, Nancy B.

    AU - Ryan, Christopher

    AU - Stadler, Walter M.

    AU - Vogelzang, Nicholas J.

    PY - 2005/10

    Y1 - 2005/10

    N2 - OBJECTIVE: To determine the prostate-specific antigen (PSA) response and time to PSA or radiographic progression in men with prostate cancer refractory to bicalutamide and/or flutamide therapy. PATIENTS AND METHODS: Men with historically confirmed prostate cancer not amenable to curative surgery or radiation therapy were eligible for the study if they had radiographic or PSA progression on at least one antiandrogen (not nilutamide) despite continued androgen suppression and standard antiandrogen withdrawal periods. All men received nilutamide 150 mg/day orally for ≥8 weeks unless there was unacceptable toxicity or disease progression. All men were evaluated for response, safety and toxicity. Baseline PSA levels, chest X-ray, bone scan and abdominopelvic computed tomography studies were obtained; the re-evaluation included PSA levels every 4 weeks and repeated imaging every 8 weeks in those with baseline abnormalities. The chest X-ray was repeated if there were pulmonary symptoms. Nineteen men were consented and 16 were evaluable for response. RESULTS: The median (range) Gleason score was 7 (6-9) and the median number of previous second-line therapies was 2 (1-4). Bicalutamide therapy had failed in all patients. At baseline, 13 (of 16 men) had radiographically evident disease, nine with diffuse osseous and four with radiographically measurable metastases. There was no grade 3/4 toxicity; the commonest grade 1/2 toxicities were constipation (three), sensory neuropathy (four), fatigue (six), and visual changes (two) involving transiently altered colour vision and sensitivity to light, respectively. Responses included three partial and 13 with progressive disease. CONCLUSIONS: The study was discontinued after a planned interim analysis because nilutamide had no apparent activity. Although well tolerated, nilutamide offers benefit to few men with prostate cancer in whom bicalutamide has failed.

    AB - OBJECTIVE: To determine the prostate-specific antigen (PSA) response and time to PSA or radiographic progression in men with prostate cancer refractory to bicalutamide and/or flutamide therapy. PATIENTS AND METHODS: Men with historically confirmed prostate cancer not amenable to curative surgery or radiation therapy were eligible for the study if they had radiographic or PSA progression on at least one antiandrogen (not nilutamide) despite continued androgen suppression and standard antiandrogen withdrawal periods. All men received nilutamide 150 mg/day orally for ≥8 weeks unless there was unacceptable toxicity or disease progression. All men were evaluated for response, safety and toxicity. Baseline PSA levels, chest X-ray, bone scan and abdominopelvic computed tomography studies were obtained; the re-evaluation included PSA levels every 4 weeks and repeated imaging every 8 weeks in those with baseline abnormalities. The chest X-ray was repeated if there were pulmonary symptoms. Nineteen men were consented and 16 were evaluable for response. RESULTS: The median (range) Gleason score was 7 (6-9) and the median number of previous second-line therapies was 2 (1-4). Bicalutamide therapy had failed in all patients. At baseline, 13 (of 16 men) had radiographically evident disease, nine with diffuse osseous and four with radiographically measurable metastases. There was no grade 3/4 toxicity; the commonest grade 1/2 toxicities were constipation (three), sensory neuropathy (four), fatigue (six), and visual changes (two) involving transiently altered colour vision and sensitivity to light, respectively. Responses included three partial and 13 with progressive disease. CONCLUSIONS: The study was discontinued after a planned interim analysis because nilutamide had no apparent activity. Although well tolerated, nilutamide offers benefit to few men with prostate cancer in whom bicalutamide has failed.

    KW - Antiandrogen

    KW - Bicalutamide

    KW - Nilutamide

    KW - Prostate cancer

    KW - Response

    UR - http://www.scopus.com/inward/record.url?scp=25844447751&partnerID=8YFLogxK

    UR - http://www.scopus.com/inward/citedby.url?scp=25844447751&partnerID=8YFLogxK

    U2 - 10.1111/j.1464-410X.2005.05765.x

    DO - 10.1111/j.1464-410X.2005.05765.x

    M3 - Article

    C2 - 16153201

    AN - SCOPUS:25844447751

    VL - 96

    SP - 787

    EP - 790

    JO - BJU International

    JF - BJU International

    SN - 1464-4096

    IS - 6

    ER -