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| Title: A controlled trial of bicalutamide versus castration
in patients with advanced prostate cancer. |
| Title Abreviation: Urology |
Date of Pub: 1996 Jan |
| Author: Bales GT; Chodak GW; |
| Issue/Part/Supplement: 1A Suppl |
Volume Issue: 47 |
Pagination: 38-43; discussion 48-53 |
| MESH Headings: Aged; Aged, 80 and over; Androgen Antagonists (*TU);
Anilides (*TU); Comparative Study; Human; Male; Middle Age; Neoplasm Staging; Orchiectomy
(*); Prostatic Neoplasms (MO/PA/*TH); Support, Non-U.S. Gov't; Survival Rate; -RN-; |
| Journal Title Code: WSY |
Publication Type: CLINICAL TRIAL |
| Date of Entry: 960226N |
Entry Month: 9605 |
| Country: UNITED STATES |
Index Priority: 2 |
| Language: Eng |
Unique Identifier: 96149765 |
| Unique Identifier: 96149765 |
ISSN: 0090-4295 |
| Abstract: OBJECTIVES. Bicalutamide is a new, potent
antiandrogen with potential efficacy in the treatment of men with advanced prostate
cancer. Although no pure antiandrogen has been well studied versus castration, potentially
fewer adverse effects could occur, making such an agent a potentially useful alternative
therapy. To date, three randomized controlled trials have been performed comparing these
two treatments. In preliminary studies, a dose of 50 mg bicalutamide per day was
selected for these trials. In two of the studies (0302, 0303), this drug was compared to
either medical or surgical castration, the latter choice being made by the patient. In the
third study (0301), bicalutamide was compared to bilateral orchiectomy. METHODS.
Using an intention-to-treat format, the outcomes assessed were time-to-treatment failure,
time-to-objective disease progression, subjective response, and survival time in men with
previously untreated metastatic disease. The incidence of breast tenderness, gynecomastia,
and hot flushes was also determined in both treatment arms. A quality-of-life
questionnaire was administered on multiple occasions after initiation of therapy. RESULTS.
Based on an analysis of > 1000 patients, the objective and subjective results favored
castration over bicalutamide (50 mg/day). The hazard ratios for time-to-treatment
failure (1.59), time-to-disease progression (1.62), and median survival (1.44) were all
significantly greater in the castration group (P > 0.001). Another difference noted at
3 months was a significantly lower median fall in prostate-specific antigen values in the bicalutamide
group (86-88% versus 96-97%). Symptomatic patients receiving bicalutamide were only
0.43 times as likely to have subjective improvement as the patients treated by castration.
A comparison of pharmacologic effects showed that only the incidence of hot flushes was
lower in the bicalutamide group, whereas breast tenderness and gynecomastia were
more common. This difference in hot flushes, however, translated into better quality of
life during the first several months with regard to sexual relations and sexual
functioning. CONCLUSIONS. Bicalutamide monotherapy at 50 mg/day appears inferior to
castration in overall objective and subjective response rates. Whether higher doses of bicalutamide
can compete more favorably will need to be tested in further clinical trials. |
| Abstract By: Author |
| Address: Pritzker School of Medicine, University of Chicago
Hospital, IL 60637, USA. |
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