Update of Monotherapy Trials
with the New Anti-Androgen,
Casodex (IC1176,334)

Iversen, Peter

doi:10.1159/000475424

Cited by 23 publications

(12 citation statements)

References 6 publications

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“…These studies showed an increasing dose response in terms of PSA for doses of 100 and 150 mg and also plasma kinetics showed con tinuing linearity of response. At the time that the phase II dose-ranging study had been completed, there was evi dence that PSA was an adequate predictor of outcome from a randomised monotherapy trial [13]. Moreover, these results had shown that the clinical outcome with 50 mg Casodex daily was inferior to castration as reflected by the level of PSA fall.…”

Section: Dose-ranging Studiesmentioning

confidence: 99%

“…This trial will continue until it is considered that no further benefit would be achieved from escalating the dose further. Following the selection of Casodex 50 mg as the optimal dose on the basis of PAP changes, a clinical trial programme was initiated evaluating this dose as monotherapy in comparison with castration [13]. A total of 1,196 patients were randomised in three separate tri als on a 1:1 basis between Casodex 50 mg once daily and castration.…”

Section: Evaluation Of Higher Dosesmentioning

confidence: 99%

See 1 more Smart Citation

Clinical Progress with a New Antiandrogen, Casodex™ (Bicalutamide)

Blackledge¹

1996

Eur Urol

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Section: Dose-ranging Studiesmentioning

confidence: 99%

Section: Evaluation Of Higher Dosesmentioning

confidence: 99%

Clinical Progress with a New Antiandrogen, Casodex™ (Bicalutamide)

Blackledge¹

1996

Eur Urol

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“…A daily dose of 50 mg was found to be inferior to castration in terms of progression-free and overall survival thus nourishing the fear that the androgen blockade with antiandrogen monotherapy may be insufficient [27]. In particular a total of 1,196 patients with advanced metastatic PC were recruited to compare bicalutamide with castration in three studies [28]. The median duration of follow-up was 72.3 weeks for the bicalutamide group and 75.1 weeks for the castration group.…”

Section: Bicalutamide Monotherapymentioning

confidence: 99%

Antiandrogen Monotherapy: Recommendations for the Treatment of Prostate Cancer

Sciarra

Cardi²,

Silverio³

2004

Urol Int

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Objective: The concept of antiandrogens as monotherapy for the treatment of prostate cancer is discussed. Methods: Both Medline and Current Contents were used to identify studies on antiandrogen monotherapy in prostate cancer. We tried to analyze this database critically to estabilish whether or not there is evidence for using this monotherapy. Results: In particular, bicalutamide in monotherapy has been compared with castration in large international trials. Results show that antiandrogen monotherapy is inferior to castration in patients with metastatic tumour but the difference in median survival is limited. In locally advanced M0 prostate cancer bicalutamide 150 mg monotherapy seems equivalent to castration in terms of overall survival and time to progression. Analysis of quality of life showed that there is evidence of some benefits from bicalutamide when compared to castration in both sexual interest and physical capacity. Conclusion: Antiandrogens in monotherapy can be effective and well tolerated. However, more research is needed because none of the available compounds have definitively been proven to be equivalent to castration.

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“…Four drugs are currently available; the steroidal antian drogen cyproterone acetate, which has additional antigonadotrophic properties, and the nonsteroidal compounds bicalutamide (Casodex™, Zeneca Limited), flutamide (Eulexin™, Schering-Plough International) and nilutamide (Anandron™, Roussel). The nonsteroidal antian drogen, bicalutamide, which in contrast to the other antiandrogens is administered once daily, has been the most extensively studied as monotherapy; three interna tional trials have been conducted in a total of 1,193 men [8][9][10]. These studies showed that while bicalutamide is effective at a dosage of 50 mg daily, progression-free survival, as measured by rising levels of PSA or the appearance of new bony métastasés, was shorter than that for cither orchidectomy or LHRH agonist therapy.…”

Section: Antiandrogensmentioning

confidence: 99%

Combined Androgen Blockade

Crawford¹

1996

Eur Urol

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Combined androgen blockade (CAB), the addition of an antiandrogen to castration (medical or surgical), is becoming a well-established option for advanced prostate cancer. CAB with leuprolide and flutamide was found to improve both progression-free and overall survival, compared with leuprolide alone, particularly in patients with minimal metastatic disease. These findings have led to an intergroup study in more than 1,300 men, including 300 with minimal disease, of orchidectomy with flutamide versus orchidectomy with placebo, which will examine which patient subgroups benefit most from CAB. This intergroup study has already provided important information regarding prostate-specific antigen as a surrogate marker for response and progression. The success with CAB in lengthening survival and improving quality of life in metastatic prostate cancer has stimulated enthusiasm for broadening the base of clinical studies for the management of this disease.

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Update of Monotherapy Trials with the New Anti-Androgen, Casodex (IC1176,334)

Cited by 23 publications

References 6 publications

Clinical Progress with a New Antiandrogen, Casodex™ (Bicalutamide)

Clinical Progress with a New Antiandrogen, Casodex™ (Bicalutamide)

Antiandrogen Monotherapy: Recommendations for the Treatment of Prostate Cancer

Combined Androgen Blockade

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