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Query: UMLS:C0600142 (
hot flushes
)
1,242
document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)
Casodex
, a new nonsteroidal antiandrogen, was investigated in this double-blind, randomized, placebo-controlled study comprising 28 evaluable patients with benign prostatic hyperplasia, who received
Casodex
at a dosage of 50 mg daily or a placebo for 24 weeks. The good safety profile of
Casodex
was confirmed. In common with other nonsteroidal antiandrogens,
Casodex
was associated with breast enlargement and/or tenderness, being reported by all patients upon direct questioning. A change in sexual function was assessed by two questionnaires, one of them revealing no statistically significant difference between the groups. However, using an alternative questionnaire, approximately half of the patients reported reduced erectile function (p = 0.002), mostly partial, and reduced sexual activity (p = 0.015), whereas libido was well maintained when compared to the placebo.
Casodex
was not associated with
hot flushes
. No other side effects of clinical significance were seen, and
Casodex
was well tolerated by the majority of the patients.
...
PMID:Safety, side effects and patient acceptance of the antiandrogen Casodex in the treatment of benign prostatic hyperplasia. 752 62
Over 3,000 men, the majority of whom were patients with prostate cancer, were treated with
Casodex
(ICI 176,334), an oral anti-androgen, at doses ranging from 10 to 200 mg daily, corresponding to a total exposure to the drug of over 1,500 patient-years. Over this period, the tolerability of
Casodex
and its effect on quality of life were closely studied. Information on tolerability is presented from three large randomized trials of
Casodex
, 50 mg/day, in patients with prostate cancer, two large randomized trials of
Casodex
, 150 mg/day, in patients with prostate cancer and three double-blind, placebo-controlled trials of
Casodex
, 50 mg/day, in patients with benign prostatic hyperplasia (BPH). Information on quality of life and assessment of sexual functioning is presented from the trials using
Casodex
, 50 mg/day, for both prostate cancer and BPH. The most commonly reported adverse events were those that would be expected with an anti-androgen (i.e. breast tenderness, gynaecomastia and
hot flushes
). Overall,
Casodex
was well tolerated; there were no reports of light/dark adaptation problems or pulmonary fibrosis, and only one case of alcohol intolerance, which was not considered by the investigator to be treatment related. Only 0.3% of patients in the whole trial programme had to be withdrawn because of changes in liver function, and there were no clinically significant changes in mean liver function tests. Although there were no consistent differences between treatments for other aspects of quality of life, there was evidence of benefit from treatment with
Casodex
in maintaining both sexual interest and functioning.
...
PMID:Tolerability and quality of life aspects with the anti-androgen Casodex (ICI 176,334) as monotherapy for prostate cancer. International Casodex Investigators. 753 64
The efficacy and tolerability of
Casodex
, a new non-steroidal antiandrogen, were studied in 267 patients with advanced prostate cancer. All patients received
Casodex
, 50 mg daily, as monotherapy. The objective response rate was 55.5% and the subjective response rate was 56.1%. The most common adverse events were the expected pharmacological effects of breast tenderness, gynecomastia and
hot flushes
. No other adverse events were reported in more than 5% of patients. There was minimal occurrence of impotence, loss of libido and diarrhea. The results show that
Casodex
50 mg is effective and well tolerated in the treatment of advanced prostate cancer.
...
PMID:Efficacy and tolerability of Casodex in patients with advanced prostate cancer. International Casodex Study Group. 757 54
A phase I study (open trial) of bicalutamide (
Casodex
), a non-steroidal antiandrogen, was conducted on 16 patients with prostatic cancer (stage C to D). The patients were given 10, 30, 50, 80 or 100 mg of bicalutamide orally daily for 12 weeks. Adverse reactions were observed in 8 out of 16 patients, but almost all were mild. Breast pain, gynecomastia and
hot flushes
were observed in 6 patients. Adverse reactions regarding liver function tests were observed in 3 patients. These were increased glutamic-oxalacetic transaminase (GOT), glutamic-pyruvic transaminase (GPT), alkaliphosphatase (AL-P) or gamma guanosine 5'-triphosphate (gamma-GTP). However, during or after the treatment period the elevated values were reversed to the pretreatment level. In terms of efficacy, anti-tumor effect was observed in 1 or 2 patients at each dose. Serum concentrations of luteinizing hormone (LH), follicle stimulating hormone (FSH), testosterone and estradiol increased during treatment. Plasma concentrations of the R (-) enantiomer, which has antiandrogenic activity, reached the steady state 6-8 weeks after the initiation of treatment; its apparent plasma elimination half-life observed following repeated administration was 8.4 +/- 1.1 days. In conclusion, bicalutamide (10-100 mg od) is considered to be tolerated well enough to be administered to patients with prostatic cancer and has shown evidence of anti-tumor effect.
...
PMID:[Phase I study of bicalutamide (Casodex), a nonsteroidal antiandrogen in patients with prostatic cancer]. 871 91
Bicalutamide (
Casodex
) is a new antiandrogen, so far approved for the treatment of prostate cancer in combinations with a GnRH agonist. Results from large, well controlled studies show that monotherapy with bicalutamide is an interesting alternative to surgical or medical castration for patients with advanced prostate cancer. The efficacy generally appears to be similar to that of castration, but without the well known side effects of castration such as
hot flushes
, reduced sexual interest and functioning, and reduced physical capacity. Bicalutamide is well tolerated, but some patients will experience gynaecomastia and/or breast tenderness, and they should be informed about this before treatment is started. Monotherapy with bicalutamide is an attractive first line treatment for these patients in order to maintain optimal quality of life for as long as possible. Studies show that many patients will respond to second line treatment with castration if bicalutamide has failed.
...
PMID:[Monotherapy with antiandrogens for prostatic cancer]. 1035 54
Men with locally advanced prostate cancer face a high risk of disease progression and cancer-related death. The traditional active treatment options for locally advanced disease, either following failure of treatment of primary curative intent or newly diagnosed, are radiotherapy and castration. Radiotherapy alone has a high failure rate, although outcome can be improved by adjuvant hormonal therapy. Castration is associated with loss of libido, sexual dysfunction, osteoporosis and
hot flushes
, which are significant drawbacks when patients may receive treatment for several years. Monotherapy with a non-steroidal antiandrogen offers potential benefits with respect to quality of life. Studies in the adjuvant setting are in progress. In the setting of previously untreated locally advanced disease, pooled mature data (56% deaths) from two major studies indicate no significant difference in survival outcome between bicalutamide ('
Casodex
') 150 mg and castration. Bicalutamide 150 mg offers quality of life benefits with respect to sexual interest and physical capacity. Preliminary data suggest that bicalutamide maintains bone mineral density. Bicalutamide 150 mg is well tolerated; gynaecomastia and breast pain, common side effects of antiandrogen monotherapy, may be managed by prophylactic irradiation or surgery. Bicalutamide 150 mg monotherapy is an alternative to castration for locally advanced prostate cancer.
...
PMID:Treatment of locally advanced prostate cancer--a new role for antiandrogen monotherapy? 1111 97
The use of the luteinising hormone releasing hormone (LHRH) analogues--goserelin (Zoladex, AstraZeneca) and leuprorelin (Prostap, Wyeth)--is well established and forms the backbone of the treatment of locally advanced and metastatic prostate cancer. Comparable efficacy with orchidectomy and, historically, diethylstilbestrol (DES) is accepted, with the advantages of reversibility and limited thromboembolic and cardiovascular toxicity, respectively. Side effects such as
hot flushes
, loss of libido, lethargy and decreased bone mineral density have recently stimulated more interest in the use of non-steroidal anti-androgens such as bicalutamide (
Casodex
, AstraZeneca) in locally advanced disease. Although better tolerated, bicalutamide has significant problems with gynaecomastia and breast pain. Maximal androgen blockade using LHRH analogues and their adjuvant use with radiotherapy are discussed, as well as their experimental application in intermittent androgen suppression therapy. Similar side effect profiles are reported for the LHRH analogues but injection tolerability differs with the smaller 23G needle for Prostap 3 compared to the 16G needle for Zoladex LA. There is no evidence to suggest a difference in the efficacy between the LHRH analogues goserelin and leuprorelin, although no direct comparison has yet been undertaken.
...
PMID:Luteinising hormone releasing hormone analogues in the treatment of prostate cancer. 1247 66