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| Title: Worldwide activity and safety of bicalutamide: a
summary review. |
| Title Abreviation: Urology |
Date of Pub: 1996 Jan |
| Author: Kolvenbag GJ; Blackledge GR; |
| Issue/Part/Supplement: 1A Suppl |
Volume Issue: 47 |
Pagination: 70-9; discussion 80-4 |
| MESH Headings: Androgen Antagonists (PD/*TU); Anilides (PD/*TU);
Animal; Clinical Trials; Human; Male; Prostatic Neoplasms (*DT); -RN-; |
| Journal Title Code: WSY |
Publication Type: JOURNAL ARTICLE |
| Date of Entry: 960226N |
Entry Month: 9605 |
| Country: UNITED STATES |
Index Priority: 2 |
| Language: Eng |
Unique Identifier: 96149769 |
| Unique Identifier: 96149769 |
ISSN: 0090-4295 |
| Abstract: OBJECTIVES. To evaluate bicalutamide as a therapy
in nearly 3000 patients with advanced prostate cancer and to determine the dose-ranging,
pharmacodynamic, and pharmacokinetic properties of bicalutamide. To evaluate bicalutamide
as a monotherapy or in combination with luteinizing hormone-releasing hormone analogue
(LHRH-A) therapy. RESULTS. Bicalutamide is a potent, nonsteroidal antiandrogen with
a plasma half-life consistent with a once-daily schedule. Monotherapy trials with 50 mg of
bicalutamide established its intrinsic activity, as demonstrated by subjective and
objective responses and decreases in PSA concentrations. In comparison with castration, 50
mg of bicalutamide monotherapy was inferior with respect to survival. In a
randomized, double-blind (for antiandrogen therapy) trial, with a median follow-up of 49
weeks, 50 mg of bicalutamide plus an LHRH-A was superior (P = 0.005) to flutamide
plus an LHRH-A in delaying time-to-treatment failure and was better tolerated, as was
evident from a significantly (P < 0.001) lower incidence of diarrhea and fewer
withdrawals for adverse events among bicalutamide-treated patients. With longer
follow-up and a 34% mortality, survival was equivalent between groups. Dose-related
effects of bicalutamide on serum PSA concentrations were clearly demonstrated in
the clinical trial program. With a total exposure of > 2800 patient-years, bicalutamide
has been shown to be a well-tolerated therapy with a low incidence of treatment-related
withdrawals. CONCLUSIONS. Bicalutamide is a new antiandrogen that offers the
convenience of once-daily administration, demonstrated activity in prostate cancer, and an
excellent safety profile. Because it is effective and offers better tolerability than
flutamide, bicalutamide represents a valid first choice for antiandrogen therapy in
combination with castration for the treatment of patients with advanced prostate cancer. |
| Abstract By: Author |
| Address: Zeneca Pharmaceuticals, Wilmington, Delaware 19850-5437,
USA. |
| Number of References: 29 |
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